chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially regular pain in the arm. Some itching in the throat. I had taken zyrtec and pepcid prior to the shot. 6 hours later I had a rush in my body, numbness, tingling, burning in my tongue. I took 2 benadryl, pepcid...no response...worse...called 911. Zofran in the ambulance. 40 mg prednisone at ER. Finally abated. Jittery all the next day...taking bendaryl, pepcid and zofran. Later that night rush of symptoms again...throat felt very uncomfortable...epipen...ambulance...ER. Monitored there. Same thing the next night. Then stayed on the bendaryl, zofran and pepcid. 1 1/2 weeks later allergist put me on a steroid regimen. Helped but still had horrible headache and rushing. Last 2 week off of most meds except for Tylenol and an occasional 1/4-1/2 pill of Ativan is symptoms worsened. 4 days ago everything came rushing back. Saw the allergist. I have started a regimen of 2.5mg methotrexate yesterday morning, last night and this morning with prednisone and ativan for breakthrough symptoms. Better yesterday after the first pill with less rushing and finally decreased headache. Last night horrible reaction with extra saliva in the mouth and rushing, numbness and tingling all over the body. Took 30 mg prednisone and 1/2 ativan. One more methotrexate today until next week when I take the 3 pills in 24 hours again and then do the same one week later.
felt dizzy during the 15 minute observation time; beasting of arm from the injection site made from the needle; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy during the 15 minute observation time) and VACCINATION SITE PAIN (beasting of arm from the injection site made from the needle) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (felt dizzy during the 15 minute observation time) and VACCINATION SITE PAIN (beasting of arm from the injection site made from the needle). In March 2021, DIZZINESS (felt dizzy during the 15 minute observation time) had resolved. At the time of the report, VACCINATION SITE PAIN (beasting of arm from the injection site made from the needle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081769 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081769:Second Dose
This  86 year old   white male received the Covid shot on    4/10/21 and  died on 4/22/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
After taking it got shingles twice/ Suspected vaccination failure; Got shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: After taking it got shingles twice/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she sat at the table at the wedding as three peoples shared as they all received Shingles vaccine. The reporter stated that after received Shingles vaccine the two of the three patients experienced Shingles twice. Follow-up would not possible as no contact details were available.
Information has been received from a physician concerning a 19 year old female with attention deficit disorder and no known drug allergies who on 12-AUG-2009 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not reported). 1 week ago, on approximately 27-JAN-2010. the patient was vaccinated IM with a third dose of GARDASIL. Concomitant therapy included VYVANSE. On 02-FEB-2010 the patient developed nausea, abdominal pain and depression. The patient was away at school and had been referred for evaluation at a local facility. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. Follow up information has been received from a healthcare professional concerning a 19 year old female student with no illness at the time of vaccination and no known drug allergies who on 29-JAN-2010, at 10:25am, was vaccinated IM into right deltoid with a third dose of GARDASIL (lot # 662765/0821Y). Within 48 after her third injection of GARDASIL, the patient had nausea, abdominal pain, depression and emotional distress. The adverse events gradually resolved. The patient did not have any reaction after first 2 injections. Additional information is not expected.
Hospitalized with a stroke reperfused via thrombectomy. Also COVID positive PCR on 1/17/2022  BOOSTER Pfizer lot 33130BA date 12/15/2021
UTI(URINARY TRACT INFECTION); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On OCT-2021, the patient experienced uti (urinary tract infection). Laboratory data included: HIV test (NR: not provided) Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of uti(urinary tract infection) was not reported. This report was non-serious.
