chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild anaphylactic shock; nauseated; about to pass out; bolt of tightness in her chest and across from her shoulder; pain in her chest; shortness of breath; dizzy/lightheadness; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (mild anaphylactic shock) and LOSS OF CONSCIOUSNESS (about to pass out) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (about to pass out) (seriousness criterion medically significant), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness). On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (mild anaphylactic shock) (seriousness criterion medically significant) and NAUSEA (nauseated). On 13-Feb-2021, LOSS OF CONSCIOUSNESS (about to pass out), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (mild anaphylactic shock) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other relevant medication was reported. No treatment information was reported.  This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
7/10/2021 ,3 days after receiving  first dose COVID-19 vaccine - Pfizer, at unknown Pharmacy on left deltoid, patient developed dystonia of left leg. Ba
Patient is our 15 month old that presents with weakness and altered mental status after receiving her 15 month vaccine today. She was in her usual state of health and went to her PCP for her 15 month checkup. She received her vaccine (dtap? mom unsure what was obtained). The left leg where the vaccine was administered was shaking shortly after the shot. Within minutes of leaving the office she had a "goofy look" on her face and could not walk. Immediately went to the ER where she continued to wax and wane. She had a GCS of 7 and the decision was made to intubate her. Life flight was called and on arrival noted that she was being hypoventilated with TV in the 50s which they increased to 100. Initial gas was 7.14/73/25/-5. Subsequently admitted to PICU. Mom notes that something similar has happened twice in the past. First was after her 12 month vaccines where she was also weak and altered that resolved within 24 hours. Second episode was not associated with vaccines but had a URI. She woke up weak and altered and this also self resolved within 24 hours. No seizure activity in the past. Seizure history on both sides of family. Hx of head trauma and skull fracture when she was ~ 8 months old when she was crawling and fell back on her head. Denies any intervention. ROS negative aside from runny nose which has been attributed to allergies. Denies fevers, sick contacts, diarrhea, rashes.
Vaccine "burned" upon administration. Following morning (L) deltoid area was itchy, red, hot and swollen and continued this way x3-4 days. Then became itchy & red x2-3 days. Then resolved.
She got her vaccine, and a couple of weeks after getting it she woke up and she was off.  She wasn't dizzy but wasn't herself, felt off.  Then she got petechia in both legs and she took it easy, drank a lot of water.  She took it easy, but ever since then her energy is not there, she is "zapped".  She has changed her whole routine, she is pretty active and now she cannot do much due to the fatigue.  She is now really concerned as it is lasting.  She feels like she is mentally confused.  She could not tell me her address without looking it up first.  It has started to subside some the feeling of being off.  She feels like that she has no blood in her.  She feels like she's out of iron, and zapped of energy.   She has not called her doctor.
Starting around 11 the night of vaccine, started getting jabbing pains in right armpit area, very swollen lymph nodes and weakness in arm.  Today is Monday and still hasn't subsided.  Have been icing and taking ibuprofen every 4 to 6 hours.   Left work early at 12:30.
patient was vaccinated at approximately 12:40 and began having an itchy face and itch throat at 1:30.  Patient is breastfeeding and decided she was going to pump and toss her milk due to getting vaccine.  When pumping she noticed that her milk was blue in color.  Today patient is feeling achy, joint and legs week.  States she feels like when she had COVID in July.
Patient woke up at 7am and had a fever of 101.8 I gave him some Tylenol and his bottle. He then went back to sleep till about noon. He didn't wake up to eat or anything. He then woke up with diarrhea and still had the fever. I gave him a cool bath a bottle and more Tylenol. He then went back to sleep again. Woke up around 2:30pm still with the same fever. He has been fussy and very tired he has also had a mild cough along with it. I contacted his doctor and they recommended Ibuprofen. I gave him a little of that around 6:00PM I'm still waiting for the fever to break if it does not we will go to the ER.
Dizziness, Headache, Sedation, Myalgia, Arthralgia,  Fever, NauseaVomiting  Sore Throat, Pain/Rednedd/Swelling/Warmth @  injection site
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/25/2023 Discharge Date: Mar 28, 2023  PRESENTING PROBLEM: Other fatigue [R53.83] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 98 y.o. male with past medical history significant for CKD stage 3,  prostate cancer s/p prostatectomy presented to ED with complaint of cough and sore throat.  Patient was found to be COVID positive with mild acute kidney injury.  He was given IV fluids improved quickly.  He was discharged back to his facility.
Patient has Parkinson?s with dementia.  There has been some history of hallucination.  Upon awakening the day after receiving the vaccination, he was incoherent and having hallucinations much more pronounced than previously observed.  This lasted for about 3 hours and he slowly returned to his baseline status.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. It was reported that, since 10-FEB-2017, the patients were vaccinated with an improperly stored dose of ROTATEQ with lot number M026315 and expiration date of 26-JAN-2018, orally (strength and dose were unknown) for prophylaxis, which was stored between 32 Fahrenheit degrees (°F) and 36°F (34.9°F) for 10 minutes. There was no previous temperature excursion and the temperature excursions were not detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007933:
DONOR NOTED A LUMP TO INJECTION SITE ON RIGHT DELTOID WHEN SHE RETURNED HOME. AN AREA OF REDNESS FORMED. AREA WARM AND HARD. SHE HAS NOT DONE ANY TREATMENT. SHE IS ADVISED TO SEEK MEDICAL TREATMENT IMMEDIATLEY.
