chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant concerning a 23 year old female with no known medical history or drug reactions/allergies, who on an unspecified date was vaccinated with a first dose of GARDASIL and on 07-FEB-2008 was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL. Concomitant therapy included TRI-SPRINTEC. Approximately 3 weeks after each dose, the patient experienced a rash. The patient called the physician's assistant for unspecified medical attention. Outcome unknown. No product quality complaint was involved. Additional information has been requested. 2/12/2010 This is a followup to  report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a physician assistant concerning a white 23 year old special education female with no known medical history or drug reaction/allergies, who on 28-Sep-2007 was vaccinated intramuscularly in the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) Lot #658560/1062U) and on 07-FEB-2008 was vaccinated intramuscularly in the left deltoid with a 0.5 ml second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot # 659962/1740u). Concomitant therapy included ethinyl estradiol/norgestimate (TRI-Sprintec). There were no illness at the time of vaccination. Approximately 3 weeks after each dose, the patient experienced a rash. The physician's assistant did not see the rash. The patient was seen by another provider the frst time and she called to report the experience after the second dose. The patient called the physician's assistant for unspecified medical attention. The patients out come was unknown. No product quality complaint was involved. Additional information is not expected.
Induration area of 6cm in diameter with red streaking down to axillary lymph nodes under L arm.  Streaking is anterior and progressing medially and then inferiorly.  Currently just symptomatic tx.
dyspnea, new CHF, possible myocarditis. This is patien'ts 3rd dose (booster)
Pt noted with jerky of arm of leg approx 13 hr post vaccination. Pt seizure lasted 3-4 min. Pt limp then irritable Temp 102 in hospital ER Rx with MOTRIN & after 1 hr became playful.
Atrial Fibrillation for 12 hours.  ER visit.  Put on beta blockers Toprol XL, 25 mg daily and blood thinners Eliquis 5 mg twice daily.
Information has been received from a physician concerning a 7 year old healthy white male with no pre-existing allergies, birth defects, or medical conditions who on 30Jun1998 was vaccinated with a first dose of varicella virus vaccine live (lot not available). Concomitant therapy included a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. On 24Jun04 the pt presented to the office with a few spots. On 25Jun04, he presented to the office again with 30-40 lesions on his trunk. They were itchy vesicular lesions and he had a cough and congestion. There was no treatment. Unspecified medical attention was sought. There was no product quality complaint. There were no relevant diagnostic tests or lab data. Follow up information received from a RN indicated that the pt developed a clinical case of varicella on 24Jun04 with approx 30-40 lesions, cough, congestion, and no fever. The pt was exposed to varicella 2 weeks prior. The outcome was reported as recovered. No additional information is expected.
Day of: Slightly sore deltoid muscle (at vaccination site); severe shivering for about 5 minutes after midnight. Day following: Episode of extreme fatigue lasting from noon to 6 pm.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of (LIQUID PEDVAXHIB lot number N034005 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
The day after receiving my COVID vaccine and Flu shot for over age of 65, I checked my blood sugar levels and noticed it was at 351,. Over the next week the range would be from 250-350. I received a call from a diabetic organization I am affiliated with checking on me because of my high levels. I contacted my physician about this and she was concerned that my glucose numbers were so high, she wanted to put me on another form of control and insulin. I went back a few days later and found that my body is producing plenty of insulin, but my cells had become insulin resistant. After a full week, my numbers returned to normal.
Vaccines administered on 3/20/19, on 3/22/19 MOC reported redness and swelling to left thigh. Keflex was prescribed by PCP.  Later on 3/22/19 patient presented to ED of Hospital, concerned that even after starting medication the redness hadn't gone down yet. Dx of cellulitis to left thigh. Staff noted, patient afebrile, no pain to leg, normal gait and patient is happy and playful running around the room.
shingles; Information has been received from a lawyer regarding a case in litigation and referred to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 20-MAY-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a painful rash on his side and back and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered not recovered. The event was considered related to zoster vaccine live (ZOSTAVAX).     The lawyer considered the event shingles to be disability.
C/O localized soreness to arm that originated at vaccination site and moved down to fingertips. C/O numbness, redness and swelling to arm. Lt. hand cold- wearing a glove to bed at night. 11/12 reported left side of chest thumb and two fingers feel like they're "on fire".
