chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine; "chills running through veins"; Paresthesia (Pins and needles in face); Vison changes; Weakness; Felt faint; Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint) and PALPITATIONS (Heart racing) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included ESCITALOPRAM for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint), PALPITATIONS (Heart racing) and CHILLS ("chills running through veins"). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine). At the time of the report, PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint), PALPITATIONS (Heart racing), PRODUCT DOSE OMISSION ISSUE (it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine) and CHILLS ("chills running through veins") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: No new information On 23-Jun-2021: Follow up received on 23-jun-2021. significant follow up. The event is added.
I received the Janssen vaccine. The same night I developed a low fever and went to bed early.  I woke up in the middle of the night because my abdomen was hurting a little, stood up and became extremelly dizzy after standing up from bed and my ears were ringing a lot. I felt like I would faint (have never fainted) and that I needed to go to the ER .  I laid down and my dizziness and ringing felt better. The whole episode was strong,  acute and lasted some minutes. The next morning I was  still a little dizzy when I walked. I took a Tylenol and my symptoms resolved thereafter. I had never experienced related  symptoms in my life, so I strongly believe they were related to the vaccine.  I believe it's medically important to share it with you. Thanks
Pallor, sweating, dizziness/lightheadedness, Nausea, Vomiting, Thirst, Tetany (Pain in the jaw)
9/8/21 G2P0102 at 31w5d presents to triage with c/o vaginal bleeding.
17MAR92 went to headstart school @ 730AM was returned home @ 800AM w/fever 101.4 - 102, was given APAP @ 3:00 woke up vomited; mom phoned HD; pt eyes glazed, instructed contact MD:
suspected vaccination failure; still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt states right upper arm hurt immediately upon 2nd COVID-19 vaccination on 7/9/21 and the pain has continued but has lessened in severity. Pt saw provider on 7/22/21 who recommended pt use acetaminophen to help with pain. Provider reviewed arm and noted there was still bruising to the area and noted that injection was done higher than normal. Discussed injection placement with vaccinator.
pt developed red spots (apprx 3) at injection site w/in 2 wk of injection.  Culture showed varicella zoster
Covid arm.  Woke up about ten days after shot with burning and itching at site injection.  Saw a ring around injection site which only lasted about ten minutes.  Site was a bit swollen and hard.  Red itchy rash.  Skin dry, raised and leathery around site.  Approximately 2"x3" oval shape.  Took an allertec and sprayed site with flonase.  Itching stopped.  Still red but not as swollen this evening.  Unknown how long it will last, but seems to be getting better.  Will probably be gone by tomorrow or the next day.
PATIENT WAS GIVEN UNDILUTED DOSE (0.2ML) OF PFIZER PEDIATRIC COVID 19 VACCINE.  PARENTS WERE CONTACTED BUT NO ADVERSE EVENTS OR REACTIONS WERE OBSERVED.
Rash on her butt and that it started on her thigh and spread.; hives; itching; bad reaction rash that swelled up like hives when itchy/swelling of the face; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash on her butt and spread to thigh, hives, itching, bad reaction rash that swelled up like hives when itchy/swelling of the face. Patient who was calling to report a rash with hives and itching after receiving the Pfizer Covid vaccine's 1st shot. Patient reported rash appeared 2 days after the vaccination and was still currently experiencing it. Patient wanted to know was this rash as a result of the vaccine. Informed patient to consult HCP for treatment recommendations. Patient stated that she had an appointment on the 28Jul2021 and had called to cancel to put it on the 30Jul2021. Stated that she had a different pharmacy that was going to take her. Stated that she had called to let someone know that she was going to have it at a different place. Stated that after 2-3 days that she started to have bad reaction rash that swelled up like hives when itchy. Wanted to know if this was a bad reaction from the first shot. Later stated that it was 3-4 days later. Later clarified that it was after the Pfizer Covid shot. Stated that she had that rash on her butt. Later stated that it started on her thigh and spread. The outcome of the event bad reaction rash that swelled up like hives when itchy/swelling of the face was unknown and not recovered for other events.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
My wife has been sick for a few days with a slight fever, chills, weakness and cough.  We figured she may have caught the Flu.  Today she woke up and had no balance with the other symptoms listed. They went over her symptoms with her and gave her a rapid COVID test , according to their test she was found to be POSITIVE for COVID-19.  Just can't understand this as she received her vaccination on the 7th.
This case was reported by a consumer and described the occurrence of pneumonia in an elderly female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified) and Advair for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. Concurrent medical conditions included osteoporosis. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route and injection site; lot number not provided), unspecified dose of Advair (unknown route, dosage and frequency). At an unspecified time after administration of Advair and after vaccination with Influenza vaccine (unspecified), the subject experienced pneumonia, she fell down and hurt her lung. The subject reported that she had to be hospitalised due to reaction of an unknown flu shot. At the time of reporting the outcome of the events was unspecified.
Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 33 years old female patient who experienced an expired ADACEL injection was given on 19-Jun-2018, while she received vaccine ADACEL. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Jun-2018, the patient received a once 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5271AA, expiry date- 10-Feb-2018 via intramuscular route in unknown administration site. It was a case of actual medication error due to expired vaccine used. Other relevant tests included No lab data. Final diagnosis was an expired ADACEL injection was given on 19-Jun-2018. The patient has had no complaints of any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a medical assistant and refers to a currently 16 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). The reporter stated that the patient received 2 doses. No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
2 migraine aura events 1 hour after booster; severe chills that night with teeth-chattering and sleeplessness; inability to walk upright (needed a walker) nausea. Threw up my breakfast in morning, severe headaches for at least 6 days following, loss of appetite.
10:13 had pre-op work for upcoming knee surgery. Took flu shot after had to stop along road twice on way home to throw up stayed sick 14th 15th of Oct. Got her in bed about 11:30pm on the 15th. Went in to get her out of bed at 10:00 AM on the 16th, she had passed away several hours prior to. Patient had taken flu shot for years. She felt good morning of 13th.
I woke up this morning (approx 18 hrs post injection of my 2nd dose) feeling some myalgia, joint pain (perhaps 7/10 on a pain scale) and fatigue. I was able to work out (exercise bike 30 mins) and shower despite the pain. Then, around noon today (nearly 24 hrs post injection) I began feeling increasingly dizzy and warm. I stood to go to my bed and lost consciousness and collapsed.   I was only unconscious for perhaps 15 seconds. I woke up feeling very shaky and cold and breathing rapidly. I was able to slow my respirations. My skin on my face and hands was very pale (lips were whitish blue). My housemate had called 911 for me: FD showed up and took a couple sets of orthostatic vitals.  My BP when seated on the floor was around 110/80, pulse 80, and my BP when standing was around 90/70, pulse 100. I was able to walk to the bed without help so I decided to stay home and just hydrate, sleep, and keep a close eye on things.   Now (1620, around 4 hrs after passing out). I still feel lots of soreness, but only very minor dizziness.
Pt in clinic with mom for 2nd Hep A. Pt tolerated well to left deltoid, but then a few minutes later started to feel like seeing white spots and white film over eyes, then feeling weak This turned into other symptoms, diaphoresis, pale complexion, white lips then tingling to legs VS: 100% , HR 98, BP 58/48 (difficult to read, manual) similar bilat, pulse equal and full bilat EMS notified, pt layed on floor in trendelenburg, legs elevated, 15L O2 with non-rebreather placed on face Pt with other symptoms, now more so chest tightness, hyperventilating, chills (anxiety attack) Once on the floor, BP immediatiately raising, BP: 90/68, color coming back to face, 02 dropped for a moment to 88-90%, but quickly came back up and stabilized at 96-97% EMS arrived, but felt patient was stable and did not even assess. Mom signed waiver stating did not want ride to hospital. Monitored for another 5-10 min in triage room floor and then slowly transitioned and walked patient to the exam room. Continued O2 and kept laying on bed for 15-20 min. Then fully re-assessed. Suspect possible adverse reaction to HepA Other factors:  no breakfast this morning, only a couple sips water this morning no symptoms prior to coming Pt does admit to anxiety
After the Moderna booster shot, I have been itching all over my body, skull, arms, legs hands feet butt and beard non stop. Breaking into hives. Never experienced this in my entire life nor after the 1st or 2nd dose. Can't sleep, work nor enjoy my time with my kids because I'm constantly itching.
Shaky and feverish at midnight; Feverish at midnight; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky and feverish at midnight) and PYREXIA (Feverish at midnight) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient medical history was not provided.  Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, ROSUVASTATIN, PRIMIDONE, METOPROLOL and PROPAFENONE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (Shaky and feverish at midnight) and PYREXIA (Feverish at midnight). On 28-Feb-2021, TREMOR (Shaky and feverish at midnight) and PYREXIA (Feverish at midnight) had resolved.            No treatment medications were reported.  Patient received the doses in her left arm, non dominant arm.   This case was linked to MOD-2021-333682 (Patient Link).
