chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT CAME TO PHARMACY TODAY ON 12-1-17 AND REPORTED A SMALL KNOT IN ARM THAT IS GETTING BETTER BUT STILL THERE AND SOME SORENESS. SHE JUST WANTED TO LET ME KNOW SINCE VACCINATION WAS GIVEN ON 11-3-17 IN THE LEFT ARM. NOTHING VISIBLE ON THE SKIN. TRIED TO FEEL IT, COULD SOMEWHAT FEEL WHEN ARM WAS FLEXED, COULD NOT FEEL WHEN ARM WAS RELAXED. TOLD HER I WOULD CONTACT HER NURSE PRACTIONER WHO SHE SEES SOON FOR AN APPOINTMENT. TOLD HER I WOULD CHECK ON HER WEEKLY TO MAKE SURE CONTINUING TO IMPROVE.
Pt presented for 2nd dose on 02.03.2021. Upon filling out VAR, pt marked they had received an IV for COVID in December, was unsure of the medication. The VAR in January did not ask that question. Confirmed with pt's Dr that pt had bamlanivimab on December 8, 2020. Deferred 2nd dose until 90 days post infusion
Cellulitis developed 6 hours after vaccine. Patient went to ER and sent home. Went to pediatrician at 8:30 am 10/21/14 and was put on KEFLEX 750MG twice daily. Patient is slowly recovering.
PATIENT EXPRESSED SHE HAD A FLU LIKE SYMPTOMS 2 NIGHTS IN A ROW PROCEEDING HER VACCINATION WITH SHINGRIX. THESE SYMPTOMS WERE (TOTAL BODY ACHE, RUNNY NOSE, AND VOMITING).
Information has been received from a registered nurse concerning a 35 month old white female with no pertinent medical history or past drug reactions or allergies who on 06/29/2001 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live.  The patient presented to the physician's office with a breakthrough case of chickenpox.  She was noted to have a rash on her chest and breast, and have malaise and a fever of 101 degrees.  She was treated with Benadryl and Aveeno.  Unspecified medical attention was sought.  There was no product quality complaint.  The outcome was reported as not recovered.  Follow up information received from a registered nursed indicated that the child presented to the office on 06/07/2004 with a fever, and a rash on her chest, breast, axilla, and both arms.  Malaise was noted 2 days prior.  The child was treated with Aveeno bath and Benadryl 12.5mg/5ml; 0.5 teaspoon 2 times per day by mouth for itchiness.  The outcome was reported as recovered.  The patient's sibling experienced chickenpox and wheezing following vaccination with varicella virus vaccine live.  No further information is expected.
I got sore at injection site, next day slight fever and chills. Then almost two weeks later I woke up with all my joints hurting me, the worst part was my wrist, ankles, feet, and the parts that were swollen were hot to touch. I went for the second dose and that was on April 24th and I'm in the same condition and it's debilitating. The Lot number for the 2nd dose of the Moderna is #006C21A.  All of my joints are swollen, wrist, ankles, knees everything.  I went to the doctor twice and they did x-rays of everything it said it was fine no swelling, and prescribed Ibuprofen for the pain but the doctor said it could be sepsis, water on the knee or arthritis.  I can?t brush my teeth, can't comb my hair, can't open a bottle or nothing. How long will this last where can I get help. I can?t curl my hands when I sleep, I can't sleep like normal anymore everything hurts. I can?t even pick up my cell phone.
throat tightness; feeling of a lump in her throat; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Jan2021 as a single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  Patient experienced throat tightness and a feeling of a lump in her throat after the first dose. She went to the Emergency Department after it occurred. She had seen her Primary Care Provider. The patient underwent lab tests and procedures which included blood work with unknown results   done by her allergist.  The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient complained of tingly lips, itchy left arm (near vaccine site).  Patient waited 30 minutes with improvement of symptoms and left the site.
