chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer, mother of the patient, refers a 12 year old female patient. On an unknown date (also reported as "couple of months ago"), the patient was vaccinated with the first dose of GARDASIL route reported as injection. On 17-MAR-2014, the patient had a two inch diameter bald spot on her head. No treatment was given for the adverse event. No lab diagnostics were performed. The patient did not see any medical attention. The outcome of the patient had a two inch diameter bald spot on her head was reported as not recovered/not resolved. Additional information has been requested.
She got chills; Rash on back; Red Arm; headache; very painful at the shot site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Arm), HEADACHE (headache), VACCINATION SITE PAIN (very painful at the shot site), CHILLS (She got chills) and RASH (Rash on back) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ESTRADIOL (MINIVELLE) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Arm), HEADACHE (headache), VACCINATION SITE PAIN (very painful at the shot site) and RASH (Rash on back). On 06-Mar-2021, the patient experienced CHILLS (She got chills). At the time of the report, RASH ERYTHEMATOUS (Red Arm), HEADACHE (headache), VACCINATION SITE PAIN (very painful at the shot site), CHILLS (She got chills) and RASH (Rash on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. No treatment medications were reported.
Noticed swollen lymph node to left clavicle area.  Node is swollen, approx 10mm diameter in size and tender to touch.  States also tired after the vaccine.
Information has been received from a nurse concerning her child who on an unspecified date, were vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced injection site reactions of rash, redness and swelling. At the time of this report, the patient was recovering. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Presented with vaginal ulcers diagnosed as lipschutz ulcer provides topical cream for treatment
Several children, ages 6-16, vax w/ booster dose; exp stinging at inject site.  Stinging lasted for 1 minute.
I had shortness of breathe and issue with my heart. I had EKG to check on my heart. No issue was found. They prescribed me TYLENOL.
In the morning I had a low grade headache before getting the vaccine. The placement of my vaccination they did hit a vein. The evening of my vaccine I had worse and worse headaches and the migraine became so back that I would feel pressure behind my right eye and I had to go lay down. When I woke up around 03:00AM the next day it was very difficult to open my eye. After taking some pain medication it did start to improve and I noticed both my eye and lips were twitching periodically. I was also getting more frequent headaches between 8 a month being very uncommon however they have dissipated now. The twitching however started to move towards my muscles in my back, abdomen, feet and calves and its only usually at rest. There is no pain, however they do vary in intensity depending on how hard I work. I did have some blood work done that did not show any types of issues that could be associated with inflammation or B-12 deficiency. I am still having normal headaches however the frequency has drastically gone back down to my normal level around once a month.
a patient was administered Flublok vaccine which was held in transition for too long with no adverse event; a patient was administered Flublok vaccine which was held in transition for too long with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical assistant) via phone at call center as the Agency (reference number: 00336138).  This case involved a 24 years old male patient who was administered with a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that was held in transition for too long (lot number: UJ509AA, expiry date: 10-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination on an unknown date (product storage error and product distribution issue).  Medical history, medical treatments, vaccinations, concomitant medication(s) and family history were not provided.  No other vaccines given.  It was a case of an actual medication error due to product storage error (latency: same day).  It was a case of Product shipment delay (latency: same day).  At the time of reporting, the patient had no adverse event.  Caller states that they received an email that states that the Flublok vaccine was held in transition for too long. They did not received the email until the end of the day and two doses had already been administered.   Product used: Used.  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.
15 minutes after vaccination. Patient felt light headed and fainted for couple seconds. She returned to consciousness immediately and sat down for an additional 20 minutes before heading out.
The patient reports that about an hour after vaccination the shoulder of the arm where she was vaccinated started hurting and she couldn't lift her arm. She reports that the bandage was much higher on her arm than she is accustomed to. She reports that as of today her shoulder still hurts.
Hives /Urticaria on lower back and up between shoulder blades. Extremely itchy. Came on about 1 day after the vaccination and has not improved in 9 days.  Very concerned about whether or not to get the second dose! Please contact me with any advice on this.
Day 6 diarrhea through day 13, Day 1: immediate hives on neck and chest within 45 minutes of injection,  Day 6 to current: ringing in ears, rapid pounding heart.  Day 9, funny coper taste in mouth, loss of appetite, dizzy, headaches, 7 pound weight loss,  day 9 palpitations, incredible thirst, dehydration.   Most have resolved by day 15 however ringing in ears and pounding heart still exist to current.
