chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dull pain from the elbow to the shoulder; This is a spontaneous report from a contactable consumer female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 09Apr2021 as single dose in arm left for COVID-19 immunization. Medical history reported was history of breast cancer and having the lymph nodes in her right arm removed 4 years ago. The patient experienced a sensation like a dull pain from the elbow up to the shoulder after the injection. The sensation felt like a dull pain only happened sporadically and did not last long before it went away completely. The consumer mentioned she does take a drug to suppress estrogen as treatment for her breast cancer. She reported she had cancer and the lymph nodes was removed in her right arm 4 years ago and do not want to take any chances. Outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
22 hours after 2nd Covid vaccine, I became lightheaded, and developed a headache and nasal congestion.  I went to bed.  My temperature began to rise from 97.9 (my normal) to 101.7.  I had mild chills.  I was fatigued and felt weak.  I took Advil.  After 12 hours, the fever broke and I sweat profusely.  My symptoms began to lessen.  By 48 hours after the vaccine, I was back to normal.
Patient received first dose of Pfizer COVID-19 vaccine on 1/21 at 1011. She presented to the ED that evening around 2100 due to concerns for allergic reaction. Pt reports the reaction started around 1930 after eating and consisted of nausea, throat tingling, facial swelling and chest tightness/SOB. Oral diphenhydramine was self-administered. In the ED, she was given IM epinephrine and IV methylprednisolone with good response. Was discharged home about 2 hours later with prescription for epinephrine autoinjectors. Pt reports no new foods were consumed that day therefore, reaction likely vaccine related. Pt advised NOT to receive second dose.
Body aches and those lasted 16 -18 hours. And they went away and have not re-occurred. They were actually horrible. I am currently in physical therapy for my knee and during two of those physical therapy appts (started on the 8th of September and then again on the 17th) - during those workouts, I clammed up (like I was hot - felt sticky and cold at the same time: heart rate increased and I couldn't catch my breath and I almost passed out both times. The physical therapist said he could see could see the color leave my face. I almost passed out but and they were able to get me to lay me down in a dark room and then I left when I felt better. I still have the fatigue, the sinusitis symptoms, headaches, indigestion (still there but has gotten a little bit better) and so for those reasons and the passing out, I called the doctor again to schedule an appt. (Note: The physical therapy sessions were started back in May 2021 and I've been going to see him continuously since then and those symptoms (that were pre-existing for the knee have gotten better).)  I have a doctor visit scheduled for this coming Wednesday - I'm waiting to get in.
SHIVERING; FEVER 102 DEGREES; This spontaneous report received from a consumer 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced shivering. On 14-MAR-2021, the subject experienced fever 102 degrees. Laboratory data included: Body temperature (NR: not provided) 102 deg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The patient had not recovered from shivering, and fever 102 degrees. This report was non-serious.
Reports symptoms of severe body aches, migraine type headache, memory loss, nausea, slurred speech, dizziness and vomiting.  Symptoms occurred towards the end of her shift on 2/2.  Called in ill to work on 2/3. Got the COVID-19 Moderna vaccine on Monday.  On Tuesday, symptoms occurred.  As the afternoon progressed, things got worse.  By 4 or 5 PM, had severe nausea and felt dizzy.  Then started having trouble thinking.  Then vomited and had her son pick her up from work.  Didn't go into work yesterday due to symptoms.  States that when son picked her up, she was slurring her speech.  Co-workers said that she seemed as though she was confused.  Son reported that she had difficulty with buckling her seat belt. Son reports that she feel to sleep in the car on the way home.Did not know if she had a fever.  Woke up yesterday morning all clammy and wet.     Did not remember what had happened at work on Tuesday afternoon or after her son picked her up. Her first memory was waking up on Wednesday morning.   Had COVID back in May.   Went into work today. Still feels a little nausea, but other symptoms have resolved.
subcutaneous administraion; A spontaneous report was received from a health care professional concerning a patient of unknown gender and unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneously/Incorrect route of product administration.  The patients medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of events, the patient received their second of two planned dose of mRNA-1273 (lot number: unknown) vaccine subcutaneously for prophylaxis of COVID-19 infection.  On an unknown date, the patient was administered mRNA-1273 vaccine subcutaneously in the triceps area, rather than the recommended intramuscular deltoid location.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event inappropriate route of vaccination was recovered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration without any associated adverse events.