In the end of May, I started developing red bumps on my arms and thought it was body acne, I decided to see the dermatologist and he believed it to be some sort of infection so they decided to prescribe Doxycycline (oral) and Fluocinonide (topical cream) for the itchiness. The dose was for 30 days and after the 30 days, I went for a follow-up. They decided to do a blood test and biopsy since it didn't look like it was getting better, the biopsy concluded that I have PLEVA (Pityriasis Lichenoides). I was then prescribed UVB Light Therapy to see if the swelling would go down, I did not see any results after a month and also felt like the spots were getting worse. I met once again with the dermatologist and they prescribed Methotrexate. I am currently taking it and don't see any progress. The symptoms of this rash are dark red swollen bumps that are very itchy and have now become blister-like acne. My skin heals very differently now and the scars are really dark, almost black. The rash has spread to my chest, lower arms, hand, thighs, knees, calves, butt, and genital area. I am not too sure if it spread to my face because I also suffer with acne.
1745 vaccine administered. 1755 a bystander alerted staff of patient having a reaction. Staff summoned clinical staff to patient.  Patient's BP 148/70 HR 120, O2 saturation 99%. Tongue appeared slightly swollen. RLL slightly wheezy, otherwise clear throughout. Patient was able to communicate with staff and consumed 500 mL water independently. 1805 50 mg Benadryl administered orally. 1810 BP 130/70, HR 90, O2 saturation 99%. Lungs clear to auscultation throughout. At 1820 patient stated she felt better and felt well enough to go home with her daughter who was with patient. Prior to departure patient was educated about when to seek further care and when to utilize emergency services. At time of departure patient had no further questions or concerns.
Arthus type reaction with redness and swelling in the upper arm surrounding the vaccination site. Pt. began noticing symptoms 1 day after vaccination. Reported she did not move are after symptoms occurred and only took Tylenol the night of 1/28/2018. No other treatment sought or completed.
01/10/2022 - I fainted. I have never fainted before. I had body aches and fatigue. I was sick all month. I went to a clinic on 02/02/2022 -they drew my blood, did a urinalysis and prescribed me a heart monitor. And I wore the heart monitor for 2 weeks. On a later date I had a CT scan and a sonogram of my carotid artery.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/24/21 2nd dose04/14/21 Diagnosed covid positive:08/20/21 Symptom onset:08/14/21 Exposure:community Symptoms: fatigue,loss of smell/taste, sore throat.
The patient reported a metallic taste and pressure behind her ears at 6:52pm, about 2 minutes after the Moderna vaccine was administered. She then reported feeling lightheaded and tingling in her lips. I assisted her to the floor and had her lay down. She reported feeling feverish and she was warm to the touch, but her temperature was 98.4 degrees Fahrenheit. Her O2 was at 99%. She briefly lost consciousness around 6:55pm as evidenced by her not responding to my questions or to me roughly shaking her arm. She regained consciousness within a couple seconds. Patient then reported a sudden headache at 6:57pm. EMS arrived at 7:01pm. The patient left with EMS.
5-10 minutes after receiving the shot I got palpitations and cold sensitivity in hands similar to Raynaud's symptoms. Within 1 hour my face began turning red and my lips began to swell. Hives became more defined on my face and lips became painful.  I called  the center where I got the shot and got a voicemail.  I proceeded to call an online doctor who prescribed a steroid pack.  I continued to cycle through episodes of lip swelling  and hives for almost a week after the shot while taking the steroid.
12 MINUTES AFTER VACCINATION: BEGAN HAVING A RASH IN ARMS, GLUTEUS, THIGHS, BACK AND FACE. EXCESSIVE THIRST. DRANK WATER AND TOOK BENADRYL.  ICE WAS APPLIED IN THE AFFECTED AREAS.
Local reaction- 5 cm area of erythema around 24 hours of vaccination. Was seen in clinic without induration or signs of cellulitis.
Upper arm became very red, swollen and painful. Also itchy. Most of the right upper arm is involved.
pt recvd vax 23APR93 & exp fever w/3min generalized sz about 18 hrs p/vax;
Patient described that on the day of the vaccine, she developed a rash on the arm she got the vaccine and also hives on her chest. On 2/3/18, she described that the rashes have improved but she then had sore throat, congestion, and muscle aches.
