chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 27 year old female patient. On an unknown date, the patient accidentally pricked her finger with a syringe that contained ZOSTAVAX (Lot # reported as J006157, expiration date 30-AUG-2014) allowing an unspecified amount of the vaccine to enter her finger. The patient was pressing her finger to try to squeeze the product out which caused her finger to bleed. The patient experienced soreness at the site. The technician stated that she believed the patient was recovering at the time of the report. Additional information has been requested.
Numbness to both arms and hands and generalized weakness (unable to raise arm over her head on 12/9/05 and unable to get up from the floor). Referred to MD on 12/12/05 as soon as reported. Medical records state GBS, decreased reflexes, anxiety. msv
GIVEN INFLUENZA HD BEFORE 65 Y.O.; NO ADVERSE REACTION REPORTED.
Patient felt a shooting pain at the time of injection (not unusual).  The unusual part is that he still feels as though the injection site is sore 3 weeks later when he came back for the second dose.
2:56pm felt dizzy/was pale, vision in and out, ears ringing  put head between legs, laid on back on floor with feet elevated on chair at 3 pm ice packs applied to forehead and wrists, 3:05pm color returned, ate a cereal bar and drank water, sat up at 3:10pm felt better
Information has been received from a medical assistant concerning a male who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# 667995/1150Z, expiration date on 4-MAR-2012). Subsequently the patient experienced cellulitis and fever after administration of PNEUMOVAX 23 and may have been hospitalized for two days (name of hospital was unknown). The patient was treated with antibiotics. She did not have the patient's chart so she could not provide patient specific information. She was requesting a lot check. A lot check has been initiated. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination, date of event, recovery status, and hospital name. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. This is one of several reports received from the same source. Additional information has been requested.
Information has been received through an agency from a nurse and physician concerning a 16 year old female with drug hypersensitivity (Hydrocodeine) and a history of asthma, selective IgA subclass deficiency, and severe bladder infection, who on 18-JUL-2007 was vaccinated intramuscularly with a 0.5 ml of her first dose of GARDASIL (lot#655620/0171U).  Concomitant suspect therapy included DTaP.  On an unspecified date in October 2007, the patient found out she was pregnant (LMP not reported).  The specific pregnancy test and date it was performed, were not reported.  In the follow-up information it was reported, that the patient had developed a severe bladder infection and was restricted to bed rest because of preterm labor.  Unspecified medical attention was sought by calling doctor's office.  At the time of this report it was unknown if the patient had recovered from her experiences.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Information has been received from a licensed practical nurse (L.P.N.) for the pregnancy registry for GARDASIL concerning a 16 year old female with a drug hypersensitivity to Hydrocodeine and asthma and a history of IgA deficiency.  On 18-JUL-2007, the patient was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot#055620/0171U).  Concomitant therapy included a dose of DTaP.  On an unspecified date in October 2007, the patient found out she was pregnant (LMP not reported).  The specific pregnancy test and date it was performed, were not reported.  Follow up information was received from the L.P.N. reporting that the patient last menstrual period (LMP) was 25-SEP-2007.  During pregnancy, on an unspecified date the patient experienced a urinary tract infection (UTI).  In February 2008, the patient took AUGMENTIN 850 mg twice a day for the treatment of UTI.  At 19 weeks of gestation, on approximately 08-Feb-2008 the patient experienced premature labor.  In April 2008 and in December "2008" the patient took "tribuatoline 2.5 mg every 4 hours"  and "vistoril 25 mg every 4 hours" for the treatment of premature labor, respectively.  The date of live birth was 12-JUN-2008, which was 36 weeks from LMP.  The infant was a normal male whose Apgar score was 5/9 without any congenital anomalies.  He weighed 6lb 5oz. length 17.5 inches, head circumference 33 cm.  No further information is expected.
After receiving the vaccine I had the normal reaction the sore arm, felling tired and headache.  However my left arm continues to hurt to this day where the injection was done, it has effect my mobility and there is constant pain in my leg arm.
Janssen COVID-19 Vaccine EUA;  at 4:15 a.m. I took a tylenol for the headache I'd had since around 8 pm; ate a few crackers with it;  then as I was going back to bed I immediately felt weak/dizzy and then I passed out on the floor.   My life partner started calling my name and check my pulse (which he said was strong) ; then I came to but was really dizzy; I was nauseous and vomited for a few minutes; extremely hot/sweating; and after I stopped vomiting, then had a bowel movement (He had to aid me in getting to the bathroom).   About 20 - 25 minutes later I felt much better; everything calmed down.  I was ultimately able to fall back to sleep.
