chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mom says via interpreter pt began w/fever (very hot) (not checked w/thermometer) approx 2hr p/vax mom states pt otherwise not having signs of illness;no cough;no runny nose;no vomiting or diarreha;taken to clinic 9JUN97 AM t105.4 R;APAP
no adverse event; The patient received a dose of improperly stored Rotateq; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and drug reactions or allergies.  On 21-FEB-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose, lot number S014947, expiration date 10-DEC-2020 for prophylaxis (route of administration was not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion below 36°F (34F) degrees Fahrenheit for 27 minutes, as recorded by a data logger. No previous temperature excursion was reported. No further adverse effect reported.
4cm x 6cm area of redness and induration at injection site seen on 04/12/2002. On 04/16/2002 developed slightly raised maculopapular rash.
Fever ( 101 to 103 orally ) for 4 to 5 days after vaccine with chills (severe)  body aches (lasted for about two weeks), fatigue for few month after vaccine. arm pain at site and into shoulder and up to neck and Jaw pain,  nausea and vomiting for two days,  sore muscle for weeks after getting vaccine. site where vaccine was given very reddness ( which spread down my arm)  warm to touch , edma at site ,  lasted for two to three weeks ,
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.). On 27-Oct-2021, PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.) to be not related. No concomitant medications were reported.No treatment information was provided.On 27-Oct-2021, 29-Oct-2021, 01-Nov-2021 and 03-Nov-2021, there was a combined total of 30 vials that were punctured more than 20 times. The staff drawing up vaccine was unaware of vial puncture limit. The event did not cause the patient to seek medical advice. It was unknown if the patient experienced a similar event in the past.Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Significant Follow-up received: Reporter causality updated. Adverse event information added.
It was reported that a 40 year old male received Imovax ID and Fluzone SV '99-'00 at 11:45 on 10/21/99. At 20:00, on the same day, the pt began experiencing the adverse event. He "presented to health services on 10/25/99, with an area of 18mm X 20mm induration to approx. 2mm in height. Denies discomfort now but states 2 days, post vax, was tender at site. States also had malaise the last 2 days." Pt has not recovered. Additional information received on 11/22/99, reported that the evening of the day, post vax, the pt experienced soreness and tenderness at the site. The injection site was red with induration measuring 18mm X 20mm. Each day this reaction began to get smaller and less red. By 11/1/99, no induration or soreness was present.
severe internal bleeding fluid build up around lungs/heart high heart rate low blood pressure low oxygen liver failure death
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long term prevention of shingles and zoster related injuries (dose, route, and lot number not provided). The vaccine did not prevent shingles or zoster related injuries as intended. On or about 19-OCT-2016, the patient was treated for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
prognosis of inflammatory myopathies. muscles not healing normally. muscle pain. fatigue. ligament damage and not healing.
Patient had 5th injection on 11/7/22, on 11/8/22 developed rash
Fever 101.4, chills, headache, fatigue, muscle aches 10.5 hours after injection; peaking 20 hours after injection and resolved 36 hours after injection. Hot flashes and night sweats 72 hours after injection, lasting >1 week after injection.
Parastesia and numbness progressing from left fingers to left torso, trunk/torso, left leg, and right hand fingers. Increasingly spreading and intensifying over time. Difficulty typing.
This spontaneous report as received from a pharmacist refers to a 66 year old female patietn. On approximately 22-OCT-2013 (last week) the patient was vaccinated with a dose of ZOSTAVAX (lot # J006829, expiration date 14-SEP-2014, dose and route unspecified) for shingles. In 2013 the patient experienced swelling and soreness at the injection site on the back of the arm. The patient called the pharmacy regarding the reaction. The patient was treatment with ice pack and over the counter pain relievers. The event outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient received COVID-19 vaccine on 4/3/21 subsequently admitted from 4/10-21-4/12/21 for acute pericarditis.
6/29 - 7/2 Red, itchy and swollen at injection site.
I was in my my car going into my garage when I felt extremely dizzy. I got out of car and tried to walk to my house.  I staggered and fell and wasn't able to get up.  My husband got me in the house.  I laid down and was very dizzy and  vomited several times.  It would not go away, so I went to Hospital Emergency. They treated me with meclicine and anti nausea medication.  Went home early the next morning and I have have been dizzy and off balance since then.  Extreme dizziness is better but I still often feel off balance.