Developed hives on her face, neck, and trunk about an hour after receiving her vaccine. Patient reported those areas were also very itchy. She also developed a warm red lump on her arm at the injection site. Patient took benadryl and recovered.
swollen lymph nodes on the left side of neck/and swelling of armpit; swollen lymph nodes on the left side of neck/and swelling of armpit; This is a spontaneous report from a contactable consumer from Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 12Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date of Mar2021, the patient had experienced swollen lymph nodes on the left side of neck/and swelling of armpit. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt received flu vaccine around 9/12/16. Patient developed left shoulder pain radiating to neck, low grade fever, stiffness and was seen at clinic. Treated and released with OTC meds. Pain worsened and pt went to ED to seek treatment 2-3 days later. Examination showed C-3-C4 discitis.
Weird symptoms in my head, hurting like very bad; Terrible pain to my head; Nose is very stuffy; Tired; I don't feel good at all; Little bit of chest pain; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, I am just calling because I had a vaccine two days ago, my first dose of the Pfizer BioNTech and I have been having like I don't know like weird symptoms in my head, hurting like very bad and my nose is very stuffy, just tired everyday like I don't feel good at all. I want to just make sure that it is okay if I get a second dose because I don't know if this is from the vaccine, but I got the vaccine at pharmacy and then ever since, I had the vaccine I have been having terrible pain to my head, like a little bit of chest pain, like dizziness, shortness of breath. So, it's kind of like concerns me a little bit. Consumer further stated, I have the numbers here. I just wanted to make sure like you know people that get reaction to the Covid Vaccine because I hear a lot of bad things like sometimes, I hear that it can cause like your heart to swell up (further clarification unknown). The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Left shoulder pain, numbness and tingling to finger tips, bicep pain, difficulty lifting arm. First reported to staff on 2/8/23. states symptoms have been improving with time.
Approximately 3 inch diameter red, warm to touch, knot that now itches. Taking ibuprofen every 6-10 hours.
On May 19th at 10:37 AM I noticed the backs of my hands and tops of my feet started itching simultaneously. About an hour later it had spread up my arms and legs. I took a cool shower to see if that would relieve it as well as took an allergy pill. Neither helped and the itching turned into pins and needles sensations on all four limbs. By the next day the bottoms of my feet and palms of my hands had burning sensations. I was able to get a doctor?s appointment and I told her how I had push mowed quite a bit two days before and had a bug bite on my leg that itched but no other signs it was from mowing and that I had taken a joint supplement that I noticed had shellfish (which I?ve never had an allergy to before) & wondered if I could have developed an allergy to it. Allergy medicine, Xanax, and neurotic (both she prescribed) did nothing to alleviate the symptoms. The numbness and tingling in my hands has subsided but I still have constant burning on the soles of my feet. I?ve now been diagnosed with sciatica and am doing PT for it. The doctor I saw and my PCP blew it off when I said it happened nearly a week to the time from my 2nd COVID vaccine but my son?s PCP said I should report it just in case it is related.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around September 2016, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, 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. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered.
Redness and warmth below injection site, accompanied by soreness, 3 days post injection, symptoms were resolving, still minor redness and warmth present.
Symptoms - Blood pressure normal (Athletic, very healthy and regimented diet and lifestyle)) before vaccine. One week after vaccine  Stage 2/3 Hypertension,, elevated resting HR and MHR +10-15  BPM , Systolic BP spiked +40, Systolic +30, four months later D+10 S +15 Stage 1 Hypertension.    Periodic chest discomfort,  headaches shortness of breath from time to time at rest, periodic weakness left arm, hand and leg. Blood pressure and heart rate highly abnormal based on 7-8 years of training and annual medical physical data. Can provide detailed evidence., has been very difficult to return to pre-vaccination cardiovascular training intensity level. Onset ringing of ears began early August first detected to now loud high pitched in right ear, lesser in left ear, worse at night and early morning.  Was tolerable up until early November 2021 now periodic low pitch in left ear beginning to trigger insomnia during night when it peaks in intensity. Ringing fluctuates in frequency and intensity shifts from ear to ear. Treatment - Exercise, reduced stress, increased cycling training from 300 miles/month to 700 miles/month, full time bicycle commuter., shifted to a four day work week.