Patient  started to experience redness, swelling, and itching around injection site on  day  2.. Redness and swelling still apparent on day 4 . Pharmacist instructed patient to take benadryl until swelling and redness disapears and if no improvement in 24 hours to see a physician.  Patient  does not have any other symptoms.  Pharmacist will follow up with patient 6/2/2019 ( next day) via phone call.
Received vaccine at 3 on Wednesday. Felt okay at 9 next morning but by 1 in afternoon felt achy with head ache. Took temp it was 99. 4. Took 3 ibuprofen. Waiting for relief.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-364557 (Patient Link).
Approximately 10 min after patient received immunization she began to complain of numbness around her mouth. She progressively became dizzy, anxious, diaphoretic, skin became cool and clammy, developed tremors and developed hives on right flank area. 911 was called and patients status was assessed continuously until EMS arrived and took over care of the patient. The patient was transported to a local emergency room in stable condition.
Side effects from COVID vaccine: -Chills -Joint Ache -Headache -Fever -Cough -Fatigue -Mild vertigo  Occurred approximately 24 hours after vaccination, lasting at least 7 hours until asleep. Symptoms cleared entirely upon waking up the following morning.
Information has been received from a certified medical assistant (CMA) referring to a patient of unknown gender and unknown age. On 20-AUG-2015, one dose of improperly stored (Oka/Merck) VARIVAX injection (lot  K010438, expiration date 22-JUL-2016) 0.5 ml in temperature excursion was administered to the patient subcutaneously. This VARIVAX (Oka/Merck) was patient's second dose but the date for patient's very first dose was not provided. No adverse effects were reported. The CMA also inquired the temperature stability. Additional information has been requested.
After about 10 days of getting the first shot of MODERNA COVID19 vaccine, I began to feel itchy on my feet starting the night before. Waking up, my feet felt unusually itchy and I checked to see that my feet were swollen with red spots. After half an hour, I began to feel itchy on my elbows and found that there are some swollen spots as well. At first I thought I was bitten by ants or bed bugs but throughout the day, hour after hour, I noticed that there are more red spots arising. Now I have these red spots scattered over the palms of both of my feet, on both sides of my hands, and all over my elbows. They feel itchy and swell larger if I touch them or scratch (accidentally).
Fever to 101; Nausea; Vomiting; This is a spontaneous report from a contactable physician, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 12May2021 at 15:45, as a single dose for COVID-19 immunisation. Medical history included lichen aureus and the patient had allergies to tree nuts, malt barley and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 21Apr2021 at 15:45, as a single dose for COVID-19 immunisation. On 13May2021 at 10:00, the patient experienced fever to 101 (unspecified unit), nausea for 1 day, and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with unspecified antipyretic. The clinical outcome of the events fever to 101 and vomiting were recovering at the time of this report. The clinical outcome of the event nausea was recovered on 14May2021.  No follow-up attempts are needed. No further information is expected.
Previously healthy 53 y/o received influenza vaccine at work around Nov. 5, 2008.  This individual has no medical problems and takes no meds.  Manufacturer was Novartis, Lot number 88637.  10 days later, the patient developed Shingles - Herpes Zoster - involving the C8 dermatome on the left arm/hand.  The Zoster appears to be mild in intensity.  Placed on Valtrex 1 gm tid x 7 days on 11/16/2008.
Information has been received from a certified medical assistant concerning a patient who was vaccinated PO with the first dose of Rotateq at 2 months of age. The second dose was missed at the 4-month visit, and was given PO on the 6-month visit. The child was told to return for the third dose in 4 weeks, but did not return. No additional information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Redness/soreness to left thigh on 10/27/15. Seen in office 10/28/15 with a 10cm x 7cm pink blanching slightly warm erythema left anterior medial area to inner thigh, non tender and no bright erythema. Advised to use BENADRYL, hydrocortisone cream and ice. Parents called next day with increase diameter redness, however redness/tenderness faded the night of 10/29/15.
