chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 5 year old white male with no past medical history who on 16-Jun-1999 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot # 628697/183H). There was no illness at the time of vaccination. There was no other immunization concomitantly or any other concomitant medication within three months of receiving varicella virus vaccine live. On 09-May-2003 the patient presented to the doctor's office. The patient reportedly "had not been well for a couple for days." The patient had a tactile fever, listlessness, slightly sore throat, and frontal headache. On the evening of 08-May 2003 he developed a pruritic rash on his torso. In the office, he had a one day history of vesiculopapular rash on his torso and head ultimately totaling about 5 to 10 lesions and group A strepococcal pharyngitis. The patient reportedly had a varicella infection. The patient's VZV IgG antibody was 5.4 with 1.1 greater indicating immunity and his VZV Ab IgM, EIA was 1.72 which was wel. within the positve range of greater than 1.1. The patient was treated with a 10 day course of cefradroxil (Duricef). The patient recovered in May 2003. It was noted that the patient did not experience any other adverse events following previous vaccinations. It was reported that the patient's brother had been exposed to natural chicken pox in April 2003, and on 23-Apr-2003 had developed symptoms (WAES #0305USA02850). The patient's other siblings also developed symptoms (WAES #0305USA02704 and WAES #0304USA02848). All were previously vaccinated. Additional information is not expected.
Five days after my COVID 19 Moderna boster vaccine, on  11/24, I began experiencing severe headache pain requiring an ER visit where I was administered fluids and a "migraine cocktail" medication in an IV. I have a history of neck and head pain from arthritis in my neck but this was so severe that I was dizzy, vomited, and my blood pressure was elevated.  This week, on 12/14 I experienced the same reaction, only the pain was much more severe and my normal medication  did not help. I again went to the ER where I was administered fluids and a  migraine cocktail of medications once again.  I have a history of arthritis and headache due to the arthritis in my neck but never such pain leaving me debilitated in such a way. I do not know if it is a coincidence or the booster exasperated my condition.
8 days after injection site of the injection became swollen and itchy. Had been fine until then. 9th day still some swelling and itching but not as bad.
the ONLY time the flu came into our house is after the husband's flu shot from the work. 3 years in a row it landed my son in the emergency room; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210303000514).  This case involves an adult patient who experienced the only time the flu came into our house is after the husband's flu shot from the work. 3 years in a row it landed my son in the emergency room (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious the only time the flu came into our house is after the husband's flu shot from the work. 3 years in a row it landed my son in the emergency room (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
PT RECEIVED PFIZER DOSE 1 ON 8/2/22, CAME FOR SECOND PFIZER DOSE TO COMPLETE PRIMARY SERIES. PT RECEIVED PFIZER BIVALENT BOOSTER AS HER SECOND DOSE OF PRIMARY SERIES.  PT INFORMED OF BIVALENT BOOSTER DOSE INSTEAD OF 2ND PFIZER DOSE, PT STATED THAT ARM SORE AND SLIGHT HEADACHE BUT OVERALL OKAY. NORMAL REACTION TO VACCINE. INFORMED PT THAT THIS PFIZER BIVALENT BOOSTER DOSE WILL COMPLETE HER PRIMARY SERIES NOW.
This spontaneous report was received from a physician refers to a patients of unknown age (gender unspecified). On an unknown date, the patients were vaccinated with a dose of 0.5 ml M-M-R II, (lot number, expiration date and route intramuscularly) which had been left out at unspecified room temperature for 7 days. The reporter could not specify whether any of the exposed doses were administered to patients. No concomitant medications were reported. Additional information has been requested.
Felt weird, dizzy, flushing/sweating, h/o multiple allergies. BPs 180/107 (pulse 126), 171/115. Given Benadryl 25 mg PO. Advised to go to ED, but patient refused.
Noted burning, soreness then swelling approximately 1 hour post immunizations. Swelling encomposed entire R deltoid lasting for 11 days. Noted a nodule after swelling subsided for 3 days. Area assessed by Medical Director. Warm to cold compresses recommended.
AS REPORTED TO DOCTOR, TINGLING ON RIGHT POSTERIOR PART OF BODY. SENSITIVE TO LIGHT TOUCH. NO RASH. DR REPORTED SHE HAD SHINGLES AND GAVE HER VALTREX ON 10/4/2012.
