chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 47-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            Concomitant medication was not provided.  Treatment information was not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Reporter stated that the longest duration of symptoms was about 3 days.
This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 21-MAR-2016, the patient was vaccinated with an expired dose of oral, ROTATEQ (lot # K017572, expiration date: 18-MAR-2016) (dose was not provided). Concomitant medication was not reported. No adverse symptoms were reported and there was not product quality complaint involved. Additional information has been requested.
Patient presented to our ED on 9/2/21 complaining of progressive shortness of breath. She tested positive for COVID-19 PCR on admission.  She expired 9/9/21 following cardiopulmonary arrest.
Fatigue Muscle pain , Swelling,  Tenderness  under left arm pit  Lump in lymph nodes Pain under right arm/breast area near lymph nodes Weakness **No Treatment ** Weekend - Health Clinic is closed!
Pt c/o itchiness 19 mins after vaccination and observed for 15 mins before d/c to home with family.  Pt stable and released from vaccination site.
Weakness on left side arm and leg.  Stroke happened on 4/8/21.
TIA, right side of body weakened to point of not being able to stand, left side of face numb, emergency hospital 24 hours for monitoring and tests.
Patient c/o two weeks of pain, sever weakness, and tingling in arm where vaccine administered.
She was given the high dose elders shot along with the high dose pneumonia shot at the same visit.  The next day she became ill, very weak and tired, achy. She went to the emergency room three times within the following two weeks after receiving the shot. She then developed pneumonia and was hospitalized for 17 days. She almost died while in the hospital. After being released, she was dizzy, had brain fog, and suffered extreme  fatigue. We had her a hair tested for metals and she had elevated levels of Aluminum, mercury, lead, and cadmium, all of which were in the two doses of vaccines she received. We did an oral chelation on her for a few weeks and she showed signs of recovery but is still experiencing extreme vertigo and fatigue.
My adverse event started on 10/21/2022 in the morning around 08:00AM. I had a rash in my back on my waist it kept moving up. On 11/02/2022 I went to my doctor because it was itching so bad and I couldn't take it any more. My doctor diagnosed me with Pityriasis rosea. The doctor gave me prednisone 20 milligrams for 1 week and loratadine 10 milligrams 2 per day for 1 week. 12/19/2022-12/20/2022 I got the rash again on my back up on my ribs way over to the side of my back. I went to my doctor again on 12/27/2022  he prescribed the same medications again but this time he gave me loratadine 20 milligrams a day for 1 month and prednisone 20 milligrams. My doctor advised me to go back after 1 month to see if the medications for the rash is working or not. As of today 01/04/2023 the itchiness and the rash is gone.
Dizziness, nausea, BP 160/85 (pulse 65). F/u BP 146/81 (pulse 60).
Systemic: Fainting / Unresponsive-Mild, Additional Details: informed by her mother that she is scared of vaccines/needles, usually gets dizzy/faints. vaccine was given, patient felt fine, stayed with her for few minutes, informed her to stay in store for 15. after she and her mom walked away, she fainted. she was okay, no other symptoms, called 911, they assessed her, all vitals were normal. patient back to normal.
No adverse event; Inbound call from HCP reporting a PROQUAD was inadvertently administered after a supported temp excursion.; This spontaneous report has been received from a health care professional, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.  On 12-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (product storage error), diluted with sterile diluent, for prophylaxis (lot number W010061 has been verified to be valid; expiration date reported and established as 20-SEP-2023) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not provided). The administered dose of the vaccine was stored at a temperature of 7.9 degrees Fahrenheit (F), during a time frame of 37 minutes. There was no previous temperature excursion. There was no adverse effect reported.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308762, 2018SA308765, 2018SA308764 and 2018SA308767. This case involves a 16 years old patient who received a dose of FLUZONE HD instead of FLUZONE QUADRIVALENT on an unknown date (batch number, exp date, dose, dose in series, route and site of administration was not reported). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration and overdose accidental (It was reported that nurse accidentally opened a box of FLUZONE HD instead of FLUZONE QUAD, and administered 5 patients under the age of 65 a dose of FLUZONE HD inadvertently). It was unknown if 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. List of documents held by sender: none.
From 2 weeks after my first Pfizer shot, I began spontaneously breaking out in hives. The hives can appear at any site of my body and spread to other areas, taking as much as 3-6 hours to go away. Please note there is no consistent site they appear. One say it may start on my right leg and then I get hives on my left arm and then my back. Other days it is on my side/lats, then on my head, then on my hand. There is no way of gauging where they will appear. Once the reaction clears (including the welts it causes), there is no scarring/no visible evidence that I had even had hives (never experienced hives before that left no visible scars). I took extensive lengths to try and identify any lifestyle changes that could be causing them so I eventually isolated my first COVID shot as the source of the breakouts and finally went to a dermatologist who was unable to identify the source, but prescribed me 10mg Hydroxyzine. The Rx said to take one per night but just one tablet is not enough to fight the reaction, I soon learned I?d need to take anything from 2-4 pills depending on severity, and the hives disappear within 1-2 hours. On/off medicine the hives will return after a down period of anything from 1-5 days.