Patient received Covid booster on 1/24/22, was seen in doctor's office on 1/26/22 for muscle aches and pain, fever, fatigue, now has developed upper Left arm pain and Left chest wall pain.
Patient vaccinated at 1035 - was in observation area for 30 minute observation. Patient reported to observation RN s/sx consistent with history of his anaphylactic allergy to shrimp - i.e. "throat closing"  patient reported not feeling like he needed to get epi yet and did not want it. RN lead notified. Patient rapidly assessed as pale, slightly anxious but reserved.  Patient was agreeable to taking 50mg Benadryl PO - given with sips of water.  VS BP 140/80 P 92 Spo2 98%RA. - Stat team initiated - pt rapidly assessed and transferred to ED per patient request.  Chart review indicates patient medicated in ER with Solumedrol, famotidine and loratadine and given a bolus of 1L of NS. VS remained stable throughout.  Discharged with 2 days of 20mg Prednisone PO daily. Pt has supply of epi pens at home.
pt recv vax 28OCT95 & exp h/a, tingling in fingertips & not feeling well;sx gradually lessened throughout the day;pt recovered;
RIGHT FACIAL PALSY 1/20/2022 CHOLEDOCHOLITHIASIS  HYPOTENSION 2/5/2022 CHOLEDOCHOLITHIASIS  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/7/2022 CHOLEDOCHOLITHIASIS  HYPOXIA 12/28/2021 CHOLEDOCHOLITHIASIS
Information has been received from a licensed practical nurse (L.P.N.), a Pregnancy Registry product, concerning a 16 year old female patient with migraine and allergic rhinitis and no drug reactions or allergies, who on 16-SEP-2011 was vaccinated with a dose of GARDASIL (Lot # 0298AA EXP 21-JUN-2013) intramuscularly. Concomitant therapy included HAVRIX and albuterol. The nurse reported that the patient received a blood and urine test on 13-SEP-2011 which showed that she was pregnant. She was brought by her mother (who did not know she was pregnant) into the physician's office on 16-SEP-2011 to receive GARDASIL. It was later found on chart review that the patient was pregnant when receiving GARDASIL. Patient's last menstrual period was on 06-AUG-2011 and her estimated delivery date on 12-MAY-2012. No known adverse effects were reported. Follow up information has been received via initial questionnaire concerning the 16 year old female patient with no previous pregnancies, asthma, and a history of tonsillectomy, adenoidectomy and tube insertion in ears, who on 28-SEP-2011 (previously reported as 16-SEP-2011) was vaccinated with her first dose of GARDASIL. The Family Practice reported that on 26-AUG-2010 an ultrasound was performed as a patient request and confirmed positive human chorionic gonadotropin (hCG). The patient was notified. Patient's last menstrual period was on 05-AUG-2011 (previously reported as 12-MAY-2011). Follow up information has been received: the outcome of the pregnancy remains pending. Additional information is not expected.
a)  pain in chest muscles b) extensive , increasing pain in muscles of  both legs  Probable diagnosis:  polymyalgia rheumatica.  Current treatment:  5 mg prednisone and 7.5 mg meloxicam
Allergic reaction with swelling and "lump-like" feeling in throat alleviated with 2 doses of 50mg diphenhydramine.
Approximately 5 hours after shot, felt sick to stomach and could not eat. Tried water and threw it up. I had hot flashes/sweats and diarrhea. Threw up again 1/21 and diarrhea continued (was not able to eat/drink x approximately 2 days). Took IMODIUM 1/21 at dialysis unit - felt better and was able to eat some.
Presented to ED w/N&V, cough, SOB; admitted for COVID-19 pna; tx w/abx, steroids, remdesivir, zinc; weaned to RA; discharged home
Red, swollen area 3? x 5?  below vaccine injection site. Warm to touch,  burning sensation, tender to touch, muscle soreness in muscle
On the right side of her eye she has blood in it. She has had diarrhea real bad and has not stopped. She has bumps around the outside portion of her eye.  She stated that the pharmacist gave her more of a doseage than she should have rcvd.
Pain all over body, swelling on injection site, fever, headache, and severe chills.
Pt recv vax on 7/15/98 and on 7/25/98 pt exp febrile seizure, temp at E.R. of 104.4, and red spots on trunk.