CoughWheeze dyspnea Narrative:  epi, albuterol, prednisone 40 mg tab, IV fluids, 25 mg benadryl
Per internal incident reporting system: "2nd Hep B vaccine given to patient a week early. No harm to patient but will need to be another vaccine to meet requirements and to make sure that patient is 100% protected against Hep B. Patient was called and updated. Apologies given and situation rectified."  First dose in series given 10/24/22, second dose given 11/15/22.
PT REPORTED FEELING FAINT AND NAUSEOUS MOMENTS AFTER VACCINE WAS ADMINISTERED. RPH  INSTRUCTED PT TO SIT DOWN AND REST FOR A WHILE. RPH OBSERVED PT FOR A WHILE HOWEVER  SYMPTOMS PERSISTED FOR MORE THAN 15 MINUTES. PT WAS THEN REFERED TO NURSING FOR  INTAKE.
While I was running errands the second day on Sunday afternoon after getting my shot I was running errands and I started to feel strange sensations, pressure, chest pain , and shortness of breath.  I went to the emergency room on Monday morning on April 12th.  I was admitted Monday late afternoon and early evening and kept until Tuesday afternoon on April 13th. I was diagnosed with Myocarditis Pericarditis  I was prescribed  colchicine and ibuprofen. I do not remember the dosage and what was put in my IV. I may have taken baby aspirin or two. I met with multiple cardiologists between stay in hospital to present. Cardiology did a stress test  I saw Dr. I have a follow-up with Medicine Cardiology group medicine and I met with another Dr. I have had one meeting with him and another follow-up later this month. Dr. has not reported anything new and nothing was prescribed.  I haven't had any further issues but I am not sure if I am recovered.
1 2 weeks after getting vaccine, patient experienced diffuse body stiffness/pain - trouble getting up in the morning. Stiffness especially in fingers, neck, legs, toes. Resolved gradually by September/October
Bilateral posterior cervical adenopathy, rash on back, chest, and neck. Joint pain.  Time of symptoms unknown but had to put in a time for screen to move forward.
ACHINESS; CHILLS (COLD SWEATS LEADING TO SOAKING WET); HIGH FEVER RANGING FROM 99.7 TO 101.8.; EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 13-MAR-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced expired product administered. On 14-MAR-2021, the subject experienced achiness. On 14-MAR-2021, the subject experienced chills (cold sweats leading to soaking wet). On 14-MAR-2021, the subject experienced high fever ranging from 99.7 to 101.8. Laboratory data included: Body temperature (NR: not provided) 99.7 to 101.8 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever ranging from 99.7 to 101.8., chills (cold sweats leading to soaking wet), achiness and expired product administered was not reported. This report was non-serious.
Headache, HYPERtension & Tachycardia Narrative: Pt received 3rd dose of Moderna vaccine on 10/28/21 at 6pm. By 6am the following day, pt was complaining of severe headaches that started at the top of the head and radiated down the neck. No NSAIDs given at that time Vitals at 0930: BP 124/84 mmHg. At 0950: BP 132/93, temp 98.1, 02 sat 98%,HR 103 bpm. At 1015, pt called PCP to see if could be seen that day. PCP recommended taking OTC pain relief meds and to present to clinic if no improvement. Pt was picked up from site by mother. At 1030: BP 136/88, temp 98.1, O2 sat 99%, HR 108, RR 18. Of note, pt does report a reaction after receiving 2nd dose of Moderna vaccine, for which she was hospitalized for 1 week. (No information provided on that even.) No follow up information found.
Red rash circle around the injection site as well as the injection site being itchy. I believe it?s being called COVID arm
Headache after injection- 2/24/21 Lasted for 2 days Headache/ extreme fatigue, neck pain, extreme left arm soreness, back pain, 2/25/21 Headache/ fatigue/ body aches - morning of 2/26/21 Rapid heart rate up to 128 bpm sitting still, rapid breathing, tight throat, low blood pressure.  These symptoms began afternoon of 2/26/21 and lasted at least 5 hours.
severe flu-like sx, joint pains in shoulders & arms, sl fever, diaphoresis; pt called for 2nd HBV vax inject 11JUN & @ that time reported adverse reaction; onset of sx w/in 24 hrs p/inject, duration of sx 48 hrs;
I experienced shortness of breath. I couldn't climb the stairs. Later I had my regular visit with my cardiologist.  I told my doctor I was having trouble breathing. I took a test and I was diagnosed with atrial flutter. I was prescribed Eliquis blood thinner and Metoprolol. Later, Spironolactone was added to my blood pressure medication.