Temperature excursion at 30.6 fahrenheit for 2 hours and 46 minutes due to refrigerator malfunction with no reported adverse event; IPOL was administered post temperature excursion with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA388426.  This case involves a 7 months old female patient who was administered IPV (VERO) [IPOL] post temperature excursion at 30.6 Fahrenheit for 2 hours and 46 minutes due to refrigerator malfunction with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On an unknown date, the suspect IPV (VERO) was exposed to a temperature excursion at 30.6 Fahrenheit for 2 hours and 46 minutes due to refrigerator malfunction with no reported adverse event (product storage error).  On 22-Aug-2022, the patient received 0.5 mL dose 3 of suspect IPV (VERO) (formulation and strength not reported; lot T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the left thigh for prophylactic immunization.  On 22-Aug-2022, (latency: same day) the patient was administered post temperature excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  It was reported, The temperature excursion was caused by a refrigerator malfunction. Max/low temperature reached: 30.6 F Duration out of labelled range: 2 hours 46 minutes. IPOL was administered to a patient post temperature excursion after it was not suitable to use.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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. ; Sender's Comments:  01282755: 01282765: 01282682:
Breakthrough case admission after three vaccines Moderan 4/21/21 Lot# 043B21;  Moderan 5/19/21 Lot# 033B21A;  Moderna 2/1/22 Lot# 068H21A
Pt. c/o hives to L and R wrist as well as hives to chest. Bi lat breath sounds clear, VSS @ 102/56 - 88 22 at 9:45. Adm. 50 ml of Hydromine Liquid P.O. Pt. states NKA and 20 mg Mune.
Fast heart beats, recorded highest rate 119 per minute.  It lasted for a week, with 3 - 4 occurrences a day, usually happened in morning and evening, a couple of time around midnight.  A little bit rash on the arms.
Case reference number 1998010461-1 is a clinical trial report from study number 208355/117, which is a single blind study, referring to a 7 month old female. At the time of the event, the subject had Mongolian spots, pale hands, and systolic murmur. Concomitant medications are unspecified. The subject received study vaccine on 10/01/97 and 02/03/98. For three days prior to dose 2, the child had mild upper respiratory illness symptoms (cough, rhinorrhea and fever). The child was afebrile at the time of vaccination. Two days after dose 2, the child developed raised red rash and vomiting x 1. the pediatrician felt the rash was related to a viral illness. the following day the child developed a fever (102.2), but no other symptoms. Four days after dose 2, the child developed 2 minute episodes of arm stiffening, unresponsiveness, and (abnormal) eye movements. Episode was thought to be either a seizure or normal behavior. the child had two more episodes the following day, and was hospitalized with a diagnosis of hypocalcemic seizure, RSV bronchiolitis, Rickets and vitamin D deficiency. She was treated with IV Calcium replacement and vitamin D, Albuterol inhalers, Calciferol, and Titrilac. The most recent info received reports the event resolved. The investigator reported the seizure, bronchiolitis and Rickets not related to treatment with study vaccine, but rather associated with vitamin deficiency RSV infection.
vaccinated past the 12 hour time frame; a bottle and opened it on 27Oct2021. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021 in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination of Pfizer vaccine (first PFIZER COVID-19 vaccination intramuscularly with lot number EN6199) on 09-Mar-2021 and Pfizer vaccine (second PFIZER COVID-19 vaccination with Lot number ER8727) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, LISINOPRIL, and SILDENAFIL for an unknown indication.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR (a bottle and opened it on 27Oct2021. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR on 27Oct2021. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021 had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was not specified   This case was linked to MOD-2021-370117 (Patient Link).
About two hours post vaccine patient presented to nurse with a rash that presented on her right arm. rash was itchy and had a red and hive type appearance. Provider in the clinic advised 25 mg oral Benadryl.
HARDLY ABLE TO WALK; LEGS HURT- NUMBNESS TO BOTH LEGS; 'FEELING VERY TIRED' WORSE WITH WALKING; SORE THROAT; HEADACHE -ALL THE TIME; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced headache -all the time. On 09-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced hardly able to walk. On 12-APR-2021, the subject experienced legs hurt- numbness to both legs. On 12-APR-2021, the subject experienced 'feeling very tired' worse with walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, and had not recovered from headache -all the time, legs hurt- numbness to both legs, hardly able to walk, and 'feeling very tired' worse with walking. This report was non-serious.
My breast have been hurting since 2 weeks after my first shot. I haven?t  seen this on the side effects list. After googling this, it seems to be a common use in women.
Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot#662100/0742X with expiration date of 06-MAR-2010) on an unspecified date. There was no concomitant medication. Subsequently the patient experienced local injection site reactions on an unspecified date. At time of reporting, the outcome of the event was unknown. The patients sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Pt received flu vaccine 10/13/2020. About three hours later a bruise appeared and pt had pain at left shoulder. She reports she is unable to move shoulder without pain. Has used ibuprofen and ice.
immobility; tremendous pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (immobility) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (The patient had a history of bodily operations(did not specify) over his lifetime and had to use his cane due to pain and immobility.).    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced IMMOBILE (immobility) (seriousness criterion medically significant) and PAIN (tremendous pain). At the time of the report, IMMOBILE (immobility) and PAIN (tremendous pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment medication were not provided..  Patient is on blood pressure and cholesterol medications but refused to name them.   This case was linked to MOD-2021-081489 (Patient Link).
no adverse effect; inadvertently administered a dose of Proquad and Varivax on same day; inadvertently administered a dose of Proquad and Varivax on same day; This spontaneous report was received from a nurse referring to a 21-year-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, dosing schedule, route of administration were not reported) lot # S019462 with expiration date 24-JUN-2021 and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, dosing schedule, route of administration were not reported) lot # S012536 with expiration date 20-OCT-2020 for prophylaxis. On 15-JAN-2020, the patient experienced overdose, inappropriate schedule of vaccine administered. No adverse symptoms reported. The outcome of the events were unknown. The causality assessment between the events and suspect therapy were not reported.
