chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STARTING TO COME DOWN WITH A COLD; BEEN ILL; TOO SICK TO DO ANYTHING; RUNNING A SERIOUS FEVER; FATIGUE; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced starting to come down with a cold, been ill, too sick to do anything, running a serious fever, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) on and off 37.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the starting to come down with a cold, running a serious fever, been ill, fatigue and too sick to do anything was not reported. This report was non-serious.
Increased breast size.; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced increased breast size. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event increased breast size was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dry mouth, bad taste in mouth, numb tongue, thirsty. these happened immediately. bad taste went away after 15 minutes, numb tongue lasted for about an hour. took 25 mg Benadryl which seemed to help.
Severe anterior bilateral neck pain due to multiple lymph node swelling. Unable to move neck without severe pain.  Lymph node swelling, tenderness and pain in arm pit on side of injection (left arm)
Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:30 (Lot number: EL3247) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 12:00, outcome "recovering", described as "Chills". Therapeutic measures were not taken as a result of chills.  No follow-up attempts are possible. No further information is expected.
14 hours after receiving my second Madura shot I have a severe metal taste in my mouth and difficult smelling. I had Cove it 19 at the end of February and had no problem with the first shot.
Pt presented to Phcy on 02/11/2017 @ 1:25 PM w/ a purple bruise on right deltiod about 1.5 to 2 inches in diameter. About 1.5 to 2 inches bellow the bruise (injection site) were 2 red whelts about 2 inches by 1 inch in size, slighty towards the rear of the arm. The bruise did not touch the welts. The welts were raised and warm to the touch. Pt said her arm "Hurt no more than usual after a shot". Pt took OTC Ibuprofen 400 yesterday and did increase her fluid intake as advised. Pt was NEG for any symptoms involving the mouth, lips, tongue, neck, throat, chest, lungs. Pt was already aware should that occure to call 911. Pt was advised to call us if gets worse.
I received the SHINGRIX Injection on 06/12/2018 at approx. 4:40 PM. Previously, 5 years ago in 2013, I had the ZOSTAVAX Live injection and had no side effects. I kept moving my R arm and put ice on it and kept ice on it until I went to bed that night. The spot where I had the injection was very sore, swollen, deep red/purple in color, and felt very warm to the touch. The next morning when I woke up, a small blister appeared on the red spot on my R arm. Each hour, the blister grew to 2 large blisters and eventually, it grew in size until it was almost the size of the top of a COKE can. I went to healthcare facility to have a nurse look at it. They advised me to take Diphenhydramine and Cetirizine Hydrochloride. This didn't really help at all. Eventually, the blister got so full, that it popped. I put NEOSPORIN on it daily with a larger BAND-AID to keep it protected during the day. At night, I removed the BAND-AID so that it could breathe. After 2.5 weeks it is now dry and healing.
Gave pt COVID vaccine yesterday morning. Was using a different syringe than normal and accidentally gave pt 1 mL instead of 0.5. Called pt 2/16/21 at 3 pm said he was doing fine just had a sore arm. Told him to call me back if he is having any issues.
On 08/18/10 pain noted by pt at injection site upper (L) arm. Pt also reported "hardness noted". No other symptoms reported. No redness or drainage noted. Small amount swelling noted only when pt lifts arm.
My arm has a big rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My arm has a big rash) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (My arm has a big rash). At the time of the report, RASH (My arm has a big rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information were reported.  Treatment information was not reported..
joint pain; chills; tiredness; injection site pain; threw up all night; feeling unwell; muscle pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration Date: UNKNOWN) via an unspecified route of administration at left arm on 06Feb2021 08:30 (at the age of 74-year-old) as single dose for COVID-19 vaccination. The patient's medical history was not reported. There was no covid prior vaccination and no covid tested post vaccination. Concomitant medications were not reported. There were no known allergies. Patient did not receive any other vaccine in four weeks.   On 06Feb2021 21:00, the patient experienced joint pain, chills, tiredness, injection site pain, threw up all night, feeling unwell, muscle pain, nausea. Patient did not receive any treatment for adverse event. The outcome of event was recovered.  Information on the lot/batch number has been requested.
Information has been received from a registered nurse concerning a 12-month-old male who on 10-Feb-2004 was vaccinated in the left leg with a dose of varicella virus vaccine live (lot #644789/0329N). The nurse reported that on 10-Feb-2004, the patient experienced a local site reaction and developed a hive at the site of injection. The patient was observed but not treatment was needed. The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that triplets experienced a similar reaction after therapy with varicella virus vaccine live  (WAES #0402USA01433 and 0402USA01540, and 0402USA01541). The nurse reported another child who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01547). It was noted that the triplets had the worse reaction. The nurse also reported two other children who experienced a similar reaction after therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (WAES  #0402USA01554 and 0402USA01555).