Fever, Chills, Headache, Lightheaded, Muscle aches, Joint pain, Swollen lymph nodes, Fatigue, Exacerbated POTS symptoms, Sacral pain, Stiff neck. Occurred about 12-18 hours after booster shot.
Nausea, vomiting, headache - pressure like headache. Lightheaded and dizzy when they get up. (All several hours after the vaccine)
Headache, fatigue, muscle ache (mainly in back), joint ache (legs), soreness at injection site. All of these started within 6 hours of having been vaccinated. Alternating ibuprofen and acetaminophen provided good relief for muscle/joint ache. This also reduced the severity of the headache, but did not relieve it. Headache, muscle ache, and joint ache resolved by 40 hours post-vaccination. Mild fatigue/tiring more easily gradually improved over the next 48 hours. I took one day of sick leave from my job to rest.
Two days post receiving the first dose of theCOVID-19 Vaccine by Moderna, I noticed menstrual spotting and abdominal cramping despite being on birth control and being a week away from my regularly scheduled period. This is extremely out of the ordinary because my periods are very regular and I have never experienced break through bleeding in between my periods. It has been only around 48 hours after receiving the vaccination that this occurred.
acute myocarditis; acute onset chest pain; admitted to the pediatric intensive care unit; about to receive IVIG. Chest pain started 5/1/20 about 2 days after her 2nd Pfizer COVID-19 vaccination
an adult patient had given the ActHib vaccine today; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 38 years old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UI795AA, expiry date: 18-Jun-2022 via unknown route in the right deltoid on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccinations or medications that day.   It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  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.  Documents held by sender: none.
Information has been received from a physician concerning an 18 month old male who 21-APR-2006 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There were 4 additional vaccinations, unspecified, given on the same day. On 26-APR-2006, more than 48 hours later, the patient experienced hives on his back, which were examined by a physician. Additional information has been requested.
Very tired and weak, bone pain, and very cold. lasting 36 hours   On 11/13/21 am Right arm felt very weak and "funny", her lymph nodes in right axilla area very swollen and sore- swelling and soreness travelled to side of right breast.  Came to the employee health clinic on site  on Monday, 11/15/21.  She saw Dr. - he examined employee. There was still some soreness and lymph node swelling- he told employee to take tylenol or motrin as needed.  On 11/19/21 time of report- symptoms are better, minimal lymph node swelling now and little soreness, other symptoms gone.
Initial report received from a physician on 10-August-2005.  A ten year old female patient developed a fever and an abscess at the injection site the day after receiving the injection of DECAVAC, lot number U1219BA in the left deltoid on 20-June-2005.  Route of administration not reported.  The day after vaccination in the left deltoid at the injection site was red, tender, painful and 3cm x 4cm in size.  The patient had a fever under 101 degrees Fahrenheit which lasted 1-2 days.  The injection site still has some symptoms.  The patient received corrective treatment with KEFLEX which was started on 10-August-2005 for a 10 day duration.  The patient is to follow up with a surgeon.  Recovery status of the patient was not reported.
I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much worse than my usual migraines. It was gone by the morning of 1/2/21. I was advised to report this.
L forearm erythema 5x6 cm2 and mild pain.  Pain killer/TYLENOL, ibuprofen as needed.
evening of vaccination developed fatigue, sweats, palpitations and subsequent DOE and orthopnea that persisted and led to hospitalization 3/7/2021 for atrial fibrillation with rapid ventricular response and acute on chronic decompensated systolic CHF.