This case was reported by a nurse via licensee and described the occurrence of injection site swelling in a 16-year-old female patient who received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Co-suspect products included Meningitis B vaccine and HPV vaccine. On 6th November 2015, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, Meningitis B vaccine and HPV vaccine. On 6th November 2015, less than a day after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced injection site swelling and feeling unwell. On 7th November 2015, the patient experienced fever. In November 2015, the patient experienced injection site erythema, injection site warmth and injection site pain. The patient was treated with ibuprofen. On 8th November 2015, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling, feeling unwell, injection site erythema, injection site warmth and injection site pain were unknown. The reporter considered the injection site swelling, feeling unwell, fever, injection site erythema, injection site warmth and injection site pain to be related to Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Additional details were provided as follows: On 6th November 2015, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and TRUMENBA in her left arm as well as Human Papillomavirus 9 valent vaccine in her right arm. On the same day, the patient complained that she had swelling at the base of her shoulder and she was feeling sick. Over the weekend, i.e. on 7th November 2015, 1 day after receiving the vaccines, the patient experienced fever on and off till 8th November 2015. The patient then received Ibuprofen. A day before time of reporting, on 9th November 2015, the patient visited the office. In November 2015, less than a week after receiving the vaccines, according to the nurse the patient's shoulder look red, hot to touch and continued to complain of sharp pain and tenderness from the shoulder to the upper neck. The sales representative of other manufacturer did not have any patient details like her medication history and other details. The doctor did not know but they suspect that all the adverse events were related to the vaccines. The doctor did not know if it was the combination of the vaccines or a single vaccine and they were actually calling to find out that and the sales representative told them to call to find the information. The reporter was called back to confirm the reporter of the adverse event and nurse was confirmed to be the reporter who had same address and contact as of doctor. The reporter did not had email address of the doctor. The reporter had limited information regarding the patient. It was unknown if the reporter considered the injection site swelling, feeling unwell, fever, injection site erythema, injection site warmth  and injection site pain to be related to TRUMENBA and Human Papillomavirus 9 valent vaccine. This case has been linked to case US2015GSK172249, reported by the same reporter.
Dizziness reported. Upon standing felt lightheadedness.  BP 131/74, HR 87. Monitored for additional 15 minutes. No further complaints. BP 118.77 HR 93. Released home after monitored for 30 minutes total.
This case was reported by a nurse via call center representative and described the occurrence of double vision in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced double vision. On an unknown date, the outcome of the double vision was unknown. It was unknown if the reporter considered the double vision to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional stated that the patient's doctor would most likely be calling in to do a follow-up report with additional information. No further details were available at the time of reporting.
itchy face, R arm and legs high BP: 146/100 fatigue, general unwell feeling light-headed/dizziness while and immediately after urinating brain fog
This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patient's relevant medical history includes sulfa allergy. The patient's concomitant medications and past drug history are unknown. On 18-APR-2015, the patient was vaccinated with ZOSTAVAX lot # K023622 dose 1, subcutaneous in the left arm. On 18-APR-2015, it appeared that the skin was not punctured and the injection solution got on the patient's jacket that was tied around her waist. The pharmacist checked the patient's arm and did not see a needle mark and there was no blood, but the patient was moving, agitated, flustered and frustrated at that time. It was unknown if the relevant lab data was done. The patient insisted that she will come back for revaccination the same day. At the time of reporting the outcome of the events was unknown. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
09 month old female patient administered Quadracel instead of Pentacel, no AE; 09 month old female patient administered Quadracel, no AE; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 month old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Patient did not received concomitant and no other vaccines.   On 10-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5656AA and expiry date: 13-Sep-2021) via an unknown route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong product administered (latency on same day).  At the time of report no adverse event was reported.  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.
Patient became pale, diaphoretic and faint following 3 minutes after injection of vaccines. He vomited. He fully recovered and was able to go home.
Case number PHEH2014US025229 is an initial spontaneous report received from a nurse on 11 Dec 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications was not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), intramuscularly reconstituted wit a sterile water instead of MenCYW-135 liquid component on 10 Dec 2014. No adverse reaction was reported following this administration error.
Polyarteritis nodosa; lesions in the feet; This case was reported in a literature article and described the occurrence of polyarteritis nodosum in a patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 21 days after receiving Hepatitis B vaccine, the patient experienced polyarteritis nodosum (serious criteria GSK medically significant) and skin lesion. On an unknown date, the outcome of the polyarteritis nodosum and skin lesion were unknown.   The reporter considered the polyarteritis nodosum and skin lesion to be related to Hepatitis B vaccine.  Additional information was provided.  This case was reported in a literature article and described the occurrence of polyarteritis nodosa in a patient of unspecified age and gender, who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis.  No information on patient's medical history, family history, concurrent condition and concomitant medication were provided.  On unspecified date, the patient received unspecified HBV vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The age at vaccination was not provided.  On an unspecified date, 3 weeks after vaccination the patient presented with systemic features of the disease and with characteristic lesions in the feet. The patient was diagnosed with polyarteritis nodosa.   Treatment was unknown.  The outcome of the event was not reported.  The authors commented, "polyarteritis nodosa following vaccination against hepatitis B virus with lower-extremity manifestations".
Event occurred after 2nd vaccine. First vaccine was on 4/4/21 and the second one on 5/5/21. Pt tested positive for COVID-19 on  11/28/21.