chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After injection administered, initially experienced mild anaphylaxis, tongue/throat swelling, shortness of breath and palpitations. PCP provided Benadryl pills and a cup of water and had patient wait an extended 30 minutes leaving the facility. Upon return home, injection site developed a red, itchy, raised rash. It was initially the size of a dime. Over time, for the next 3-4 days, it grew to the size of the patient's palm (approximately baseball sized, slightly larger). Itching was intense to the point of opening the skin. Patient contacted PCP office 3-4 days after injection and advised to use Benadryl or Cortisone cream on injection site. She was to take Benadryl until symptoms no longer persisted. After 2 weeks, the rash, hives and itching went away. A week later, the rash, hives and itching returned to the same size and intensity as initial reaction. This persisted for 4 days before fading away. Another week later the itching returned. The area previously raised with hives and rash, turned dark like necrosis. This dark patch persisted for 3 weeks before fading away.
I had swollen lympnodes  along my clavicle and neck. I had lymphedema.
HOSPITALIZED; This spontaneous report received from a consumer concerned a female 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, batch number and expiry were not reported) dose, start therapy date were not reported 01 total administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, it was reported that reporter's mother was hospitalized after receiving the vaccine, and number of days of hospitalization not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220832500-covid-19 vaccine ad26.cov2.s-hospitalized . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Treatment of COVID-19; Treatment of COVID-19; Heavy chest; runny nose; clogged head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9810), in right arm, on 28Feb2021 as dose 2, single (Lot number: EN6198), in right arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Treating high blood pressure" (unspecified if ongoing). There were no concomitant medications in 2weeks. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". The following information was reported: CHEST DISCOMFORT (non-serious) with onset 12May2022, outcome "not recovered", described as "Heavy chest"; HEAD DISCOMFORT (non-serious) with onset 12May2022, outcome "not recovered", described as "clogged head"; RHINORRHOEA (non-serious) with onset 12May2022, out-come "not recovered", described as "runny nose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of chest discomfort. Anti viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03May2022, Treatment stop date: 08May2022, Indication: Treatment of COVID-19. No treatment for adverse event.
?Covid arm? rash and hives with itching appeared on vaccine injection site on day 8. Area was also firm and warm to the touch and itchy. Subsided slightly on days 9-11 with mild itching and treatment of Loratadine. Rash has reappeared, slightly larger on days 12& 13, but firmness has subsided.
Mom reports red size raise welt at Right Deltoid area, about the diameter of a soup can.  Patient is scratching at it so mom doesn't know if it is causing pain or itch and patient has sensory issues due to autism so not able to really verbalize clearly what the discomfort at arm is.   Not oozing at site.  No other swelling reported at extremity at this time.  Mom reports hot to the touch.  Mom has only tried cold compresses.  Patient is afebrile and no changes in behavior.   Mom applying cold compresses, giving tylenol OTC and advised to mark margins so as to see if it enlarges.  No swelling or other injury noted to extremity.  Mom asked to call back or seek urgent care if no improvement or worsening of symptoms.
Menstrual cycle following vaccination lasting 18 days. Normal menses for patient is 5-7 days.
Received Zoster vaccine 8/29/2008.  Called administering clinic on 10/1/08 to inform that she was diagnosed by her physician on 9/30/2008 with Shingles.  Said she had been having back pain, used a heating pad, noticed blisters, causing her to go to her doctor.
This spontaneous case reported by a consumer, describes the occurrence of nausea, headache and myalgia (sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced nausea, headache and myalgia (sore arm). At the time of the report, nausea, headache and myalgia (sore arm): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Patient stated on Apr 15, 2021 she is feeling better; she can eat now.
Patient reports vertigo, tinnitus, nausea/vomiting for 2 days, 1.5 days after receiving the vaccine. States that she is having auditory issues and is being tested for hearing loss.
Day 1: tiredness and swelling on face/eyes  Day 5:Pleurisy...shortness of breath and difficulty taking a deep breath. Felt like a punch in my lower left lung. A doctor said my lungs were clear, pulse ox good, but likely inflammation around my lungs. Take Advil to reduce swelling  Day 6: pain  radiating in left arm. Now upper lung feels pain. Difficulty taking deep breath.  Day 7: went to ER. Couldn?t move left arm without severe jabbing pain to left lung. Can?t take deep breath. Hurts to even take short breath. Pressure in left shoulder and lung.