Kinrix was accidentally given instead of Pediarix; kinrix given to 4 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 15-MAY-2023, the patient received Kinrix. On 15-MAY-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was accidentally given instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: kinrix given to 4 month old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2023 The reporter was an office manager. The information for the immunogenicity, safety and recommendations was solicited and given.  Information about vaccine, patient and event were collected.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The 4-month old patient received Kinrix accidentally instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Blotchy, warm to touch, itchy, raised, red rash at the injection site 2 weeks after vaccination. Rash has grown and is currently 4 inches by 2.5 inches
a 11 year and 5 month old patient who was supposed to receive Tdap but was given Daptacel instead with no reported adverse event; a 11 year and 5 month old patient a dose of Daptacel with no reported adverse event; The patient already had 5 previous doses DAPTACEL and received sixth dose of DAPTACEL instead of Tdap  with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00588679) and transmitted to Sanofi on 05-May-2021.  This case involves experienced a 11 year and 5 month old patient (gender unspecified) who was supposed to receive DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [Tdap] [lot number, expiry date and other dosing details were not applicable] but was received sixth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] [lot number, expiry date and other dosing details were not reported] instead (wrong product administered, product administered to patient of inappropriate age and extra dose administered).  Medical history, medical treatment, family history and concomitant medication were not reported.  It was reported that, the patient already had 5 previous doses of Daptacel vaccine.   It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. (latency: same day)  At the time of report, no adverse event was reported.  At the time of report, reporter would like to know about any safety information and any long-term effect information.    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.
Woke up this morning with a throbbing headache and tightness/soreness from my shoulder to up my neck. It feels like I slept funny and have a bad kink in my neck. I am also feeling a little light headed and slightly nauseous. I ate some oatmeal for breakfast and took 1000mg of Acetaminophen and it has not helped. Its been almost 2 hours since I took the tylenol with no result.
Pt recvd vax 28SEP92 & 2 to 3 days p/vax pt exp itching from head to toe which persisted for aprox 3 days followed by a rash on face, arms, legs, & trunk which persisted for 2 days; also had swelling of eyes; pt latered recovered;
First he complained of pain, we noticed it was very swollen, raised and red. He complained of pain throughout the day.  The next morning the swelling was down but the area was bright pink in a well defined 2 inch area around the shot, and it was warm to the touch.  He was a bit grumpy, and didn't eat well for those two days.  The next morning it looked fine.
Was driving and had a seizure; Banged her head; This spontaneous case was reported by an other and describes the occurrence of SEIZURE (Was driving and had a seizure) in a 54-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.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Was driving and had a seizure) (seriousness criterion medically significant) and HEAD INJURY (Banged her head). At the time of the report, SEIZURE (Was driving and had a seizure) and HEAD INJURY (Banged her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
BODY ACHES; FEVER; CHILLS; ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. .The patient received covid-19 vaccine ad26.Cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 12:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the  patient experienced body aches. On 08-MAR-2021, the  patient experienced fever. On 08-MAR-2021, the  patient experienced chills. On 08-MAR-2021, the  patient experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain, was recovering from chills, and had not recovered from body aches, and fever. This report was non-serious.
HEADACHE; VISION BECAME VERY BLURRY; GOT VERY HOT; STARTED TO SWEAT/SWEATING; FELT LIKE WAS GOING TO PASS OUT.; This spontaneous report received from a parent concerned a 26 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:1816022, expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced vision became very blurry. On 18-AUG-2021, the patient experienced got very hot. On 18-AUG-2021, the patient experienced started to sweat/sweating. On 18-AUG-2021, the patient experienced felt like was going to pass out. On 19-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision became very blurry, got very hot, and felt like was going to pass out. on 18-AUG-2021, had not recovered from started to sweat/sweating, and the outcome of headache was not reported. This report was non-serious.
Patient is a 93 year-old male, with past medical history significant for HTN, prior ICH, suspected CKD, meningioma and recent SARS Covid 19 infection.  Prior to his hospitalization, patient was hospitalized, early September, 2021 when tested positive for COVID on admission on 09/02/21 . Reportedly his symptoms started on 08/30/21. He was found to have right upper lobe consolidation. He was treated With Rerndesivi rand ceftriaxone, which was transitioned to Cefdinir upon transfer to skilled nursing facility on 09/08/2021.. At that time, he was fully oriented and able to talk over the phone. Since then, he reportedly became increasingly confused. disoriented, with nonsensical speech without focal deficits. While at hospital, he was incidentally noted to have meningioma on head CT.  Patient was seen at ED on 09/19/21 for reported acute respiratory distress. His oxygen saturation was reported to be in the 60% range. He was on NRB, which was slowly titrated down to 6L via NC. He was also hypotensive.  Patient died 9/23/2021 at 2: 19 AM. Cause of death acute hypoxemic respiratory failure, bacterial pneumonia; nonSTEMI, severe aortic stenosis, recent COVID-19.
