chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired ACTHIB vaccination with no adverse event; Initial information received on 22-Feb-2022 regarding an unsolicited valid non-serious case from patient.  This case involves a 3 months old male patient who received an expired ACT-HIB vaccination no adverse event while receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertusis vaccine acellular, Tetanus vaccine toxoid (Daptacel); and Rotavirus vaccine for Immunization.  On 22-Feb-2022, the patient received 0.5 ml dose of HIB (PRP/T) Vaccine once (lot number: UJ143AA and expiry dates: 03-May-2021)via intramuscular route in the thigh nos for immunization.  On 22-FEB-2022 the patient received an expired ACT-HIB vaccination with no adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  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 the 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.
pt recv vax 1MAY96 & varicella antibody titers in OCT96 & JAN97 were negative;
12 hours after this second dose (7/23/21 at around 2 AM) I woke up with chills, headache and body aches.   The body aches and headache persisted through the day, as did low grade fever of 99-99.9 F and fatigue.  With ibuprofen taken every 5-6 hours I felt better by the evening of  7/23/21, though  remained very tired.   I awoke at 1:30 AM 7/24/21 with dizziness, which has been persistent.   I no longer have aches or fever, but the dizziness remains ( as of 7/25/2021)
Patient had a reaction to Fluzone High Dose with no other medical issues or explanations; Initial information was received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves elderly patient (age and gender unknown) who experienced patient had a reaction to fluzone high dose with no other medical issues or explanations (vaccination complication), after the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had a reaction to the vaccine (vaccination complication) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At the time of report the event outcome was unknown.  There will be no information available on the lot number for this case.
Two medications were drawn up at the same time which were the (TDAP) and (MMR).  TDAP was given (SQ) versus (IM). MMR was given correctly. The shot was administered at 1430 and was discovered at 1435. Informed student of incident after consultation with physician on site. Told student to contact "Health Clinic" if he sees and feels any irregular swelling or pain and to come in for a visit.
Patient was accidentally given a Pediatric Pfizer rather than a full dose of Pfizer since he is a 12 year old. There were no reactions and the patient's mother was made aware of the incident he will be completed series after his next dose which will be the normal Pfizer dose for his age.
I have been having a period every 2 weeks instead of having a 28 day normal cycle. I do have a practitioner that have prescribed me progesterone to see if that could get my cycle back to every 28 days instead of every 14 days. I had a blood test which came back normal, but low in progesterone.
The day of the injection I did not have any side effects.  But 1 week from the initial injection, the injection site became raised, very warm to touch and extremely itchy.  It had a radius of 3 inches.  I took Zyrtec to help, cold compress and hydrocortisone cream. Nothing worked. My doctor has prescribed me triamcinolone for the itch and and epipen if I have any swelling or can't breath. As well as a possible antibiotic if the swelling spreads for possible cellulitis.  It is still raised and warm to touch and the itch has subsided slightly. It has not spread.
no adverse effects reported; inadverently administered an expired dose of MMRII; This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug allergies or reactions and concomitant therapies were not reported. On 17-APR-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered) therapy type as rHA (recombinant human albumin), lot # N009799, expiration date 24-MAR-2019 via a subcutaneous route(dose, dose number were not provided) for prophylaxis. There were no adverse effects. There were no temperature excursion. The outcome of expired product administered and no adverse event were unknown.
Ringing in ear; Feet are so swollen; Ankles are so swollen; This is a spontaneous report from a contactable consumer, the patient.  A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in left arm on 18Mar2021 at 11:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included ankle reconstruction from 2019/2020 and high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. On 21Mar2021, the patient experienced ringing in ear and reported that her feet and ankles were so swollen that she could not wear her shoes. The patient had ankle surgery on both ankles in 2020 and the swelling was down. The patient was able to wear her shoes and walk. Approximately 3 to 4 days after vaccine, her ankles and feet were so swollen that she could no longer get her shoes on. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of the events. The clinical outcome of the events ringing in ear and feet and ankles were so swollen was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reported to have severe arm pain for 4 to 5 days following Pfizer dose #2, fatigue. Patient still have sore arm and contact her doctor. Her doctor said injury may have gone into bursa, muscle weakness and fatigue; and wanted her to report to us.