After receiving MENACTRA and VARIVAX in right arm, patient complained of right hand feeling tingly.  Happened for 10 minutes.  Applied ice pack and patient stated it felt better.
severe muscle spasms from head to toe n.  im going on my third day with only ibprophin . which didn't help. . Imagine a Charlie horse that does not quit. I am callin the doctor to get something to stop this
I developed a rash of little tiny red bumps around my stomach to my back. my back is very itchy. Its from my waist down and all the way around. its spotty.
Pain in entire deltoid at injection site, developing into overall muscle aches overnight (injection at 3:30 pm).  Muscle aches mild but similar to flu-like symptom.  Managing muscle aches with Ibuprofen.
received an expired dose of Boostrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3YN2L, expiry date 12th March 2021) for prophylaxis.   On 13th April 2021, the patient received Boostrix. On 13th April 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Boostrix which was expired, which led to expired vaccine used. The reporter consented to follow up. No date of birth of patient was available at the time of reporting.
In 2009 she received her 8th AVA while out of the country. In the next couple of days her arm became swollen from shoulder to elbow accompanied by pain (9/10), heat, erythema and tender axilla. She also developed a red, splotchy, papular rash along that side of her trunk from axilla to waist. She does not recall any systemic symptoms such as fever, chills, malaise, but the pain was severe. She was seen by the medic and the symptoms resolved after a couple of weeks. There are no sequelae. Lot # not known.
Headache, Myalgia, Arthralgia, Fatigue Weak, "run down", Chills, Runny Nose Narrative:
pt recv vax 16JUL97 & same day devel a fever of 101.2;
4 hrs p/shot pt had a 2 hrs episode of unconsolable crying @ an extremly high pitch; also had swelling @ inject site; t102 az;
Large Local reaction with fever and fussiness for 2 days.  Fever of 101
Rebound of Covid symptoms after seemingly resolved.; Rebound of Covid symptoms after seemingly resolved.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "hemolytic anemia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LIALDA also received as other medication in 2weeks product. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown" and all described as "Rebound of Covid symptoms after seemingly resolved.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective included Paxlovid, treatment start date-18May2022, treatment stop date-23May2022.  Clinical course: Rebound of Covid symptoms after seemingly resolved. Felt completely better day 7. Slightly elevated temperature and cold symptoms resumed day 10. Cough, sore throat, runny nose.  No follow-up attempts are needed. No further information is expected.
Patient comes in with  round red area upper area of arm. Where the immunization was administered. It was red and hot at touch as described by patient.  She indicated the red area was getting bigger. Advised to apply cold to area and take Tylenol. Also advised to see her physician.
Severe burning pain of back (skin only not internal). Two days later skin peeled off as a sunburn would. Also change in personal body odor (not unpleasant just different) - obvious to other family members not just me. It's 6 days since vaccine and I'm still feeling clammy.
to ED c/o abd pain, dyspnea, not hypoxic so no steroid or O2 requirements, D-dimer +, CRP 0.28; TX: zinc, vit C, no indication for remdesivir; d/c'd home
Headache & fever of 99-100 degrees lasting 1 week.  No redness or swelling of arm, but still have discomfort when lifting any weight with that arm.  Two days after shot, very itchy rash appeared on both shins.  By 5/28 rash & itchiness on left leg gone, but not on right leg.
Almost immediately post injection, experienced tingling around lips, whole oral area, ears, quickly followed by generalized facial swelling to a moderate degree.  By approx 30 min post, throat started to tighten. Staff quickly administered Epi-Pen, with resolution of throat symptoms, no change in facial swelling with tongue swelling also evident. Developed a few abdominal small petechiae. Monitored at site for additional 30 min, while experiencing increased throat mucus and metallic taste. Sent home with instructions to report to ER for continued monitoring. Did so, admitted to ER for approx 1.5 hours of monitoring, given IV Benadryl , and discharged home in stable condition. Still no change in facial swelling and swollen tongue. Today, 20 hours later, I have weakness, fatigue and minor loss of sensation in tongue.
Approximately 15 minutes after receiving Yellow fever vaccine pt became hoarse, coughing, chest felt tight and tickling sensation in throat. Pt given .4mg. Epinephrine SC, Diphenhydramine 50mg IM, IV access was obtained, 4 L 02 via nasal cannula transported via ambulance to hospital. Hospitalized x24 hrs then discharged to home in stable condition.