A rash on my left torso appeared 04/11/21 and I received a  Shingles diagnosis the same day. I started Valacyclovir HCL 04/12/21 and Gabapentin 04/14/21. I?m still experiencing nerve pain and exhaustion.
Patient received Moderna for first dose.  Today Pizer was given for second dose (error).  Patient had no adverse or allergic reaction.   Patient was in observation for an hour from 1230 to 130pm.  Monitoring vitals and SP02%.  Patient decline any symptoms and stated she felt fine at the time of discharge at 130pm.
1255: Informed patient was experiencing nausea, no other symptoms to report; BP: 150/98; HR:100;RR:24; no LOC, not diaphoretic, having no other symptoms other than nausea. This nursed placed cool towels to patient's anterior and posterior neck - per patient, "it felt good." Patient transferred to a cot from her chair and placed in a supine position. 1300: BP:138/78; HR:80; RR:20; O2 sat:99%; patient stated nausea feeling was fading 1305: BP:132/76; HR:82; RR:16; O2 sat:97%; patient stated she was barely feeling any nausea 1310:BP:132/72; HR:76;RR:16; O2 sat 99%; patient sat up slowly and denied c/o dizziness; still with minimal nausea. Had three small sips of cool water and tolerated w/o emesis. 1330:Patient cleared by this nurse and patient was escorted out by her co-worker. Nausea had resolved. 01/01/20201: This nurse contacted patient @ 1634 and asked patient to return call.
Local allergic reaction with skin induration, erythema, and bulla distal to vaccination site
This spontaneous report as received from a regulatory authority refers to a 16 years old male patient with attention deficit hyperactivity and prophylaxis. The patient was vaccinated with dose 0 GARDASIL on 24-APR-2012, Other suspect therapies included LEXAPRO and clonidine. Concomitant medications included MENACTRA and STRATTERA. On 24-APR-2012 the patient experienced jaw fracture, 1 day after onset of therapy, syncope, surgery and fall. No treatment information was reported. The outcome of jaw fracture, syncope, surgery and fall is unknown. The relatedness for jaw fracture, syncope, surgery and fall is unknown for GARDASIL. Additional information is not expected.
Information has been received from a licensed visiting nurse concerning a 6 year old male who on 04-MAR-2009 was vaccinated SC with second 0.5mL dose of VARIVAX (Merck) ( lot number 661989/1740X). On 08-APR-2009 the patient was seen at physician's office and was described as having "mild case" of chickenpox. No lab studies were performed. The patient was being treated with ZOVIRAX. At the time of reporting the patient was recovering from the event. This is one of two reports from the same source. Follow up information has been received from a health professional concerning a 6 year old male with no pertinent medical history reported, no known drug allergies and no illness at the time of vaccination who on 04-MAR-2009 was vaccinated in the right arm with the second dose of VARIVAX (Merck) (lot number 661989/1740X). The health professional reported that on 08-APR-2009 the patient presented to the office with a mild case of varicella. The patient recovered on an unspecified date. No further information is available.
I felt itchy, headache, cough, difficulty breathing, fever, and lethargic. I tested positive for COVID-19 at home. I talked to my doctor, and she prescribed albuterol, but I did not pick up the prescription because I already had one. I did use it a few times. I am still having difficulty breathing and cough.
