chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my arm was really sore; profusely sweating and then freezing; profusely sweating and then freezing; as white as a ghost; her body felt like a bag of bricks; Incredibly Nauseous; profusely puking/ Vomiting; I lost control of my bladder while I was puking/ had no control over her bladder and pee was coming out; diarrhea really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 14:30 (Batch/Lot number: unknown) at the age of 46 years 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: NAUSEA (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "Incredibly Nauseous"; VOMITING (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "profusely puking/ Vomiting"; URINARY INCONTINENCE (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "I lost control of my bladder while I was puking/ had no control over her bladder and pee was coming out"; DIARRHOEA (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "diarrhea really bad"; PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "unknown", described as "my arm was really sore"; HYPERHIDROSIS (non-serious), FEELING COLD (non-serious) all with onset 07Apr2021 01:20, outcome "unknown" and all described as "profusely sweating and then freezing"; PALLOR (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "as white as a ghost"; FEELING ABNORMAL (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "her body felt like a bag of bricks".  Additional information: The patient did not have adverse event prior vaccination within 4 weeks and no family medical history relevant to adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
31.5x7cm area of increased erythema , heat and induration over deltoid surface of left upper arm.
Reported to me on 2/19/2007: Pain in left arm that won't go away.  so intense that it wakes me up at night, can be deep and cause the bicep to cramp on several occasions, limited range of motion.  Was advised to see her PCP. Spoke with her last week - PCP thinks that it's tendinitis - was placed on Naproxin - doing much better.   (Reason this is reported was because one of the rare side effect is deep aching pain and muscle wasting in upper arm)  <Had a difficult time  entering #13 for Vaccinations given - there is not the correct manufacturer for Tetanus Diphtheria - Aventis Pasteur>
17mnths male here for 1st dose of varicella. MA requested Mother to hold child for medication administration and to prevent needle stick. Patient moved while vaccine administation. 1st attempt dose given was 2.1, as advise per immunization chief nurse, medcation was approved to administer with remaining dosage of 2.9 with 1 inch apart. MA proceed with administration of varicella vaccine.
Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.
Subsequently post vax, the pt developed a local reaction that consisted of a wheal around the size of a dime surrounded by a red area around the size of a quarter. The pt was seen by a physician and administered Benadryl by mouth.
Had a stroke on may 1. Symptons were not severe and defined so medical help wasnt sought until may 3. Luckily stroke apparently was considered minor
patient who was back for second Imovax injection, the first being 24 days ago, no AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18 years old female patient who was vaccinated with first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] vaccine and the patient came back for second dose after 24 days of first dose administration (PT:inappropriate schedule of product administration).  Medical history and concomitant medications were not reported.  On an unknown date, the patient received the first dose of RABIES (HDC) VACCINE  and on 31-Aug-2020, the patient also received 0.5 ml of the second dose of same vaccine (injection,lot number and expiration date were not reported for bot the regimens) via unknown route in unknown administration site for unknown indication.  It was an actual medication error case due to inappropriate schedule of vaccine administration .  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Tinnitus starting day 3-4 off and on, Continuous ear ringing after day 4/5 getting worse and going on for 3 days without sign of going away. Plus Sore arm, chills, fatigue, sore muscles, minor headache, night sweats decreasing over a week with chills, sore arm, etc. still after day 8.
After initially receiving the vaccine.  I had soreness at the injection site for about 2 days. On the night of January 18th, my left are started to itch at the injection site. Next morning I had a rash from my tricep area to about my elbow. On the 20th the rash covered my entire tricep and appeared at the same spot on my right arm. On the 21st, the rash started to travel down my left forearm. On the 22nd, the rash traveled down my right forearm and had spread down to my left hand as well. On the 23rd, the rash reached my right hand. The rash has only been my located on my left and right arms and nowhere else.  As of today, mild improvement has been noted on my left tricep area. Right hand has worsened slightly.  Steroid ointment was prescribed. Have not begun using medication yet.
Dizziness, nausea, sweating, fatigue.  No actual loss of consciousness but became very lethargic. Administered ammonia inhalant. Patient immediately responded and began talking to us. Still felt quite ill, checked BP 90/60, laid on floor with feet elevated for next 20 minutes, slowly began feeling increasingly better. Slowly moved to upright chair, then walked to waiting room, then released once patient stated she felt "normal" again. Total time spent with patient was one hour.