Fever ranging from 99.4-100.4 starting 26 hours after injection and lasting at least 12 hours.  Also chills and extreme muscle and joint aches and exhaustion during the time of fever. Woke up the morning of March 30 feeling completely normal.
lt arm deltoid area warm to touch, swollen-hard-DTP given 8JUN94;
Pt reported severe pain on L arm, and swollen lymph nodes on neck, axillae, consulted PCP on weekend.
I received my second dosage of the Moderna vaccine March 17.   A couple of hours afterwards I began to cough without stopping for about 20 minutes. I later went to bed and during the middle of the night I felt so sick; my who body was on fire with great pain with a temperature of 104. The shoulder where the injection was taken had swollen so big. I couldn't move. I had my husband to take me to the bathroom and back and put me in the bed. Then later on in the morning I got the chills; I was freezing; my husband had covered me up tight with my thick bed jacket and I had on flannels; I was still cold. All day Thursday was the same thing. I wanted a bunch of icy cold water (I never drink cold water). The water helped. That night was the same so bad I began crying. I thought of going to the ER but wanted to see how the morning turns out. Around 5:00 am Friday morning I noticed the pain and the chills had ceased; by 6:00 am I really felt good. Whatever that was (side effects)   Around 4 days later I developed the Covid Arm.  Nasty redness, blueish,  shoulder with rash and shoulder very painful and painful to touch.  My could move my arm at all; the should was hard and stiff and felt exactly like after my shoulder surgery I had years ago.  I followed up with my ortho doctor who told me that looking at my x-rays  it looks as if the vaccine took an effect on my rotator cuff. She also stated that sometimes when given a shot,  the provider should make sure the shot is given in a specific area and this time it may have hit my rotator cuff.  She gave a shot of cortisone, I forget what she said was added also to it.  My are began to move for use but I'm still not there yet.  It still hurts and very painful if I trying moving my arm in certain areas, the shoulder bone cracks with each movement.  I go to see another ortho surgeon on Tues 20th.
Received #2 varicella vaccine on 8-17-12. On 8-14-12 began having vesicle filled lesions to arms, chest & legs, on 8-27-12. Continues to have lesions to these areas with itching. Taking BENADRYL prn - doing okay no fever or cough. 8/28/12 - saw client areas were clustered raised red rash - no vesicle noted. Still has lesions to legs. One scabbed area to leg on 8-30-12.
Vaccine was taken for shingles prevention - Zostavax. Pain in right eye. Dr on 2/20/15 diagnoses as corneal ulcer.
Information has been received from a certified medical assistant referring to an unknown number of patients. Since an unspecified date in February 2015, the patients had been administered subcutaneously PROQUAD (Merck) injection which was not stored properly, (lot number, expiry date and dose were not reported). No adverse effects reported. Additional information has been requested.
Information has been received from a consumer, a 67 year old white female secretary with hypertension, arthritis, vertigo, osteoporosis (Dexa Scan Feb 2003-reported as doing better), and diverticular disease who on the morning of 09/03/03 at 10:00 was vaccinated with a first 0.5mL dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Concomitant therapy included rofecoxib (dose and indication not reported), lisinopril-HCTZ (dose and indication not reported) and Actonel. The consumer reported that by that afternoon, on 9/03/03 she had noticed a bruise about two inches below the injection site. On the evening of 09/03/03 she noticed "it had become painful". It was noted that on the following day (09/04/04) she noticed pain and tenderness throughout her bicep. On the evening of 09/04/03 she noticed that "it was red, raised and hot to touch". The reporter indicated that "today" (09/05/03) the pain has lessened and that it looked as though the swelling had moved to the back of her arm just above the elbow. The pt indicated she spoke with her physician and he gave her prednisone. Treatment was required for the adverse event, and it was indicated that the adverse event abated. The pt's outcome is not recovered. There was no product quality complaint involved. Follow up information received from a health care provider indicated that the adverse event onset was 09/03/03 at 12:30PM. On 09/03/03, the pt was in for a routine check. She was generally feeling fine, and "her knee is better after 3 Syndisc" injections". At the visit, the pt indicated that she would be traveling and wanted prophylaxis. At that time the pt's pneumococcal vaccine 23 polyvalent was up do date and she was given ciprofloxacine hydrochloride (Cipro) for travel precautions. On 09/05/03 it was noted that the pt had an allergic reaction to the pneumococcal vaccine 23 polyvalent approximately 2 hours after injection in the right arm. The pt developed warmth, swelling, and mild discomfort in her biceps. The pt was also mildly pruritic. The area was approximately 15x7cm raised erythematous non-vesicular area in the medial portion of the upper arm. The physician indicated that this is an allergy to pneumococcal vaccine 23 polyvalent. This improved over a couple of days. The pt was prescribed prednisone taper 30mg for 3 days and to cut off after 9 days. The pt was instructed to follow up with any problems. Additional follow up information indicated that the pt recovered on 09/20/03.  No further information is expected.
