chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had COVID arm. The frist three doses I had in the past did leave me with a very sore arm. This time it started as a very sore arm, and then about 36h after the bivalent booster I noticed a bulge con mi right arm at the site of injection which was very red and itchy to the touch. This is ~5-6 inches in diameter.   Then, 72h (9pm) after the injection I had a rash on both forearms, (on the inside of the arm, palms to the sky). It started in the right arm and minutes later on the left arm. More prominent towards the armpit and the pivot of the elbow (areas with more sweat) . I woke up the next day with a rash in my stomach, mainly under the breast area. A big red rash on the back of the neck, stomach and chest.
1 day following vaccine had swelling and pain; on day 2 reported to clinic for evaluation where he has 1 cm round patch of dark erythema surrounded by 15cm mild erythema with swelling and warmth and pain; no vesicles or other skin changes
Headache, Myalgia, NauseaVomiting,  pain injection site, chills Narrative:
I am having extreme muscle pain and joint pain. I am also experiencing an intense headache and my eyes are burning. And lastly I am extremely exhausted.
Narrative: COVID infections following completion of COVID vaccine series 01/21/21 COVID vaccine dose #1 02/18/21 COVID vaccine dose #2; pt reports "feeling like crap" - tiredness, nausea, fatigue, increased urination, insomnia 04/18/21 Preop COVID test for colonoscopy - COVID NEGATIVE 07/14/21 Pt reports upper respiratory infection with symptoms of sinus drainage and dry cough; COVID tested at outside facility - COVID POSITIVE 07/26/21 Pt reports cough, diarrhea, fatigue, headache, loss of taste/smell, nausea, runny nose, shortness of breath, sore throat that started 07/14; advised to go to ED due to SOB; CXR WNL; ED discharged her home with rx for albuterol, vitamin C, vitamin D, aspirin 07/28/21 Pt reports cough , runny nose, SOB, sore throat; rx given for benzonatate, vitamin D 07/30/21 Pt reports slight improvement in cough and intermittent SOB 08/01/21 Pt reports continued productive cough, fatigue, SOB, runny nose 08/03/21 Pt reports cough improving; clinically resolved
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-MAY-2016 the patient received a dose of ZOSTAVAX (lot number L036454, expiration 22-DEC-2016) (dosing regimen and frequency unknown) and sterile diluent (manufacturer unknown) for an unknown indication. On 15-FEB-2018 the patient received a dose of ZOSTAVAX (N021171, expiration 01-NOV-2018) (dosing regimen and frequency unknown) and sterile diluent (manufacturer unknown) for an unknown indication. No adverse events were reported. There was no product quality complaint reported.
Patient states redness and swelling started yesterday (6/6/19), one day after vaccine. This morning she came into the pharmacy to ask about the reaction. She said the redness was spreading and it had swollen a little more. I advised the patient to take OTC ibuprofen and use an ice pack to help with swelling and inflammation and to check back in with us if it doesn't improve over the weekend.
Developed a varicocele in my left testicle, and constant pain. Started almost two weeks after COVID-19 vaccination with Pfizer/BioNTech.
extreme pain/stiffness in injection arm  lasted 2 days diarrhea lasted 3 days so far persistent head ache  lasted 3 days so far pain in injection  arm pit 3 days after shot lasted 1 day severe chills started first day  lasted 3 days extreme fatigue  started second day  lasted 3 days so far
ACHES; PITIFUL FEELING; CHILLS; FEVERISH FEELING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 21-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 22-JUL-2021, the subject experienced aches. On 22-JUL-2021, the subject experienced pitiful feeling. On 22-JUL-2021, the subject experienced chills. On 22-JUL-2021, the subject experienced feverish feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, feverish feeling, and pitiful feeling. This report was non-serious.
