chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching this morning and Red and blotchy on cheeks; Left arm red; Swollen; area is also warm to touch; upper outer left arm has red rash; reports a numb feelling in area of shot on left deltoid; axillary tenderness; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (area is also warm to touch), VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid), PRURITUS (Itching this morning and Red and blotchy on cheeks), VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included UTI. Concomitant products included AMOXICILLIN for Stye, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 05-Jan-2021 to an unknown date for UTI.   On 29-Dec-2020 at 4:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid) and AXILLARY PAIN (axillary tenderness). On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (area is also warm to touch) and VACCINATION SITE RASH (upper outer left arm has red rash). On 06-Jan-2021 at 7:45 AM, the patient experienced PRURITUS (Itching this morning and Red and blotchy on cheeks). 06-Jan-2021 at 7:45 AM, the patient experienced VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE WARMTH (area is also warm to touch), VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid), AXILLARY PAIN (axillary tenderness) and VACCINATION SITE RASH (upper outer left arm has red rash) outcome was unknown, PRURITUS (Itching this morning and Red and blotchy on cheeks) had not resolved and VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of these events included cool compresses.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. However a temporal association cannot be denied and a causal relationship cannot be excluded'.
Pt had joint pain for about a month following injection. Injection may have been administered too high. Pain now resolved. Pt mentioned it to Dr. when going to Dr. for another reason but pain had already resolved.
patient 12wks gestation given LAIV instead of influenza injectable vaccine-no sx or tx.  2/13/09 MR received for DOS 1/12-13/2009 with D/C DX:  Intrauterine Fetal Demise at 16 weeks.  Oligohydramnios 2' to rupture of membranes. S/P medical induction of labor.  Pt pregnant at 16 wks presented to ER with c/o cramping and bleeding x several days.  Seen 2-3 days prior for same with US OK. on exam membranes noted to be ruptured tinged with blood.  FHTs unable to be obtained manually but 150's on US. Admitted for ROM and UTI. Fetal demise. W/U (-). Labor induced.
pt devel a chicken pox rash 2 wk p/relative was vaccinated w/varicella vax;the vaccinated child never devel the rash;
Child began complaining about stomach pain and no appetite along with leg soreness and fatigue. Shortly after she started to run and fever and vomited once. She continued to be very tired, no appetite, and with continued leg soreness for the following 48 hours.
Disc a little tender; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Disc a little tender) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue). On 01-Oct-2021, the patient experienced SPINAL PAIN (Disc a little tender). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, SPINAL PAIN (Disc a little tender) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient experienced fatigue after booster shot. In OCT2021, disc felt a bit tender. It was tested years ago and doctor had said he had a bad disc.   Reporters causality for the events with Rinvoq is no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ADDERALL, start date: 03Jan2016; ADVAIR, start date: 06Feb2000; ALBUTEROL [SALBUTAMOL], start date: 04May2003; SERTRALINE, start date: 15Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (05Jan2023) Negative; (09Jan2023) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Dec2022 to 05Jan2023 (Lot number: GG3517). The patient initially tested positive on 31Dec2022 and began taking Paxlovid. Finished Paxlovid on 05Jan2023 and tested negative.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Large area upper left arm, raised, warm, central reddened - clear d/c - no nodes.
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05263 and 2013-05268. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case involved a 59-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 24 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
Patient complained of pain in deltoid, redness and swelling in left arm. Adverse reactions started the next day after administration.
Within an hour after receiving immunizations the client returned to the clinic c/o itching on the feet and legs. Did have hives below the waist. Treatment was Benadryl 50mg IM in left deltoid. Which the client tolerated well and relief was noted.
Pain and soreness in arm after shot that lasted a few days. Developed "covid arm" 8 days after 1st shot with itching, swelling, redness and pain lasting for a week in the right arm. Also, experienced brain fog for a couple of weeks after the first dose.
11-12 hours after the vaccination: Severe chills began, inability to stop shaking or get warm.  Inexplicable fear of being paralyzed and dying ( somewhat delirious overnight)- inability to sleep the evening after the shot.  The full day after the vaccination, body temperature rose--couldn't stop sweating and had a searing headache. Took tylenol to reduce the symptoms.   The following day (today) had severe dry mouth and very sore throat. Felt about 60% back to normal health. I am a very fit 26 year old (run and exercise daily)
Throat tightness, chills, uncontrollable shaking, & nausea.  Went to bed and woke up without any symptoms the following morning.  Denied previous reaction to flu vaccine, egg allergy or intolerance, or any new foods, sushi, or foods with MSG.
Information has been received from a female who was vaccinated intramuscularly with 0.5 ml third dose of GARDASIL vaccine (yeast). Subsequently the patient experienced "muscle pain and weakness". At the time of report, the outcome was unknown. No further information is available.
approx an hr p/vax pt started chilling had blueness about mouth & on nail beds-then became very pale; Ax T102;
Pt woke up 4 days after receipt of ZOSTAVAX with a rash on upper body. Pt took BENADRYL with no relief. So he went to his doctor who diagnosed patient with shingles.