Patient developed vesicular rash below injection site of Zostavax. Vaccine given on 4-8-08, SQ rt. upper arm.  Patient developed rash 48 hrs later, 4-10-08. 2 x 2 1/2 inch circular area of vesicular rash on right upper arm only, painful.Patient seen in office on 4-12-08. Given Rx. for Valtrex and Medral Dose pack.  Patient to call office in 72 hrs if not improved.
CV: left arm/shoulder: goose egg size swelling & rash with pain/itching at injection site for 5 days Flu: right arm/shoulder: no significant reaction  Developed pain in upper right abd then shingles rash within 7 days of initial cv vax
Injection site reaction, red, warm, raised, about 6" diameter. MD diagnosis possible cellulitis.
3/17/11 Given PCV13. 3/18/11 Redness (about 2 cm) at injection site, increased to 10 x 10 cm on 3/19. Also developed itching at neck/ears/legs (red & excoriated ears/neck on 3/19) scattered mac-pap rash on legs 3/19/11.
Fogginess in the head, dry mouth, increased heart rate 120s-140s No treatment Lasted approximately 3 hours
Patient's daughter reported symptoms via patient and his wife of extreme shortness of breath that caused him to almost pass out in the bathroom. His daughter said it may have come from heart palpitations but wasn't sure it could have been shortness of breath. He also has extremely painful headaches. He also was winded going up the stairs.
a four different patients received an expired dose of Daptacel vaccine which was expired on 30Jan2020/No AE; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from the  other health care professional.  This case involves four patient (gender unknown) who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] which was expired on 30-Jan-2020 and was administered to these patients on 20Feb2020, 24Feb2020, 25Feb2020, and 04Mar2020 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report 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 holders compliance with the requirements set out in Directive and Module VI of the 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 on the batch number was requested.
pt recv vax 15OCT98 & 30hr later pt became tired, had h//a lasted through weekend;Monday got throbbing h/a w/disorientation while playing football;insomnia;lethargy & mood disturbance, depressed;poss sinus infect;inability to concentrate;
on 7/15 10 min. after getting shot started coughing & wheezing  used inhaler, water & cough drops 6-7 min later felt okay.   on 7/16  Woke up with headache & arm was sore.  around 1-1:30 pm began to have flu like symptoms coughing, chills, muscle aches, fever 102.  Took Motrin, Tylenol, used  Inhaler, went to bed  around 7pm fever went down.
Allergic reaction to my skin. Itchy,  tight, sore, painful and burse. From my 1st Vaccination Moderna.
Patient received a Tdap and 1st Hepatitis A and within 5 minutes, broke out in a rash and had trouble breathing and swallowing.  Patient reported he had a milk allergy.  We administered Benadryl 50 mg and monitored patient and he recovered well after approximately 1 hr and 45 minutes in the office.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of (Merck) PROQUAD L026728; expiry: 15-JAN-2017, L030587; expiry: 10-FEB-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
After waiting the 15 minute period, we left the vaccination site.  5-7 minutes later patient began coughing and had watering eyes while describing an itchy throat. Itching sensation continued, along with the coughing, intermittently for about 15 - 20 minutes. We had liquid Benadryl in the car and gave patient one dose of the appropriate amount. Symptoms were already beginning to subside when Benadryl was given and Benadryl was precautionary.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 03-APR-2018, the patient was vaccinated with expired VARIVAX lot # M012992 with an expiration date 14-MAR-2018 for prophylaxis (dose, route of administration or anatomical location were not reported). Sterile diluent (MERCK) used for vaccination was not expired (lot# M041812 with an expiration date 17-MAY-2019). No adverse effects were reported.
dyspnea, chills, body pain, dizziness,, fatigue, nausea
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4399802-00.  A 19-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), on 12May2021 as dose 2, single (Batch/Lot number: unknown) and on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Moderate to severe hidradenitis suppurativa" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA subcutaneous taken for hidradenitis. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19".  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID 19 cannot be excluded based on temporal association and available information.
She got her vaccine, had no problems until 1/26/23 when she noticed that she had a rash on her right shoulder blade.  Then the next day she had a bunch of blisters on the shoulder blade.  Then it became like 50 blisters and one dense blister and it was on the weekend and within the 2 days by Monday she had a big red blotch and after the blotch it was almost becoming blisters on crack as they forming so fast that the redness turned into them.  She has had friends that had shingles before and they said that they had never seen anything like it.  She is still recovering from he blisters even though she has recovered from it.  It went over her chest, to her armpit, her inner arm, forearm.  She went to see her PCP and she gave her a prescription to pick up, the rash proceeded to take over her body and went to the ER and they were going to hospitalize her for 10 days.  She was then given Valtrex IV and put her on really strong RX like 1 gram t.i.d. of Valtrex and then Gabapentin for the nerve pain.  She had mentioned to her sister that she thought she had singles, and had the shingles vaccine 2 years ago.  She is a nurse so she figured it was shingles, and then the PCP gave her medicine and then ER confirmed that she had shingles.  They called the infectious disease doctor and treated her with the IV Valtrex and then sent her home on it as well.  After she finished the prescription that since it was so severe to let them know if she didn't get rid of the blisters to let them know and she was extended it and now on it prophylactically for 6 months.  They have all crusted over and her skin is still healing, still has some tenderness and dark areas on her skin and hoping that is going to lighten up and having nerve pain as well so continues to take the Gabapentin.
