chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About three minutes after the injection, my heart started to beat very fast. Felt like my heart was racing. I told the pharmacist and he asked if I was having difficulty breathing. I told him I was not. A few minutes later, the right side of my body started shaking uncontrollably. Mostly my upper body. I could not stop it. My hands started to sweat. The pharmacist gave me water to drink.  He asked if he could contact my physician. My physician told him to tell me to go to the closest ER to be monitored. My sister came and drove me to the local ER. By this time (45 minutes later) I could feel my symptoms start to get better.
Information has been received from a physician via company representative to three female patients of unknown age. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (one time injection, dose, strength, lot# and expiration date unknown) subcutaneously. On unknown dates, the three patients experienced a shingles rash around there eyes after receiving the ZOSTAVAX. The patients sought medical attention by calling the office and were referred to ophthalmologists. Unspecified treatments were given by the ophthalmologists. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; 9 days after first dose (4/7)- sudden chills, fever followed by severe chest pain. Resulted in ER trip fearing heart event. continued chest pain; Doctor thought I either had a virus of some sort; elevated D Dimer test; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was sensitive to estrogen birth controls. Facility type vaccine was other. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. Post vaccination covid tested was unknown. Reported, 9 days after first dose (4/7) sudden chills, fever followed by severe chest pain on 07Apr2021. Resulted in ER trip fearing heart event on Apr2021. continued chest pain and multiple clinic visits with Doctor/chest scan w/ contrast after elevated D Dimer test, doctor thought patient either had a virus of some sort on Apr2021 and advised not to skip her second dose of covid vaccine. Chest pain had started to subside. Treatment 2x physical therapy was received for adverse events. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken for all the events. The outcome of event was resolving for chest pain and for other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Pt. received two vaccines in her right deltoid area. Developed localized rash. Currently, lesion is approx. 4" in diameter, warm to touch, & tender. No drainage. Induration is present. Color to lower arm fine. Pt is able to use arm, hand & fingers well.
Info has been received from a health professional concerning a 10 year old male with no medical history or allergies who on 10/10/00 was vaccinated with an 0.5 mL 2nd dose of MMRII. There was no concomitant medication. In November 2005, the pt developed mumps. Unspecified medical attention was sought. No lab/diagnostic tests were performed. At the time of the report, the pt was recovering. There was no product quality complaint involved. Additional info has been requested.
Based on additional information received on 31 August 2015, this case became medically confirm. Initial unsolicited report received from a non-healthcare professional on 19 August 2015. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number- U5271AA, expiry date: 10 February 2018, route and site of administration were not reported) on unspecified date. On an unspecified date, after vaccination, the patient experienced swelling arm. Laboratory investigations and corrective treatments were not reported. At the time of this report, swelling of arm had resolved in one week and patient had recovered from the event on an unspecified date. Documents held by sender: none. Follow up report received from a nurse on 31 August 2015. This case is linked to case ID: 2015SA126700, 2015SA126707, 2015SA126715. No new information reported.
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. On 17-SEP-2014 the patient was vaccinated with a expired dose of ZOSTAVAX (lot # J000444, expiration date:11-APR-2014), (dose, route were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected due to no consent for follow up.
This spontaneous report was received from a nurse, via a company representative, regarding an unspecified number of infant patients (reported as "many babies") of unknown gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of ROTATEQ oral liquid (dose, lot number and expiration were not reported) administered orally for prophylaxis. According to the reporter, the patients spat the vaccine out and did not get the full dosage. It was reported that was a common problem and they cannot give more ROTATEQ as the patients only got what they could manage to swallow. The outcome of the event was not provided. The reporter did not provide a causality assessment between infantile spitting up and the suspect vaccine. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA015046:
Moderna COVID-19 Vaccine  mild fever and extreme shivering was preceded by slight feeling of physical exhaustion, and perhaps exacerbated or triggered by brushing teeth and washing hands in cold water and urinating (very slight body temperature drop), which evolved into almost-teeth-chattered uncontrollable shivers for 1+ hr and an extremely slow increase to 101-102 degree fever over the next three hours. Patient took a full dose Advil (ibuprofen) which seemed to relieve symptoms after perhaps 4+ hours of sleep. Patient was physically unable to meaningfully move or reposition themselves in bed for 1-2 hours due to exhaustion, but could have perhaps done so if roused by necessity.
This spontaneous report as received from a registered nurse refers to the patients of unknown age and gender. The reporter stated that there was a supported excursion affecting GARDASIL (lot# K004204, expiry date: 12-JAN-2017; lot # K004205, expiry date: 12-JAN-2017), which was also affected by prior supported excursions, starting 19-NOV-2014. Subsequently incorrectly stored GARDASIL was administered to the patients. There were no adverse events observed in patients post-vaccination and the patients did not seek a medical attention. Additional information has been requested.
