chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Every year in October and always on a Friday to help with "flu-ish" symptoms; pain in the injection site that tends to both her for 24-36 hours after vaccination; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Every year in October and always on a Friday to help with "flu-ish" symptoms) and VACCINATION SITE PAIN (pain in the injection site that tends to both her for 24-36 hours after vaccination) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Every year in October and always on a Friday to help with "flu-ish" symptoms) and VACCINATION SITE PAIN (pain in the injection site that tends to both her for 24-36 hours after vaccination). At the time of the report, INFLUENZA LIKE ILLNESS (Every year in October and always on a Friday to help with "flu-ish" symptoms) and VACCINATION SITE PAIN (pain in the injection site that tends to both her for 24-36 hours after vaccination) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown whether the patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that the patient takes moderna vaccine every year in October and always on a friday to help with "flu-ish" symptoms and pain in the injection site that tends to both her for 24-36 hours after vaccination.  No treatment medication was reported.   This case was linked to MOD-2023-747870 (Patient Link).
Vomiting onset 08/10/10. DX: Intussusception 8/11/10. Surgery 8/12/10 - unable to reduce in radiology.
Background, I had Covid back at the end of May/beginning of June with 1 week of constant fevers (with 500mg tylenol q6), shortness of breath, fatigue, but no real cough. O2 sats somtimes in low 90's . I am one of the radiology faculty at the hospital I work at. Received my 1st dose of the Pfizer vaccine on Friday Dec 18 at about 21:30. After the injection, I had moderate pain at the site of injection about 6 hours later, not unexpected. However, the next evening, I was feeling fatigued and went to bed at about 7 p.m. For the next three hours, I felt chills and finally at about 10 p.m. I took my temp after I felt that my fever had "broke" and temp was 101.9. Used a finger pulse ox just to make sure sats were ok, they were at 97%, but unexpectedly, resting heart rate was 130 bpm. I took some tylenol and called the ER, and they suggested calling the covid hotline pager and coming in if I did not improve. I called the hotline pager, and we discussed things and eventually decided that I should go to the ER as temp remained at 101.6. By the time I reached the ER, my temp was down to 100.8, but pulse still 122 (EKG with no other abnormalities) and BP was 165/100. I had no other symptoms to account another infection. Over the next two hours, vitals became more normal with HR down to 95 to 100, and BP down to 145/85 or so without any other intervention.  Sunday, still with some mild low grade temps of 99.8, but heart rate at 85 to 90 (I'm usually at about 80).   In the ER, we came to the conclusion that my body mounted a significant immune response to the production of antigens after processing the mRNA given the lack of alternative diagnosis and the improvement of sx without any other intervention besides the 500 mg of tylenol I took before coming in.
I received shot at 1:15 pm by 4 pm my right arm was swollen red, firm, inflamed and painful from right shoulder to elbow.  I was unable to sleep due to extreme pain in right upper arm. 1/28 The next morning I had a low grade fever, chills, diarrhea, fatigue and continued arm pain I proceeded to take ibuprofen and tums.  1/29 an allergic  itchy rash appeared from site of injection to elbow around circumference of arm with continued pain, I then started taking Benadryl, Pepcid and ibuprofen which I continued until 2/2. All symptoms resolved by 2/5/21.
A non-serious, spontaneous report of administration of H1N1 to a 52-year-old has been received from a consumer concerning a 52-year-old patient. The patient's medical history and concomitant medications were not provided. The patient received H1N1 on 22-Oct-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Open sore left side of face. Tingling Left Side of Face. Porcupine needle pricks all over body. Swollen face left side. Red Rash lower back, left side torso, thighs, upper back. THis started 2 days after the shot. It is now 1 week later and my left face is hurting around site of open sore that popped up. I have never had an open sore on my face. This is NEW.
No adverse event occurred, but there was an administration error.  This was the patient's second dose, and Moderna was supposed to be administered. The patient was given Pfizer by mistake.
Itchy small bumps that develop into a child fist-size big red bump that is warm to the touch. Used Benadryl gel and it helped soothe the itch for a couple of days. The bump is gradually disappearing, but still red. The itch came back three days later in the evening, used Benadryl gel again and it helped.