This spontaneous report was received from a registered nurse refers to unspecified patient(s). The nurse reported that improperly stored M-M-R II (dose, route, lot# and expiration date not provided) may have been administered on an unspecified date. No adverse event was reported. This is one of several reports received form the same source. Additional information is not expected.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient complained of getting warm and itchy and thought she was having an allergic reaction. Gave patient 2 diphenhydramine 25mg and pt said she felt better after waiting 15 minutes. Counseled to call us if anything more serious happens. Employee to check in on pt at 5:40pm
Administered expired initial Shingrix immunization to patient on 6/5/2023.  Discovered immunization was expired upon completion of paperwork later on in the day.  Expiration date of 11/07/2022
Immediately after receiving vaccine patients entire arm began burning. He also started to feel lethargic and sweaty. He was able to breath fine and speak. This lasted for about 30 minutes, then he was able to return to work without further issue.
Appx 30 mins after recieving flu shot (Aventis LOT#U1075AA Exp 6/30/04) and Hepatitis A (Merck  LOT# 1411L Exp 3/14/2004) patient had appx 30 second grand mal seizure. This was observed by mother only who wheeled pt back to dept for appx 90 min observation. No further seizure activity was noted by medical personel or mother. Patient has severe CP, non-verbal, seizure disorder. Has been on Lamictal daily for several years. The medical record received on 2/3/04 states postictal. sleepy.
Information has been received from a licensed practical nurse concerning a 71 year old retired white female with diabetes who on 10/15/02 (previously reported as 10/28/02), at 10:00am, was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), IM in the left deltoid. That same day, on 10/15/02 (previously reported as approximately 10/28/02), the patient experienced an injection site reaction described as redness from the shoulder to the elbow, swelling extending to the armpit, hot to the touch and soreness. The nurse reported that the patient did not require treatment and was not hospitalized. As of 11/4/02, the nurse indicated that the patient was fine. Follow up information from the nurse indicated that the patient did not require any diagnostic or lab tests and that the patient had not recovered from the injection site redness and soreness. The nurse also provided information regarding another patient's experience. The patient sought unspecified medical attention. Additional information is not expected.
Skin rash, redness and itching at site of injection. 2 days later the patient has put after bite (Sodium Bicarbonate) on the site, she has been instructed to put on a cold compress and and hydrocortisone cream for the itching. If the rash did not get better in 2 days she was instructed to see a doctor and follow up with us as well.
increased bowel movements after the vaccine when she goes like 3 times a day; heart palpitations; could not lift her arm; pain; cough; hot on his right arm; itchy on his right arm; hard on his right arm; red on his right arm/red mark 2 in wide 1 in wide; very swollen area,/approximately 2 inch high and 3 in wide/raised; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), PALPITATIONS (heart palpitations), LIMB DISCOMFORT (could not lift her arm), PAIN (pain) and COUGH (cough) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu in 2020. Concurrent medical conditions included Autoimmune deficiency syndrome (with MTHFH methyltetrohydrofolate reductase deficient and cant convert Vitamin B.), Gluten intolerance and Homocysteinemia. Concomitant products included THYROID, PREDNISOLONE ACETATE and FISH OIL (OMEGA 3 COMPLETE) for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In November 2021, the patient experienced VACCINATION SITE WARMTH (hot on his right arm), VACCINATION SITE PRURITUS (itchy on his right arm), VACCINATION SITE INDURATION (hard on his right arm), VACCINATION SITE ERYTHEMA (red on his right arm/red mark 2 in wide 1 in wide) and VACCINATION SITE SWELLING (very swollen area,/approximately 2 inch high and 3 in wide/raised). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), PALPITATIONS (heart palpitations), LIMB DISCOMFORT (could not lift her arm), PAIN (pain) and COUGH (cough). At the time of the report, FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), LIMB DISCOMFORT (could not lift her arm), PAIN (pain), COUGH (cough), VACCINATION SITE WARMTH (hot on his right arm), VACCINATION SITE PRURITUS (itchy on his right arm), VACCINATION SITE INDURATION (hard on his right arm), VACCINATION SITE ERYTHEMA (red on his right arm/red mark 2 in wide 1 in wide) and VACCINATION SITE SWELLING (very swollen area,/approximately 2 inch high and 3 in wide/raised) outcome was unknown and PALPITATIONS (heart palpitations) had not resolved.      Co-suspect product included  Pfizer with unknown batch number on unknown date. Patient reported that C reactive proteins levels were natural high for her. It was also reported that patient was on OTC medications. No treatment reported.
Information has been received from a physician concerning a patient (unknown gender and age) who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (dose and lot number not provided) instead of a dose of zoster live (Oka/Merck) (lot number not provided). It was not reported if medical attention was sought or what the patient's outcome was. There was no product quality complaint. No further information is available. In follow-up information received from a physician, it was confirmed that this event was not a case of product confusion, but a result of human error. No further information is available. This is one of several reports from the same source.
