chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy hives over her torso; Allergic response; itchy; This case was reported by a nurse via sales rep and described the occurrence of hives in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix. On 1st December 2019, 4 days after receiving Shingrix, the patient experienced hives, allergic reaction and pruritus. The patient was treated with benadryl (nos) (Benadryl), loratadine and prednisone. On an unknown date, the outcome of the hives, allergic reaction and pruritus were unknown.   The reporter considered the hives, allergic reaction and pruritus to be possibly related to Shingrix.  Additional details were provided as follows: Four days after receiving the Shingrix vaccine, patient developed itchy hives,allergic response over her torso and both sides of her body.  There was no scabbing. Difficult to knew the etiology for certain.  Timing would suggest shingrix. This second phase of a reaction to a full week later was confusing. The patient would  used Benadryl 25 mg daily at bedtime and loratadine twice a day during the day. The reporter inquired If not responded adequately to this, can we called for a prescription of prednisone. The second Shingrix vaccine would be given, she should premedicate with Benadryl and use prednisone if needed.
Bad reaction to the moderna covid vaccine; COLITIS; Injection site itching; Injection site hives; Injection site tenderness; Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), URINARY TRACT INFECTION (Urinary tract infection), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site hives) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis. Concomitant products included COVID-19 VACCINE for COVID-19 vaccination.   On 06-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2022, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). On an unknown date, the patient experienced IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), URINARY TRACT INFECTION (Urinary tract infection), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 10 out of 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. The reporter's causality for the events of bad reaction to the Moderna covid vaccine, colitis, injection site reaction/ itchiness/hives/tenderness unknown onset, urinary tract infection with adalimumab solution for injection was not provided.
Redness/Swelling & Itchy on site area where vaccine was given. Also Right ear was itchy starting 09/25/2019 @ 10:00 AM.
The pfizer pediatric vaccine was improperly prepared with sterile water for injection instead of 0.9% sodium chloride. The patient's parents were contacted and they reported the patient had a sore arm and neck. They patient also reported the vaccination was more painful than the primary series.
This spontaneous report was received from a physician via company representative and refers to a 64 year old female patient. No pertinent medical history reported. On an unknown date (a couple of years ago) the patient was vaccinated with ZOSTAVAX (dose and frequency unknown), (lot number not reported) through an unspecified route for prevention of shingles. No concomitant therapies reported. On an unknown date in August 2014 (reported as last week) the patient presented to office with a rash. The patient sought medical attention. The physician prescribed unspecified steroid to rule out poison ivy. The redness resolved yet rash remained. The physician diagnosed it as shingles and the physician ordered unspecified antiviral therapy as treatment. The outcome of shingles was unknown. Causality for the event was unknown. Additional information has been requested.
Miscarriage after vaccine. I was 11 weeks pregnant.  Estimated date of delivery is 9/20/21.
This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. On an unknown date, the pregnant patient was vaccinated with a dose of VARIVAX (Merck) (lot#, dose, route and site of administration were not reported). The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. The patient sought medical attention (unspecified). No more details regarding pregnancy were reported. Additional information is not expected because the patient did not want to participate in the adverse event report.
lt ax swelling & went to pvt MD & MD dx acute serum sickness w/synovitis of the lt shoulder;26SEP95 tx w/Depo medrol & ice packs to lt shoulder & sx @ MD ofc;lt arm remained swollen for approx 1wk & then resolved;
pt recvd vax;12-24 hrs later, devel inflam at inj site, & a knot below the inj site;
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Herper Zoster (shingles) Left Eye and Left side of the face and head
tested positive for COVID-19; Tiredness; sore arm/pain in his left arm when he holds it parallel to the floor; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/pain in his left arm when he holds it parallel to the floor), SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) and FATIGUE (Tiredness) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm/pain in his left arm when he holds it parallel to the floor). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tiredness). On 05-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). On 18-Feb-2021, FATIGUE (Tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm/pain in his left arm when he holds it parallel to the floor) outcome was unknown and SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) had resolved.            Patient was told to take Tylenol and Flonase for his symptoms   This case was linked to MOD-2021-069798, US-MODERNATX, INC.-MOD-2021-069883 (E2B Linked Report).; Sender's Comments:  MOD-2021-069798:First dose case US-MODERNATX, INC.-MOD-2021-069883:Crosslinked (second dose)
PATIENT REFERS THAT 60-90 MINUTES AFTER VACCINATION HAD A EYE EDEMA AND TEARY EYES.
He had a seizure and we called 911 and the paramedics came to our house and transported him to the hospital for follow-up
Patient came into vax clinic to report a mild redness/rash that appeared on her  cheeks and chin yesterday evening. Yesterday she received both a flu and bivalent  covid vaccine. Patient says rash is itchy but not painful; she has not tried  anything for it yet. Denied any swelling of face, neck, hands or trouble  breathing.  Explained that an allergic reaction can be a side effect after receiving a covid  vaccine. Recommended she take a benadryl tab before bedtime and to use benadryl  cream on the face during the day to help prevent drowsiness at work.  Instructed her to go to ER (or call 911 if necessary) if face/neck start to swell  or she has trouble breathing. She approved of the plan and went to go check to  see if she could be seen by a provider today.
Developed fever 2/19/15-6 AM-100.7 to 101.4. Mild achy feeling. No N/V/D.
Fevers; chill; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fevers"; CHILLS (non-serious), outcome "unknown", described as "chill"; NAUSEA (non-serious), outcome "unknown".  Additional Information: It was reported that patient had Fevers and chill and nausea with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to (Patient Link).
