chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling below injections site; fatigue, fever (100.3), headache, chills.
LEFT ARM STARTED TO GET RED AND ITCHING, ALSO REDNESS STARTED TO SPREAD TOWARDS ELBOW
a patient age 32 received her 1st shot in 1/2020 and her 2nd shot yesterday; This spontaneous report has been received from a health professional referring to a 32 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unspecified date in January 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 16-MAR-2021, the patient was vaccinated with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, frequency, anatomical location, lot # and expiration date were not provided) lot number T008151 with expiration date of 21-JUN-2022 for prophylaxis (inappropriate schedule of product administration).
Adverse event started on 3/20/2021 (2nd Moderna shot given in p.m. on 3/18/2021 in right arm. First Moderna injection  had been in left arm with only mild muscle tenderness reaction) On 3/20/2021 in a.m. swollen lymph nodes appeared in armpit of right arm. (arm of injection).  Next day moved to rt. side breast tissue.  Third day moved to collar bone and lower neck. 4th day moved up neck to behind ear. Lasted approx 3 days in ear area before totally dissipating.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient got the shot and months later got shingles. The reporter said shots are not 100 precent either. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
beginning Thursday, 8/26/2021 Difficulty breathing , Lightheaded, dizzy, loss of balance, rapid heart  Symptoms went into 8/28/2021,  No issues 8/30/2021
After an investigation determined that patient received 0.3cc of air and did not receive vaccine. Patient's mother notified. SHe is bring patient back today to get re-vaccinated.
Nine days after the shot I have developed a red rash around the injection site.  It has pink welts, is warm to the touch, itches.
Woke up 9/26/03 at 6 Am. Mother thought she was going to throw up, but became unresponsive. Called ambulance. Taken to hospital. Seen by Doctor. CAT scan done, negative UA, negative. No temp on admission to hospital. Just appeared drowsy. Was kept in hospital most of day. Discharged that evening 9/25/03.
herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, the pt suffered herpes zoster. As a result of these symptoms, the pt was seen and treated by health care providers (reported as medical providers) and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The event herpes zoster was considered to be disabling by the lawyer.
Shingles Vaccine - 08-07-07. Severe shingles on head. Temple, around Rt. eye, etc. Began 10-5-08, continues, (Though less severe) one year later.
Pt returned to pharmacy 6/6/13 and reported itching, swelling and redness, localized around the site of injection. Pt did not report any shortness of breath, difficulty breathing or fever. Pharmacy manager said that he would follow up with patient to check on her progress. On 6/7/13 the pharmacy manager followed up with the patient who was concerned enough to consult with her dermatologist (unknown). Prescribed clobetasol ointment and prednisolone tablets.
Very swollen & lg redness on inter arm, very painful. Referred to PCP 10/7/11 told to take IBU and ice it.
Described patient is the wife of a patient who was vaccinated. She is currently seven weeks pregnant. Wife was innoculated by contact with vaccination site. Localized lesion currently. Wife was not known to be pregnant at time of vaccination.  Listed date of vaccination is for the husband.  Wife's lesion is, per history, 3-5 days old.
Flu-like symptoms muscle, joint pain, nausea/vomiting 2 days after vaccine. Aug. 4 - dx with cellulitis (antibiotics) swollen, tender, red arm/numbness adverse reaction to Tdap. Sept - dx with post vaccination syndrome allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, chronic sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan diagnosed with fibromyalgia.
Symptoms started the morning after the vaccine. Temps up to 102 when not taking tylenol or ibuprofin. Joint pain and muscle fatigue started at same time. Extreme fatigue and lethargic. These 3 symptoms started 24 hours after injection and ended about 36 hours after they started. 48 hours after injection experienced arm swelling and redness similar to a wasp sting. This symptom is till present today.
feel dizzy/having dizzy spells; Sinus congestion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy/having dizzy spells) and SINUS CONGESTION (Sinus congestion) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.  The patient's past medical history included Glaucoma. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (SUDAFED OM SINUS CONGESTION) for Sinus congestion, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MECLIZINE HCL, URSODEOXYCHOLIC ACID (URSODOL) and PANCREATIN (CREON) for an unknown indication.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (feel dizzy/having dizzy spells). On an unknown date, the patient experienced SINUS CONGESTION (Sinus congestion). At the time of the report, DIZZINESS (feel dizzy/having dizzy spells) and SINUS CONGESTION (Sinus congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Primary care gave him meclizine for dizziness. Sinus congestion was put on sudafed   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: date of birth of patient updated in followup
Severe nausea, vomiting and vertigo within 24-hours of receiving the 1st dose of Moderna COVID-19 vaccine. Extreme fatigue for days afterward. Then tested positive for COVID-19 on 12/29/2021: headache, body ache, cold symptoms, cough and sore throat. Finally started to feel better around 1/4/2022. Overall sick for 2-3 weeks after the first dose of Moderna.