Right eyelid twitches daily (approximately 12-14 times/day at random)
Went to bed  on fourth night after shot with symptoms from shot seemingly resolved.  Woke up the fifth day and got out of bed to discover intense pain in right leg. Nothing like a charley horse cramp.  Small nodule about the size of a pea, located 6 inches up from outside ankle bone. ¼ inch beneath skin. Great difficultly putting weight on right leg,  created acute feeling of pinching or twisting pain. Level of pain (1-10) was an eight [note: my definition of the ?worst pain imaginable? has been altered after being stung by a tarantula hawk wasp]. I hobbled to the bathroom and took two aspirin. Hobbling around on flat surfaces gradually reduced pain to a level 3-4, though I had trouble walking up and down steps for the remainder of the day (level 5-6).  Fifth day, the pain level on flat surfaces was down to 1-2, on stairs, 2-3. at end of sixth day, no pain on flat surfaces, 1-2 on stairs.  No pain by evening. I took two aspirin in morning and two in afternoon during this period. Seventh day, I woke up to find pain returned as I got out of bed (level 4) but was walked out within in three to four hours. I had talked with my sister (an extreme case of Factor five leiden, which I do not have) and felt this was not a blood clot, but went in to the doctor?s because my husband and I were about to leave on vacation. She ordered a Doppler and ultrasound (which showed no blood clot) after telling me this type of muscle/nerve pain was just starting to be reported in patients after the vaccine. She had seen an earlier patient who had swelling and inflammation, which showed no other explanation after testing than post-vaccination reaction. I felt no lump, heat, or tenderness pushing on the skin.  Doctor requested I report it on-line.
Received vaccination Saturday afternoon at a pharmacy. Sunday I felt achy, tired, and feverish, with symptoms diminishing over the next two days. Monday afternoon I began experiencing mild vertigo. Onset was slow and gradual. I laid down and shut my eyes which made the experience much worse. Began having trouble walking and went to see PCP.  Upon evaluation PCP believes vertigo is due to combination of FLU and COVID-19 vaccine being administered together. Doctor prescribed two medications for dizziness and nausea.
"Patient is a 5 y.o. male who presents to the ED with abdominal pain. The patient received his COVID19 vaccine on Friday afternoon. Saturday morning, the patient developed fatigue, fevers, chills, aches, abdominal pain, nausea, vomiting, and decreased appetite. The patient's max temperature was 102 measured at home by mom. Per mom, the patient has said he is hungry throughout yesterday and today, but will barely eat the food put out for him. He has well-controlled constipation at baseline and last had a BM earlier today. He has not had diarrhea. There is no one else sick in the household. He had no symptoms prior to the COVID vaccination."  "Patient was admitted to the Surgery service with abdominal pain, nausea, and vomiting in the setting of recently receiving the COVID19 vaccine. Given his symptoms, he was worked up for possible appendicitis; his appendiceal US was equivocal for appendicitis and his abdominal exam was benign. He was admitted for observation and serial abdominal exams. He did well with resolution of his abdominal pain and he was advanced to a general diet which he tolerated.    Overall, he did well and followed the expected course including resumption of a diet appropriate for age, return of bowel function and baseline activity.  His vital signs and temperature curve are within normal limits for age. Patient has met all criteria for discharge including tolerating a diet appropriate for age and ambulating with good pain control on oral pain medications."
?  Right external iliac vein: A(n) acute deep vein thrombosis is present and appears to be slightly mobile. ?  Right common femoral vein: A(n) acute deep vein thrombosis is present and appears to be slightly mobile. ?  Right femoral vein: A(n) acute deep vein thrombosis is present. ?  Right popliteal vein: A(n) acute deep vein thrombosis is present. ?  Right posterior tibial vein: A(n) acute deep vein thrombosis is present. ?  Right peroneal vein: A(n) acute deep vein thrombosis is present. ?  Right gastrocnemius vein: A(n) acute deep vein thrombosis is present. ?  Right greater saphenous vein: A(n) acute superficial thrombophlebitis is present. ?  Right small saphenous vein: A(n) acute  superficial thrombophlebitis is present.
inappropriate schedule of vaccine; painful blisters; Right arm was red; Right arm was warm; Looks like shingles/ blisters rash/ rash on his right elbow and forearm; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (when the patient was young) and shingles (on his back when he was older). Previously administered products included Zostavax (many years before the time of reporting).   On 16th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On 17th May 2019, the patient experienced vesicular rash and pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the vesicular rash, pain and incomplete course of vaccination were unknown and the outcome of the erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, erythema of extremities, skin warm and pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix vaccine on right arm. Less than a week after vaccination, the patient's right arm was red and warm which resolved later. The patient experienced painful blisters and rash on his right elbow and forearm. The pharmacist stated it looked like shingles. This was not confirmed by his physician. The blisters (mosquito bite like) resolved in 4 to 5 days. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Itching to back of neck, aching to nech, extreme headach, and lower back ach.