Chills, nausea, intestinal cramping, low grade fever and body aches.
Fever: 101, gave Tylenol. 11/16/13 diarrhea and vomiting, took to ER 11/17/13, on Pedialyte and prednisone to day of report.
Child developed blotchy facial rash within 5 minutes of vaccine administration.  Urticarial appearance on my exam.  No lip or eye swelling.  No wheezing or stridor although crying limited exam.  Had been eating peanut butter cookies just before shot had peanuts multiple times before with no adverse events.  Diphenhydramine 12.5mL was given within 5-10" of reported symptoms.  Child had good relief with diphenhydramine within 5-10".  Mom discharged home at 3:30 PM with prescription for diphenhydramine 12.5mg every 6 hours and instructions to call if recurrence of symptoms as may require PO steroids.  Released home with facial rash almost completely resolved and no complaints, no increased work of breathing or stridor.
dizziness, felt on the left side of his head and ear beginning 4/19.  Gradually improving over the next few weeks, but then after second vaccine dose on 5/5 symptoms worsened again.
17 y.o. patient no medical problems, received TYPHIM VI injection. Within 3hrs had swollen eye, blurred vision, hives on face and neck, difficulty breathing. Received oral BENADRYL with improvement.
Pt has redness and swelling (8cm x 8.5cm) around left arm injection site and low grade fever 99.7 orally on 6/11/03.
Patient developed persistent pain in left upper extremity in the upper arm, and has had persistent pain there with some initial numbness/tingling in that arm that resolved, but pain persists and also a complaint of weakness in that arm.  She complains of mild area of swelling, but not at site of injection, a few inches below.
Pain in shoulder to neck to chin, jaw and ear on R side, extreme and uncomfortable. Went to bed painful arm to  shoulder to neck, restless. Nurse call in the morning - advised to use warm or cold compress - patient used warm compress - no relief, neck swollen tender to touch, painful. Friday 7:00 PM Advil 200 mg. Next day discomfort neck, chest, shoulder. Red area in chest appeared, warm to touch and swollen. Nurse at clinic of vaccination clinic site advised  to follow up with urgent care, possible infection.  Cheilitis skin infection diagnosis at urgent care. B 12 injection on left side same day of vaccine.
No adverse event; Gave 0.25 of the Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient was with comorbid conditions.     On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster).    No concomitant medication was reported.  It was reported that on 29-Sep-2022, a technician gave 0.25 of the Bivalent booster to 5 patients. The CDC website says to re-administer the dose. No treatment medication was reported. This case was created for elderly patient number 3 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654608, US-MODERNATX, INC.-MOD-2022-654610, US-MODERNATX, INC.-MOD-2022-654611 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654608:Patient 2 US-MODERNATX, INC.-MOD-2022-654610:Patient 4 US-MODERNATX, INC.-MOD-2022-654611:Patient 5
The pt developed varicella lesions on 12/4/01. Treatment on 12/6/01 with Zovirax 2 1/2 tsp qid X 5 days. Also had strep proctitis on 12/6/01. Atarax prescribed for itching. He will recover.
Patient states that two days after vaccination he developed painful swelling right elbow region. The vaccination had been administered to left arm.
Sudden sensorineural hearing loss in my right ear.  No improvement. Tinnitus- Severe
After I received the flu shot I became very ill and my vision was  blurred, I also had a real bad headache  and I  became very tired. As of 10/09/2019 I am still feeling the same. I usually get the flu every year after the flu shot but this year I became ill right after the shot and things were different.
Mother reported that day of receiving vax pt developed an injection site reaction characterized by a rash on her left thigh. The rash was managed with hydrocortisone cream as instructed by health care provider. The rash resolved on 5/27/01. Three days post vax, pt developed a fever of 102F. The fever continues and usually occurs in the afternoon or evening. The pt's pediatrician told mother "that fever may be viral and didn't believe it was due to the Prevnar."