This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a infant male patient who received ROTARIX for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, PENTACEL for prophylaxis and PREVNAR for prophylaxis.  On an unknown date, the patient received ROTARIX (oral), Hepatitis B vaccine at an unknown dose, PENTACEL at an unknown dose and PREVNAR at an unknown dose. On an unknown date, less than a year after receiving ROTARIX and not applicable after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and diarrhea rotavirus (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the diarrhea rotavirus was recovered/resolved. It was unknown if the reporter considered the vaccination failure and diarrhea rotavirus to be related to ROTARIX. It was unknown if the reporter considered the diarrhea rotavirus to be related to Hepatitis B vaccine. Additional details were reported as follows: The Registered Nurse (RN) reported that patient received ROTARIX along with the other infant vaccines (PENTACEL, PREVNAR, and Hepatitis B vaccine) and since then had diarrhea for the past 22 days. They had 2 positive cultures for rotavirus in their stool culture. The patient came to office for a 4th opinion. They received the vaccines at a different location so healthcare professional (HCP) had limited information. It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus and diarrhea to be related to PENTACEL and PREVNAR as well. Consent to follow up was given. This case was considered as suspected vaccination failure as time to onset for the event, and details regarding vaccination schedule was unknown.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Reported to have began same day as injection and persisting at time of call
MILD HEADACHE; DISCOMFORT OF THE JAW; DISCOMFORT OF TEETH; INJECTION SITE/ ARM SORENESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included glaucoma, alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma. On 30-MAR-2021, the subject experienced injection site/ arm soreness. On 02-APR-2021, the subject experienced discomfort of the jaw. On 02-APR-2021, the subject experienced discomfort of teeth. On an unspecified date, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site/ arm soreness, and mild headache, and the outcome of discomfort of the jaw and discomfort of teeth was not reported. This report was non-serious. This case, from the same reporter is linked.
States that after last flu shot, got sick x 4 weeks and lost about 30 lbs.
mom offers screaming more evening of inj;onset of fever & constant crying next morning noted onset of rash face, head, extremities on 30MAR98;saw CNP allerg rxn to shots given DPH;mom states pt was allergic to baby shots too;blisters legs
At 2 am on 1/1/21, sudden onset severe left calf muscular cramping which resolved in about a minute.  Soreness persisted for 4 days. No preceding activity peformed to have caused this. Same evening, insomnia, uncomfortable abdominal bloating, vivid dreams, and ?light? night sweats primarily affecting lower extremities. This also lasted for about 4-5 days. On 1/6/21, 7 days post injection, woke up in morning completely drenched from a night sweat. Things improved in days to come although a certain subtle feeling of hyperalertness has persisted.    On Tuesday 1/12, began with a mild to moderate bifrontal headache. Fortunately, I do not typically get headaches. Tylenol and sleep relieved but headache returned on Wednesday evening and persisted through late afternoon Friday 1/15 possibly lateralizing slightly to the right. Saturday morning 1/16, no headache, but sudden onset of focal right lower neck tenderness situated around the thyroid/sternocleidomastoid region. No throat pain, sneezing, coughing. This progressively got worse throughout the day and particularly at night(8-9/10 pain scale) with discomfort on swallowing and with radiation to right subdmandibular region and right ear. Some temperature imbalance overnight and last few nights with slight night sweats. Not feeling feverish.   Neck pain has persisted since then to today 1/20/21 and steadily improved. 2 separate Ibuprofen doses have appeared to help.   ENT to be seen today.
3 employees recvd 1 dose of Engerix-B; all exp fever, h/a, & myalgias;
Patient received Influenza vaccine on 10/13/2009 in (L) deltoid; next day in A.M. arm was "sore", has been up to today. C/O fatigue with raising (L) arm, pain putting clothes on with MOTRIN, has full ROM, pain starts at 45 degree angle, decreased grip in (L) hand intermittently. Denies muscle spasms, rxn at site or swelling. Has taken MOTRIN OTC per home meds RTC since vaccine. Has applied heat to arm with no relief.
On 1/24; nausea, vomiting, chills, and fatigue.
Weakness and pain in both legs. Limited mobility as a result. Less pain after taking Gabapentin and MethylPREDNISolone tablets ; however, I am still experiencing difficulty walking.
Mild fever, severe fatigue lasting over 72 hours, increased sleep need up to 12 hours per night. Improvement about 90 hours post dose.