Knot under site of injection. Rash on back of neck and scalp. Went to Urgent Care. Dr. did CBC workup. RX - Bacterium. Still swollen. Pt feeling better on 10-28-10.
information has been received from a literature article titled invasive pneumococcal infections ins pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal 20(10); 946-950, Oct 01) concerning an approximately 45 month old male pt with a history of a cardiac transplant, bacteremia with serotype 19F seen on a blood culture, pressure equalization tube placement for recurrent otitis media and a brief cardiopulmonary arrest during the tube placement. The pt was vaccinated with one dose of pneumococcal vaccine 23 polyvalent after his 1st infection (bacteremia) at 21 months of age. Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. 2 yrs later, the pt developed a bacteremia with serogroup 9V. It was noted that the isolates were susceptible to penicillin and ceftriaxone. The pt was not taking anti microbial prophylaxis at the time of either infection. It was noted that this information was received from medical records of all cardiac transplant pt's receiving their care at a hospital form3/90 to 11/00 that were reviewed for cases of invasive bacterial infection caused by S pneumoniae that occurred after transplantation. The risk factor for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range, 3 to 48 months) Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia / purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medication at the time of infection including cyclosporin. Azathioprine, systemic corticosteriods and mycophenolate mofetil.  It was also noted that four other patients were vaccinated with on dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 0110259,01104800, 01104801, and 01104802). A copy of the published article is attached as further documentation of the pt's experience. This report is considered to be an "Other Important Medical Event".
I developed a rash on my chest soon after receiving the Booster Johnson and Johnson COVID shot. Pathology confirmed Malignant Atrophic Papulosis (Degos Disease). I am alerting you to this event because of the Extreme Rarity of Degos Disease. I find it an odd coincidence that I received the Johnson & Johnson COVID Booster Dec 8, 2021 and developed the rash in Jan 2022. My apologies if I have wasted your time.
left arm pain all the way down arm also; every time I sneeze, I wee wee a little.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure from an unknown duration. The patient did not have allergy to any medications, food, or other products. Concomitant medications included acetylsalicylic acid (aspirin) (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), and zolpidem tartrate (AMBIEN); all were taken for unknown indication and within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 11:00, the patient experienced left arm pain all the way down arm, since got the vaccine, every time when the patient sneeze, the patient urinated down the leg (as reported). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left arm pain all the way down arm, and wee wee a little on sneezing was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
body aches; chills; fever 100.4; headache; runny nose; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL0140; expiration date: not known), intramuscular on left arm on 07Jan2021 10:00 at single dose for COVID-19 immunization, administered in hospital. Medical history included COVID-19 (reported as "COVID prior vaccination: Yes"). The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccine and no other medications received within 2 weeks of vaccination. The patient experienced body aches, chills, fever 100.4, headache, and runny nose on 07Jan2021 20:00. The reported events were non-serious. There were no treatment received for the reported events. The patient underwent lab tests and procedures which included nasal swab on 01Oct2020: negative; blood test and antibody test on 06Oct2020: unknown results and positive respectively. The outcome of the events was recovering.
Cloudy urine 11+ days Smelly urine 11+ days Orange urine 9 days Body Temperature fluxuations 10 days Achy back 11+ days Fever over 102.1 2+ days Vomiting  2 days Shaking Chills 10 days Night Sweats 11 days Shakiness 10 days Slowness10 days Stiffness 10 days Unsteadiness 10 days Extreme Fatigue 11 days Diarrhea 2 days
Covid Arm at the injection site.  Rash at least 6 inches in length and 5 in width.  Swollen lymph nodes at the axillary and supraclavicular.   Huge lump on my neck.  All very painful and sore to the touch.  Muscle twitching (all over my body) that lasted for 7 hours, that started 9 hours after the injection.
Very Sore Arm, could lift over head; Red Blotchy Rash / Little bumps on rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Red Blotchy Rash / Little bumps on rash) and VACCINATION SITE PAIN (Very Sore Arm, could lift over head) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Red Blotchy Rash / Little bumps on rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (Very Sore Arm, could lift over head). At the time of the report, RASH (Red Blotchy Rash / Little bumps on rash) and VACCINATION SITE PAIN (Very Sore Arm, could lift over head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 29-Jan-2021, the patient she got a delayed reaction, hot itchy rash. A round rash, little bumps and some bumps on the rash. First day or two, very sore arm, could lift over head. Concomitant medications were not provided. Treatment information was not reported.
Patient came in for HIS first dose appointment / IM injection for Moderna Covid 19 and gave him Intramuscularly on left arm after 10 minutes of the shot, he FAINTED.  Got him up from the ground, checked for any kind of head injuries ( NONE ) but regained consciousness immediately, gave him a little bit of bottled water, asked him if he can move his hands, legs ( movements ok ) , checked his breathing, pulse ( doing great ) , asked to say his name and where he is at ( answered everything correctly) and kept an eye on him until 911 Ambulance came to check on him ( all happened between 4:45 - 5 pm )04/27/2021 - I called his cell number  to check up on him and he is doing fine at this moment - Asked to call or report any kind of skin/breathing issues
Soreness at injection site. Redness/localized reaction ~2.5 inches in diameter. Severe muscle pain in neck and shoulders. Debilitating migraine headache. Nausea (possibly related to headache rather than vaccine). Subclinical fever. Mild chills.