I started to have pain in my sciatic area after receiving the vaccine. I was in the shower and attempted to hit a spider and started to have pain and later developed it in my right leg. I didn't feel the shot until the 28th. I have had sciatic issues all of my life. I feel like my rectum is in the back of my back. Using the bathroom causes me to mess up the seat and my urine in little drops instead of the way it normally flows. I feel it in my right leg more than anywhere else. I have been doing exercises for it but it has not gotten any better. I think I will need an MRI. The doctor wanted to wait until next Monday to check on my condition.
I was fine initially as I expected. I wasn?t even sick the day afterwards. About a month later I was working out and I felt very very strange. I have passed out before and this was similar but yet very different. It was as if everything was losing its color and I felt very lightheaded. I became extremely pale to the point my lips were almost white. Being a mom I thought back to anything that may have caused it and the only thing that had happened recently was that I had gotten my second Covid shot. I had not expected to have any adverse effects from the shot and thought people who were sick the next day were being babies and just wanted an excuse to take a day off of work. To this day any time I am in a crouched position and get back up it happens again. I can?t work out like I used to and it?s made me cautious whenever it comes to changing elevation and getting up quickly.
approx 3-4hr p/vax pt was found limp, grey w/no color in lips;rt eye watery;episode lasted 1hr per mom resp nl;pt was awake;t101.6 observed over noc w/AM d/c;no further problems noted;
Breakthrough COVID case: Around 5PM I started sneezing and I felt congestion in my sinus'. I did not take anything because I thought it was allergies. The symptoms got worse and started a hollow cough and a headache. On 04/25/2022 I took some Nyquil because I thought I was having a cold. The next morning I took a rapid test and it came back positive. I went to the pharmacy to do a PCR test on 04/27/2022 the results came back positive. I contacted my doctor and I asked for Paxlovid and they denied because she stated I was vaccinated. Instead they prescribed some antibiotics and steroids. On 04/28/2022 my chest felt heavier and I went to the ER and they treated me with some anti-inflammatory and they gave Paxlovid. I took the medication and got very nauseous and couldn't keep anything down. On 05/01/2022 I went back to the ER and they gave IV fluids and nausea meds and antibiotics because it appeared I was getting a UTI. I'm taking naproxen for the aches and Zyrtec for my sinus'.
Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
Chronic pain and fatigue since  2nd shot, joint pain in feet and hands, migraines, hair falling out.  I have been on steroids for 2 months with little relief.  I am a healthcare worker and have had to significantly cut back on my hours because I am physically unable to work long hours.  I was completely fine before the vaccine with no pain or problems and working long 24 hour shifts.
Large area (17x12cms) of maculopapular rash with Erythemous (L) arm - almost into the elbow with feeling feverish (0 temp recorded) Pt afebrile in clinic Treatment - Zyrtec, TAC Cream, Keflex 500mg q 6hrs Evaluated & treated today
About a week after I got my first dose of Moderna, I began having pain in my left shoulder. I was only able to get relief when I placed my arm above my head, and I also had to do this while I slept. When I got my booster shot in the left arm, the problem was exacerbated. At the time of this writing, the increased severity persists.
This spontaneous report as received from a registered nurse refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9 with lot # M041212 and expiration date of 21-JUN-2019 (strength, dose and route of administration were unknown) for prophylaxis. No adverse effects were reported. Additional information has been requested.
PER FAMILY, PATIENT HAD EXCESSIVE IRRATABILITY FOR 1-2 WEEKS AFTER VACCINATION.  TREATMENT W OTC MEDS.