Pt recv vax 10Mar97. Approx 1 wk later pt exp weakness.Pt devel staggered gait & tingling in arms when held up. Becomes "very tired" after working 2 hr. Unable to work for 3 months.1 MD dx fatigue syndrome. 1 MD tx w/Prozac.SEE comments
pt recvd vax & 2-3wks post vax exp poss erythema multiforme;
Feel like she had pression in her ear; Enlargement lymph node reaction on her collarbone; That area hurt a little until near her ear, neck; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (That area hurt a little until near her ear, neck), EAR PAIN (Feel like she had pression in her ear), LYMPHADENOPATHY (Enlargement lymph node reaction on her collarbone) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history was not reported .    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever). On 28-Feb-2021, the patient experienced NECK PAIN (That area hurt a little until near her ear, neck) and LYMPHADENOPATHY (Enlargement lymph node reaction on her collarbone). On an unknown date, the patient experienced EAR PAIN (Feel like she had pression in her ear). At the time of the report, NECK PAIN (That area hurt a little until near her ear, neck), EAR PAIN (Feel like she had pression in her ear), LYMPHADENOPATHY (Enlargement lymph node reaction on her collarbone) and PYREXIA (Fever) had not resolved.            Concomitant medications reported were thyroids medication No Treatment information provided
Injection site raised; Injection is reddish; Lymph node under the arm is a little swollen; Injection site got itchy; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT SWELLING (Injection site raised), VACCINATION SITE PRURITUS (Injection site got itchy), VACCINATION SITE PAIN (arm sore), VACCINATION SITE ERYTHEMA (Injection is reddish) and LYMPHADENOPATHY (Lymph node under the arm is a little swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm sore). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site got itchy). On 15-Jan-2021, the patient experienced VACCINATION SITE JOINT SWELLING (Injection site raised), VACCINATION SITE ERYTHEMA (Injection is reddish) and LYMPHADENOPATHY (Lymph node under the arm is a little swollen). At the time of the report, VACCINATION SITE JOINT SWELLING (Injection site raised), VACCINATION SITE PRURITUS (Injection site got itchy), VACCINATION SITE ERYTHEMA (Injection is reddish) and LYMPHADENOPATHY (Lymph node under the arm is a little swollen) had not resolved and VACCINATION SITE PAIN (arm sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Five after the after the vaccine. I was on a ladder and I got dizzy. My head was spinning and I slept until the next day. I had a numb feeling in the left side of my face. I had chest pain and dizziness and the tip of my tongue hurt. I had a headache and I went to the Urgent Care. My blood pressure was very high. It is still a little elevated after four months. The headache lasted a few days. I had the chest pain and face numbness lasted for two months and it was constant. I have not gotten the second shot because I am nervous that the symptoms will be worse.
TWO DAYS AFTER RECEIVING ANTHRAX #6 PATIENT EXPERIENCED REDNESS AND SWELLING COVERING ENTIRE RIGHT TRICEP.  NO AXILLARY LYMPHADENOPATHY, NOR STREAKING REDNESS.
Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the entire night with a bucket.  For the next week every morning, diarrhea and unsettled stomach, lack of energy, excessive sleep, no ability to exercise without severe fatigue or a return of digestive problems. This lasted a week. Sexual activity also impossible, erection quality greatly reduced. Many of these symptoms got better but have now returned with my second dose. Second dose has given me significant fatigue, digestive problems again, diarrhea, and reduced erection quality once more. I hope these problems resolve themselves. The vaccine has made going to work very difficult and I will seriously reconsider taking any vaccine in the future.
Left arm pit pain, left neck pain,  intermittent left ear pain.  Tolerable mild discomfort. No treatment.
pt recv vax & devel an inj site rxn;the inj site had a red wheal w/white dot in the center;
Patient experienced lightheadedness, sweating, nausea, blurry vision, fainting, and tingling in hands.  Administered vaccine to patient then going to administer to her husband. She said she felt dizzy, I had her sit down for a few minutes. I administered flu shot to her husband and and they proceeded to leave. She felt dizzy and fainted in the store on the way out, her husband was holding her so she did not injure herself. We laid her on the floor for a few moments the had her sit in a chair for about 20 minutes and gave her some water. She had not eaten much this morning. She tensed up when gave her the vaccine and she said she felt it going in. After the 20 minutes in the chair she said she felt better and  we helped her to the car and they drove home. I recommended they contact the doctor or go to the walk in clinic if she didn't feel better. I contacted the house and spoke to the husband about 3:00pm and he said that she was better.
vaccine leaked out of injection site; Underdose; Inadvertent exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm, please see case US2019AMR124438).   On 30th June 2019, the patient received the 2nd dose of Shingrix. On 30th June 2019, immediately after receiving Shingrix, the patient experienced injection site leaking, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age grp was been updated as adult as per vaccine indication. The reporter stated that, the patient received 2nd dose of vaccine but some of the vaccine leaked out of the injection site after injection which led to underdose and injection site leaking. The reporter stated that his colleague administered the vaccine and he had limited details available. The reporter declined to provide any further information.
No adverse event. the patient was given the vaccines in error. Call mom states that the patient was okay
Went to medical center on 8/25/11 after school went to cheerleading practice - where she started vomiting - 2 episodes. Hot and flushed but states so was everyone else on the cheerleading squad. Brought to ED and only c/o abdominal pain when actively vomiting, arms sore from her vaccines - mild global headache given ZOFRAN 4 mg ODT and TYLENOL 500 mg.
pt with sensation of tingling of the right lower leg 10 min after first covid vaccination. pt denies, rash, flushing, hives, chest pain, palpitation, shortness of breath, wheezing , stridor or altered mental status. symptoms resolved 40 min without intervention except observation and reassurance. pt instructed to follow up with pcp
Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of injection.  All accompanied by the usual fever, body, and joint aches which subsided at 48 hours after injection.  Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling  still present.
felt a lump above her collar bone; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and LYMPHADENOPATHY (felt a lump above her collar bone) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (headache). On 24-Jan-2021, the patient experienced LYMPHADENOPATHY (felt a lump above her collar bone). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt had local reaction to varivax vaccination to right thigh. Instructed to administer Atarax 1 tsp Q10.