Incredible bilateral finger joint pain which has overshadowed the pain of a FULLY TORN ACETABULAM right hip--hip tear on 3/04/11; this pain in finger joints is deforming, inflammatory and I was even placed on Fentanyl for this increase of pain; a LESION appeared on the top my left hand and it was quickly seen by a dermatologist who not believing my medical HX misdiagnosed it as Eczema; a divit exists in the muscle at injection site, which hurt for over one month and is still tender to the touch.  My rheumatologist is non-interested and claims there is nothing wrong; The medical assistant who gave the injection had been self-touching and I get on him to wash again, change gloves, etc. for the B 12 shots I quit getting there.  My finger pain and deformation were also seen by my hand doctor but this was months ago and the pain and deformity have me wanting hospice, but NO ONE WILL DIAGNOSE THIS!!!!  Also, I had a low-grade fever for 7-8 days.
Injection site achiness; High fever of 102 F; Chills; Headache; Felt drained; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Plasma donor (She donated plasma for antibodies, after recovering from Covid-19.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained). At the time of the report, VACCINATION SITE PAIN (Injection site achiness), PYREXIA (High fever of 102 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt drained) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Unusual sluggishness and confusion the next morning.  Also, unusual levels of aches and pains.
Narrative: Patient reported a severe reaction of shortness of breath and hypotension with their first dose of the COVID-19 vaccine
I had an ear ache and stuffiness from my right ear after about a day.  I had a hearing test down one day later for a new job.  They reported that my right ear did not pass.  They stated that my right ear could not hear all the higher tones/pitches.
No adverse reaction noticed from the pneumonia vaccine  The Shingles vaccine reaction was a severe painful rash all over the lower right leg. The skin later pealed off but I still have some of it on leg and it has been 50 days. I had shingles once before about 5 years ago to right side of face.
pt recvd shot 26OCT93 1 wk later came down flu; fever 101.7, chills, ache;
Patient received a second dose of high dose fluzone 20 minutes after receiving the first dose.  two different staff members administered 20 minutes apart, one in the right arm, one in the left arm.
One day after SHINGRIX administration, patient developed inflammation and redness at the site of injection. The next day the inflammation got worse but on the 3rd day which was today the symptoms are getting better and patient just wanted to let us know. The pharmacist told her to continue taking TYLENOL every 4-6 hours as needed for pain, apply cold compress at the site for 10-15 minutes and use anti-histamine to bring the swelling down. If the symptoms are getting worse or no changes then contact the physician as well as the pharmacy.
Patient came in to receive the COVID vaccine and decided he also wanted the FLU vaccine. Registration staff confirmed that the patient did not receive a flu vaccine and informed the nursing staff. Nursing staff vaccinated the patient and begin to chart his information only to see he actually did get a flu vaccine a week ago. The FLU vaccine showed up in database, but did not show in other system. Nurses received the patient information and informed him about the incident. Nurses and site lead talked to employee regarding the incident and will each be filling out a client report.
Soreness at injection site (left arm); mild left hand muscle cramping; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications in two weeks. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. On 25Feb2021, the patient experienced soreness at injection site (left arm) and mild left hand muscle cramping. Patient received no treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Resident given Bivalent booster by pharmacy during a clinic 10/21/22 And consented for a dose 10/2722 when VAccine was being administered for clinic - No Adverse reaction noted for 4 hr. past.
No additional adverse events were reported.; Field employee called to report an AE in behalf of a nurse.   The nurse told the field employee that a 15 month old patient suppose to receive only PROQUAD but the patient received PROQUAD and then received VARIVAX on the same day, 9/15/2022.  No add; This spontaneous report was received from a registered nurse referring to a 15-month-old, patient of unknown gender, whose medical history, concurrent conditions, and concomitant therapies were not provided.  On 15-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (exact dose, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not provided); it was administered together on the same date with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, for prophylaxis (exact dose, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) (overdose). No further information provided.  No additional adverse events were reported.
Adminstered TRUMENBA vaccine on Right arm and BOOSTRIS on left arm. Patient stated her right arm was hurting and began to feel hot. She was sweating and her eyes rolled back.  Patient stated she was "not feeling good". Patient is actively going through a fast and hasn't eaten since 4am today. 911 was called immediately. She drank sips of Pedialyte/Powerade, but it did not help.  Stopped beverages. Paramedics arrived on site within 2 mins. Patient felt better after 10 minutes.
Buzzing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Buzzing in ears".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384196 Different patient, same product and event
Arm swelling and pain, including redness and fluctuance of the lower bicep region without firmness or warmth on day of visit. Patient reported firm lump in lower bicep on 04/05/18, fever and fatigue.
Systemic: Fainting / Unresponsive-Mild, Additional Details: The patient just fainted after recieving covid shot briefly. She stated that she usually faints after receiving shots or needles.
Mom called at five stating patient screaming non stop. Shots given at 10:00. TYLENOL given by mom with cold compress. Calmed down in doctors office.
Child developed hive reaction located to the face (cheeks) approximately 45 minutes after vaccine administration
Recieved meningococcal and yellow fever vaccines and within an hour recieved call from client at local hospital emergency stating on route home she started itching, hives and throat tightness.
Swelling on the left side of neck; Pain on the left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 (at the age of 43-years-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 09:00, the patient experienced swelling and pain on the left side of neck about half an inch below the jaw bone and extending back below ear. The patient did not receive any treatment for reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling on the left side of neck and pain on the left side of neck were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
can't stay awake, unable to stay awake; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Spinal stenosis" (ongoing). Concomitant medication(s) included: NORCO taken for spinal stenosis (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "a little soreness on the arm". The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "can't stay awake, unable to stay awake". The event "can't stay awake, unable to stay awake" was evaluated at the emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after receiving the vaccine, patient experienced dizziness and a strange taste in her mouth. She sat down for approximately 10 minutes, drank some water and felt better. BP test 139/80, pulse 78 (R) arm.