I waited 30 minutes after the vaccine at the pharmacy and then left. At my home I started to feel terrible and started vomiting and could not stop vomiting for 24 hours.  I had terrible muscle pain, vertigo, loss of sensation in the opposite hand, pins and needles all through my body, extreme fatigue, could not think, delusions.  My parents took me to the hospital when they could not stop vomiting with over the counter meds and they were backed up for  hours.  The next morning I contacted an online virtual care doctor through telehealth app and he prescribed me dissolvable Zofran pills.  I had to take double dose to finally stop the vomiting.  I still feel nauseous, weak, brain fog and body aches. I have never felt sicker in my whole life despite having the regular flu many times in the past.  I have not seen people report extreme vomiting so I believe this was an adverse reaction.  I am terrified of ever having the second shot and most likely will not be doing it if I had this reaction on the first one.  I literally felt like I was dying from the way I felt after receiving that vaccination.
Received the vaccine Wednesday evening, after work. Waited the recommended 15 minutes, then went home and went to bed. Woke up Thursday feeling fatigued and had injection site pain, no other side effects or fever. Thursday evening, I developed body aches and a low-grade fever. I took Tylenol and went to bed. Friday, when I woke up around 1pm, I noticed a small rash behind my left knee. I took Benadryl and ended up falling back asleep. When I woke up Friday evening, I had the rash, and hives, and red/white splotches all over my legs. I took Benadryl and consulted my doctor. The rash continued to spread to my arms, and stomach. The rash itched and burned. I went to the ER Friday night for it. Before they gave me medication, I started coughing, couldn't breathe for a minute, and got lightheaded. They gave a steroid, Pepcid, Benadryl, and fluids. They observed me for several hours. I felt better then was discharged. They told to continue to take Benadryl or Zyrtec for a couple days. 5 days later, the rash/hives are still red, itchy and present, especially when Benadryl wears off.
Nurse went through the consent with the patient prior to administration of vaccinations. Patient denied any medical history; allergies; and did state that she had eaten this morning. Nurse was administering immunizations to the patient who was sitting in a chair. Patient was holding a conversation the entire time with the nurse during the administration. Nurse administered all three vaccinations and as the nurse went to place a Band-Aid on the last injection site the patient fell back abruptly in the chair. Patient was completely unresponsive, however patient had a pulse. Nurse initiated Health Department protocol by using her whistle to call for assistance twice. After the second whistle was blown the patient started to regain consciousness and asked "Am I in a Basketball game?" Assistance came and vitals were taken. Patient was slowly still regaining consciousness and stated the she "felt funny'. 911 call was made by the Nurse Manager. Vitals were as follows: 8:05am Pulse: 49BP: 102/70; O2: 84% RA Oxygen was placed on patient at 2L. 8:06am Pulse: 60 O2: 99% with 2L of oxygen. 8:07am Pulse 50 O2: 99% with 2 L of oxygen, patient given Mountain Dew (sugar source); 8:08am Pulse 78 O2 99% oxygen removed; 8:11am Pulse: 70 BP: 120/70 O2:99% RA: paramedics arrived and evaluated patient. At this time patient was able to sit up on her own and stated the she "did not want to go to the hospital". Paramedics reviewed and agreed with nurses that patient should not drive today. Patients mother was called and confirmed that she would come pick the patient up. Patient stayed in the immunizations room until mother came and picked her up. Patient's final vitals were: Pulse: 65 BP: 120/72 O2 99 RA. Patient was able to stand up and walk on her own.
A report has been received from a Health Professional concerning four or five patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST (Intranasal) started on an unknown date. The patients experienced runny nose and congestion/stuffy nose. The patients recovered from the event of runny nose and congestion/stuffy nose on an unspecified date. The runny nose was considered to be non-serious by the reporter. The company physician captured congestion/stuffy nose together and assessed as non-serious.
FEVER (101F); COLD; FACE HOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18020N, and batch number: 18020N expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-MAR-2021 17:00, the subject experienced fever (101f). On 06-MAR-2021 17:00, the subject experienced cold. On 06-MAR-2021 17:00, the subject experienced face hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (101f), cold, and face hot. This report was non-serious.