Right side abdominal pain started night of 10/19/2022, improved the next day, then started again at night and was worse, again improved the next day, then started again morning of 10/22/2022, went to emergency room, diagnosed by CT with 2 mm kidney stone on right side nearing bladder. Given oxycodone for pain and FloMax to flush urinary system. Pain on and off since 10/22/2022. Will follow up with urologist on 10/31/2022.
On March 10, 2023, I was admitted to the hospital and diagnosed with acute kidney failure.  I have no memory of any symptoms. My husband states that I was unresponsive, and he called for an ambulance.  In the hospital I was in a coma or 7 days.  Once my kidneys began to function again, I was able to be released.
Patient reported experiencing trouble breathing and feeling like her left side of throat is closing along with tightness around the throat area.
Had H1N1 12/1/09 hives on torso, both arms, one leg. One arm bright red and warm. Her MD said it was probably a reaction to the vaccine.
Patient stated increasing soreness started "a couple days" after the shot and continued to increase for several weeks. She still has soreness, a knot at injection site, and reduced range of motion. She has not seen her PCP for the issue. She said she mentioned it to the orthopedist while on a visit for an unrelated issue, but has received no treatment.
The vaccination was given subcutaneously about 8 inches below sholder, 3 inches above elbow.  There was erythema, pain, swelling, and redness at the injection site the day I received it.  My husband,a hand surgeon with knowledge of arm anatomy was concerned about nerve damage(based on location of injection), infection, and abscess. Fortunately none of those things happened. I started taking amoxicillin right away.
Patient states she began feeling feverish, achy about 6 hours after administration. Vaccine site is red, swollen and hot to touch.
Injection into low end of deltoid.  Temperature on Wednesday night. Temperature returned to normal on Thursday. On Thursday: Black and blue mark at injection site. Redness around the bruised area. Hot feeling around the site. Inflamed area progressed on Friday and Saturday. On Saturday: Inflamation reached elbow. Patient visited physician who diagnosed cellulitis. Prescribed Cephalexin and bought Benadryl and a probiotic. As of Monday, 9/14: Inflammation still present but improved. Not a full recovery yet.
Patient reported dizziness/itching during observation period. Wanted antihistamine dose. Administered diphenhydramine 12.5 mg/5 mL-10 mL dose (25 mg). NCD00536077085 lot 3J19 exp 09/15. Encouraged pt to stay for further observation but "had to leave".
This is a spontaneous report from a contactable other health care professional. This is the first of the 2 cases, this case is for first dose of BNT162B2. A female patient of  51:Age (Unit: unknown) received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration and administered in left arm on 05Jan2021 as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient also received second dose of BNT162B2 on 26Jan2021 and experienced adverse events. Patient experience side effects after receiving the first and second dose of the COVID-19 vaccine. Patient received the first dose of the vaccine on 05Jan2021, in which she noticed a couple days before receiving the second dose that she had swollen and enlarged lymph nodes specifically on the left supraclavicular side just above left clavicle. She noticed a bump on her neck on 23Jan2021. These lymph nodes appear rounded, hypoechoic, largest 1.2cm. Additional smaller node with some internal debris measuring up to 4 mm in level 5B was found as well. Patient states that the right side did not have any findings and reported that she received the vaccines in the left arm. The patient underwent lab tests and procedures which included mammogram: large lymph nodes, discovered three large lymph nodes under arm in axilla ranging in size, but the largest was measured at 20 x 17 mm on the left side, ultrasound scan: lymph nodes that were small preexisting lymph nodes that were small, but appeared to have increased in size when examined. Prominent lymph nodes in left axilla measuring up to 7 mm. The outcome of events were unknown. Follow-up attempts are completed. No further information is expected.
Fever, aches, round, red, hot swelling under Pneumovax injection site, fatigue
Dermographism relapse.   I was diagnosed with dermographism and general skin itchyness in 2007.  I took Loratadine (Claritin) for it, but gradually stopped taking Claritin every day with no issues.  After my 2nd booster, the dermographism symptoms returned.  I talked to my doctor about it during a physical on 7/21/2022 and he prescribed Cetirizine (Zyrtec).  I put 2 and 2 together after reading this site which is not scientific, but made me think there could be a link: website
Started w/vomiting & high fever @ 730PM; fever went to 104.2 ax @ aobut 1015PM & was seen in ER; MD said ear pink, but didn't really find anything on exam; Later seen by MD who felt had virus;
The Medical assistant made a mistake and used an expired covid vaccine for this patient. The manufacture date expired first on 11/30/2022 rather than the 10 weeks out of the date received which would of marked it 01/13/2023. MA thought it was a typo on the expiration date and proceeded on giving the vaccine.  Patient reports no symptoms.
