chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 101 degrees F; chills; fatigue; weakness; Rash on the lower back, right side; rash that appear a purplish brown; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 26th November 2019, refer case US2020086074).   On 4th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, 16 days after receiving Shingrix, the patient experienced fever, chills, fatigue, weakness, rash and skin discoloration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills, fatigue, weakness, rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, fatigue, weakness, rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The patient received Shingrix and 16 days after experiencing fever of 101 degrees F, chills, fatigue, weakness and rash. The rash was most apparent on the lower back, right side and was becoming thick and yellowish, and there are portions of the rash that appear a purplish brown. The symptoms at time of report had not improved. The reporter did not consent to follow up. Did not wish to provide contact information for provider until after discussion with her husband and the doctor. She provided a case number if the decision was to allow contact with the doctor.
sick; My voice is real weak right now; This is a spontaneous report from a contactable consumer. This 70-year-old consumer (patient) reported that: A 70-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, NDC number and Expiry Date: Not Provided, Batch/Lot number was not reported) via s unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included cardiac failure congestive, need to get off these cigarettes, got hurt and was in pretty rough shape, patient had 6 heart attacks and had a stroke, diabetes mellitus, rheumatoid arthritis, chronic obstructive pulmonary disease, for all-from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced sick, patient voice was real weak right now. it was reported that phone call received from the patient regarding enrollment in PAP for Chantix. During the call, the patient stated, could not wait 90 days. patient just had congestive heart failure last weekend and ended up in the hospital and need to get off these cigarettes or they're going to kill me. That was patient problem 70-years-old patient been smoking for 60 years. So, obviously, patient in trouble and took Chantix, um, 12 years ago. Patient quit smoking and about 4 1/2 -5 months into it patient was driving down the road. patient stopped at the traffic light and patient got broadsided and got hurt and patient was in pretty rough shape Since then it's been hell. Patient never went back on Chantix because didn't have the money to go back on Chantix, patient had 6 heart attacks and had a stroke. patient got, now, congestive heart failure I've got diabetes, RA, COPD. We can keep going. There's a list I've been in the hospital for every one of these over the years patient voice was real weak right now. Patient sound like patient 103 and have a very weak voice right now It's gotten down, its actually come back this week. Beginning of the week, you couldn't even hear me. patient couldn't talk breathing treatments and all that stuff and it just tore patient throat up and took Chantix. Patient didn't get any side effects and took them for 4 1/2 months. Patient no problems whatsoever. The only thing that happened was in 4 days patient still had 3/4 of a pack left because patient was not smoking and we had your virus shot As sick. patient can't be around someone because patient won't make it. They've already warned me of that again patient didn't want to get the Johnson and Johnson shot and they said let me put your mind at ease we don't have the Johnson and Johnson shot. We've got Pfizer. The outcome of events was reported as unknown. The patients date of birth was not provided on the phone call. The following information was not provided during the call: Patient gender,  No follow up attempts are possible. No additional information expected. Information about Lot/batch number is requested
tinnitus, hearing loss, it has not stopped, it sounds like the room next door is full of rattlesnakes or locusts.
SWELLING ON LEFT DELTOID AREA WITH ECCHYMOSIS AND PRURITUS FOR THE PAST 3 DAYS.  HE WAS GIVEN Tdap ON THAT AREA 3 DAYS AGO.  HE WAS TREATED WITH BENADRYL AND GIVEN FOLLOW UP.
Chills on 5/11 at 2:30am, sweats and nausea at 3:15am. Dizziness, weakness, nausea, headache, high temp at 9am throughout entire day. Took Tylenol every 6 hours. Symptoms lessen with Tylenol but don?t go away completely
Rash developed into some really bad itching; Rash developed into some really bad itching; A little red rash on her left lower shin; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm on 17Mar2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 55-year-old). Medical history included reflux. Concomitant medication included pantoprazole taken for reflux from unspecified date in Dec2019. On an unspecified date, about a week after vaccination, the patient got a small rash on the lower left leg. It spread more into a rash but still didn't associate it with the vaccine. The rash developed into some really bad itching. She thought it might be a mosquito or spider bite, she didn't think anything about it. It did spread a little bit and she was putting Aloe Vera and Calamine lotion on it thinking it was a bug bite. The rash still spread to the whole body and the primary care doctor decided to refer her to a dermatologist. The urgent care doctor prescribed Prednisone and an antibiotic. The rash didn't get better. The rash turned into a full body rash and hives. She does not know the name of the antibiotic. Both bottles or containers of the Prednisone and antibiotic have been thrown away. On an unspecified date, the patient underwent lab tests and procedures which included skin biopsy: unknown. The patient was treated with steroid topical oil last Tuesday as a therapeutic measure of rash developed into some really bad itching and a little red rash on her left lower shin. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  No Follow-up attempts completed. No further information is expected.
