chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shots hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: Shots hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she had shingles and deep bone pain for 2 months that was very worst. The reporter told to the patient to receive the vaccine and patient stated that the vaccine hurts. The reporter stated that there was no pain anywhere amount to the pain, blistering, scabs sticking to clothes then ripping scabs off then bleeding, weeping and screaming for weeks or months so get the vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR046152:Same reporter
It was repported that a 48 year old female patient received a Fluzone SV '01 -'02 vaccination administered on 10/19/01. Sometimes after the vaccinations (date not specified), the patient developed "flu-like" symptoms, HA, muscle aches, malaise and itching all over. Patient took Benadryl and feel better now.
See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand  balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.
This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # L017265, expiry date 10-FEB-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the improperly stored vaccines experienced three different temperature excursions (1.6 degrees Celsius for 3 hours and 54 minutes, 1.6 degrees Celsius for 1 hour and 22 minutes and 1.5 degrees Celsius for 1 hour and 22 minutes). No adverse effects were reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Mild fatigue, erythemic anterior / lateral URE. Tenderness over injection site. NO LAD.
Body Aches, shaking, fever (100+), extreme weakness, and hands wanted to curl up as if I was extremely dehydrated. Lasted approx 15-20 hours. Began to subside at 10 hours.
Pityriasis rosea, slight itching of the skin with dryness.  No other side effects or symptoms of sickness.  Eruption about 1 mo post second vaccine dose.  Began on chest with 1 single lesion, and then spread through out the chest and mid/upper back within a few days.  It has slowly been decreasing in visibility over the last week.
kicked in his rheumatoid arthritis; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced kicked in his rheumatoid arthritis. It was reported that the patient previously received his first dose of the vaccine on 03Mar2021 which kicked in his rheumatoid arthritis. The patient asked if he should receive the second dose of the vaccine to complete the series. The patient stated that his rheumatologist  would be sceptical to receive the second dose, PCP reported of not having enough information to guide him in his decision making. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Joint and muscle pain, no bowel movement all week (since 2/4/19), vomiting, chills and today (2/8/19) is developing fever blisters.
approx 5 mins p/receiving DTP/MMR pt suddenly fell backwards & lost consciousness for approx 30 sec; pulse upon awakening 80 & reg; pale & limp; responded to name alert able to follow directions;
Narrative:  Patient received Dose 2 of JYNNEOS Vaccine series on 11/1/22 and dose was drawn from an expired vial. Patient received 0.1 mL Intradermal Dose of JYNNEOS authorized under Emergency Use Authorization. JYNNEOS is available as a 0.5 mL vial, which contains up to 5 doses for patients receiving the intradermal EUA regimen. Stability information available from the CDC instructs sites to draw up each dose on demand at the time of use, so JYNNEOS vials are loaded into the Pyxis medication refrigerator for use at the beginning of each vaccination clinic day. A vial that was initial punctured on 10/25/22 was left in the fridge and the dose was inadvertently pulled from this vial and administered to the patient. The provider was made aware on 11/2/22 and notified the patient. Both are monitoring for signs of infection. There is erythema and swelling around the injection site but per the manufacturer local reactions are more likely with the intradermal dosing regimen than with subcutaneous. Writer reached out to manufacturer to obtain stability data and determine if patient requires re-dosing of second dose. Manufacturer instructed to re-dose Dose 2 as soon as possible. Writer submitted report.
feel pain at the left deltoid, which was the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date 17th December 2021) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 5 days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The health care professional reported that the patient received Shingrix and 5 days later started to feel pain at the left deltoid, which was the injection site, the pain continues at the time of reporting and was increasing The reporter did not consent to follow up.
Chronic Spontaneous Urticaria, widespread of hives and red scratch marks all over random parts of body, comes and goes usually lasting 15-60 mins then disappearing only to appear on a different part of my body. The hives are extremely itchy so I?ve had to take all sorts of over the counter allergy medicine but no signs of the hives going away anytime soon.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017 and 12-FEB-2018, the patient was vaccinated with ROTATEQ) (strength were unknown) (lot # N004815 and expiration date 07-OCT-2018; lot # N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
SORE THROAT; BODY ACHES; CHEST IS HURTING; HAVING DIFFICULTY BREATHING; HEADACHE; This spontaneous report received from a patient concerned a 24 year old male. The patient's weight was 140 pounds, and height was 68 inches. The patient's concurrent conditions included: alcohol use, and smoker, and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-AUG-2021, the patient experienced sore throat. On 26-AUG-2021, the patient experienced body aches. On 26-AUG-2021, the patient experienced chest is hurting. On 26-AUG-2021, the patient experienced having difficulty breathing. On 26-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. This report was non-serious.