Moderna COVID-19 Vacine EUA hives all over body as itchy lumps relieved by diphenhydramine HCI 50mg antihistamime.
Mother brought patient in for 6 mo well child exam on 6/11/14 and stated knot on right thigh has been there since the immunizations at last visit. No other symptoms.
I got the PREVNAR 13 Syringe vaccine at 1200. I had 2 seizures at 1900 while sleeping and had to be taken by ambulance to the ER.
Urticaria, induration and erythema. Benadryl 25mg po q 4 prn.
11/1/10 had burning and itching of both ears. 11/3/10 boil appeared (R) ear, went the following day went to primary dx. with sinusitis. 11/11/10 watery & swollen (R) eye.
A non-serious spontaneous report of gave FLUMIST to a child that is less than 24 months of age was received from a health professional concerning a 24-month-old male. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
3:12 pm: shot  7:00 pm: very painful to move arm 10:00 pm: body aches  04:00 am: body aches and chills, limited range of motion of arm 07:30 am: finger tips ache, arm pain with anything touching it 08:30 am: called husband crying to come home  09:30 am: whole body felt heavy, entire body hurt, chills 10:00-2:00pm: light sleep any movement of body woke me up  2:00 pm-05:30am: light sleep on and off, body aches and chills 05:30 am-10:30am deep sleep  11:00 am felt better but arm tender for days afterwards
Pt received a bivalent Moderna Booster. Pt stated he needed to use the restroom. Pt noted to be unsteady on his feet and slightly diaphoretic.. Pt assisted to a chair and given food and juice. Pt stated he was feeling better after eating and refused EMS. Vital signs were stable during the incident. Pt's skin color, temp, and condition returned to normal approximately 20 mins after the incident. Pt signed AMA form as pt informed he needed to be evaluated by EMS.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/17/21 (EP7534) Pfizer Dose 2 4/7/21 (ER8729) COVID Positive 11/29/21  11/29/21: Patient is a 55 year old male with a past medical history of morbid obesity, who is vaccinated against COVID-19 presented to ED from Urgent Care for acute hypoxia.  Patient has been fully vaccinated against COVID-19. He reports his son came home from school sick 11 days ago, he developed sinus congestion the following day. His symptoms progressed into body aches, chills, fatigue, chest congestion and productive cough. He has had increased shortness of breath for the past several days and was seen at Urgent Care today. His oxygen saturation was 86% on room air, EMS was called and he was transported to ED. He denies any chest pain. No nausea or vomiting. He does report several episodes of diarrhea for the past few days.  On arrival to ED patient was hypoxic at 89% on room air, 5 L supplemental oxygen was applied with improvement oxygen saturation to 93%.  hyponatremia 133. Hypokalemia 3.2. Transaminitis ALT 105 and ALP 105. D-dimer 0.79.  Rapid positive COVID positive.  CT chest no PE.  Patchy multifocal bilateral ground-glass airspace disease compatible with viral pneumonitis.  Ceftriaxone and azithromycin initiated in ED.  12/11/21: 55 year old man who presented to the ED with shortness of breath to the ED.  He was hypoxic and found to be positive for COVID-19 infection.  He was started  on supplemental oxygen, remdesivir, decadron and empiric antibiotics.  Clinical response was favorable with improvement in oxygen requirements.  Oxygen walk for home determination done, patient requires 2 liters/minute with activity via nasal cannula and none at rest.  He has been discharged today in stable medical condition.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt started having severe tremors all over within 15 minutes of injection-Severe
Mild headache, vision spotty. BP 146/86 SpO2 97% pulse - 92
delayed cutaneous hypersensitivity - redness, warmth, and mild swelling at injection site on day 9 after injection
pt was having a hard time breathing @ approx 1150PM;pt was picked up & stared, was shaking & still having breathing problems;called ER & they verified over phone sz;went to ER & they observed pt & concluded febrile sz; tx w/med & sent home;
After vaccine, I had arm soreness, 24 hrs later because of asthma I had difficulty breathing  and fatigue, but I still have a rash all over my body. The pharmacist said to take Benadryl but I've had an allergic reaction to Benadryl,
Fever on 3-18-14. Presented in the doctor's office w/a full body rash on 3-20-14.
