chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain and product supply issue. On an unknown date, the outcome of the pain and product supply issue were unknown. It was unknown if the reporter considered the pain 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 it was selected as adult as per vaccine indication. The healthcare professional did not have a specific patient and was making a general comment about the SHINGRIX stating her patients had mentioned that the vaccine was painful and did not want to restart the series if the vaccine did not come in time for their 2nd dose. The healthcare professional reported that they were having a hard time getting SHINGRIX ordered.
severe lower back pain; This is a spontaneous report from a contactable other HCP. This 34-year-old female other HCP (patient) reported for herself that: A 34-years-old non- pregnant female patient received bnt162b2 (BNT162B2; solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Jul2021 13:15 (at a age of 34-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypertension, and back pain was ongoing. same pain 7 years ago after epidural for pregnancy. No covid prior vaccination, no covid tested post vaccination, no Known allergies and no other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced severe lower back pain on 27Jul2021 13:15. No treatment received with AE. Outcome of event was recovered with lasting effects on unspecified date.  Information on the lot/batch number has been requested.
tinnitus two weeks after last dose have constant ringing and buzzing in my ears 24 hours a day
Headache, Myalgia, 1/27 SEVERE H/A SORE THROAT, CHILLS, JOINT PAIN MUSCLE PAIN, SHARP PAIN IN RT GREAT TOE AND BACK PAIN. 1/29 SAME PAIN AND ACHES,2/1 MUSCLE /JOINT PAIN CONTINUES I HANDS FINGERS Narrative:  EMPLOYEE STILL HAVING JOINT PAIN IN HANDS,LEGS, FINGERS CALVES WITH HEADACHE.
Pt recieved vaccine and began to experience an episode of "tachycardia" with left-sided chest pain/pressure about 10-15 minutes later.  She rated the chest pain at 5/10.  She did not seek medical attention and the tachycardia resolved after a few hours.
pt recv vax & devel an inj site rxn;this is 1 of 4 pt from this site to have an adverse exp p/vax;
Felt faint as soon as vaccine administered. Had sensation of heart racing. Blood pressure (systolic) was in 150s. Diastolic unknown by reporter. Heart rate was in 70s. Nurse held patient until systolic number was in 130s.
Information has been received from a nurse practitioner concerning a 21 year old female who on unspecified dates was vaccinated intramuscularly with the first and second doses of Gardasil. Subsequently, the patient experienced dizziness and injection site stinging following the first vaccination and injection site stinging following the second vaccination. It was reported that the events occurred immediately after vaccination and resolved after about 5 minutes. Unspecified medical attention was sought. Additional information has been requested.
Swelling and pain within 2 hours. After 12 hours - nausea, vomiting, fever, chills.
Moderate feet and ankle swelling (maybe calves also),  especially in right leg, with elevated blood pressure (173/101).  Still present  over 2 weeks later - again mostly on right side.  BP improved slightly.
rt arm w/erythemas, swollen to front side, 2cm around, warm to touch;pt w/full mobility, equal strength to hand grips;mom reports pt passed out @ time of exam;no problems since, playful mom pointed out pt rt arm believes vax to be cause
An allergic reaction that has caused Bronchitis, headache pain and swelling at injection site.
I started having  a swollen throat after the vaccine later in the night I noticed it was more difficult to breathe I felt like I wasn't able to catch as much air. I wasn't able to do much. The next day, Sunday , it was even harder I couldn't walk It wasn't that my throat was closing up I just felt like something heavy was on my chest. On Monday I went to work and I could not walk even three ft. I went to the hospital I then followed up with my primary care. I was given an inhaler which I used for 2 days after which things began to return to normal. It was about a week total from the vaccine that I began to feel better.
This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved.  7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception  ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1
Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a nurse referring to  a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 07-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # T021302 (also reported with lot # T011302), expiration date 19-DEC-2020, 0.5 milliliter, subcutaneous for immunisation (vaccination scheme frequency and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of -5 degree Celsius (°C) for 20 hours as recorded by a data logger. There was no previous temperature excursion reported.  Lot # T011302 has been verified to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot number T011302 is a valid lot number for sitagliptin phosphate (XELEVIA).
shingles type rash with severe itching developed several days following injection, still active 2 1/2 weeks later.