Started 45 minutes after, feeling faint and fatigued. Next morning feeling generalized pain fatigue later in the day had a temp and feeling chills as well.
Patient had a nonST Myocardial infarction.  The Catheterization done while in the hospital showed the affected vessel open.
15 hours after my first dose of Pfizer Covid vaccine I had intense uterine pain. My arm also hurt a lot (tho that did not worry me as "injection site pain" is listed everywhere as a "common" side effect). I couldn't sleep because the pain in my abdomen was so strong; I finally fell asleep at 3 a.m. .. and when I woke up at 6 a.m. I was perfectly fine - no pain at all, not even my arm (!) Zero pain. Then 4 days later I got my period. Getting my period was notable because my last period prior to this was 5 months ago. I am reporting because nowhere are these side effects listed as possible so I was pretty scared. I have since heard anecdotes from people having similar side effects and so in case you are planning to update "possible side effects" I wanted to make sure to add my story, in case it could help someone in the future. Side Note: your website  warnings about false reporting are jarring and inappropriate. It is too bad that you believe so many people are planning to somehow sabotage this reporting system. Maybe it is necessary. But it sure didn't make me want to report my side effects. Thank you for reading my "report" ~
Patient began having vomiting and dark colored stool. He was sent for a KUB which showed distended small bowel and subsequently barium enema was ordered.  The patient was found to have an intussusception.
Pronounced redness and swelling in arm next day. he was instructed to take BENADRYL and seek medical attention with doctor. He said swelling & redness has improved.
Next day or two noted red lump at injection site and swelling at lymph nodes axilla. Today notes Rosacea outbreak on face, made worse than usual.
Severe dizziness, nausea, headache, fatigue from 12-36 hours, which made it difficult to walk or do anything (all I did was sleep).  Headache and fever came and went until day 5.  More intense period than usual started 48 hours after vaccination, which I wouldn't mention but I've been reading it could be considered a side effect for women.  Other side effects include initial chills from 12-18 hours and sore arm for 72 hours.
Received following vaccines on 6/15/11. On 6/21/11 started with facial rash, spreading to chest/back, then limbs. Fever, vomiting  & diarrhea. Rash was coalescing flat-topped papules & macules, geographic edges, morbilliform. Started to improve 6/23/11. Initially treated with cetirizine. 6/23/11 ED visit revealed posterior pharynx vesicles.
PATIENT'S MOTHER CALLED ~ 2HOURS AFTER PATIENT HAD RECEIVED IMMUNIZATIONS FOR YELLOW FEVER, MENINGOCOCCAL, AND HEPATITIS A.  PATIENT WAS EXPERIENCING HIVES OVER ENTIRE TORSO WITH ITCHING AND EXPERIENCING SOB.  DENIED DIFFICULTY SWALLOWING.  MOTHER HAD GIVEN PATIENT A BREATHING TREATMENT WITH XOPENEX AND BENADRYL 50 MG. P.O. BEFORE CONTACTING OFFICE.  PATIENT WAS ADVISED TO GO TO ER IMMEDIATELY OR CALL 911 FOR TRANSPORT TO ER.  MOTHER VERBALIZED UNDERSTANDING.
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with ROTATEQ, orally, that had been improperly stored (dose, lot # not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Swollen lymph node; Dose number :3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. This is the first of two reports.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 17Dec2021 at 10:00 (Lot number: FE3594) at the age of 61 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8730,  Administration Time: 10:00, Anatomical Location: Left arm, Route of Administration: unspecified), administration date: 03Mar2021, when the patient was 61 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0162, Administration Time: 10:00, Anatomical Location: Left arm, Route of Administration: unspecified), administration date: 15Apr2021, when the patient was 61 years old, for COVID-19 immunisation, reaction: "Inappropriate schedule of vaccine administered".  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 10:00, outcome "unknown", described as "Dose number :3"; LYMPHADENOPATHY (non-serious) with onset 19Dec2021 at 08:00, outcome "recovering", described as "Swollen lymph node". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  Follow-Up (04Jan2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101862262 similar report from same reporter
During routine visit 3months after 2nd COVID-19 vaccination mother noted that patient was shaking terribly with chattering teeth for about 2 hours, she thought he was having a seizure. Patient during this episode was alert, speaking with mother through chattering teeth while shaking. there was no eye deviation, no drooling, no stiffening, no perceived loss of consciousness. Mother gave Tylenol during the episode and symptoms resolved within 2 hours. Patient has no known history of seizure activity. Patient was not taken to Emergency Department, nor was patient was brought in for clinical care/evaluation.  With this situation, mother is refusing any further vaccination of the patient for COVID-19.