at 1845 patient began to complain of itchy rash on right shoulder, rash spread to her back, I gave 25mg capsule of diphenhydramine that I had in my purse.   At 1906 patient began to have facial spasms on the left side of the face with inability to move right side of face with rash spreading to left shoulder then eventually to chest, neck and face.  I took the patient to the local ER and they administered 25mg IV diphenhydramine and 125mg IV methylprednisolone at 1948 and monitored her til discharge from ER at approximately 2200.  Diphenhydramine and prednisone prescribed with follow up if symptoms returned.
radiated up to my entire upper shoulder for a week then it got better but then all this week I have had pain; severe pain begin at the injection site; numbness; tingling; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), PAIN (radiated up to my entire upper shoulder for a week then it got better but then all this week I have had pain), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling) and VACCINATION SITE PAIN (severe pain begin at the injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing). On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling). On an unknown date, the patient experienced PAIN (radiated up to my entire upper shoulder for a week then it got better but then all this week I have had pain) and VACCINATION SITE PAIN (severe pain begin at the injection site). At the time of the report, DYSPNOEA (difficulty breathing), PAIN (radiated up to my entire upper shoulder for a week then it got better but then all this week I have had pain), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling) and VACCINATION SITE PAIN (severe pain begin at the injection site) had not resolved. Not Provided          Concomitant product use was not reported. Treatment information was not provided.
light headed for half day; chills; felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headed for half day"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "felt tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 65 years old female patient. On 10-SEP-2012 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012 intramuscularly in deltoid. It was reported that the patient had called the pharmacy on 13-SEP-2012 complaining that she "wasn't feeling well" and that she thought her blood pressure might be elevated. The patient did not seek medical attention. The outcome was unknown. Additional information has been requested.
Their mother died days after the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Their mother died days after the first shot". The date and cause of death for the patient were unknown.  Subject: Patient Assistance. Customer Verbatim: Is it ok for our children to get the COVID shot now that results show a high risk of serious side effects on children getting the shot? Their mother died days after the first shot. She was 30 yrs of age, healthy, energetic, great mom and wife. Now she is dead and the kids are motherless. Will the kids die too if the get the pfizer shot?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Their mother died days after the first shot
Fatigue, joint pain, unproductive cough, elevated temperature. Made appointment for follow up but symptoms got worse over next few days. Applied for Emergency Room admission on 04/13/2015 about 8:00 PM.
This is a 60-year-old male thats presents to the ED complaining of back pain as well as abdominal pain. Onset of symptoms within the past 3 days. States that he drove up to his cottage 3 days prior & developed symptoms on arrival. He has not been able to eat for the past 3 days. There is associated nausea but no vomiting or diarrhea. He has recurrent bouts of pancreatitis, but is unsure of the cause. He denies alcohol use. He states he is vaccinated for COVID with Pfizer.   Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Negative for facial swelling and trouble swallowing.   Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Positive for abdominal pain. Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and frequency.  Musculoskeletal: Positive for back pain (right paraspinal thoracic). Negative for neck pain.  Skin: Negative for rash and wound.  Neurological: Negative for weakness, light-headedness and headaches.  Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.
Information has been received from a physician concerning a 4 year old patient who on 18-DEC-2007 was vaccinated with two 0.5 ml doses of VAQTA (no lot numbers provided) rather than one dose.  The patient was to receive a "handful of other vaccines and accidentally vaccinated with 2 of the same."  It was unknown whether medical attention was sought.  There was no product quality complaint.  Follow-up information from a pediatric office indicated that the 4 year old male was given the first and second doses of VAQTA (lot# 657842/0494U) in the left anterolateral thigh by mistake at his 4 year check-up.  There was no illness at the time of vaccination.  The patient was supposed to receive a dose of MMR II and a dose of VAQTA.  It was also noted that the patient's sibling was to receive the other dose of VAQTA.  The patient did not seek medical attention.  No labs or diagnostic studies were performed.  Subsequently the patient recovered.  Additional information has been requested.