Information has been received from a nurse referring to a 4 years old patient of unknown gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions was not provided. On 04-JAN-2019, the patient received a dose of ZOSTAVAX (route reported as intramuscular, lot # N025703 and expiration date16-DEC-2018; frequency was unknown) for prophylaxis (inappropriate schedule of product administration, expired product administered and incorrect route of product administration). No adverse effects were reported.
Adverse Event:  sore arm, could not raise right arm above should height, fever 100.4; onset at 4-5 hours after injection.  Very tired; achy especially painful in knees and lower back.  Took one Tylenol every 4 hours on Tuesday and Wednesday.  Felt fine at 4:30 a.m on the 11th of March.  Slept most of Tuesday from 5 p.m until next day.  Wednesday, again achy, fever, exhausted, pain in joints, arm warm to the touch.  Slept thru most of the day.
Tested Positive on January 6th, 2021 Bad headache, I hurt all over just like when I had the Covid Virus, Joints were the most painful, My body had hives on all places I was able to see, Eyes were very red with red rings around the outside of my eyes and eye lids, Nausea, my skin had a red look and there were red lines on my arms and legs, Every vein on my limbs were very pronounced, I had a "restless" arm and leg" vibrations and I had to get up and walk to make the feelings stop. I fought against the symptoms.
2 weeks post-vaccination experienced severe headache and neck stiffness/heaviness with lower extremity paresthesias that required emergency department visit. COVID testing negative, lab tests showed significantly elevated d dimer. MRI/MRV was negative for clot, DVT study negative.  Repeat d dimer trending down 1 week later.   2 months after this occurrence significant hair shedding started. Lab tests done by doctor revealed elevated TSH. Previous labs earlier in the year BEFORE vaccination showed a normal TSH and NO history of thyroid issues in family or self.  Thyroid antibodies now also positive suggesting acute onset of Hashimotos.   Now currently seeing an endocrinologist who believes the vaccine may have triggered this condition. Currently on synthroid. Still experiencing hair los and severe fatigue.
Information has been received from a Nurse Practitioner (also reported as nurse prescriber), referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Since an unknown date (reported as every 5 years), the patient had been vaccinated with PNEUMOVAX23 (dose, strength, anatomical location, lot number, expiration date were not reported) for prophylaxis. On an unspecified date, the patient experienced chronic lymphocytic leukaemia (reported as her condition, from an unspecified date). On 10-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L022795 (dose, strength, anatomical location, expiration date were not reported) for prophylaxis. At the time of this report, the outcome of chronic lymphocytic leukaemia was unknown and the causality assessment between the event and the PNEUMOVAX23 was not provided by the reporter. Upon internal review, chronic lymphocytic leukaemia was considered as a medically significant event. No product quality complaint (PQC) was involved. Additional information has been requested.
Some up 14 hours after second dose cold and shaking uncontrollably.  Progressed to fever, nausea, headache and shortness of breath.  Sweating.  Nausea and fever subsided by 7 pm. Some up the next day still having a headache and shortness of breath. Could not work that day.  All symptoms gone by 3 pm the next day.
Facial Flushing, face tingling, tongue swelling, appx 5' after injection.  transferred to ED & tx with  Benadryl, Pepcid. solumedrol IV. : with sx resolution  - observed for 4 hrs in ED & d/cd
extreme pain, redness and swelling in left arm almost to the elbow.  Worse on front of arm than the side where the injection was.  Fever and chills to 101 degrees. Headache, body aches, inability to sleep.
shoulder pain started right after administration and has persisted. pt just reported to pharmacy on 2/15/22 because the pain is still an issue. hasn't seen a dr yet but is planning on it now that he has insurance.  has used otc ibuprofen and a thc cream to help manage pain.  pain is in back of shoulder area, upper arm and does travel to elbow.  worsened by movement
Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on approximately 11-MAR-2008, in the last two days, was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 659149/1383U). On approximately 11-MAR-2008, in the last two days, the patient experienced an injection site reaction. There was a large red area that was swollen and painful. At the time of this report, the patient had not recovered. The reporter is requesting a lot check be done on this lot number. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
After about a week and 1/2 started to cough ?? I thought it was asma went to Dr several times even went to the hospital and right now I?m still coughing!! The medicine will only make it a bit easy but the cough will not go away!!