Pt reported severe muscle spasms of arms and legs, severe back pain radiating to hips, patient could not walk, touch toes due to leg spasms for 2 days.  Symptoms have subsided now.
Arm soreness for 3 days following injection Fatigue day after injection Sore throat, feels like swollen tonsils began 2 days after injection and continues today Visible sore under tongue began 2 days after injection and continues today
after given vaccine she woke started feeling itchy around the area where varicella was administered, then the next morning when she woke up she started to notice her arm swelling.
1st Vaccine 1/29/2021; seen on 2/4/2021 at ED in the am and discharged home from ED same day with DX Acute shoulder pain onset 1/29/2021; then later seen at ICC 2/4/2021 for same complaint of left shoulder pain onset 1/29/2021; DX's Tendinitis Left Shoulder, Osteroarthritis Left Shoulder.
Pt  is a very active and strong young man. He had his first Pfizer vaccine on 11/20/21. Sour arm after one day rest he was all good. Cause he has lots of exercises and activities, we were planning to have his second dose next week. But he started to complain one side of his chest hurts while breathing yesterday morning (12/11/21). He had a swimming meet the night before, the first swimming meet after his first dose vaccine. But he went to swimming practices 3 times per week and Speed skating 3 times per week. No complain before the swimming meet.
pt recv vax & pt in MD office 28OCT96 w/bruises on legs;dx thrombocytopenia problem ITP 1NOV96 CBC nl;
Low blood pressure Sweating all the time Loss of energy Dis colored urine   All systems are still on going  I don't have health insurance and no one will see me
Severe joint pain mostly at night in legs and arms which started approximately 8 weeks after my last vaccine dose and lasted about four months.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # L013203 with expiration date: 28-JAN-2017, lot# K010755 with expiration date: 19-MAY-2016, oral, dose was unknown) (incorrect product storage). The vaccine was excursion to -3.8 degree centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Woke at 2 am with severe muscle and joint pain, muscle/joint fatigue and low-grade fever. This continued for approximately 36 hours. This was the worst, continuous muscle and joint pain I have ever experienced. I've had numerous broken bones, injuries and child birth. My pain tolerance is pretty high at this point. The closest in pain/fatigue I could compare this to is after I took a 6+ hours trip via horseback up into the mountains. I had quick and severe reaction to shot 1 & 2. I expected comparable but this was worse, much worse. I fear a 4th shot might do me in.
less than ten minutes after administration of JJ vaccine, patient started to complain of nausea, palpitations, and a "warm flush feeling", but the patient did not exhibit any signs of visible color change.  All of the stated symptoms appeared with rapid onset together over a period of 1 to 2 minutes, then started to reside.  Patient was given 25mg diphenhydramine and stabilized.  Patient instructed to wait additional 30 minutes in pharmacy and had no additional symptoms and stated she felt ok prior to leaving.  Follow up phone call 4/7/2021 and patient stated she experienced no additional or subsequent events/symptoms.
Bilateral lower extremity edema and paresthesia in feet with pain when walking or standing. Pt advised to elevate legs, compression sleeve given for left extremity ( right leg/ankle had improved by time of visit). Pt advised to take Tylenol for pain, started on HCTZ 12.5mg  for edema.
PATIENT'S WIFE CALLED APPROX 5:45PM 3/9/18 TO SAY PATIENT WAS EXPERIENCING NUMBNESS IN LEFT HAND AND NUMBNESS IN TONGUE. PATIENT WAS TOLD TO GO TO HOSPITAL, BUT REFUSED.  PATIENT FELL DOWN FLIGHT OF STAIRS THE FOLLOWING DAY (3/10/18) AND WAS HOSPITALIZED UNTIL 3/12/18. TREATMENT RECEIVED AT HOSPITAL NOT KNOWN TO REPORTER OF THIS FORM.