Patient noted to have redness and swelling of right deltoid on 11/30/00.
Area of redness 11cm x 9.5cm noted today. Increased induration 4cm X 3cm. Complained of intermittent discomfort and itching. Hard and warm to touch. Normal ROM.
SICK AFTER TAKING VACCINE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a male 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sick after taking vaccine, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick after taking vaccine, and nausea. This report was non-serious. This case, from the same reporter is linked to 20210436706 and 20210436253.
After injection, patient became very pale, became unresponsive, and was unresponsive for approximately 4 minutes.  Patient was eased to the floor, vital signs monitored, and O2 administered until paramedics arrived.  Patient was transferred to ER. Hospital.  Patient returned to the Health Department in approximately 1 hour and states that he was fine.  ER doctor states he just fainted.
Expired vaccine given.  Parent contacted.  Aware booster dose will need to be re-administered.
Information has been received from a registered nurse concerning a 12 month old female who on 05-JUN-2002 was vaccinated with the first dose of VARIVAX (Merck) and on 15-JUL-2008 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 659942/1797U). The registered nurse reported that on 21-JUN-2009, the patient had numerous scattered and crushed vesicles mainly on her legs. The patient also had some on her left anterior shoulder, trunk and upper arm. Some lesions were vesicular. The patient was receiving topical symptomatic relief. At the time of the report, the patient had not recovered. The patient sought medical attention at the physician's office. Additional information has been requested.
After receiving my second vaccine on Monday, (09/20/21) I had the usual symptoms of fever/chills/nausea/body aches for about 24 hours. I was forced to be out of work on Tuesday due to the symptoms but by Tuesday evening I was feeling pretty normal again. Beginning Tuesday morning, I did notice that my chest felt tight. I again felt like that this could be normal. I returned to work on Wednesday sept. 22nd. Wednesday morning I again felt chest tightness but throughout the morning/afternoon I would notice times where I would feel like my heart was racing. I work at a health place on a- hospital campus. Our building  has Cardiac Rehab on our lower level. My co-worker convinced me to just go down and let them put the 3-lead monitor on me to make sure it was nothing serious. They did note some PAC?s and increased heart rate while just sitting at rest. My typical heart rate is low (50?s) when this was happening my heart rate would jump from 50?s to 100?s.   I have never experienced any type of heart issue or ever felt this type of thing happening before. I am a runner and athlete so I am relatively aware of odd occurrences in heart beat/rhythm along with my normal bodily functions. I still felt these weird bouts that my heart was racing throughout Wednesday evening. I have since not felt this happening again. I was advised to contact you. My employer  is a hospital system.
59 yo patient administer Fluzone High-Dose rather than Quadrivalent, no AE; 59 yo patient administer Fluzone High-Dose rather than Quadrivalent, no AE; 59 yo patient administer Fluzone High-Dose rather than Quadrivalent, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old patient who was vaccinated with first dose 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ288AA via intramuscular route in the left deltoid instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Batch number, expiration date, dose and site of administration was not reported) on 12-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered, Inappropriate age at vaccine administration and overdose. It was reported that the patient was accidentally administered with Fluzone HD rather than Quadrivalent at a flu clinic.  At the time of reporting, no adverse event was reported.  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.
Information has been received from a registered nurse concerning an 84 year old female whose 14 month old grandson was vaccinated with a dose of varicella virus vaccine live on 01/06/2002. The pt's grandson did not develop a rash or any other symptom. Three weeks post vaccination on approximately 01/27/2002, the child briefly visited his grandmother. The nurse reported that the pt was healthy and no immunocompromised. Three weeks after the child's visit, she developed shingles on 02/22/2002. Unspecified medical attention was sought. Additional info has been requested.