Came in on 8/29/16 for vaccine update-PEDIARIX, HIB, PREVNAR, ROTATEQ-pt. was slightly fussy prior to vaccines and had been up the night before; temp check at office. Rectal temp 99.1 prior to vaccines. At 6pm; mom reported pt was "sweaty"; pt's head flopped forward and eyes appeared to roll back for a few seconds per dad. Pt very "floppy" vomited and seemed out of it for 3 minutes then seemed fine.
abrupt onset of high fever 104-106 w/prolonged grand mal sz about 10hr p/vax;recv anticonvulsant meds w/resolution of sx;
Pt reported an swollen lymph nodes under her arm on the left side, which was with the Covid vaccine. The 2nd day she had an excruciating headache which resolved. But the pain moved down her spine. Currently 9/26 the pain is so bad she is unable to sleep and she is unable to bend her head forward. Her back also hurts to be touched. She states this is different then the disc pain she is used to experiencing.
Information has been received from a licensed practical nurse concerning a 7 year old female who on 13DEC1999 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The nurse reported that the patient developed break through chickenpox. On 09SEP2003 the patient presented to the doctor's office with four to five pock marks on the forehead, cheek, and back of the next. On day two, the child had more pox marks on the abdomen. the pt was treated with benadryl and zyrtec for itching. The pt had less than 50 lesions and the itching had decreased. It was noted that a prescription drug was required. At the time of the report, the pt was recovering "with sequelae." A product complaint was not involved. Follow up information was received from the licensed practical nurse which indicated that on 09SEP2003 the pt experienced a chickenpox outbreak. It was noted that the pt had a clinical exam only. further info has been requested. The nurse also reported a similar reaction in a male pt after possible vaccination with a dose of varicella virus vaccine live.
Initial and follow up information has been received from an RN concerning an 18 year old white female student who on 16 Aug 2006 was vaccinated with her first dose of Gardasil (yeast). It was reported that she experienced pain at injection site several days post injection. On 13 Oct 2006 the patient received her second dose of Gardasil (yeast), IM, lot #653736/0689F. After the injection the patient complained of pain at injection site with radiating pain even at shoulder blade area several days post injection. Medical attention was sought. On 16 Oct 2006 the patient recovered from injection site pain and radiating pain. Additional information is not expected.
Information has been received from a nurse referring to a patient of unknown age and gender. On 20-JUL-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M037015, expiration date 22-NOV-2017; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009387.
dizziness within 1 minute after administration, then seizure/fainting within 5 minutes after administration.
This spontaneous report has been received from a nurse practitioner referring to a female patient of unknown age. Information regarding medical history, concurrent conditions, drug allergies and concomitant therapies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis, and then on an unknown date outside of the recommended intervals the patient was vaccinated with another dose of GARDASIL, (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis. This is one of two reports received from the same reporter. Additional information is not expected because the reporter details were not provided. Sender's Comments: US-009507513-1701USA005467.
Inflamed supraclavian lymph node and local site injection inflammation. Stated lymph node became inflammed the day after injection, which subsequently was misinterpreted by a physician as a potential aneurysm (pulsating mass), resulting in unnecessary hopsitalization. With reference to the site injection, left deltoid became red, itchy, and hot initally  surrounding local site only. However, as days progressed, reddening spread radially to extend to a final diameter of approxiamtely 5 inches, which also required medical intervention. I was presecribed steroids and anitbiotics which alleviated said symptoms. The symtpoms went away 3 weeks after first dose injection. Physicians advised against taking second dose.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L040460, expiration date 27-MAY-2017; site, doses and route of administration were not reported). No adverse effect was reported. This is one of the several reports received from the same source. Additional information has been requested.
1410 PM Symptoms: hives over upper body, eyelids swollen, pruritis severe, brought back to clinic by mom. 1415: 0.2ml epinephrine per MD's order after exam. 1418: 0.7 ml Benadryl per MD's order after exam. 1420: hives clearing up, no problems breathing. 1430:  itching gone, redness almost gone. 14:45 Client no longer scratching, hives almost gone, no problems breathing, drawing on paper at this time. 1500 follow up call-mother states "he is sleeping and isn't having any problems". Prescriptions written by MD and explained by nurse when to give as prescribed starting at 1800, next dose; to go to ER if any other problems arise.
7.5 x 6 cm area of erythema on right deltoid- warm to touch.
Rash at site of injection on a frequent basis; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender receives pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash at site of injection on a frequent basis on an unknown date. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.