8 hours after getting the vaccine I started to get the chills and couldn't get warm. I took my temperature and it was 99.7. I wait a another hour and I still had the chills and started to have terrible body aches. I took my temperature again and it was at 101.3. This stayed the same until the follow day (03/07/2021) My fever finally went down around 2pm. And the body aches stopped around 4pm.
Information has been received from a field representative after speaking to a pharmacist concerning two patients of unknown age and gender who on an unspecified date were vaccinated with 25/0.5 of PNEUMOVAX 23, (route not provided). The pharmacist reported that the patients were administered expired doses of PNEUMOVAX 23. The patients were unaware that the vaccines were expired. No adverse reaction was reported. At the time of the report outcome was unknown. Additional information has been requested.
On June 18th I started running a fever. At the max it was 104.2 degrees. My PCP sent me an antibiotic. That didn't help. My breathing became more labored. On Friday of that following week I was unable to barely walk or couldn't breath. I went to the ER. I was hospitalized for 8 days. They ran many test while I was there. They found a blood clot in my lungs, and said that I also have pneumonia. I was prescribed Potassium, Eliquis, and Lasix. As of now I still have trouble breathing.
On 8/4/14 child woke up with hives all over his body. A few days ago had mild fever, no other symptoms other than rash, not ichy. No coughing, no rhin. no diarrhea. Good appetite. No new foods eaten, no meds currently.
Tingling on face, feet, legs, arms, hands, difficulty swallowing, leg weakness. Began on face, then feet, legs, arms, hands, then difficulty swallowing, then legs became weak. Began 10/25/12, not resolved as yet.
I got the covid shot on 7/25 on 7/26 I started experiencing tingling in my right foot, this lasted a few days, I contacted my Doctor at the time via email Approx 8/1 and she said tingling should not have been a side effect,  I was unable to make an appointment to be seen in person due to lack of insurance. By early August the tingling had subsided, but almost every time I sit on my leg it twitches excessively and 6 months later this has continued to be an issue.  I still have been unable to attend a doctor's appointment about it due to an insurance issue.
This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which experienced a temperature excursion of 22 Fahrenheit degrees for an unspecified timeframe. It was unknown if there were previous temperature excursions. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA007466: US-009507513-1707USA000722: US-009507513-1707USA000723: US-009507513-1707USA000724.
Developed a small red spot on skin near the injection site. It has continued to expand where it covers a much larger  area and has expanded around  my arm to the under side. It is not painful, but uncomfortable. Continues to expand, not decrease.
Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM; Received expired 2nd booster beyond 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022 at 8:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022 at 8:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster beyond 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (Via was punctured on 18-Jul-2022 about 8AM to 8:15AM, stored in room temperature and administered on 19-Jul-2022 at 08:54 AM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Patient received second booster. Dose was administered more than 12 hours post puncture. Vial was arrived in liquid condition, and it was placed in the refrigerator. Vial did not undergo any temperature excursions. Vial was stored in room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8-degree to 25- degree Celsius equals to 46-degree to 77-degree Fahrenheit) was 24 Hours.  No treatment medications were provided.
Patient was given the 1st dose of the Moderna Vaccine before her 18th birthday. There were no reported symptoms or side effects when the patient left the clinic. The Chief Medical Officer, was notified of the adverse event.
Very painful and large swelling and red discoloration around vaccination site on the left arm. Swelling lasted about 10 days. Discoloration is still present
So I was a little achy on Sunday, But I don't believe I had a fever. it was mostly muscle aches and joint aches. I didn't have any redness at the injection site. I did have some itching at the injection site for about 3 days. I also noticed a red itchy spot under my breast. it looks as though there are small blisters around the spot. It is currently still there and it itches. I scheduled a doctor appointment to get it checked out. not until may 18th.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient compained of shakiness immediately after receiving immunization. Had patient sit for 10 minutes. CHecked blood pressure and was elevated (156/80) and patient reports usual BP around 110/80. Had patient sit for awhile longer and symptoms continued to worsen. After another 15 minutes BP was up to 158/84 with a pulse of 98. Adminstered benadryl 25mg and had patient sit for additional 20 minutes. No change in blood pressure and pateint continued to have shakiness, but no worsening symptoms.