accidentally gave a Shingrix shot, she completed her series; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received in May 2021).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 1-Apr-2022 Reporter's comments: Healthcare professional accidentally gave the patient a Shingrix shot. Then the reporter found out she completed her series in May 2021. The reporter asked if they should be concerned for the patient's safety.No further details provided on form. Specialist submitting all available details. The consent to follow up was given. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
no adverse event; 3rd dose administered on 13JUN2022, expired dose administered; misuse also included since the patient received a third dose of the vaccine.; This spontaneous report was received from a nurse and refers to a 43-year-old male patient. His medical history, concurrent condition and concomitant therapies details were not reported.  On 17-OCT-2019, the patient received the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No adverse event was reported after first dose. On 21-MAR-2019 (conflicting information), the patient received second dose of hepatitis a vaccine, inactivated (VAQTA) (strength, lot #, expiry date, and route of administration were not provided). No adverse event was reported after second dose. On 13-JUN-2022, he received third dose of hepatitis a vaccine, inactivated (VAQTA) vaccine lot #104058, expiration date 28-MAR-2022 (extra dose administered, expired dose administered). No additional adverse event or product quality complaint was reported.  Lot number 104058 is an invalid lot number for Hepatitis A Vaccine, Inactivated (VAQTA).
Thought she was going to faint, got very weak, got very hot & turn red all over face neck and pain so severe.
Patient received the vaccine on a date beyond the BUD. BUD was 12/21/2022, the vaccine date administered was 02/01/2023
This was my second dose , the same day I started with very high fever , chilling , terrible headache , nauseas , diarrea , body ache ,  very bad cough , and dizziness , this same  síntomas , last for 3 nights and 4 days , totally in bed , after the 4 days , I continue with dizziness , diarrea , low level headache and nauseas  for 4 more days . ( I thought this was normal , but after all this time and family and friend taking the shot , with out síntomas or very mild , I started to be worry , and I want better explanation , more personalize why , the vaccine make me so sick , like never before in my 48 years . Thanks in advance , a waiting for some answer .  I never went to the hospital , I take care with over the counter medicine .
This is a spontaneous report from a noncontactable consumer (patient). A 43-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine: batch/lot# unknown), at the age of 43, via an unspecified route of administration, left arm, on Apr 30, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 43, via an unspecified route of administration, left arm, on Apr 9, 2021, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 30, 2021, patient experienced fatigue, fever, chills, joint pain, skin aches, pains, headache and nausea. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient has not tested for COVID-19. The outcome of fatigue, fever, chills, joint pain, skin aches, pains, headache and nausea: recovering (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected
Excessive stomach gas build up causing uncontrollable belching. This occurs numerous times throughout the day.
pt recvd vax 430 & 5Pm on 22JUL93 had temp 104.9 # 3AM 23JUL93 mom reports had given APAP & sponged; seen by MD may have had virus;
PT SAID HER SYMPTOMS STARTED ON 07-06-2019 , PAIN, HOT, SWOLLEN AND ITCHY ARM,   PT WAS ADVISED TO TAKE BENADRYL ON 07-07-2019.  ON 07-08-2019 SHE WENT TO URGENT CARE SINCE HER BODY HAD STARTED TO ITCH EVERYWHERE.   SHE WAS ADVISED BY URGENT CARE TO STAY ON BENADRYL.  AND TO MAKE A FOLLOW UP VISIT HER REGULAR PCP
Shingles episode after first dose administration.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at event onset was not reported but it colud be 77 or 78 years. The patient received Shingrix and developed episode of Shingles. The reporter did not consent to follow up. No expiration date nor lot number were provided.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose02/18/21 2nd dose03/12/21 Diagnosed covid positive:08/24/21 Symptom onset:08/19/21 Exposure:COMMUNITY Symptoms:fever, SOB,fatigue,muscle aches,sore throat,diarrhea,chills, runny nose,HA
Also received 1st dose COVID19 (Pfizer) at same place.  Administered on 6/12/21.  Lot number of first vaccine EW0182.  Patient developed acute chest pain on evening of 7/5.  Had some shortness of breath and vomiting.  Brought to ER.  Troponin was found to be elevated at 3238.9 (normal range 0-54).  COVID-19 PCR and respiratory viral panels were negative.  Admitted to ICU for observation.  In morning, feeling much better.  Troponin down trending.  Echo was normal.