Vasovagal episode. pt briefly passed out after reported blurred vision, dizziness and tingling arms. Staff supported patient by moving pt to ground and elevated pt feet. pt did not lose consciousness  and reported feeling better after laying down for a few minutes. We moved her to a sitting position on the ground, then to the chair. continued to monitor and pt reported feeling fine. Patient recovered within 10 minutes of episode.
Pt received his first Moderna injection on 2/6/21.  On 2/7/21 he developed chills and fever in the afternoon.  Pt woke up on 2/8/21 and had pronounced weakness.  Nursing Home/Assisted living reports falls x 2 this am.  First at 4 am and the second at 6 am.  Pt normally is ambulatory and still capable of driving a car.  Reports today generalized weakness.  He is having difficulty walking and lifting his extremities.  He also is having difficulty lifting his head off the pillow.  He reports generalized body aches and lower  back pain.  He presents to the ER with a rectal temp 100 degrees.  His vital signs are normal otherwise.  He had a septic work-up in the ER that included labs, urinalysis and imaging.  Only abnormal lab was a elevated lactic acid.  Pt received IV fluids and was admitted to the hospital for further monitoring.  He is routinely tested for COVID in the NH.  Last time was Friday 2/5 21 and was negative.  The patient had rapid COVID testing repeated in the ER again the results were not detected.  He has no swallowing issues and he is able to move extremities but again demonstrates pronounced weakness.
Excruciating headache for first 10 hours,  headache still lingered  on moderately for 4 days after shot; chills, body ache, skin sensitive to the touch, secondary anxiety due to the symptoms being present lasted 10 hours. treated all symptoms with Tylenol and Motrin.  Arm is still sensitive 5 days later but tolerable.  *Seems that if a person with a headache disorder gets the shot, this may be the biggest challenge to combat, in my opinion, and that should be made more aware to public.
First booster dose. Received 0.2ml instead of 0.3ml of Pfizer
Headache, Severe burning in both nostril's, Severe nose bleeding X 2+ days  (have VonWillebrand's disease. Breathing issues.
Became sick with COVID 19 on December 23. Symptoms: Bad headache, fever on day 2, congestion Tested positive...day 1...December 23, 2022 Treatment: contacted doctor.same day...prescribed Paxlovid, MethylPrednisolone dose pack, Azithromycin dose pack Tested negative on 6 day on December 28 2 days later, congestion and headache return Tested positive again on January 4 Doctor recommended an 2nd dose pack of Methylpredisolone & Azithromycin (did not take) Tested negative on January 8
PT FATHER  SAID A KNOT DEVELOPED ON LT THIGH A DAY AFTER THE VACCINATIONS WERE DONE . IT WAS LARGE SWOLLEN AND HOT .IT BEGAN TO RESOLVE THE NEXT DAY . TODAY THERE IS A SMALL BALL LIKE KNOT ON THE OUTER ASPECT OF THE LT LASTUS VATERALIS.NOT HOT , NO PAIN .
Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of GARDASIL (not GARDASIL 9) (dose, route and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
dehydration; throwing up starting 45 minutes after vaccine/can't keep anything down; Lightheaded/dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheaded/dizzy), DEHYDRATION (dehydration) and VOMITING (throwing up starting 45 minutes after vaccine/can't keep anything down) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, FLUOXETINE HYDROCHLORIDE (PROZAC) and OLANZAPINE (ZYPREXA) for an unknown indication.    On 30-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (Lightheaded/dizzy) and VOMITING (throwing up starting 45 minutes after vaccine/can't keep anything down). On 31-Mar-2021, the patient experienced DEHYDRATION (dehydration). At the time of the report, DIZZINESS (Lightheaded/dizzy), DEHYDRATION (dehydration) and VOMITING (throwing up starting 45 minutes after vaccine/can't keep anything down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are lisinopril, hydrochlorothiazide, Prozac and Zyprexa.  Treatment reported as ER   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Email document received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a patient who on 07-AUG-2000 was vaccinated with a dose of Varivax. Subsequently, on 21-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Extreme pain on the left side of the body in chest and legs, shaking, sweating and difficulty breathing
Pfizer-BioNTech COVID-19 Vaccine I have had numbness and occasional pain in my feet as a result of scoliosis. After the first shot, I experienced additional numbness in both feet as well as some loss of sensation in my left calf.  Additionally, I experienced severe pain in my toes.