Pt recvd MMR/DTP/OPV/HIB 21MAY on 22MAY began w/fever 102, 23MAY t101, diarrhea Sunday & Sat rash over body Sunday 24MAY in afternoon;
Severe headache, pain behind eye, profuse sweating, nausea, lethargy, pain and redness at injection site, lasted 1/1/21-1/2/21
Information has been received from a 57 year old female patient who on 08-SEP-2009 was vaccinated with one dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included influenza virus vaccine (unspecified). ON 08-SEP-2009 the patient experienced muscle pain in the shoulder and thumb sized red splotches. The patient did not seek for medical attention. At the time of the report, the patient was not recovered. Follow-up information has been received from the consumer's husband who indicated that suspect therapy on the same day included a dose of influenza virus split virion 3v vaccine inactivated  (MSD) (Lot # 06449111A) on the left shoulder. Subsequently, the patient had severe pain in her left shoulder, fever and blotchiness around the injection site to her elbow. At the time of the report the patient's outcome was not specified. This is one of several reports received from the same source. Additional information has been requested.
hard to breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced DYSPNOEA (hard to breath). At the time of the report, DYSPNOEA (hard to breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  4 days after receiving the first vaccine dose, the patient was having trouble breathing. The wife eventually called an ambulance. The wife reported that her husband is "ok now."   It is unknown whether the patient received his second planned dose scheduled on 16MAR2021.    Reporter did not allow further contact
BRUISING ON MY RIGHT SIDE. I NOTICED FIRST BECAUSE MY NECK HURT. LOOKED IN THE MIRROR-BIG BRUISE THERE SIZE OF MY FINGERS. ABOVE THAT IS A SCRATCH! I HAVE A BRUISE ON MY RIGHT BREAST! AS I STAYED IN BED THE WHOLE ENTIRE DAY AFTER THE SHOT FEELING LIKE I HAD A HORRIBLE HANGOVER! I HAVE A DOG SO HAD TO TAKE HER OUT A FEW TIME ONLY TO GET BACK INTO BED AND DRINK WATER WHICH IS ALL I HAD THE DAY AFTER THE BOOSTER. SHOT ON THURS. IN BED FRIDAY. TODAY I WENT TO THE PHARMACY AND TOLD THEM WHAT MY EFFECTS ARE. HE TOLD ME TO KEEP A LOOK OUT ON MY LEGS FOR THROMBOSIS!!! MY HEALTH HAS BEEN PERFECT.
Major diarrhea, multiple times a day; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 22May2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22May2021 at 14:00, the patient experienced major diarrhea, multiple times a day. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event major diarrhea, multiple times a day was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
On 11/4/00, at 10:45AM, parent reports child taken to ER on 11/3/00 and dx'd fever, swelling and redness to thighs. Child to take Motrin and alternate with Tylenol and Pedialyte, per ER instructions. Mom reports temperature still 101F. Mom to follow-up with PMD or ER if further problems.
Vesicular lesions with a red base scattered throughout the body, face, scalp and back in various forms - approximately 25.
On 12/14/2000 the patient experienced chickenpox with a rash or lesions. The lesions were papular/pustular and all over the trunk, legs and arms. The patient was itching and crying. Medical attention was sought. Follow up from the physician reported that the lesions were dry and he will obtain a specimen for analysis. A specimen was obtained on 12/15/2000.
This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. Her medical history included allergy to salicylate. Concomitant medications included methocarbamol, levothyroxine and phenytoin. On 02-OCT-2014, the patient received intramuscular AFLURIA (batch number T58906) in the right arm. ON 02-OCT-2014, the night of the vaccination, the patient developed a headache. ON 03-OCT-2014, the patient developed swollen, burning rash one inch below the injection site. The rash was hot to touch and painful when touched. Patient stated that it did not itch. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (Nasopharyngitis) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Jun-2022 at 5:59 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jul-2022, the patient experienced NASOPHARYNGITIS (Nasopharyngitis). At the time of the report, NASOPHARYNGITIS (Nasopharyngitis) had resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2022-612804 (Patient Link).
Pain; This spontaneous case was received on 30-Sep-2023 from other non-health professional (consumer) via Company (reference number SEQW23-02831) with additional information received on 03-Oct-2023 (being processed together) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 24-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, and anatomical location: not reported) for flu vaccination. The batch number was not reported.  On an unspecified date in Sep-2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient felt pain.  The outcome of the event of pain was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with the case 202304402 (the same reporter).  Company comment: A female patient of unreported age was vaccinated with Fluad Quadrivalent. In the following six days, patient complained of pain. Patient's medical history and concomitant medications were not reported. Due to plausible temporal relationship, causal role of the suspect vaccine is assessed as possibly related for the reported event.; Sender's Comments: A female patient of unreported age was vaccinated with Fluad Quadrivalent. In the following six days, patient complained of pain. Patient's medical history and concomitant medications were not reported. Due to plausible temporal relationship, causal role of the suspect vaccine is assessed as possibly related for the reported event.