Atrial Fibrilation; This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown.   The reporter considered the atrial fibrillation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced atrial fibrillation after receiving Shingrix. The patient believed the atrial fibrillation was attributable to receiving the vaccine. No additional details available, The reporting pharmacist received this as hearsay and has no direct relationship to the patient.
Initial vaccination failure in inflammatory bowel disease patients; 149 patients with inadequate baseline titers; Overall, 58.4% (n = 87/149) of patients received 1 or 2 sequential HBV revaccination doses within a 6- month time period, and 41.6% (n = 62/149) of patients received 3 sequential revaccination doses during a 12-month time period; Information was received from the authors in a published literature article titled as stated below. The aim of this article was to analyze the association between additional vaccination doses and HBsAb seroconversion in infIammatory bowel disease (IBD) patients. This case concerns 149 unspecified patients of unknown genders and age. This retrospective cohort study of patients seen in a large tertiary care facility from 2000-2014. Inclusion criteria: age >=18, diagnosis of Crohn's disease (CD) / ulcerative colitis (UC), prior vaccination history/presence of >= 1 +HBsAb level <10 IU/l, follow up HBsAb level after re vaccination. Patients were separated into study arms based on the number of additional vaccine doses received: 1 and 2 (within 6 months) or 3 (within 12months). Follow-up serum HBsAb, demographic info and IBD medications received in the 6 months prior to titer measurements were reported. Seroprotection was defined as HBsAb >= 10 IU/l.   On unknown dates, the patients were vaccinated with hepatitis b vaccine (manufacturer unknown), lot number, expiration date, dose and route were not reported, for prophylaxis. On unknown date, the patients showed inadequate baseline titers (vacination failure): 63 then received 1 dose, 25 received 2 doses, 61 received 3 doses. Following 1, 2 and 3 doses, average follow-up titers were 122.8, 55.1 and 263.8 IU/l, respectively. Following 1, 2 and 3 doses, 41.3, 40 and 62.3%, respectively, developed HBsAb 10 . Patients exposed to immunosuppressive therapy within 6 months of titer measurement were significantly less likely to seroconvert after any number of additional vaccinations.  A copy of the published article is attached as further documentation of the patient's experience.  Follow up information was received on 25-APR-2019 to this previously non-valid case, from the authors in a published literature article titled as stated below, regarding 81 female patients from 149 patients in study cohort.  It was also reported that unspecified number of women (of a total of 87 out of 149 patients) received 1 or 2 sequential HBV revaccination doses within a 6-month time period (previously reported as 88), and unspecified number of women (of a total of 62 out of 149 patients) received 3 sequential revaccination doses during a 12-month time period (previously reported as 61).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter.
Swollen under the armpit and rib on the left side at the first vaccination and at the second vaccination body pain and fever. I took paracetamol. Intermittent dizziness. The swelling went away after 6 days. The dizziness returns and I vomit 2 weeks after the second dose and the swelling is now all over the body, at night a little burning in the legs. I have 6 days like this and I am taking loratadine thinking that it is an allergy, it is the first day today and for dizziness I took zinaricin and diphenidol these last symptoms decreased but I took my blood pressure and it was high.
Hard shaking chills enough that he almost fell while walking to the bathroom. These shaking chills lasted about an hour and he could feel his heart racing and a feeling that he was going to die. Every injury he has had since childhood hurt. He stayed in bed and in pain for eight hours. The next 48 hours were less eventful and he stayed in bed but mostly for fatigue. Patient did have COVID in December 2020.
Left arm swollen erythematous shoulder to elbow. 08/08/2002 2 day flu with PCP, Tylenol, swelling increased to forearm and left upper chest, capula area, emesis prious
Less than a week after the shot i discovered a lump on the left clavicle area measuring 0.6 x 0.6 x 0.7 cm via ultrasound.  A second hypoechoic area was found measuring 0.6 x 0.3 x 0.6 cm. I also had discovered a small lump on my left ear. All of these condition are on the same side of the body as the injection site.