chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received flu vaccine on Oct. 25,2002 at 0910am in the Rt. Gluteus Max.  Awakened at 1100am (works nights) with severe muscle and body aches, esp. in the lower part of body.  Was unable to move legs briskly and felt like a load of bricks were sitting on legs.  Felt restless and could not get comfortable because of body pain and soreness.  Has chills and was dozinf off and on.  Had some confusion, found self running down the halway at home very dizzy, lightheaded.  Had sensation of blacking out, did not fall.  HR 120 - 130  BP 112/88 T- 99.4 - 101.8 Has audible wheez  wiht exertion.  Severe weekness, fatique. No discomfort at injection site.  Hve feeling of heart pounding.  Nausea wiht dry heaves, loss of appitite.
1:40 pm-slight bleeding @ injection site-stopped immediately, but rapid swelling 1/4-1/2" around; applied gentle pressure & ice-patient denied am discomfort & unconcerned. Sent ice home w/pt. 3pm called patient @ home-was fine, no swelling, nausea, soreness or bleeding.
This spontaneous prospective pregnancy report as received from a health care worker refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot # L043212, expiry date: 28-AUG-2017) (route of administration: intramuscular). On an unknown date, the patient inadvertently received a dose of GARDASIL 9 while she was pregnant (inadvertent exposure to vaccine), (vaccine exposure during pregnancy). No adverse effects reported. The outcome of the events was not reported. Additional information has been requested.
Tinnitus both ears at 4:30 am (9/23/23) following vaccination the previous day (9/22/23) at 10:00 am.  It was very loud --about the same as a smoke detector alarm and woke me up.  Milder form this morning (9/25) at 4:00 am.  The vaccination site also was very sore and again, still sore but less so, this morning (9/25).  I am waiting to see if it resolves over the next week.
REDNESS IN RT UPPER ARM 3IN.DIAMETER/SLIGHTLY WARM/2" LONG/PUFFY
Initial unsolicited report received from a Nurse on 16-May-2018. This case involves a 34-year-old patient (gender was not reported) who was vaccinated with a fifth dose of ACT-HIB on an unspecified date. It was a case of actual medication error due to extra dose administered. 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. Documents held by sender: none.
felt like her body was disoriented and tried to walk to the right and my body went to the left; crying; emotional; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt like her body was disoriented and tried to walk to the right and my body went to the left), CRYING (crying) and EMOTIONAL DISORDER (emotional) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BUSPIRONE for Antidepressant therapy, FLUOXETINE for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (felt like her body was disoriented and tried to walk to the right and my body went to the left), CRYING (crying) and EMOTIONAL DISORDER (emotional). At the time of the report, DISORIENTATION (felt like her body was disoriented and tried to walk to the right and my body went to the left), CRYING (crying) and EMOTIONAL DISORDER (emotional) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient received the 2nd Moderna Covid-19 vaccine in left arm shoulder deltoid muscle and no adverse reactions or side effects reported for 2nd dose. Patient felt reactions were due to her antidepressant Buspirone. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Follow up contains no new information.
Vesticular leisions, consistant with varicella #25-50. Pt eventually admitted to prior exposure to varicella.
Three weeks later pt had to have an appendectomy . Pt had a fever and hospital stay not due to vaccination.
MMR #1 was administered to patient on 03/29/2023. She developed joint pain, headache, epistaxis, and nausea within 24 post-injection. No life-threatening conditions were reported. No rash, palpitations, SOB, urticaria, angioedema were reported.
Right deltoid area edema and erythema. 6x8cm. apply ice and motrin prn.
Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2); No adverse event; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)).    No Concomitant medications were provided. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that temperature excursion was occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2).  No treatment medications were provided.
This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, at 1 year of age, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route of administration, anatomical location, lot# and expiration date were not reported). At 4 years of age, the patient was vaccinated with the second dose (dose, route of administration, anatomical location, lot# and expiration date were not reported), 3 weeks after the second dose the patient received the third dose (dose, route of administration, anatomical location, lot# and expiration date were not reported). Thus, the patient received a total of 3 doses of VARIVAX (Merck) on unspecified dates. No adverse effects were reported. Additional information is not expected, no contact details were provided.