This case was reported by a physician via sales rep and described the occurrence of injection site itching in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site itching, injection site erythema, injection site swelling, injection site rash and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site itching, injection site erythema, injection site swelling, injection site rash and intramuscular formulation administered by other route were unknown. The reporter considered the injection site itching, injection site erythema, injection site swelling and injection site rash to be related to SHINGRIX. Additional information was received as follows: The call center representative was attending SHINGRIX program on 3rd May 2018. The physician reported the events experienced by the patient who had received SHINGRIX vaccine. The caller stated that the reporter did not want to be contacted regarding this report. The caller stated that the reporter noted that the patient within the last few days had gone to a pharmacy to receive SHINGRIX shot. The reporter thought that the patient was given the vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The caller stated that the reporter noted that the patient also developed a very swollen arm, rash, redness and itching at and around the injection site. The caller stated that the reporter instructed the patient to put ice pack on the arm and use TYLENOL and ADVIL as needed. The caller stated it was unknown if these events had resolved. The caller stated that no additional details were available.
Pt complained of 5/10 chest tightness and no other symptoms at 1211. Pt reported similar episodes when under stress. Pt asked for water. Pt given water. Pt vitals assessed: 125/80 BP, 65 BPM, 98% SpO2.  Pt reported hx of atrial tachycardia and no current medications. Pt AxO x4 with unlabored respirations. Pt offered EMS. Pt declined EMS. Pt advised to wait 30 mins.  Patient reassessed at 1219. Pt reported chest tightness at 4/10.  Pt reassessed at 1230. Vitals were 120/80 BP, 60 BPM, SpO2 98%. Pt rated chest tightness at 2/10. Pt reassessed at 12:45. Pt was AxO x4 with unlabored respirations. Pt rated chest tightness at 1/10. Patient offered EMS again. Pt declined EMS. Pt  offered transportation. Pt declined transportation. At 1245, pt left facility to self with steady gait and unlabored breathing.
Extreme arm pain began about 36 hours after first injection. It lasted five days. The pain was gone for six days.  Then it returned. Right now it has been three more days and the pain is still extreme. The pain has not stopped again yet for the second time.
Persistent Cough Flu - 2 weeks after first dose Persistent chills Fever Persistent headaches  Joint aches Occasional episodes of shortness of breath
19may89 pt vax hepta B.  pt ex arthralgia w/ edema and numbness of 3r, 4th,& 5th proximal interphangeal joints of hand but maintained full motion.  pt remained under treatment.
elevated temperature above normal; Face redness; hives or slightly itchy bumps on legs around knees; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old non pregnant female patient received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 at 09:30(at the age of 48-years-old) administered in Arm Right as a single dose for COVID-19 immunisation at Workplace clinic. Medical history included Diabetes, slow thyroid, Penicillin allergy, bees and insects (all from an unknown date and unknown if ongoing). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) and Diabetes meds taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Mar2021 at 15:30, the patient experienced Face redness, elevated temperature above normal, fade heart rate 80-90 beats, hives or slightly itchy bumps on legs around knees. Therapeutic measures were taken as a result of events.The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Had flu vaccine administered 10/31/01 and developed sore throat, achy, temp, sore muscles axilla area L arm. 14 hrs after vaccine given.
On 6/12/01, seen by doctor with fever of 103F, nausea and vomiting and diarrhea. CNP says she doesn't think it's related but even if it is, she wouldn't omit vaccines as benefits outweigh the risks. On 6/13/01, called back, and said to give remaining vaccines one at a time.
This spontaneous report was received from the mother of an approximately 12-year-old female patient. The patient's concurrent condition was not reported. The patient did not have any pertinent medical history, concomitant medication and drug reactions or allergies. On 14-MAR-2019, the patient was vaccinated with her first dose of GARDASIL 9 injection in arm (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis (reported as to prevent cancer). On 25-MAR-2019 (reported as one week later), the patient started experiencing multiple seizures a day. The patient went to see the doctor and a neurologist. Treatment was given for the event. Blood work and magnetic resonance imaging (MRI) was performed and the results were not reported. There was no product quality complaint associated with this report. The outcome of the event, seizure was reported as not recovered. The causality assessment was not reported. Upon internal review, the event seizure was determined to be medically significant.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient medical history and concurrent condition was not reported. On 19-JAN-2015 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J000192, expiry date: 07-JAN-2015) 0.5 ml, subcutaneously. No adverse experience reported. No product quality complaint (PQC) reported. Additional information has been requested.
Vaccine that administered beyond use date after the thaw process/ Expired vaccine administered; Second dose received 0.25 instead of 0.5; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/ Expired vaccine administered) and UNDERDOSE (Second dose received 0.25 instead of 0.5) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/ Expired vaccine administered) and UNDERDOSE (Second dose received 0.25 instead of 0.5). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/ Expired vaccine administered) and UNDERDOSE (Second dose received 0.25 instead of 0.5) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 29 years 7 months.  No concomitant medication was reported. No treatment medication was reported.  On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.  Patient was administered with a beyond use date of some lot numbers for Moderna. There was no adverse reaction noted or reported regarding these administrations.
Lymphadenopathy in armpit on same side as vaccination site. Started 4 days after vaccination