About 6 hours after receiving vaccine, I had a rash on my face.  It started out about 2 inches long and about 1/4 inch wide next to my nose on my left cheek.  Sunday morning, rash had spread to my entire left cheek.  By that night, my nose was covered in rash.  The rash was now swollen and hurt.  Monday morning the rash had spread over my nose.  I could not wear my glasses due to the swelling.  Monday night the rash had spread to my hair line on my left side.  Tuesday morning the rash has spread to cover half of my right cheek.  Monday afternoon I saw my doctor.  She gave me a six day prednisone prescription.  I started taking the pills this morning (Tuesday).  She told me to see my dermatologist if the prednisone didn't take care of the rash.  I also had a low-grade fever, was drained of energy, and still don't feel well.  With the other 3 vaccines, I had very little reactions (mostly a sore arm).  This time my arm still hurts and was very sore.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 30 Oct 2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event.HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. No treatment medication information was provided.
Patient stated that she had syncope, sweating, nausea, weakness, and tingle in her hands. We monitored her blood pressure, elevated her feet, applied cold compress to injection site. Her supervisor called 911. 911 crew monitored her blood pressure and check her blood glucose. All results were normal. Patient decline to be hospitalized for further treatment.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
Redness in arm; Swelling in arm; Hotness in arm; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), SKIN WARM (Hotness in arm) and PAIN IN EXTREMITY (Soreness in arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Significant Medical History).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), SKIN WARM (Hotness in arm) and PAIN IN EXTREMITY (Soreness in arm). At the time of the report, ERYTHEMA (Redness in arm), PERIPHERAL SWELLING (Swelling in arm), SKIN WARM (Hotness in arm) and PAIN IN EXTREMITY (Soreness in arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
itchy at injection site; raised redness at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (raised redness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (sore arm). On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (raised redness at the injection site). On 23-Jan-2021, MYALGIA (sore arm) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (raised redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided
slight chills; slight fever (99F); tiredness; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) via unspecified route of administration on right arm on 11Feb2021 at 12:00pm as a single dose for COVID-19 immunization. Patient's medical history included hypertension from an unknown date and unknown if ongoing controlled with medication. Patient's concomitant medications were not reported. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) via unspecified route of administration on right arm on 21Jan2021 at 12:00pm as a single dose for COVID-19 immunization. On 12Feb2021 at 10:00 am, patient experienced slight chills, slight fever (99 F) and tiredness. The patient underwent lab tests and procedures which included body temperature 99 Fahrenheit on slight. No treatment was given to the patient for the events. Outcome of the events was recovering.
Vials stored in refrigerator from 21 Apr until their administration on 25 May; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials stored in refrigerator from 21 Apr until their administration on 25 May) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials stored in refrigerator from 21 Apr until their administration on 25 May). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Vials stored in refrigerator from 21 Apr until their administration on 25 May) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with unspecified doses of ZOSTAVAX (lot # L002423 and expiration date 23-APR-2016)(dose and route were not reported) which was improperly stored. No Product Quality Complaint (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Patient experienced the normal redness/soreness at and around the injection site. But about 2-3 days after immunization patient experienced a rash around neck, on her torso (under breast) and around her groin. Patient reports no itching or pain associated with rash. Patients PCP recommended hydrocortisone cream.
Patient was given Moderna Bivalent instead of Moderna Primary vaccination. No treatment was needed. Pt will be given Moderna primary.
This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical history was provided by the Reporter. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided. Concomitant medications were not provided by the reporter. This case was linked to MOD-2021-244657 (Patient Link).