Injection site began itching night of 3/11/21 getting more and more itchy through 3/12/21 and worse today 3/13/21. Very very hot to touch, swollen, firm, red, in about a 6inch diameter
2-3 hours following administration of flu shot patient broke out in blotchy red rash starting on right leg, it then spread to right arm & face, then continued to spread to entire body, transported to ER, as clinic was closed. BENADRYL given & 12 hours following, rash has resolved.
Running nose; a sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose) and OROPHARYNGEAL PAIN (a sore throat) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Running nose) and OROPHARYNGEAL PAIN (a sore throat). At the time of the report, RHINORRHOEA (Running nose) and OROPHARYNGEAL PAIN (a sore throat) outcome was unknown.            No concomitant medication was reported. It was reported that the patient was vaccinated (2 times with Moderna and his booster was Biontech/Pfizer). The patient suffered from a running nose and a sore throat. No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Strong chest pain diagnosis  PERICARDITIS arritmia and heart attack per EKG MRI and Catéter
DAY AFTER VACCINE ADMINISTERED C/O SWELLING, REDNESS, PAIN AT SITE.  2 DAYS AFTER-ALL SX WORSE. 3 DAYS AFTER SWELLING & HARD AREA IN AXILLA.  ALSO C/O NAUSEA & VOMITING.  SENT TO MD AT THAT TIME.  5 DAYS AFTER ADMINISTRATION OF VACCINE REDDENED AREA AT SITE WITH DARK AREA NOTED.  STILL C/O NAUSEA.  SENT BACK TO MD.  PHENERGAN GIVEN.  6TH DAY PAIN & SWELLING SEEM TO BE LESS.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 07-MAY-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # J008802, expiration date: 19-OCT-2014), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA At about 10:00pm Wednesday, I started to have a headache and feel tired. My temperature was mostly normal (99.4F) when I went to bed around 2:00am. When I woke up at 12:00pm Thursday, my temperature was 103.9F. By 12:30pm, it was 102.9F. I had a very bad headache, sore throat, nausea, and some light-headedness. My fever went down throughout the day with 2 doses of Tylenol at 1:00pm and 6:30pm. The sore throat, nausea, and light-headedness resolved during the evening, but my headache was constant until I went to bed. Today (Friday), I woke up with a slight headache but no fever or other symptoms.
ZOSTAVAX administered 2/18/08. Hearing loss in Rt ear approximately 10 days later.   8/11/09 Otolaryngology consult records received DOS 2/05/02 to 7/21/08. Patient presents with sudden hearing loss. Concerned that hearing loss occurred because she "exercises too much". She washed out the ear with Murine which made things worse. Cerumen impactions.
Chest pain starting about 55 hours after second Pfizer shot. Patient described it as medium pain and it?s not constant but hurts when his heart beats. No other symptoms. Other symptoms from about 36-48 hours post second shot included fatigue, low grade fever, and head pain. Course of treatment for chest pain, per pediatrician, administer ibuprofen to see if improves chest pain and go to hospital if symptoms worsen.
Hives (right side on shoulder); Itchiness; Headache; Fatigue; Pain at injection site, Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives (right side on shoulder)), PRURITUS (Itchiness), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site, Soreness at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy and Drug allergy (Minocycline Allergy.).    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced URTICARIA (Hives (right side on shoulder)), PRURITUS (Itchiness), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site, Soreness at injection site). At the time of the report, URTICARIA (Hives (right side on shoulder)), PRURITUS (Itchiness), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site, Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported No treatment information was not provided
Swelling, redness with streaking down left arm. Onset began within 24 hours of vaccine being administered.