Two days after the vaccine (first dose) I developed sharp stomach pain and what felt like severe anxiety, I started vomiting agressively and this kept up for about the next 8 hours even if I had a sip of ginger ale or bite of cracker. Following day I can keep small amounts of food/water down in the morning but still have dull stomach pain and just started vomiting again after attempting a cracker around dinner time. My temperature is running 2-3 degrees high.
I felt like I couldn't breath; itchy everywhere; chills; nausea; vomiting; diarrhea; face swollen. I still have pain on my vaccination site. I went to the urgent care and they said it was an allergic reaction and put me on steroids for the itching and swollen face.
Hives and rash on the arm where the shot was given. The patient reported the hives started about 12 hours after vaccination. The rash has not completely cleared as of 10/12/2020
This is a spontaneous report from a contactable other hcp (patient herself).  A 52-year-old female patient received the first dose of BNT162B2, (COMIRNATY, solution for injection, Batch/lot number: EL-3247, Expiry Date: unknown) on 22Feb2021 14:45, via an unspecified route of administration, in left arm as UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included atrial fibrillation. The patient's concomitant medications included famotidine; ibuprofen (ADVIL [IBUPROFEN]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient experienced mild fatigue on 22Feb2021 18:00, left arm and injection site soreness on 22Feb2021 18:00, mild muscle soreness 6-18 hrs after administration. The symptoms were gone at 24 hrs. The outcome of the events was recovered after 24 hours, on 23Feb2021. No follow-up attempts possible, no further information is expected.
1. severe headache began 2.5-3 hours after vaccination that lasted over 16 hours  2. soreness at injection site
Itching near the injection site; Rash near the injection site; Hot to touch near the injection site; A spontaneous report was received from a consumer concerning a female patient of 95 years of age,who was administered with Moderna's covid-19 vaccine and experienced itching and rash near the injection site and hot to touch near the injection site.  Patient's medical history was not provided.No relevant concomitant medications were mentioned.  On 05-FEB-2021,patient received the first of two planned doses of mRNA-1273(Lot number:unknown) for prophylaxis of covid-19 infection.  8 days later, On 13-FEB-2021,the reporter mentioned that  her mother started experiencing "moderna covid arm" reactions. Treatment options included Benadryl and ice packs.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events were unknown.
Strep throat; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 30Jun2021 (Lot number: EW0202) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious) with onset 12Jul2021, outcome "recovering", described as "Strep throat"; OROPHARYNGEAL PAIN (non-serious) with onset 06Jul2021, outcome "recovering", described as "Sore throat". The events "strep throat" and "sore throat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal discomfort, oropharyngeal pain.  Additional information: Reporter was concerned because her 16 year old son was scheduled for his second dose of the Pfizer Covid 19 Vaccine tomorrow and was currently taking Amoxicillin for strep throat. Reporter was wondering if they should wait until he was recovered and done with the medication or go ahead and get the second dose of the vaccine tomorrow. Patient was taken to the clinic for a sore throat on 06Jul2021. His strep test was negative. He was given Claritin and took it for a week. Patient was taken back to the clinic for sore throat on 12Jul2021.His strep test was positive. He was placed on Amoxicillin 875mg twice a day, morning and night, for 10 days. Patient had no any Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
I prepared the vaccine with no issues. When I went to vaccinate the pt, the syringe malfunctioned and the vaccine came out of the syringe and onto the pt's arm. No part of the dose was successfully administered. That was my last dose so the pt will be coming back to get vaccinated tomorrow.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # K022990, expiration date 26-JUN-2016, route defaulted to oral (dose and dose number were not reported). There were no adverse effects. This is one of two reports received from the same source. Additional information has been requested.