& Sore arm from injection Prednisone 40 mg once take two tablets by mouth now
HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022. See additional AEs filed under interaction 02221034.  No PQCs reported at this time.; This spontaneous report was received from a medical assistant referring to a 5-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2022, the patient was vaccinated with an improperly stored first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml, lot number W002781 with expiration date: 24-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).; Sender's Comments:  US-009507513-2208USA004135:
haD PCOS; Lower back pain; This case was reported by a consumer via interactive digital media and described the occurrence of polycystic ovarian syndrome in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced polycystic ovarian syndrome and low back pain. On an unknown date, the outcome of the polycystic ovarian syndrome and low back pain were unknown.   It was unknown if the reporter considered the polycystic ovarian syndrome and low back pain to be related to HPV vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced PCOS and lower back pain. This case has been linked with the case US2020AMR247394, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247394:same reporter
Weakness dec range of motion left arm pain swelling redness itching stiff neck hoarseness.
Patient sat in the waiting area and soon she said she is feeling dizzy and  wants to lay down. Helped her get on the floor to lay down. She said she also had a vision black out. She was conscious throughout and said she is feeling better after laying down. This was her 2nd shot and she had done fine with that. She had not eaten for a while and then said she had similar reaction with the 3rd HPV shot. Took her BP and  it was normal. She laid on the back for a while and then sat in the chair with her feet elevated. After about 40 minutes she said she is doing fine and left.
Patient states area of vaccine is tender to touch, and can not lift arm, hurts to raise arm
Within 4 hours arm was red, sore and patient felt she couldn't bend it. She had hand numbness and tingling. Temperature of 102 for 2 days.
Patient was accompanied by her mother who also signed consents. Vaccinated with Jansen Covid 19 vaccination and not yet 18 years old.
101.8 fever since vaccine, nausea and vomiting since vaccine, severe headache that will not go away since vaccine, can?t eat, drinking fluids, nose stuffed up, can?t hear in r ear/clogged, nausea is overwhelming, vomited all I can. Fever causes sweating then I get cold. Face is very painful with pressure and headache
11/14/09 - Mom reports child having redness/swelling (R) leg (thigh) - favors when walking, tried BENADRYL - no relief. Took to ER. No treatment ordered except ice/heat/analgesic.
PATIENT HAD THIRD DOSE ON SHINGRIX ON 6/20 (prior shots in 2019 were not reported on registry)  AND CALLED PHARMACY TODAY TO REPORT ADR INITIALLY IT WAS INFLAMMED ARM AND REDNESS WITH SWELLING to the size of a baseball. SHE HAS SINCE DEVELOPED A REDNESS WITH FOCUS BEING ON HER ARMS AND CENTRAL FACE (CONCENTRATED AROUND SINUS PASSAGES AND FOREHEAD) AND RASH/BUMPS IN SOME LOCATIONS. SHE DENIED PROBLEMS BREATHING, BUT DOES HAVE SWELLING OF THE LIPS AND DRY LIPS. I COUNSELED HER TO TAKE ANTIHISTAMINES (CLARITIN OR ALLEGRA ONCE DAILY) AND TAKE 1-2 BENADRYL AT BEDTIME AND TREAT ANY PAIN/fever SYMPTOMS WITH TYLENOL.  I also counseled on using hydrocortisone 1% 2-3 on face avoiding eyes and prn on other locations that are causing itching. SINCE THIS HAS BEEN GOING ON FOR >WEEK I SUGGESTED SHE CONTACT MOUSHOURES (I LEFT A VM WITH THE OFFICE INFORMING THEM OF THE ISSUE) AND SUGGESTED SHE MAY NEED STERIOD.  I encouraged her to seek care if fever or problems breathing begin.
Presented to ED on 10/13 - CC right facial numbness and weakness which he noted over the last 2 days. Saw ophthalmologist 10/12-had R facial drooping and difficulty closing right eye lid. Evidence of cranial nerve VII palsy on physical exam. MRI negative for CVA. Dx with Bell's Palsy - started on prednisone and valacyclovir as treatment.
2 days after receiving vaccination a rash broke out on patient's buttocks. Doctor confirmed the rash was shingles and gave patient an antiviral med.
vaccine breakthrough event  dose 1 1/13/21 Pfizer EL3248 dose 2 2/3/21 Pfizer EL9265
Pt recvd vax & pt devel a h/a that required MD visit & was indicated to have subsided by reporter; pt also devel a h/a;
Case number PHEH2014US020441, is an initial spontaneous report from a consumer (patient) received on 08 OCT 2014. This report refers to a 72 year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411301) intramuscularly on 08 SEP 2014. On the same day, within 40 to 45 minutes after vaccination, he felt a click in his head and got really dizzy. It was stated that it was not a heavy nausea but his stomach was not doing well and had a dull headache. His doctor thought that it was viral and then tried Z-pack. Outcome of the events was unknown. Seriousness and causality of the events were not reported.