Per patient sore right shoulder down to the elbow per patient (husband). Patient received on 10/13/21. Patient went to an urgent care on 11/06/21 and was given TYLENOL and prednisone. Per patient spends 80% of time in bed. Patient  contacted again on 11/15/21 and patient is doing better and will see primary care physician to follow up.
About 8 hours after receiving the the 3rd covid vaccine shot (booster) I started to have extreme aches in my bones and joints. I had shivers, my left arm and the area around my left armpit/breast were in severe pain. My head hurt, my jaw heart, and I had low fever (38c) which I never never have (no fever ever). The day after I noticed that a lymph node under my left armpit got swollen to a size of a tennis ball.  For three days after the vaccine I had these strong symptoms. I took Ibuprofen and Tylenol and took a lot of super hot bathtubs which helped with the left armpit, left arm and joint/bone pain. I was also very fatigued for about 10 days after the vaccine. It took about a 10 days for the lymph node to go back to a normal size.
pneumonia; pneumonia; upper respiratory issues; allergic to the Flu Vaccine, Pneumonia Vaccine; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at dose number unknown, single for immunization. Medical history included allergy to eggs. The patient's concomitant medications were not reported. The reporter stated that the patient was allergic to the flu vaccine and pneumonia vaccine. The patient also had upper respiratory issues and had pneumonia twice on unspecified dates. The reporter asked if the COVID vaccine was safe for the patient. Outcome of the events was unknown.  Pfizer is marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report in situations where another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association
L arm (deltoid) 5 X 6cm area of erythema at injection site w/1cm firm ecchymotic center (presumed sterile abscess).
I'm a 70 year old ovarian cancer patient, had total hysterectomy on Oct 23 and received my first chemo treatment Nov 7 and my second treatment of TAXOL/Carboplatin on Nov 28. At that appointment my oncologist said I should get a flu shot, which I did on Nov 29 about 12:30 PM. About 9 PM that evening I experienced tightness in the center of my chest and tightness in my neck. We went to the ER and they ran EKG, echocardiogram, vascular ultrasound and blood work and found no heart problem. I was admitted and monitored overnight. I've never had a flu shot before, so I don't know how I'd respond if not getting chemo. I read the info sheet on the possible flu shot side effects and saw that even though rare, the chest and throat tightness are listed as possible side effects and felt I should report it.
Client reports around 11:00pm of the day he received the vaccine he developed a "blood clot" at the left AC area. He called Health Department on 9/15/21 at 10:22am to report the incident. He had tried to call his doctor that morning and did not get in touch with them.  Health Department staff encouraged him to go to the urgent care. Client went to facility on 9/15/21. A left upper extremity venous doppler ultrasound was performed and the impression was "No deep vein thrombus in the left upper extremity." Client reports they told him it must have been a burst blood vessel. He denies pain or swelling of the mentioned site. His deltoid is sore at the vaccine injection site.
Accompanied by: grandparent. The onset of the rash has been acute. The rash has been occurring for minutes. It has been occurring in a perisitent pattern. The course has been decreasing. The rash is characterized as itchy and red. The rash was first seen on the entire body. Medications used: antihistamines. Rash notes: soon after immunization with varicella, became itchy upset, breathing fast. Never looked hypotensive or truly distressed, just upset and agitated. Received 0.3 cc epi, 25 mgm Benadryl and 30 mgm of Oraped chewable. Settled after 30 minutes and sent home...also aerosol of Albuterol and Pulmicort because of some slightly stridorous breathing. Permission received from mom because of prior issue with immunization.
Broken out in hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 17-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number J9F97, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, 15 min after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that the patient after vaccination have broken out in hives. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Headache, NauseaVomiting,  severe migraine, arm pain-sore for 2 weeks, red streak up the  shoulder and neck  Narrative:  Experienced a red streak that went up the shoulder  and neck from the injection site. Also felt very foggy, difficulty  focusing.
Received PNEUMOVAX on 2-8-17. Next day noticed redness near site (2-9-17). Today (2-10-17) redness from injection site to below elbow, (L) elbow very painful, hot to touch. Treated with cephalexin.