We vaccinated 15 years old female which is outside of manufacture guideline(over16 yrs old). After pharmacy member found out and contacted pt. Pt's dad aware this fact but pt has irregular heart murmur condition and wanted to get vaccine sooner than later. Pt didn't have any side effect from vaccine and pt's dad actually wanted to get her 2nd vaccine in 3 weeks. However  we advised him to wait after her 16th birthday and come back to get 2nd vaccine.
Information has been received from a registered nurse concerning a 9 week old male, with no medical history and no allergies, who on 02-OCT-2006 was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  There was no concomitant medication.  On 04-OCT-2006 the patient developed vomiting.  He was seen at the physician's office on 06-OCT-2006 and by then was experiencing vomiting and loose stools.  He was admitted to the hospital on 09-OCT-2006 for vomiting, diarrhea, and acidotic dehydration.  He was being given intravenous fluids.  At the time of the report the patient had not recovered.  Vomiting, diarrhea, and acidotic dehydration were considered to disabling, life threatening, and other important medical events by the reporter.  Additional information has been requested. (OMIC)
RpH from pharmacy, was the immunizer that administered Covid vaccine for the health facility. He was incorrectly given a list of patients that needed to receive a second dose of the Covid vaccine . Unfortunately, the patients had already received their second dose on 2/2/2021 and received a third dose. The patients  were not able to communicate the receipt of the second dose earlier.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
Vaccine administered as outpatient. Next day started with fever 103F, pain 7 on a scale to 10, warmth and redness x 2 days.  Emergency room treated with Tylenol and Ancef and admitted to rule out other infection process and treat cellulitis of arm. Ancef continued and changed to Keflex at discharge.  Length of stay 3 days.  Near resolution at that time. 12/17/08-records received for DOS 9/26-9/29/08-DC DX: Probably cellulitis of right upper extremity,  possibel allergic reaction to pneumovax. Admitted with fever and chills. Injection site red, swollen hot.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of VARIVAX (lot#: L037565, expiration date: 29-SEP-2017; lot#: M042858, expiration date: 21-OCT-2018; lot#: M019643, expiration date: 20-APR-2018; lot#: M042858, expiration date: 21-OCT-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA002262: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299.
Dizziness/lightheaded @ 2:30 - evening severe headache and weakness @ 7:30 am - 4:30 weakness continued through evening.
had a feeling of impending death and thought he was gonna die.; Syncopal episode; My platelets counts drop; metallic taste; Potassium level went down; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) first dose on 12Feb2021 on Deltoid Left at single dose for covid-19 immunisation. Medical history included Covid-19 and High cholesterol. Concomitant medications were not reported. He said that he was 60 days post COVID and his doctor advised him to get vaccinated. He was feeling fine, but after 10 minutes into the shot, he had a metallic taste in the mouth. After 12-13 minutes, he had a feeling of impending death and thought he was gonna die. It freaked him out. He was rushed to the ER and had a complete blood count (CBC) and Basic Metabolic Panel (BMP) test run on him. It was that his Potassium level went down to 3.3 and his platelets dropped to 141. He had tests on 28Jan2021 and mentioned that his Potassium levels were normal and had a platelet count of 181. He mentioned that there was no other way but the vaccine that could have caused this. He is if he would already have passed away from the shot from his opinion. Patient had a Syncopal episode of some type. He had an intended feeling like he was going to die after the shot, he was 60 days post Covid when he get that shot, he was getting over Covid and he was 60 days and he didn't wait the 90 days his primary doctor care told me that he can get it too because he was feeling better which he was feeling better but since then he have gotten that shot, he went to the doctor on the 28Jan2021 and he had CBC drawn on him and he went for his regular physical and Covid follow-up at his doctor, his platelets counts drop since he have had shot struck at 40 points, feels concerning. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "feeling of impending death and Syncopal episode " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who all received flu vaccine. This case deals with fifteenth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 22-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative and case comment were corrected.
Patient received pfizer vaccine on 4/21/21 and 5/19/21 and the booster dose with moderna vaccine on 12/1/21. patient presented to hospital with pleuritic chest pain, troponin leak and EKG changes most c/f myopericarditis secondary to covid booster. troponin: 686-> 791 -> 880, initial EKG: diffuse STE, not seeing any PR depressions, repeat ECG improved. Covid negative. CRP 24.3. Cardiac MRI revealed myopericarditis and patient was treated with ibuprofen and colchicine and symptoms completely resolved within 2 days.