Got the shingles. Breakout was on the right side above the waist, on the rear, below the breast line.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
This spontaneous report as received from a nurse refers to her husband - a male patient of unknown age with urinary retention and Parkinson's disease. On 19-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). On the same day, the patient started therapy with SINEMET (lot #, expiration date, strength, dose and frequency were not reported) for Parkinson's disease. On an unknown date (reported as after started SINEMET) the patient became blistered from neck to ankle (also reported as allergic reactions). SINEMET was discontinued and the blistering cleared up (on an unknown date). On an unknown date, the patient began taking MIRAPAX and experienced slurred speech, impaired gait and "seemed like he was drunk when he wasn't". The nurse said after 48 hours, the MIRAPAX was discontinued and the patient went back to normal (on an unknown date). The nurse stated that the patient was then started on a medication for urinary retention called MYRBETRIQ, and that he immediately "started breaking out again" so it was discontinued immediately. Outcome was not reported. The nurse stated that the patient was not taking any medication for Parkinson's disease or urinary retention because of the allergic reactions and that both conditions are "progressing rapidly". There was no treatment given for adverse events. Patient sought medical attention via visiting the office. The relatedness between adverse events and suspected therapies was not reported. Additional information has been requested.
On 12/5/14, twins returned home saying they felt dizzy. They took a nap and mother found them with fever (tactile) at 1 AM. Tylenol given. By 6 AM, both girls had facial swelling and reported itchy feeling in lips/mouth. One twin had swelling and redness to R jaw. Other twin had swollen eyes (nearly shut), red eye lids and significant facial swelling around cheeks and lips. Mom took girls to hospital where they were treated, one twin with IV steroids. Both girls were discharged home by 8 PM on 12/6.
EXTRACTION OF MODERNA VACCINE FROM VIAL WAS NOT CONSISTENT WITH MODERNA TECHNIQUE I.E. MORE THAN 20 DOSES WERE DRAWN UP FROM THE VIAL
Narrative:  Patient was immunized in timely manner x 3 with pfizer mrna vaccine--booster on 9-9. Patient presented to ED with complaints of diarrhea causing painful rash and fatigue. Predominant COVID sx included fatigue, diarrhea, and anorexia causing dehydration. Patient received monoclonal abs as the only covid treatment--no O2 support needed. Patient developed pseudomonas UTI requiring 2 week course of abx in facility. Patient was treated for these complications, improved and was discharged home after a lengthy hospital stay
The patient came in to receive his first dose of moderna vaccine, he stated a history of fainting.  We watched him after his dose of Moderna and about 5 minutes later(3:55pm) he became sweaty and stated he was light headed. I gave him a cold  compress and he proceeded to lose consciousness. we had him on the floor with his legs up however the patient did stop breathing and turn purple.  At this point I gave a dose of epipen. the patient did wake up after the epipen. He was out for about 15 seconds but unresponsive for a couple of minutes until after the epipen dose. (given at 4:00pm) we had 911 on the line and the paramedics were here by 4:08pm and his blood pressure was at 142/82. he left with the paramedics.
"Red, blotchy rash - almost solid - covering chest & stomach. Some on back & low-grade fever 99.8" Began 1FEB91 A.M. gone completely on 4FEB91. Dr. dx over the phone. Benedryl 1/2 teas.  3x per day for 3 days.
was diagnosed with a blood clot in my left leg and in my lungs.  Dr put me on blood thinner Xarelto.  Still going thru treatment but believe the blood thinner removed the blood clot.
THROMBOSIS ARM; SHORTNESS OF BREATHE; ARM BURNING; ARM DISCOMFORT; SWOLLEN ARM; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included blood clots treated with Eliquis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported,1 total administered on 08-MAR-2021, left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, two weeks after vaccination the patient experienced swollen arm and arm discomfort. On 29-MAR-2021, the patient experienced shortness of breathe and arm burning. On 30-MAR-2021, the patient experienced thrombosis arm. Laboratory data (dates unspecified) included: Scan (NR: not provided) Right Arm Occluded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and shortness of breathe, and had not recovered from thrombosis arm, arm discomfort, and arm burning. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 59-year-old of unspecified gender, currently on Eliquis for history of blood clots noted swelling of arm with discomfort and burning (described as "like from a match") as well as shortness of breath 14 days after receiving COVID-19 VACCINE AD26.COV2.S on left arm.  Scan showed right arm was occluded.  Treatment for the events was not reported; the patient is recovering from swelling of arm and shortness of breath; the patient have not recovered from thrombosis of arm and arm discomfort/burning.  The event is confounded by the underlying history of blood clots that is being treated medically.  However, the events are assessed as indeterminate with a causal association to immunization, per the causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism.  Considering temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
On the day of the vaccine - tiredness, weak stomach, light headache, chillness, swollen arm. Next day - short breath, constipation, tiredness, weak stomach, swollen arms lasted 5 - 7 days and for 2 weeks I was tired and swell of arm lasted 3 weeks also.