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: symptoms occured 30-45 minutes after vaccination -Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Said he felt dizzy when he got up (about 10 minutes post) to go to restroom.  He said he sat for an additional 30 minutes then left.  While driving he felt lightheaded and pulled over.  He also reported stomach cramps at that time.  He felt better and drove back to the store. NP looked at him and checked bp and O2 sat level.  Bp was little low. Advised have someone pick him up and he felt any worse to go to urgent care. After 15 minutes pt said he felt much better and left. Unable to reach f/u.
pt recv vax & parent noticed inconsolable crying, swelling, redness, fever & twitching/jerking of limbs;sx were reported to MD but no action was taken;
mom took pt to MD office 19DEC96 c/o congestion & day care stated jerking to lt side-no fever;no crying episode-questionable sz;was seen on 30DEC96 for f/u-no further problems x/treated for ear infect & cold;
Nausea and vomiting lasting 10-15 minutes, 8 hours after vaccination.
Information has been received from a registered nurse concerning herself, 49 year old female with no medical history and no known drug allergies who reported some VARIVAX (Merck) (lot # was not available) splashed into her left eye and face on 16-APR-2009. There was no concomitant medication. On 16-APR-2009 the patient's left eye was burning. The patient did not have lab diagnostics studies performed. The patient did not seek medical attention. At time of the report the patient was not recovered. Follow-up information was received from the registered nurse who reported that on 16-APR-2009, a small amount of VARIVAX (Merck) was sprayed onto left side of her face and in left eye as she was drawing up the vaccine. Her eye was irrigated right away. The nurse stated that she had no problem since. At the time of the nurse had recovered. No further information is available.
p/ vax pt son called & states mom blacked out @ home @ 12:00PM-12:30PM , called next day pt's son again states mom has no health problems & did fine w/1st dose of hep b but hosp for possible CVA at hosp;mom could not move arms or legs;
I had my first shot of the COVID vaccine last Friday, March 12. On Saturday I realized my vertigo was back more intensely than I have had it before. A few people I talked to said they had light-headedness or some dizziness as a side effect. Didn't think too much about it as I have had vertigo symptons on and off for at least 10 years. I figured it had to do with my ears and the constant ringing I hear in my ears. Sometimes when I roll over in bed the room will spin for a few seconds. After this Friday, the room spins a lot longer and faster. I have to make sure I am balanced when I stand up and just tilting my head can cause me to feel unbalanced.  I am being careful and it is not stopping me from functioning. Just thought I should report it to someone. I am hopeful that it will go away as it usually does. Other than a sore arm the first night...this was the only side effect I have noticed. If you have any suggestions to help please let me know. Otherwise just letting you know.
Cold symptoms x 3 days. Skin with many scatered vesicles with dry areas with ulceration upper in number over 2 h. Symptomatic Tx.
The following symptoms began the day after the shot:  headache, dizziness, tiredness, fever, complete loss of hearing in right ear, partial loss of hearing in left ear,  Hearing loss lasted 6 hours before beginning to improve.  Most symptoms were gone by end of 4th day.  Tiredness remains along with occasional dizziness.
Following patient's immunization, she began having right arm soreness that increased in intensity for a few days until it became intolerable, and proceeded to the ED, where she was found to have elevated LFTs and rhabdomyolysis, along with acute on chronic hyponatremia.
Pain in injection site when moving arm upward; Pain in injection site when moving arm upward; This spontaneous case was received on 29-Oct-2020 from a pharmacist via Med Communications (reference number: SEQW20-04435) and concerned a 36-year-old, female patient.  The patient's medical history and concomitant medications were reported.  On 21-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; route of administration: intramuscular, anatomical location: not reported) for flu prevention. The batch number reported was P100270298 and expiry date reported was 30-Jun-2021. After batch mapping, these two Seqirus' batch numbers were identified as possible matches P100270294 and P100271298.   On 22-Oct-2020, one day after receiving Afluria Quadrivalent, the patient experienced pain in injection site when moving arm upward. The pain persisted even one week after getting the flu shot.  At the time of initial reporting on 29-Oct-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The patient developed pain and vaccination site pain one day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain and vaccination site pain one day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Redness and an itchy rash (appox 1.5" round)  at the site of the injections. It is also a little warm to the touch.
