chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a booster dose 0.25mg and this should have been full dose 0.5mg as it is first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment medications was not reported.
07/18/06 called office. Stated child had immunizations on 7/5/06. R leg got red swollen. Vomited that night 6-7 times, refused to eat. Jerky movements in sleep and when awoke excessive BM's. Ok by 1:50PM 7/6/06
THE NEXT MORNING THE AREA OF INJECTION WAS SLIGHTLY SWOLEN AND VERY SORE TO TOUCH.  IT STILL IS TODAY.
Vaccines given on 1/26/04. By history, pt developed a petechial rash on 2/1/04. He was also noted to have bloody "spit up," blood in his stool and a bruise on the R arm. Pt was brought to medical attention on 2/5/04 and was noted to have a diffuse petechial rash and bruise as noted above. He was admitted through a local ER.
Soreness at the injection site; Fatigue; Chills; Achiness; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Supraclavicular lymph node by my left collar bone became tender and swollen/Lymph node in my left armpit became tender and swollen; Runny nose; Scratchy throat; Nausea; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar; This is a spontaneous report from a non-contactable consumer (patient). This 43-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 09:45 AM (lot number: ER8729), in left arm. as the first single dose, for COVID-19 immunisation. Medical history included allergies to triamcinolone acetonide (KENALOG), minocycline, doxycycline, sarecycline. The patient did not have COVID prior vaccination. Concomitant medications were none (no other vaccine in 4 weeks, no other medication in 2 weeks).  The patient experienced soreness at the injection site and fatigue on 08Apr2021, starting a few hours after the shot and lasting for over a week. On day 4 (Apr2021) she experienced chills for a day, achiness for a week, supraclavicular lymph node by her left collar bone became tender and swollen, lasting over three weeks, runny nose and scratchy throat. This was the same side as the shot. The healthcare worker injected the shot very high on the corner of my shoulder, almost on top of her shoulder. She also experienced. On day 5 (Apr2021) she had nausea lasting for two days. On day 7 (Apr2021) she experienced lymph node in her left armpit became tender and swollen. She couldn't close her arm without causing pain to the lymph node in my left armpit. On day 9 (Apr2021) she had chills again for a day. On day 10 (Apr2021) she had another lymph node by her left collar bond which became tender and swollen, lasting over three weeks. The other swollen lymph nodes grew in size. Period came two days early. It was very heavy and included unusually large clots that were larger than a silver dollar. The patient had recovered from the reported events without any treatment. COVID was not tested after vaccination.  No follow-up attempts are possible. No further information is expected.
Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture; Dose was given past 12 hour post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given past 12 hour post-puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given past 12 hour post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given past 12 hour post-puncture) and PRODUCT STORAGE ERROR (Vial was punctured on 10-Mar-2022 at 9:24 and refrigerated post 12 hours puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored in the refrigerator on 10-Mar-2022. Vial was punctured on 10-Mar-2022 at 9:24 and stored in fridge post puncture. Vial did not undergo any temperature excursion. For a very minimal time vial was exposed to room temperature (8 to 25 degree Celsius)  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 18 months old male patient who received a expired dose of DAPTACEL lot C5169AA, expiration date: 16-Mar-2019 via unknown route in the left thigh on 19-Mar-2019. The patient's past vaccination(s) included was 3 DAPTACEL doses. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included was HIB VACCINE and HEPATITIS A. It was an actual medication error due to expired vaccine used. A 18 month old boy received a expired dose of DAPTACEL. No adverse events reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
The shot was given in my left shoulder.   Two days later the left shoulder blade became rather painful, making movement difficult.   E.g. turning my head to the left was very uncomfortable.   These symptoms lasted about two days -- by a week later they were gone   I used a hot pad and tylenol to become more comfortable.   Probably not a very significant issue, but it was uncomfortable,   I wondered if I perhaps had "pulled a tendon" or something like that.
received only the adjuvant; received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number H9LL4, expiry date 24th November 2023) for prophylaxis.   On 10th November 2022, the patient received Shingrix. On 10th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's comment: The nurse reported that the patient received only the adjuvant of Shingrix.  The reporter consented to follow up. Additional supportive information: The patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a physician concerning a female who was vaccinated with Gardasil (lot# not reported).  Per the reporter, the patient fainted but recovered quickly.  The physician stated "it wasn't like real syncope."  The patient sought unspecified medical attention in the physician's office.  No further information was provided.  The physician did not wish to be contacted.  Additional information is not expected.
About 7-8 hours after the shot, I ended up with 2 red spots on my upper body. Not injection site, but very close to it. Looked like bug bite. I dismissed it as such. By the next morning those became big in size (1 inch in diameter) and very itchy. And 5 more appeared on my stomach and legs within next 24 hours, also about in inch in diameter and extremely itchy.