1046 - patient complained of itching on her right thigh and a "slight headache" and "feeling warm". Patient states this is how she starts to feel when she is allergic to something,  BP 140/98, SPO2 98, HR 83, RR 20, upon visual observation patient appeared flushed from her face,  25 mg of Benadryl given orally to patient per protocol, cold compress applied to area of itching, water provided to patient, patient advised she will continue to be monitored for worsening symptoms, patient verbalized understanding 1105 - patient evaluated, patient states itching on right thigh has resolved, "slight headache" still present and has some itching on her neck,  patient does not appear flushed from her face, BP 136/90, SPO2 98, HR 62, RR 16, 25mg of Benadryl given to patient orally, patient informed she will continue to be monitored, patient verbalized understanding 1130 - patient evaluated, per patient headache has resolved, itching on neck has resolved, patient denies new onset of symptoms,  1135 - patient left vaccination area without signs of distress, no complains of, patient informed to follow up with her primary care provider, patient provided V-Safe information, reviewed allergic reaction symptoms and when to contact 911 or go to the nearest hosptial, patient verbalized understanding
Since getting vaccine, joints in my body are cracking more than usual.  Usually occurs a couple times a day if I stretch parts of my body, or even just tilt my body slightly, or breath deeply.  The joints that are effected are in my spine and neck.  My spine never cracked before I got vaccinated - especially not like this or this often.  I thought it would be a temporary side effect related to the expected inflammatory response of the vaccine, but the adverse symptoms persist three weeks after my 2nd vaccine dose on April 11, 2021.
Hospitalized;  COVID-19 positive (9.13.21);  fully vaccinated.  Admission Date: 8/27/2021 Discharge Date: 9/15/2021  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Surgical wound infection  Post-operative wound abscess  Incisional pain    HOSPITAL COURSE: Patient is an 81 year old male with a PMHx significant for asthma, hypertension, type 2 diabetes, hyperlipidemia who presented on 08/27/2021 with a left femur periprosthetic infection.  He initially went an intramedullary nail in November of 2020 for a left intertrochanteric femur fracture.  He presented on 08/24/2021 where he underwent an operative irrigation and debridement with exchange intramedullary nailing with an antibiotic coated nail.  He continued to have copious drainage through his previous incisions while at his nursing home, and a CT image demonstrated a deep thigh abscess superficial to the iliotibial band.  He had been started on ceftriaxone 2 g daily for a course of 6 weeks during his previous admission.  Due to the drainage in need for repeat irrigation and debridement, he was admitted to Orthopedic on 08/27/2021.   On 08/30/2021, he underwent irrigation debridement of his left thigh wound with wound VAC placement.  Copious purulent drainage was noted at the time.  He underwent a left lower extremity I and D with wound VAC application 09/02/2021, where again purulence drainage was noted and a sinus tract between his lateral and anterior incisions deep to the fascia was noted.  He underwent an irrigation debridement of his left thigh wound with implantation of absorbable antibiotic beads and application of an incisional wound VAC on 09/07/2021.  At this time, there was no additional purulent drainage noted and the underlying tissue appeared healthy and viable.  His incisional wound VAC remained in place for 3 days and then it was removed at the bedside.  He continued to have serosanguineous drainage on dressings overlying the incision on his lateral thigh that slowed down gradually over period of several days.  Infectious Disease was reengaged during his most recent hospitalization, and they have recommended he continue on 2 g Rocephin for 6 weeks from his most recent I&D, (09/07/2021) followed by 3-6 months of suppressive amoxicillin.  Intraoperative tissue cultures collected on his I&D's performed on 08/30/2021 and 09/02/2021 all came back negative.  He did have a COVID swab performed prior to discharge on 09/13/2021, which was positive.  He was placed in respiratory isolation.  He was completely asymptomatic.  He had 2 additional COVID tests performed on 09/14 and 9/15 which were negative.  He was discharged to his skilled nursing facility in stable condition, tolerating a general diet.  He is to remain nonweightbearing in his left lower extremity until he follows up in clinic with Dr.  He had a PICC line placed in his right upper extremity prior to discharge and should receive 6 weeks of IV antibiotics from his most recent I and D followed by 3 6 months of amoxicillin, as per Infectious Disease recommendations.
devel severe hypotonia approx 48hr p/vax;duration about 14 days;poor intake & loss of DTR;pt not examined until 2wk later;
I have been bleeding vaginally ever since I got the vaccine - today is day 8. I had had my menstrual period the Sunday-Thursday prior to the vaccine.
Information has been received from a physician concerning his 15 year old daughter who on 03-JAN-2007 was vaccinated with a first dose of HPV VLP vaccine (yeast). On 03-JAN-2007 the patient fainted and experienced soreness at the injection site. Unspecified medical attention was sought.  Subsequently, the patient recovered. No product quality complaint was involved.  Additional information has been requested.