rash appeared on buttocks & genital area-swollen genitals shiny, glassy around penis area;t104 x 2hr rash spread to chest, neck, back, ears, mouth;
Janssen COVID-19 Vaccine EUA  Pt lost consciousness after vaccine while waiting the 15 minutes before leaving.  Father notified us at that time that he loses consciousness after all his vaccines. Pt is now okay and has left with father.
where 2 doses were given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number M7S2F, expiry date 12-OCT-2024) for prophylaxis.   On 12-SEP-2023, the patient received Arexvy. On 12-SEP-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: where 2 doses were given). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023. An anonymous healthcare professional called in to request information about the protocol for the scenario where 2 doses were given.  They provided partial information about vaccine, event and patient. Follow-up accepted. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2 doses of Arexvy at a time, which lead to overdose.
Fever , muscle aches, joint pain, tiredness, headache Took ibuprofen 400 mg when temp reached 38.9C
Day after receiving influenza injections awoke with a sore neck, pain. Has seen private doctor x 2, orthopods x 2.
Pain at injection site (0.5 hr after administration) , 5 hours later severe stomach cramp, nausea and urge to vomit (dry heaving), intense perspiration, almost blackout with tingling in both arms. 12 hrs later fever and shivers, general malaise. 24 hrs later muscle ache, headache. After about 36 hours gradual recovery. Thank you
Extreme irritability and Injs and refused to eat mom instructed to give Tylenol 9.5hrs, ice bags to injection sites, To go to ER in 3hrs if not resolved.
pt recv vax 23JUL96 & on 7AUG96 pt devel erythema multiforme " minor rash" all over the trunk, the rash was not very itchy.
death Narrative: Pt has been declining prior to starting COVID vaccine doses; then he got COVID after first dose (VAER reported); and then was admitted to hospice for dyspnea, chronic pain, pressure ulcers, urinary incontinence with foley catheter in place, bedbound, dysphagia.
After child received 2 vaccines in clinic, he walked out to lobby with his dad, 2 siblings - 5-10 min's after shots - color grey - pale - staring - placed on floor awake slow to answer questions but given sucker; cool cloths - responded well - walked out 10 min's later.
Within 24 hr of vax pt devel inject site rxn of redness, swelling & soreness. As of Oct. 2, 1997 a red ring remained. Reporter indicates that of 300-500 vaccinees, 25 exp this rxn. Add.reports to follow.
Headache, no fever, sweats or chills.  RUA 3x4.5cm area of tenderness, redness and heat at centralized raised area 1x2cm.  Singular axillary node, no redness or tenderness extends from affected area.
30JAN97 t99.8, cough, nasal congestion;4FEB97 med given x 21 days;
Subsequent to receiving varicella virus vaccine live, pt was diagnosed with chickenpox on 10/30/99. On 11/1/99, the pt recovered. No further information is available.
Pt. states that after receiving the 2nd dose of Moderna 09/30/2021, started experiencing symptoms 10/01/2021 of dry skin at the injection site, discoloration, nausea, fatigue, and loss of appetite. Primary visit noted for 11/03/2021, still continuing to experience symptoms.
The day after receiving the vaccine, my arm is aching and it is swollen from my shoulder to my elbow.
PATIENT'S MOTHER REFERS THE CHILD BEGAN VOMITING, NASAL CONGESTION AND IRRITABLE.
7/26 positive for COVID, placed on Azithromycin and Prednisone; hx of IDDM, chronic lymphocytic leukemia, asthma; presented to ED on 8/4 with weakness, N/V/D, diaphoretic, fever; COVID pneumonia; placed on BIPAP, required reintubation; pt's condition worsened; pt's wishes to not be on life support for long; pt was extubated and passed away in the hospital
Patient called clinic to describe reaction to injection site to back of left arm. Patient describes adverse reaction began 24 hours after injection which included back of arm swelling to a golf ball size, warm to touch, painful; describes site as a "knott".  R arm injction site was also swollen, but to a lesser degree. Patient states she has no fever. She state she is on a 6-day course of Augmentin 800 mg dailey for a throat cyst and started antibiotic on day of injection. Discussed monitoring for a fever, worsening symptoms, continuing antibiotic course to completion and taking tylenol or motrin for pain.  Patient will call if symtpoms do not improve.