Patient broke out in hives a couple hours after vaccine. Nothing else changed or different for her. BENADRYL helped for a couple of days. On 11/18, felt tongue/throat swelling so went to ER. Starting steroids on 11/19.
low grade fever; body ached; slept all day; the injection site feels like there is a pinch in the booth arm; break out on torso with a cluster of pimples; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), MYALGIA (body ached), SOMNOLENCE (slept all day), VACCINATION SITE PAIN (the injection site feels like there is a pinch in the booth arm) and RASH (break out on torso with a cluster of pimples) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever), MYALGIA (body ached), SOMNOLENCE (slept all day), VACCINATION SITE PAIN (the injection site feels like there is a pinch in the booth arm) and RASH (break out on torso with a cluster of pimples). At the time of the report, PYREXIA (low grade fever), MYALGIA (body ached), SOMNOLENCE (slept all day), VACCINATION SITE PAIN (the injection site feels like there is a pinch in the booth arm) and RASH (break out on torso with a cluster of pimples) outcome was unknown. Not Provided
Had seizure - grand mal - 11 days after GARDASIL.  Diagnosed idiopathic generalized epilepsy, CT scan - NL. 11/10/08-EEG report received for DOS 1/10/08-first seizure 1/8/08-with fall to floor and generalized tonic clonic seizure.
Soreness at the injection site for approx 30 hours; insomnia (still ongoing); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 12:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "reactive airway disease" (unspecified if ongoing); "apraxia" (unspecified if ongoing); "ehlers-danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; PROBIOTICS.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Oct2021 12:15, outcome "not recovered", described as "Soreness at the injection site for approx 30 hours"; INSOMNIA (non-serious) with onset 23Oct2021 12:15, outcome "not recovered", described as "insomnia (still ongoing)". Therapeutic measures were not taken as a result of vaccination site pain, insomnia.  Additional information: The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. There were no known allergies. Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks were reported as Clartin, multivitamin, iron supplement, probiotics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In the middle of night I woke up with 103 fever and vomiting, called ambulance, very wobbly and spaced out. Ambulance transported me to hospital, Tylenol, Zofran, had me drink a lot of water. Fever went down and I rested there at ER, hospital called my husband around 6 to pick me up. When I got home I stayed very tired and in bed for a few days didn't eat much those days.
Severe pain in right side radiating up to shoulder.  Diagnosed as a Pulmonary Embolism.   On April 7, 10 days after second Pfizer Covid vaccination shot, (administered on March 26), patient developed severe pain in her left leg.  Numerous tests for blood clots proved negative and on April 10 she developed a rash and blisters which is believed to be Shingles.
15`45 C/O feeling faint and lethargic states anxiety for needles, BP103/70 HR 93, Pox 97,R 20 Placed in recline position with legs elevated, 15.55 ,, ,Snack and PO fluid offered ,accepted, 16.11 Pt states she is better, BP111/79 HR 95 R18,  Spouse present to drive home,instructed to get Urgent care if symptom continues,
06/10/2021 Shortly after the vaccination, my elbow began hurting again. It did go away faster than with the previous vaccine. At the beginning, I would have bad pain every month which progressed to weekly. In December 2021, I began having the pain daily that lasted around an hour or two. By February 2022, the pain would last every hour all day. I have random pain that will just fire anywhere in my body, from my toes to my head. I also have weakness and imbalance. Last week, I spent 4 days in the hospital. Through multiple tests, they discovered it had attacked my muscles. It is perhaps an auto immune attack on my muscles. I have an appointment with Rheumatologist, next week.
Myoclonic jerking & "out of it" episode lasting about 1 hr w/fever of 100-102F; Onset 30 hrs post inject; Seen in ER;
Pt states the site of the injection is very painful, tender to the touch, red warm to the touch and feels like there is a lumb at the site.
A patient received two doses of vaccines in same pregnancy one month apart, no AE; Vaccine exposure during pregnancy; Initial information was received on 01-Mar-2021 regarding an unsolicited valid non-serious case from other healthcare professional in the United States.  This case involves a female patient (age not reported) who received a dose of suspect of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in same pregnancy one month apart (Suspension for injection, batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (extra dose administered) while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Past medical treatment, vaccination, concomitant medications and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.  It was case of vaccine exposure during pregnancy.   Pregnancy outcome was unknown at the time of report.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine was not provided.  There were no lab data/results available.  This was a case actual medication error due to extra dose administered (latency same day).  At the time of reporting, patient had no adverse event.  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.  There will be no information available on the batch number for this case.
Flushing, numbness of mouth tongue, neck.  Thirst, Chills