8 minutes after administration of the vaccine, the patient began to experience  nausea. She rolled her eyes and the individual accompanying her noticed that she  was about to fall to the ground, so he helped her in order to prevent head trauma.  The patient reports that she does not remember falling. Her legs were elevated, and  she was given water. The patient recovered and returned to a seating position.  After 5 minutes, her nausea resolved and the patient's symptoms improved. She  was alert and oriented. The patient was examined by Dr., who  recommended that she be examined at the urgent care clinic nextdoor. A staff member  from the clinic walked the patient to the urgent care. The patient had no issues walking, did not expereince dizziness, and arrived at the care clinic in a stable condition.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-AUG-2014 the patient was vaccinated with an improperly stored VARIVAX (Merck) (lot # J012328, expiration date: 02-OCT-2015, dose, units, route of administration, anatomical location were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Pruritic papular rash on face in scattered areas. Developed shortly after vaccine, persisted for several weeks and then spontaneously resolved. Pt has not had prior hx of rash. Rash was not observed during my appt with patient. Occurred again with 2nd dose of pfizer vaccine, but I do not have that vaccine administration details available
Rash (red spots) on stomach after 24 hours.; Over next 48 hours the rash spread to front and back of torso; mild discomfort; dose received 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 (Lot number: FL3198) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171), administration date: 25Apr2021, when the patient was 35 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737), administration date: 03Apr2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Jan2022, outcome "unknown", described as "dose received 3"; DERMATITIS CONTACT (non-serious) with onset 12Jan2022, outcome "not recovered", described as "Rash (red spots) on stomach after 24 hours."; RASH (non-serious) with onset 12Jan2022, outcome "not recovered", described as "Over next 48 hours the rash spread to front and back of torso"; DISCOMFORT (non-serious) with onset 12Jan2022, outcome "not recovered", described as "mild discomfort".  Additional information: The patient prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Fussy right afterward, Vomitting less than 24 hours after, and Fever less than 24 hours
Fever, delirious, diarrhea, flu-like symptoms, cold sweats; gave Tylenol, checked temperature, contacted a nurse.
Pt reports pain in left upper arm/shoulder since administration of vaccine in superior deltoid about finger width below acromion worsening in last 48 hours with difficulty raising L arm above shoulder and sensation of heaviness in L arm.
38-year-old male with past medical history of anxiety, sleep apnea presents to the emergency department with throat tightness.  Patient received his first dose of vaccine at 130 on 3/16/21.  He waited for approximately 20 minute without any symptoms.  On the way to his car approximately 30 minutes after the vaccine he started having his throat tightness.  When he got home he drank some water to see if it was a sore throat however he had no pain anywhere.  He feels like he was having difficulty swallowing his saliva however he was able to do it.  He also was able to drink fluids.  He called the nursing hotline who told him to take Benadryl (50mg) and come into the emergency department. His symptoms are still present but have improved.  He denies any headache, vision changes, neck stiffness or difficulty moving his neck, chest pain, shortness of breath, difficulty breathing, nausea, vomiting, diarrhea, abdominal pain, rash. Physical exam significant for mildly edematous uvula.  He was given 10 mg of dexamethasone in the ED Patient was monitored in the ED for 5 hours after exposure.  Symptoms resolving after Benadryl and dexamethasone.  Mildly edematous uvula without other signs of edema or allergic reaction on reassessment.  Patient without stridor or respiratory distress.  He no longer has throat closing sensation.  He was discharged with an EpiPen, prescription for 3 days of cetirizine, instructions to follow-up with his primary care provider for further workup and for discussing options for receiving his second COVID vaccine dose, and given ED return precautions
03/28: At 9 PM (9 hours after shot), I rapidly experienced fatigue, fever (101 degrees), chills, aches, and slight nausea. I took my vitals during this time: SPo2 of 98-99%, BP was 123/80, and heart rate was in the mid-to-high 80s. By midnight, I felt much better and assumed everything was over.   03/29: Woke up feeling fairly tired. As I was trying to do my normal morning routine of cleaning up, taking out trash, etc. I noticed a shortness of breath. No fever or other symptoms from the night before. I checked my SPo2 levels with 3 different oximeters, and all gave readings in the 93%-94% range. My heart rate, which is usually in the 80s and 90s when moving about, was in the low 70s, bottoming at 72. This was nerve racking. This along with intermittent dizziness persisted for 24 hours. I got COVID tested and it came back negative. Flu came back negative, too. A consult with a doctor inferred that "everyone has different vaccine side effects." Not helpful.   This shortness of breath/fatigue/low blood oxygen saturation continued persistently for the next 48 hours. I was essentially advised to stay home and rest. I noticed some lymph node swelling, too.   By day 4, I was feeling much better. My heart rate had gone back up into the 80s, and my blood oxygen sat. had increased to 96-97%. I was still somewhat tired and got winded very, very easily.   It's been over two weeks since my second shot upon writing this. I didn't want to report, but I can't make heads or tails as to why this happened. The only change in my health was taking the vaccine. I don't have any blood clots, asthma, or underlying issues. However, these side effects, if they are as such, need to be discussed. I know others who got the Moderna vaccine with similar anecdotes. The difference is, living with a clinician, I monitor my vitals all the time and knew enough to take measurements.
w/in 1-2 hrs of post vax devel red rash over entire body & eyes began swelling;