Pain in shoulder continued for 1 month - he came to our clinic to pick up prescriptions and for his 2nd Shingrix (RZV) dose.
pain level was higher then normal; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program. A female patient of an unspecified age received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date in May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had her 1st dose of the Pfizer vaccine 2 weeks ago (May2021). She said her pain level was higher than normal on the first day after vaccine and by the third day it was almost back to normal. Now (May2021) she had her second dose and her doctor wants too put her on immunosuppressant. Outcome of the event was recovered in May 2021. Information about batch/lot number has been requested.
2 days p/vax pt devel an inj site rxn characterized by induration, swelling, itching, redness & warmth;pt recovered;this is 1 of 8 pt of this facility to devel an inj site rxn p/vax;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 04-NOV-2015 the patient was vaccinated with VAQTA (lot # L002717, expiration date 02-JUN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
He reported a GBS-type reaction where his tingling in his legs got worse and he was paralyzed from the waist down to the point that he couldn't walk.  These symptoms lasted about a week.   He brought this up later after the side effects had resolved.  He also reported a transient amnesia episode where he forgot where he was driving locally and had to have some one come pick him up 2 weeks after the 2nd vaccine.  Both of these side effects occurred after the second vaccine.
1st dose on 23-Oct-2019, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 23rd October 2019) and Zostavax (dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's Comment: The reporter was the patient.   Reporter did not want to give her date of birth however she did indicate that she was over the age of 65. She received Shingrix 1st shot.  She had no record of receiving Shingrix 2nd shot. Did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Reports per patient as follows.  Patient also reported to V-safe.  Day 1 - Within 2 hours of the vaccine, I started feeling nausea, headache, extreme fatigue, soreness of the right arm injection site. Chills and temperature developed later in the evening. Contacted employee health to understand the next steps. I was advised to contact again within 48 hours if symptoms persisted for a COVID-test.  Day 2 - Nausea, extreme fatigue, muscle aches, fever (100F), stomach pain, back pain, chills. Later the evening fever continued reaching (104 F). Contacted ER department, spoke with nurse supervisor about my high fever. Recommended alternating Tylenol and Ibuprofen. Advised that current protocol and restated to wait 48 hours.  Day 3 -  Extreme body aches, chills, fever (100-102F), arm soreness, nausea, fatigue.  Day 4 - 6 - Symptoms persisted, headache, fogginess, extreme fatigue, nausea, and low-grade fever.   I contact Employee Health again on Tuesday 2/16/21 and was scheduled for an Employee COVID-19 Test on 2/17/21 at 11:30 am. No additional instructions provided besides getting tested and need to follow-up with the provider if symptoms persist.  Day 7 - COVID-19 Test Results are Negative. However, my symptoms still continued with a low-grade fever (99-100) for an additional 4 to 5 days.
30 minutes after vaccine was given, pt complained of itching and tightness of the throat.
COVID arm. Large red, hot and raised around injection site. It?s been 2 1/2 weeks and there is still a rash although it?s not red and hot anymore.
8 day post vax, mother phoned to report daughter had a migraine headache with nausea and vomiting and severe vertigo. Has seen MD, to see Neurologist. Migraine and nausea and vomiting improved but still complaining of vertigo.
After the Dose 1: I had sharp pain and numbness in left arm and down left side. Occasionally, I would have tightness in the chest. That has subsided. After Dose 2: The night of the vaccine I didn't feel well. I had a fever, nausea, and had a fever of 100 degrees. I felt dizzy, couldn't hardly stand. I was bed for three days. I could not walk across the house. I could only drink water. I was sick like this for about three weeks. I thought I was dying.
pt recvd vax 9SEP95-to MD 19SEP95 w/rash & t97.2 (10 days following vax); 20SEP95 more rash on face (cheeks, chin, sl periorbital edema-upper arm patches-upper legs & back of calves
Painful at time of administration. Pain increased to unbearable by 1:00pm. Called doctor advised to take Aleve. No redness or swelling at site. Going to neurologist for nerve test. After 3 weeks still has pain in the arm and has difficulty moving the arm.
The day after shot I noticed pain on my right side chest. That pain lasted till January 3- I felt my chest and noticed there was a swollen bump. I went to the ER where they did an X-ray. They didn't see anything and dismissed me with swollen Lymph nodes. My Lymph node is still swollen till today.
arm soreness; achiness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On 20th May 2019, several hours after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported some arm soreness and achiness a few hours after receiving Shingrix on left arm. The reporter did not consent to follow-up. There is a discrepancy with respect to the outcome of the events soreness and achiness, In database core the outcome is reported as not recovered for both the events, however in provided source document it is recovering/resolving. The outcome of these events retains as per the database structural field.