Immediately following vax pt c/o tingling in arm/hand, & a knot in the neck which did not subside; sx continued through pt shift; When awoke next morning, tingling sensation was no longer present, however the "knot" in the neck remains;
Around 6 :45 injection area very itchy. By 7 extreme itchiness,  By 7:45 shoulder to elbow extreme itch debated if I should contact pharmacy.  Around 8 p.m.  I noticed heart palpitations along with the itchiness going up along my neck now. And down the left trunk of my body. I'm feeling nausea at this point. I decide to lay down. By 8:45 my left arm, left neck, trunk , stomach area are itching beyond comfort levels , nausea is bad and heart palpitations are intense but no difficulty breathing.  So I lay here thinking how absurd this is. My husband also had his second dose at the same time he was doing fine. So I take a Zofran for nausea and an antihistamine for the itch and a Ativan. I advise my husband of the situation so he's aware . In case of something worse prevails. I wake up in the morning feeling fine.
Second dose was overlooked and patient received a third dose. The nurse was told it was his first dose. Nurse was notified after administration by nurse working at facility that is was his third dose.
was just depressed; had covid-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms). At the time of the report, DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided
: got second dose of covid vaccine today, having bilateral eye swelling, no throat swelling,able to talk in full sentences     History of Present Illness: Pt is a 49 year old female who presents to the ER with eyelid swelling, possible reaction to COVID vaccine. Patient received her 2nd dose of Moderna COVID vaccine at 9:30AM. Was feeling okay during obs period, and then when she went to her care, noted eyelid swelling. Eyes still feel sore and heavy. No lip swelling, no tongue swelling, normal voice. No wheezing or SOB.
12/31/21: Presents to ED reporting woke up with swollen face with her "eyes slit shut."  Complained of swelling to hands and feet.  Several episodes of diarrhea since the vaccine; no diarrhea now.  Noted: patient had facial fillers placed 3 months prior to 1st dose Moderna vaccine.  VS: BP 140/78, T 97.5F, HR 64, RR 18, SpO2 99% on RA, Height 68", Weight 130lb. Meds given in ED: famotidine (PF) (PEPCID) 20 mg in sodium chloride 0.9% (NS) 50 mL IVPB (premix) (20 mg Intravenous New Bag/Syringe 12/31/20 1100); diphenhydrAMINE (BENADRYL) injection 25 mg (25 mg Intravenous Given 12/31/20 1059); methylPREDNISolone sodium succinate(PF) (Solu-MEDROL) injection 125 mg (125 mg Intravenous Given 12/31/20 1059)
Initial unsolicited misuse report received from a nurse (consumer) on 15 December 2015. This case involves a female (age was not reported) patient who was vaccinated with a 0.1 ml intradermal dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone QIV) (batch number UI431AC, expiration date, dose in series were not reported) in forearm on 15 December 2015 instead of Tubersol. Reporter denied illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions included Fibromyalgia, HTN (hypertension), elevated cholesterol. Concomitant medication was not reported. On 15 December 2015, same day following the vaccination, the patient experienced a site reaction of redness and a lump at the injection site. It was also a wrong vaccine administered case. Lab data and corrective treatments were not reported. Outcome of events was reported as unknown. Follow-up information received from a physician on 09 February 2016. It was reported that this case involves a 61-Year-old patient who was vaccinated with a first dose of Fluzone QIV. No Lab data was performed. On an unknown date, patient recovered from the events. List of documents held by sender: none.
Patient received the Janssen vaccine at 16y.o. when the vaccine is only approved under the Agency's rule for use in those ages 18 and older. When the mistake was noticed, around 15 minutes after the vaccination, patient was notified of the event. Patient received information and reported no current ill effects. Patient was encouraged to register and report to system.
Shaking after vaccine. Gave patient water and advised to sit for 15-30 minutes. Patient got up towards bathroom and her vision went dark. She was caught before she hit the ground. We laid her down with a pillow and called 911. She was sweating. After 2-3 minutes she was okay and able to speak and call her mother who is a doctor. We were able to sit her up in a chair and her mother came to take her to the hospital/office.