A serious medically important event of flattened right facial area with uneven smile, cheek felt heavy, chewing favored on left side, right eye dryness and pain was received from a physician concerning a ten-year-old female. The patient's medical history include a recent treatment with Diflucan for vaginal moniliasis. No concomitant medications were reported. The patient received one dose of FLUMIST intranasally on 06-Nov-2007. On 08-Nov-2007, the patient's father noticed that the patient had an uneven smile; preferred to chew on the left side of her mouth. There was no complaint of pain or difficulty in swallowing. The patient was seen at the reporter's office on the same day. On examination, flattened right facial area was noted along with complaints of right eye felt dry with slight pain and right cheek felt heavy. No redness or swelling noted and patient felt skin touched and pricked. No laboratory tests were done. There was no treatment done except for observation and close contact with patient's father. The events were resolved by 12-Nov-2008. The patient did not experience rechallenge. The reporter did not provide a statement of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
18 days after 2nd shot- Polymyalgia rbeumatica attack, extreme muscle weakness, dizziness 2 trips to the ER, in bed for 30 days, too weak to get off of the sofa or eat much for 30 days. I was very "unwell" had to hire someone to stay in my home with me in the mornings 8am until 12 noon. I lost 20 lbs, both arms feel very heavy with a very stiff neck, trembling hands and anxiety due to immobility.
1JUN92 pt recvd Engerix-B vax & exp elevated liver enzymes & w/in hrs of inject exp flu-like sx; events reported as being immed life threatening;
Breakthrough case admission after 3 vaccines Pfizer 2/16/21 Lot# EN6200;  Pfizer 3/9/21 Lot# EN6207;  Pizer 10/5/21 Lot# FC3181
Swelling and redness at injection site - immediate and still suffering 6/28/2019.  Cannot raise my arm Headache - immediate and still suffering 6/28/2019 Muscle ache - started 6/27/2019  still suffering 6/28/2019
Patient received J&J covid vaccine on 4/7/2021.  Patient presented to the ED on 5/3  for right arm swelling with redness.  Patient was found to have proximal right upper extremity DVT extending to right subclavian vein along with bilateral PE in the ED.    The provider noted the patient had no risk factors other than receiving the vaccine, requested a hematology/oncology consult for evaluation hypercoagulable , patient started on bivalirudin while HIT work-up completed plan to transfer to oral anticoagulation upon discharge.
Initial report received from a health care professional on 27 May 2010. A 56-year-old male patient, with no medical history reported, received an injection (route and site not provided) on 03 May 2010 of ADACEL, lot number C3438 AA, and received a second injection (route and site not provided) on 24 May 2010 of Diphtheria, Tetanus and Acellular Pertussis vaccine, manufacturer and lot number unknown, and on 26 May 2010 experienced diarrhea, headache, dizziness and stomach ache. The patient received the first vaccination at an office and then received the second vaccination at his work because he had forgotten he had already had the vaccine. The outcome was not reported. Documents held by sender: None.
Varicella vaccine breakthrough. Diagnosed with varicella on 5-30-07. Had approximately 20 lesions. Afebrile.
The patient received her vaccine then went to go get other scripts at check out. During this time she stated that her lips started to feel numb. We brought her back into the consultation room for her to sit down and to further observe her. A few minutes later the patient stated that she was feeling better and the numbness started going away. She stated that she has never had a reaction to a vaccine before. She stated again that she was fine and left with her spouse. No medical intervention was needed.  Called the patient the next day and again she stated she was fine and the numbness was gone by the time she got home.
Relatively immediate onset of chest pain with elevated blood pressure above normal.  Longer term response was palpitations and irregular pulse limiting regular activity for just over one month. Cough and fluid accumulation in lungs began day 5 (similar to my presentation of Covid-19 infection but less intense).  Regular exercise was able to resume approximately 2/26/21
Patient developed generalized puritis, nausea, hives to left triceps. Patient stated she is prone to allergic reactions to other medication therapies.
On day 3-5 I was very fatigued.  I could continue doing my daily routine, but had to stop and take a lot of breaks.  I felt winded and just the way I do after giving blood, just wiped out. Today, a week after, I feel back to normal.
CLIENT RECEIVED INFLUENZA VACCINATION ON OCTOBER 11TH, 2008.  CLIENT REPORTS THAT SHE EXPERIENCED SYMPTOMS THAT SHE REPORTS WAS RELATED TO THE VACCINE ABOUT 1.5 HOURS LATER.  CLIENT STATES SHE EXPEREINCED " A SEVERE HEADACHE", "FELT CLAMMY", AND HAD DIZZINESS AND VOMITING. CALLED EMERGENCY MEDICAL SERVICES.  BLOOD PRESSURE WAS 160/118.  TAKEN TO EMERGENCY DEPARTMENT AND RECEIVED A CT SCAN WHICH WAS NEGATIVE.  GIVEN DARVOCET FOR HEADACHE AND PAIN.