Bilateral ear swelling, redness/rash along back of ears extending from neck to scalp, large painful lump on back of head, neck pain/stiffness, facial swelling
Information has been received from a medical assistant concerning a her about 13 year old daughter with drug reactions or allergies reported as none who on an unspecified date was vaccinated with a second dose of GARDASIL (lot # not reported) intramuscularly. On an unspecified date the patient experienced a localized reaction at the injection site that included a burning sensation. This experience only occurred after the second dose of GARDASIL. The patient did not seek medical attention. At the time on the report on 27-AUG-2009 the patient had recovered. Additional information has been requested.
Staff member reported itchy throat, chest tighness, hoarse voice and swelling of neck area and eyes. On site physician was called, and staff member was evaluated. Pharmacist (myself) and director of nursing was present. Patient O2 sat was checked at 99% and BP noted to be 170/116. Staff member was able to swallow water and speak however recommendation made to call 911. EMT brought staff member to hospital where throat and chest tightness progressed. Staff member was given epinephrine, steroids and benadryl q6h and referred to her allergist.
Burning pain in arm up to neck, confusion, chills, elevated heart rate, shortness of breath, burning sensation in back, joint pain, fatigue, took 2 Tylenol every 3 hours.
RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
45 min. after vaccine was administered, he started geetting flushed,lips were swollen and rash (hives) all over. Was given Decadron 10 mg and Benadryl 50mg. After 1 hour he started to feel better, rash went away after 2 hrs.
Information has been received from a 27 year old female who was vaccinated three times with Gardasil.  Subsequently, the patient experienced arm pain with all 3 doses and after the third dose, broke out with a rash on the arm that she had received the vaccine.  The patient outcome was not reported.  No further information is available.
Myalgia, Fever, Inj site swelling and pain, fever, chills and body aches Narrative:
This report was received from Pfizer and was assigned manufacturer report number 2015142956 for PREVNAR 13. The originally reported by a pharmacy student concerning to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, route application site were not reported) and she had a local reaction. No concomitant therapies were reported. The outcome of the vaccination site reaction was unknown. The reporter considered vaccination site reaction to be related to PNEUMOVAX 23. Additional information has been requested.
Moderate to severe pain in the joints and muscles of the arms, legs and back. Low grade fever for 3 days. Shooting pains in the arms and legs. Nightmares. Severe headache and neck pain. Hyperesthesia.  Within a 1-2months after my second dose of Moderna I began to experience knee pain which became increasingly worse, impairing my ability to work. I finally had an MRI that August and it revealed severe changes to the intraarticular cartilage. Other joints are affected as well.  During this time I experienced muscle cramps and aches and also lethargy.  Autoimmune profiles negative except for Hashimoto?s disease (not previously diagnosed as autoimmune). Conservative therapy for arthritis has been largely unsuccessful.
Per the DOH we were advised to enter same date as administered for the adverse event.  There was no adverse event.
her son was a little tired and had a tiny bit of soreness in his arm at the injection site; son was a little tired and had a tiny bit of soreness in his arm at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 16:30 (Lot number: ER2613) at the age of 16 years 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: FATIGUE (non-serious) with onset 13Apr2021, outcome "recovered" (14Apr2021), described as "her son was a little tired and had a tiny bit of soreness in his arm at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 13Apr2021, outcome "recovered" (14Apr2021), described as "son was a little tired and had a tiny bit of soreness in his arm at the injection site".  Additional information: When probing for information regarding side effects for the first Covid 19 vaccine, reporter stated that her son was a little tired and had a tiny bit of soreness in his arm at the injection site. She thought the soreness in his arm was because her son doesnt like to get shots and doesnt like needles. With the first dose, his side effects started the day after receiving the first vaccine on 13Apr2021. His side effects only lasted that day on 13Apr2021, by the next day, 14Apr2021, he was fine. patient had not attended any Emergency Room and Physician Office. Patient had not received any Prior Vaccinations within 4 weeks. No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 53-year-old white female pharmacy tech with allergies to codeine, NOVACAINE, had reactions to first few flu shots (had skin test), some environmental allergies and a history of asthma and hypertension who on 06-FEB-2007 was vaccinated with a dose of Pneumovax 23 (lot number 651406/0620F) IM at 2:15 PM. On 07-FEB-2007, the patient awoke during the first night after being vaccinated, with pain in her left arm. On 08-FEB-2007, she was seen in the physician's office. She had erythema at the injection site and tenderness in the left axilla (no enlarged lymph nodes were felt). The patient was being treated with warm compresses and ADVIL. Follow-up information was received from the registered nurse. At the time of reporting, the patient had recovered. No additional information is expected.