I received the vaccine on a Wednesday.  Initially, I noticed normal redness and some soreness at the injection site. It was a little puffy but nothing unusual.  Later on, the arm became extremely red from the upper shoulder to the inner part of my arm up under the armpit and it was very tender.  It was extremely blood-red in color. My arm was pretty much paralyzed, my hand wouldn't close and it was swelling. There was intense pain in my hand but I couldn't move it or use it.  The palm of my hand hurt really bad. I was nauseous and had a bad headache. This went on for 3 days and by Sunday I could see the red going away, I had some use back, I could close my hand better. Still sore to the touch but otherwise everthing is back to normal today, 10/27/2023.
Approximately 12 hours after injection, began to run fever over 101 degrees and have severe chills and shaking. Soreness at injection site became inability to lift left arm, along with continued fever, fatigue, and chills for approximately 24 hours.   Approximately 9 days after, became fatigued again, fever of around 100 degrees off and on, and swelling in tonsils/throat, in spite of very limited exposure to other individuals.
Two hours after vaccines given flat rash developed on legs by 10PM covered child's body, no fever, sleepiness, no unusual fussiness. Was seen by child's doctor and rash was to be monitored. Rash almost gone by next day.
2nd dose administered 01/13/2010 by Feb 2010 day time sleepiness, weight gain, vivid dreams resulting in countless tests finally revealing narcolepsy 8/9/2013.
Chest felt heavy about a half hour after injection. Having chest pains on and off ever since first dose from middle of my chest to my shoulder.
Red and swollen right arm that spread down to the elbow from the shoulder area. Per the patient, very uncomfortable and had difficulty sleeping. Patient took Naproxen to alleviate the pain. Patient was seen by the PCP and was given Amoxicillin/potassium 875/125 mg, ZYRTEC 10 mg and Probiotics.
received her COVID Moderna 1st dose vaccine on 3/15/21 in the late afternoon. After she had her vaccine she sat down in a chair and waited out her 15 minutes. During this time she said her ears were ringing and she felt faint. We switched her chair to one with larger arms to sit. She asked for water, we provided her a bottle of water and she started to breathe heavily. Her mom was with her and also was vaccinated waiting for 15 minutes. During this time her breathing became labored and she was feeling very faint. I called 911 and EMS arrived about 10 minutes later to see how she was doing. At no point did Taylor pass out or lose consciousness. She was cleared by EMS who checked her blood pressure which was normal and she did not have labored breathing after their visit. During the EMS check they asked the last time she ate and that was at 11 am. She declined medical transport to the hospital and was able to walk out of the facility.
On Monday 4/30/18 at 8:30 am I received first of two injection dosed of SHINGRIX 50MCG SUSR. On Wednesday 5/2/18 during the evening my wife noticed significant area of redness on my upper arm and took a picture to send to my doctor. The area was a bit swollen, hot, and tender to the touch. My doctor's office contacted me Friday indicating that the picture indicated a possible cellulitis, which my wife was concerned about. By Friday afternoon the swelling and redness had subsided but the area was still tender.
Left arm will hurts where vaccinated and can not raise it in abduction.  Received two vaccine shots (Hepatitis A and B).  Do not know which one was administered in left arm.
Pt developed fever, hospitalized w/2-3day hx dehydration & suspected influenza or bronchitis; BC showed strep pneumonae, SOB, hypoxia, CXR show lower infilitrate consolidation, atrial fib, vent tachycardia, oliguria, pruritic rash;
Headache, NauseaVomiting, Initial BP taken was 97/72 with HR 94. BP upon leaving clinic was 108/79, HR 93.  Narrative: Employee stated that she had the same reaction(N/V and HA) with the 1st Moderna vaccine as well. No airway issues noted. Pt did not want to be sent to ER. Reiterated to employee to see emergent care of any airway symptoms were to appear or she worsened. Employee still felt nauseous upon leaving the clinic. She did note that with the reaction she had to the 1st Moderna vaccine she had vomiting as well. No vomiting noted during this event.Employee was in no acute distress and exited the clinic pre steady gait ambulation to speak with her supervisor and visit her PCP.
Information has been received from a registered pharmacist concerning a female patient who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: not reported). The registered pharmacist stated that the patient developed shingles after getting ZOSTAVAX (Merck). The patient had the "horrible" and painful shingles on her face. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Aches and arthralgia Headache  Tender left deltoid Nausea Chills/rigors Fever to 102.4F by forehead probe Fatigue