Bodyache and fever (up to 101.0 degrees) X 2 days.  Local swelling, erythema of entire upper arm/triceps X 7 days.  Urticarial - like rash & itching around injection site X 7 days.
The above referenced individual received two vaccines this evening.  He went into the tent, checked in, received his vaccine, and was observed.  On leaving the tent, he ??followed people into the trailer?? bypassed the check in folks (who had others in front of them at the time), went directly to the vaccinator, and received a second shot.    What we found is that both vaccinators had the same initials (AS).  Nurse (in the trailer) thought that the check in staff had written her initials in, and administered the second vaccine.  When questioned, the gentleman had no answer as to why he would have permitted two vaccines to be given in a single visit.  Staff emailed Dr, who stated that we would be able to administer the second dose, and cited the response from the CDC on receive two doses too close together.  The individual was observed for an extended time by EMS, and refused evaluation in the ED.  He was counseled with regard to the possibility of an increased immune response.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a female patient who experienced vaccine got on her hand/felt wetness on my hand and leaking prefilled syringes, while using vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was exposed to dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6258MA. It was a case of actual medication error due exposure via skin contact, accidental exposure to product and Syringe issue. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient took first Shingrix dose 2 months ago and experienced swollen area on the shot site about the size of a large lemon maybe 3 inches. The skin was very dark, really red on the site. Patient had pain in her temples on each side of her head and area felt warm on the touch.  Patient took second dose Monday 11/23 at the same pharmacy and this time experience added symptoms such as bad fever 101.4F, body shaking, hard time walking, pain at the injection site, numbness on face (whole face) for about 4 hours, pain in temple area and other parts of head, pain in  hips, very sharp pain in legs making it very hard to ambulate. The symptoms stayed for the whole day. Patient woke up this morning 11/25 feeling normal other  than soreness on the injection site - about the size of a quarter on the injection site. Did not have any problems when she took it first time in 2012.
My arm burned to the hand before bedtime.  I could not move normally in the morning, and had to leave the bed by crawling on my knees on the floor and then pulling myself up.  The pain moved to my right shoulder and neck.  I ended up needing x-rays and PT.  Arthritis, tendons and rotater cuff all seemed to get set off from the shot.  I am still needing PT, and possibly a shot of cortisone.
This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 35-year-old male patient who received BOOSTRIX (batch number 9PD92, expiry date 30th May 2020). On 22nd April 2018 14:45, the patient received the 1st dose of BOOSTRIX .5 ml. On 23rd April 2018, 1 days after receiving BOOSTRIX, the patient experienced leg pain and back pain. On an unknown date, the outcome of the leg pain and back pain were not recovered/not resolved. The reporter considered the leg pain and pain to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in right deltoid. The pharmacist reported that the patient called today (on the date of reporting) and reported that he awoke with body aches in his back and legs yesterday morning after receiving BOOSTRIX vaccine on 22nd April 2018. The reporter did text to MIS for duration of events.
On 8/21 Pt received vaccination. Mom called on 8/23 to report pt had right arm red and swollen no c/o pain starting on 8/22.
Information has been received from a Certified Medical Assistant in a physician's office concerning her 24 year old daughter who on unspecified dates were vaccinated intramuscularly with the first and second 0.5 mL dose of GARDASIL (LOT# not reported). After receiving her second and third dose of GARDASIL the patient developed syncope. The syncope was recovered on unspecified dates. No further information is available at the time of reporting. Additional information has been requested.
Multiple sclerosis symptoms got significantly worse; Vertigo; Ataxia; Difficulty standing; Difficulty walking; Disequilibrium; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 03121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse) (seriousness criterion medically significant), VERTIGO (Vertigo), ATAXIA (Ataxia), DYSSTASIA (Difficulty standing), GAIT DISTURBANCE (Difficulty walking) and BALANCE DISORDER (Disequilibrium). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis symptoms got significantly worse), VERTIGO (Vertigo), ATAXIA (Ataxia), DYSSTASIA (Difficulty standing), GAIT DISTURBANCE (Difficulty walking) and BALANCE DISORDER (Disequilibrium) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided.  Company Comment:  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.