11th or 12th - was feeling pretty wiped out and by the 18th, I was on the couch and had overwhelming fatigue and some headaches. 19th, I napped because the body aches were coming on big. Fatigue, joint aches, ears were pulled, swollen feeling on throat and neck; headaches and the back of my tongue was a burned tongue sensation. I had some sneezing. I had hot gritty eyes. I was pale as a ghost and chapped lips and the worse stiff neck.  On Sunday, 22nd, I went and took a instant COVID test (20 minutes) - negative; Wed, 25th, Telehealth with Dr and PCR COVID test - drive-through - that came back negative. I started feeling myself again on September 1st. I was very sick between the 11th of August and Sept 1st. I had took lots of Advil through it is all. Notes: June 12 - Shingrix vaccine - first dose;  Injection upper left arm.
I had upper respiratory congestion, fatigue, fever, chills, headache. I used a home COVID-19 test that came back positive, I called my doctor to have a telehealth visit. Once I had my visit, we discussed my symptoms and positive COVID-19 result. I was prescribed the Paxlovid that I was able to start the Paxlovid on March 20, 2023. I got diarrhea and the metallic taste in my mouth along with severe nausea. These symptoms from Paxlovid lasted so much longer than having COVID-19. I do still have a phlegmy cough left over but for the most part I am recovered.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer Vaccine on 8/13/2021 and 9/19/2021. Presented to ED 1/24/22 for increasing SOB x/10 days 2/2 COVID-19 PNA c/b acute on chronic CHF with worsening renal function. On arrival to the ED pt was tachypneic then pt desaturated to 85% on RA. ED lab work up including CBC, CMP, COVID, influenza, RSV, BNP, troponin, Mg, phos, VBG, PCT, and D-dimer notable for + COVID PCR, WBC 13.2, platelet count 81K, glucose 171, Cr 2.12 (baseline 1.8), BNP > 5000 (up from 1800), troponin 0.10, unremarkable PCT and D-dimer WNL for age. Treated w/decadron and ceftriaxone. Transitioned to comfort care, expired 1/31/22.
pt recvd vax in AM; 10 1/2 hrs later had generalized sz; duration 50 minutes; stopped w/valium; hospitalized for observation;
Numbness in legs, sensitivity in the head area, fatigue, swollen and red eyes. Severe hives covering entire body including scalp of the head, difficulty breathing, sore throat, reflux worsened. Was prescribed Prednisone by healthcare professional.  Rash/hives come and go.
1 year and 5 months ago I applied a facial filler with hyaluronic acid in the area of ??dark circles on my face, I received the modern covid vaccine (031A21A) on March 17, 2021 at 9:00 am. Apparently everything was going well during that day, only my arm hurt but nothing alarming, but at 9:00 pm I began to feel a little discomfort in the area of ??dark circles in my eyes, I did not care and I fell asleep, next day I woke up with a LOT of INFLAMMATION IN THE EYE AREA. I called my facial doctor and he told me that he will take LORATADINE every 12 hours. This inflammation lasted 4 days. I want to know if I can wear the 2nd. Dose. I already have the appointment scheduled for the second dose on April 14, 2021. Please help me know why I had that allergic reaction.
PT SAYS SHE WAS BEDRIDDEN FOR 2.5 WEEKS AFTER ADMINISTRATION OF THE TWO VACCINES FLUZONE HD AND PNEUMOVAX CONCURRENTLY. HEADACHES, FEVER, CHILLS, DIARRHEA, VOMITING, BODY ACHES WITH EXTREME FATIGUE.
12 hours after COVID-19 booster shot I experienced chills and shaking. Following the chills, I was extremely hot. My entire body ached. I had a headache that rivaled the pain intensity of a migraine.  I spent the entire day in bed. The fever, body aches and headache all lasted 24 hours.