Appendicitis; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in left arm on 20Apr2021 at 16:15 (at the age of 53-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 administered in left arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any medications within two weeks of vaccination. On 20Apr2021 at 16:45 (30-minutes after vaccination), patient experienced appendicitis. The patient was hospitalized for appendicitis on an unspecified date in Apr2021. Therapeutic measures taken as result of appendicitis included appendectomy. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): Negative on 20Apr2021 and appendectomy on an unspecified date. The outcome of event appendicitis was recovering.   Information on the lot/batch number has been requested.
Die 4 months after shingles shot; Had a break out after shingles shot/Suspected vaccination failure; Break out; Develop a tumor; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Die 4 months after shingles shot) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Had a break out after shingles shot/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Break out) and neoplasm (Verbatim: Develop a tumor). The outcome of the vaccination failure was unknown and the outcome of the shingles and neoplasm were not reported. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 15-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient developed a tumor, break out and die 4 months after shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case was 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR118387:Same reporter US-GLAXOSMITHKLINE-US2021AMR263783:Same reporter US-GSK-US2023AMR047859:Same reporter; Reported Cause(s) of Death: Unknown cause of death
DIZZINESS; APPETITE WAS POOR THAT THERE WAS DIFFICULTY IN FINISHING A MEAL; FEVER; COUGHING; WEAKNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, administered administered to the right arm, on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced weakness. On 29-MAR-2021, the subject experienced coughing. On 29-MAR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced appetite was poor that there was difficulty in finishing a meal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, and had not recovered from weakness, coughing, appetite was poor that there was difficulty in finishing a meal, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
sweating (1st dose); shakes (1st dose); arm soreness (1st dose); fever (1st dose); This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (sweating (1st dose)), TREMOR (shakes (1st dose)), MYALGIA (arm soreness (1st dose)) and PYREXIA (fever (1st dose)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HYPERHIDROSIS (sweating (1st dose)) (seriousness criterion hospitalization), TREMOR (shakes (1st dose)) (seriousness criterion hospitalization), MYALGIA (arm soreness (1st dose)) (seriousness criterion hospitalization) and PYREXIA (fever (1st dose)) (seriousness criterion hospitalization). At the time of the report, HYPERHIDROSIS (sweating (1st dose)), TREMOR (shakes (1st dose)), MYALGIA (arm soreness (1st dose)) and PYREXIA (fever (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication provided.  Company comment: This case concerns a 34-year-old male subject who experienced the serious, unexpected events of hyperhidrosis, tremor, myalgia, and pyrexia. The events occurred approximately 1 month after the first dose of Spikevax. Patient's medical history was not provided. The rechallenge was not applicable as the patient was yet to receive the second dose of the vaccine.Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-319719 (Patient Link).; Sender's Comments: This case concerns a 34-year-old male subject who experienced the serious, unexpected events of hyperhidrosis, tremor, myalgia, and pyrexia. The events occurred approximately 1 month after the first dose of Spikevax. Patient's medical history was not provided. The rechallenge was not applicable as the patient was yet to receive the second dose of the vaccine.Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
I was sick to my stomach for 24 hours. I had the dry heaves. I had COVID-19 2/2021 and getting the vaccine was horrible.
The patient reported to the pharmacy for their second dose of the Pfizer vaccine. The patient was accidentally given a dose of the Janssen COVID vaccine in place of their second Pfizer vaccine. The patient was monitored for 30 minutes after the event and reported feeling no side effects and reported the same as they did after receiving their initial Pfizer dose. The patient did not receive any additional treatment or care after being monitored.
Pt received FLUZONE vaccination at health dept on 10/8/13 at 3:00 pm. Upon arriving home pt. stated she began to experience SOB, eye irritation, N/V, and throat tightening. Pt. took 50 mg BENADRYL. Pt. husband drove her to medical center. Arrived at hospital 5:30 pm. Pt. was examined and treated with famotidine 20 mg, methylprednisolone sod. succ. 125 mg. NS bolus infusion and ondansetron 4 mg for allergic reaction and pt released.
Information has been been received from a pharmacist concerning a patient (age and gender not reported) who was vaccinated with a dose of improperly stored PNEUMOVAX 23. The patient was then revaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced an injection site reaction. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
It was reported that a 43 year old female pt received a Tetanus Toxoid vaccination on 10/23/00. Reportedly, on 10/25/00, the pt complained of febrile for 2 days and a red, tender, enlarged area of the left inner forearm. From additional correspondence received on 3/6/01, the correct responsible physician's name was provided.