Hospitalized 12/2/2021; COVID-19 positive 12/2/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: * Primary Care Provider: MD Admission Date: 12/2/2021 Discharge Date: Dec 8, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: SAH (subarachnoid hemorrhage) [I60.9] Generalized weakness [R53.1] Syncope, unspecified syncope type [R55] COVID-19 [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 79-year-old male, presents to the hospital on 12/2 after he fell at home, syncope.  Patient apparently was feeling weak on Thanksgiving Day and was walking to his bathroom and fell backwards hitting his head on the bathtub.  Patient had been diagnosed with COVID-19 on the day prior to fall, he started to feel lightheaded, dizzy and nauseated after urinating and then proceeded to fall. Patient had his laceration on the scalp on the left side stapled with 4 staples (which have to be removed in about a week post discharge through PCP office.)  Chest x-ray showed COVID pneumonia CT C-spine without any acute pathology but CT head questioned a possible subarachnoid hemorrhage.  Trauma felt that he did not needed official consultation.   Syncope:  This is felt to be related to his poor oral intake secondary to his struggles with ongoing COVID infection.  Orthostatics were negative.  Echocardiogram was unremarkable.  Bilateral carotid ultrasound were also normal.  Patient tolerated out of bed activity, PT/OT recommending home with physical therapy. Subarachnoid hemorrhage:  This was suspected on initial CT however not seen and repeat CT. COVID-19 pneumonia:  Associated with hypoxic respiratory failure.  Patient was previously vaccinated.  Patient will finish 10 day course of dexamethasone.  He was arranged with home oxygen at the time of discharge. Patient did complain of left-sided rib pain, however her rib view chest x-ray was negative for any rib fracture.  Lidocaine provided some relief. Recommended him to follow-up with PCP in 1 week to have the staples removed and also discuss further need of oxygen. Because syncope was felt to be related to generalized weakness, poor oral intake driving restriction was felt not to be needed.  More over patient had negative orthostatics while at hospital.
vasovagal syncope, approximately 8 hours after administration. patient stated started to feel sick around noon or one o'clock and rested, then around 8pm, felt severe lightheadedness and almost fainted and lost control of bowels. he stated he does have heart condition and was not feeling well a month prior to vaccine, July 28, 29, 2019. he also stated took a tramadol prior to reaction and wondered if that could have contributed. he stated he has had flu shots in past and didn't recall any adverse reaction. he stated he would contact doctor for follow up.
Severe pain in sciatic,, left side. Couldn?t move. Numbness in front left leg. Lasted about 3 weeks! Yes, 3 weeks. Pain n sciatic lasted about a week that was severe then subsided a little. I slowly regained motion where I could walk but used a walker in the house. Stayed in the house! Took acetaminophen. Rubbed muscle in left leg and sciatic and glut. Exercised leg, stretching etc. When I felt less pain and could walk a little with confidence  I walked in the house, slowly, carefully. Did not see physician or go to emergency or hospital.
nose was runny; voice was a little scratchy; Tired and nostalgic; bad headache; tenderness of her arms; Felt sick; Nauseous; throwing up; Fever; Shaking; teeth were clattering; Joints and elbow were hurting; Gums were hurting; Cheeks hurting; A spontaneous report was received from a consumer who was also a 60 year old female got the Moderna COVID-19 vaccine around 10:00 am on Jan13 in her left deltoid muscle at her house (foster care location).   Right after administration she did not feel anything besides tenderness of her arms but nothing bad. By 19:00 she felt so sick she did not want to eat; the smell of food was making her nauseous but forced herself to. By 21:00 she was throwing up her food, had a fever of 104 degrees F and was shaking. She drank tea to help but she couldn't hold the cup right because she was shaking, her teeth were clattering, and her joints and elbow were hurting even though her rheumatoid arthritis is under control. She also mentioned her cheeks and gums were hurting also. This lasted a total of two hours.   She took Tylenol also which helped. The next day she was feeling out of it, tired and nostalgic. She had a bad headache but the third day she was feeling better. Jan 15 she was feeling a little tired, but she was better overall. Now (Jan 19) she noticed her nose is runny and her voice is a little scratchy.