Patient called the clinic on 9/8 to report that 2 hours following his meningitis vaccine that was administered on 8/30 that he developed numbness in his left foot. Vaccine was administered in the left deltoid. States the numbness has since spread to his left arm and right side over his face, also had difficulty eating. Denies SOB or chest pain. Also stated he spoke to his PCP. Informed by both myself and his PCP to proceed to the nearest ER today- patient verbalized an understanding.
muscle pain in her legs, back; muscle pain in her legs, back and groin.; bad muscle pain in her legs; bad muscle pain in her legs; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bad muscle pain in her legs), BACK PAIN (muscle pain in her legs, back), GROIN PAIN (muscle pain in her legs, back and groin.) and PAIN IN EXTREMITY (bad muscle pain in her legs) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 21ac09021a) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced MYALGIA (bad muscle pain in her legs). On an unknown date, the patient experienced BACK PAIN (muscle pain in her legs, back), GROIN PAIN (muscle pain in her legs, back and groin.) and PAIN IN EXTREMITY (bad muscle pain in her legs). At the time of the report, MYALGIA (bad muscle pain in her legs), BACK PAIN (muscle pain in her legs, back), GROIN PAIN (muscle pain in her legs, back and groin.) and PAIN IN EXTREMITY (bad muscle pain in her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 17-year-old male patient who received BEXSERO (batch number 151401, expiry date December 2016). Concomitant products included MENACTRA. On 6th JULY 2016, the patient received BEXSERO .5 ml in JULY 2016, 1 day 6 hrs after receiving BEXSERO, the patient experienced fever, light headedness and nausea. The patient was treated with ADVIL. On an unknown date, the outcome of the fever, light headedness and nausea were unknown. It was unknown if the reporter considered the fever, light headedness and nausea to be related to BEXSERO. Additional details were provided as follows: The case was previously reported to the manufacturer. The reporter stated that, 30-33 hours after receiving BEXSERO at 1:30 in left deltoid the patient experienced nausea, fever (104 degree F) and light headedness. On 7th JULY 2016, the patient received MENACTRA (non-GSK) for the first time.
Patient received an influeza (FLUAD) vaccine instead of Shingrix vaccine due to pharmacist error. Patient thought she was receiving Shingrix, but when pharmacist was done giving injection, patient realized that FLUAD was given instead of Shingrix. The patient had already received her influenza vaccine at her doctor's office within the last month so this is second influenza vaccine within one month. Patient reported no adverse reaction at time of injection or to the pharmacy since the event.
Patient experienced dizziness, weakness and went pale per mother, about 15 minutes after vaccine was given.
1 day after vaccinations, pt starting to get swelling of injection site area and a rash started to develop. rash starting moving across the pt's arms.
I was having random pains in my chest and arm on the left side. I went to the doctor on 10/29/2021 at Primary Care. They ran tests and everything came back normal. They didn't give me a diagnosis, and I wasn't prescribed anything. Ever since then I have been feeling fine now.
Pt's mother brought pt to ER on night of 9/26/18 stating he was having allergic reaction to injection. Pt's left thigh was found to be red, warm to touch and swollen. Pt was given PRELONE 15mg/5mL 24mg po in ER and certirizine 2.5mg. script for PRELONE 15mg/5mL, 5 mL po QD x 5 days at home. Instructed to f/u with PCP in 10-14 days or sooner. Cool compresses as needed. Pt came to clinic on 9/27/18 and clinic nurses observed some redness and swelling. Mother states it is much better. Redness was marked with marker for mother and told to notify us if redness went out past lines.
7 125/97 108, 98% 20 RR.  1630 136/91 108 24 98%  1628 911 arrived.  1634 Discharged to ER. Patient fiance made aware per patient request.    ,Patient arrived to observation with NKDA, no history of hives or anaphylaxis. Placed on 15 minute observation. AtVasovagal response
Jynneos administered intramuscularly; Case reference number US-BN-2022-001858 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (ninth out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local case ID.  This case is linked to cases no. US-BN-2022-001839, US-BN-2022-001851, US-BN-2022-001852, US-BN-2022-001853, US-BN-2022-001854, US-BN-2022-001855, US-BN-2022-001856 and US-BN-2022-001857, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Redness and soreness began on night of injection and has continued to grow in scope 5 days in.   Fever of 100, 24 hours after injection and continuing for 48 hours.   Sniffles 24 - 72 hours after.  Tightness in chest - deep breaths hurt for 24-72 hours.  Low energy beginning 18 hours after injection and continuing 5 days after. Massive, almost non-stop headache from 8 hours after injection lasting 72 hours.
Patient was vaccinated with Moderna COVID booster vaccine on 11/16/21 at an outside facility. On 11/25/21, the patient was discharged from another facility after reporting to the ED with new left Bell's palsy symptoms. She reported this visit to her PCP on 11/26/21. No treatment was provided for Bell's palsy from this facility. On 11/27/21, she experienced worsened left facial numbness, left facial droop, spreading paresthesia and numbness/pins and needles throughout left arm and reported to ED. Other symptoms the patient presented to ED with were trouble swallowing, fatigue, myalgias, and pain from dry left eye. Patient was admitted to hospital on 11/28/21 for one day for observation and began prednisone 40 mg by mouth once daily and valacyclovir 1 gram by mouth twice daily. Patient will be completing a seven day course of both medications. She will also use saline eye drops every hour and as needed for left eye dryness. Of note, the patient has history of right Bell's palsy experienced in 05/2021.