Very cold with chills but no temperature, headache, back, neck & shoulders ached, nausea, tiredness, no appetite. Took Tylenol and slept most of the day.  I did vomit at midnight Wednesday, 4/14, but it was nothing but water since I had only ate a cornbread muffin the entire day, but drank lots of water. Wednesday morning  I was achy all over with a slight headache.  Still slightly nauseous. When I would eat something, toast in the morning, mashed potatoes at lunch, I would be more nauseous and have diarrhea about an hour later. Lunch at noon on Thursday 4/15 was the first meal that I did not have diarrhea after eating.
fever 104 R, sweating babysitter;would not stop crying unlss held;finally p/2hr went to sleep;began jerky type movement of extremities;instructed to call PMD;rx for Ibuprofen;
2 days after the vaccine I began to experience extreme decreased appetite, on and off numbness/weakness in my extremities, restless leg, heart palpitations, shortness of breath, extreme anxiety, depression, and OCD, weightloss, upset stomach/loose stools,  dizziness/ as if I was rocking on a boat that was and still is present but manageable with Physical Therapy and other treatment.  None of these symptoms did I ever struggle with until the vaccine event. At the time of the vaccine I was a healthy 19 year old, full time college student and part time nanny. I was very active in my school's community and was very active. I went from working out 5-6 times a week to getting breathless going up a few stairs and extreme weakness. I lost about 10ish pounds, but keep in mind I am 5'3 and prior to the vaccine was around 123-125 pounds.   While many of my symptoms have gotten better, it was not without running all around to the cardiologist, ENT, SEVERAL visits to my pediatricians office of which the doctors did not listen to me. I did not get the help I needed to start feeling better until I started seeing Dr. and Dr.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patients pertinent medical history, drug reactions/allergies were not provided.  On 30-OCT-2014, the patient was inadvertently vaccinated with dose of M-M-R II, 0.5 ml subcutaneous, lot H015829, which had expired on 24-AUG-2014. No adverse effects were reported. Additional information is not expected since no consent to contact the reporter was granted.
pt recv vax & devel a rash w/50-100 lesions w/many of the face;f/u pt was reported to have devel approx 35 varicella from papular eruptions & OM;
Client complained of lightheadedness shortly after receiving the Janssen vaccine.  At 0830, VSS: 104/60-58 hr and regular, 99% oximeter.  Encouraged to drink some fluids and did take water and snack.  Waited 30 minutes until resolution of dizziness and was able to leave facility safely.  Works at location and had worked the night before.  Encouraged to sleep and drink plenty of water.
Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed Expand All Collapse   COVID VACCINE CLINIC 1/6/2021    Date:  1/6/2021    Subjective Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting.         ALLERGY REVIEW OF SYSTEMS:  All other systems negative   Patient complains of dizziness          Objective    Vitals Vitals:   01/06/21 1216 01/06/21 1229 BP: 124/81 117/81 Pulse: 76 69 SpO2: 99% 100%   BS not done; no diabetes or history of hypoglycemia. NO allergies.    Physical Exam Vitals signs reviewed.  Constitutional:      Appearance: Normal appearance. She is normal weight.  HENT:     Head: Normocephalic.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat.     Palpations: Abdomen is soft.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert.        Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Patient rested on gurney with head elevated for approximately 15 minutes with symptoms resolving without intervention other than water.        PA-C Electronically Signed 1/6/2021 12:29 PM
Chills; ever (highest noted was 102); nausea; vomiting; severe body aches; muscle cramps; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 06Apr2021 at 11:00(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to melons, certain nuts and seasonal allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE); both for unspecified indication and unknown start date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 21:00, the patient experienced chills, fever (highest noted was 102), nausea, vomiting, severe body aches & muscle cramps, fatigue. The patient did not receive any treatment for the events. 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. On 06Apr2021, the patient underwent body temperature and the result was 102(unit unknown). The clinical outcome of the event chills, fever (highest noted was 102), nausea, vomiting, severe body aches & muscle cramps, fatigue were recovering.  No follow-up attempts are needed. No further information is expected.
Severe pain and muscle stiffness radiating throughout body (not limited to area or limb of injection site). Inability to move arms or legs from straight, extended position for 16 hours from time of injection.
This spontaneous report was received from a physician's assistant refers to a female patient of unknown age with hereditary spherocytosis. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (lot #, expiry not reported). On an unknown date, the patient developed shingles. The outcome of shingles was unknown. The causality was unknown. This is 1 of 2 reports from the same reporter. Additional information has been requested.
2 days after the shot, I began showing signs of a cold sore on my left nostril. By Wednesday night, I had 5 cold sores. One in each nostril, one in my septum, one on each side of my lower lip. I've suffered with cold sores my entire life but have never had more then one at a time
dull headache in beginning became intense with nausea and diarrhea for 3 days, pain at the injection site.
Delayed second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delayed second shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) (Was hospitalized for cancer and had a blood infection) since 14-Mar-2021.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Delayed second shot). On 16-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Delayed second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Pox-like structure on the arm where the zostavax was given.  Lasted 3 days and was a little painful.  Generalized nerve pain randomly throughout her body.  also lasted for 3 days