PT reported tachycardia approx 10 minutes after vaccination (140bpm according to apple watch).  Pt then was light headed, dizzy, felt disconnected, etc.  Symptoms resolved and flared up several times over the course of an hour.  Cold compress, elevated feet were used initially, then a snack (it had been several hours since last meal).  Pt reported no difficulty breathing throughout, but symptoms continued. After about 45 minutes pt reported that she "felt her pulse through her whole body".  Diphenhydramine 50mg was given at that point according to emergency protocol, and EMS was called.  Pt was evaluated by EMS.
pt recvd vax 12OCT94 & 16OCT started exp pain in area of hip joint, occasional pain in thigh & calf;no tenderness/fever;had sweating & chills since 16OCT;ER visit x2 18OCT & 24OCT;x-rays, ultrasound, blood work WNL;rx percodan
Became ill on the way home in the car. Crying without stopping all night. When he finally slept he slept much longer than normal. Became clammy to the touch, listless, only wanted to sleep. Began to have diarrhea right away also. Was not able to get the diarrhea to stop for two years. As soon as he became physically well enough to get out of the crib, it was apparent he had changed. No eye contact, stopped talking,  didn't walk any more, no longer interested in doing anything but watching a Disney Winnie the Pooh movie over and over and over again.
pt recvd 2nd dose of vax & 15 mins later devel severe frontal h/a; confusion; lightheadedness; chest pressure; numbness, weakness of lt arm & leg; seen in ER;
Baby develops 1-2 mm, papular, non itchy rash after 2 months and 4 months vaccines on anterior thighs.
h/a, fever x 48 hrs, vomited 3 times over 72 hrs, diarrhea for 72 hrs, dec appetite for 72 hrs; APAP only treatment;
pt began experiencing red area warm to the touch beginning 7-28-20 but not sore.  at time of phone conversations she estimated the size to be about 5in long and 2.5 in wide.  has gotten better today per pt (7-29-20)
DTaP-HIB given to a child too young to receive vaccine. no side effects reported.
Redness, swelling, and discomfort at injection site. Gradually improved over the next 5-6 days. Symptoms now almost resolved.
I tested positive for COVID-19 on 12/9/22. I had a sore throat, runny nose, cough, fatigue, and body aches. This lasted for about four days. I contacted my doctor, but they did not prescribe medication. I took over the counter MUCINEX. I also had Mastitis. I was having pain and redness in my breast, fever, and body aches. My doctor prescribed dicloxacillin. I ended up switching to BACTRIM. Now, I am having an allergic reaction to BACTRIM, I think. I am currently sitting in the emergency room.
How long does the fever and pain last?; How long does the fever and pain last?; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and fever after vaccination.
4.5 x 6 cm area of redness at the injection site no pain not warm to touch
Information has been received from a physician concerning an 8 month old male with reflux and history of "MSPI type" diet with no other medical history or drug allergies who on 22-MAR-2007, 24-MAY-2007 and 25-JUL-2007 was vaccinated PO with his first, second and third doses (lot# 656381/0875U) of Rotateq. Concomitant vaccinations administered on 25-JUL-2007 included a dose of DTaP, a dose of poliovirus vaccine inactivated (unspecified) and a dose of (Prevnar). Other concomitant drug therapy included nizatidine (AXID) drops for reflux. On 04-OCT-2007 the patient experienced intussusception and was hospitalized. Medical attention was sought through the physician. Labs and abdominal x-rays were performed. A barium enema was also performed to reduce the intussusception. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.  10/26/07 Patient demographics provided by CDC.  10/30/07 Reviewed vax records which confirms RO dose & lot as reported & provides other vax info.  VAERS database updated w/same.  11/2/07 Received hospital medical records which reveal patient experienced bilious vomiting x 2 days & 1 episode of bloody stool.  Seen by pcp, sent to ER when vomiting persisted.  Admitted 10/4-10/5/2007. Noted to have exanthem, lethargy, reduced oral intake & urine output.  Progressed well s/p enema reduction & d/c to home. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
Red swollen rash (hives), and achy at injection site. It was a delayed reaction, about 8 days later
Fever greater that 10 x 12hrs (at time of visit) fussiness x greater than 24 hrs -Parent reassurance, observation, recheck if not improving over next 24-48 hrs.
Information has been received from a physician's assistant concerning a 12 month old pt who was vaccinated with a dose of varicella virus vaccine live. The reporter noted that he did not "have information on whether the child received Varivax or not". Subsequently, the pt developed lesions on the thigh that "somewhat follows the dermatome". The reporter did not know whether it was "truly herpes zoster". VZV ID via PCR was offered, but declined. The pt sought medical attention. Additional information has been requested.
he felt feverish; had a headache; Fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was stated the reporter's husband has a family call weekly with his siblings. The reporter participated in the call on 10Jan2021. During that call, one of his sisters mentioned her son had a second COVID vaccination and had a mild reaction. Later in the conversation, it was clarified that it was the Pfizer vaccine. It was reported that the patient got the vaccine on 'Friday' (unspecified date); on the next day, he felt feverish, had a headache and fatigue and was better by Sunday. The events were resolving.  The information on the lot/batch number has been requested.
This spontaneous report was received from a female patient of unknown age concerning herself. On 28-MAY-2010 the patient was vaccinated with GARDASIL (route and lot # not provided) dose 1. The patient reported that she received only one dose in the series of GARDASIL, which was other than indicated. No adverse effects were reported. Additional information has been requested.
Died from cardiac arrest; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 24Mar2021 as single dose for COVID-19 immunization. Medical history included heart disease, kidney issues, and physical disability from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin; spironolactone; lisinopril; and ubidecarenone, vitamin e NOS (COQ10 COMPLEX) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 on 03Mar2021 11:00 AM, on Left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was reported to have died from cardiac arrest on 26Mar2021. The reporter did not know if it was related to vaccine. The patient died on 26Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: It appears he died from cardiac arrest.
01/05/22 presents to ED for "Fever" "nausea and diarrhea". PMHx of "DM2, OSA, DVT, COPD, CAD"
Received intradermal vaccine (influenza). Immediately experienced shortness-of-breath, coughing and wheezing and redness and itching at site. Given 25mg BENADRYL and albuterol inhaler. Took a total of 2x 25mg BENADRYL.
rash in her biceps; some allergic reactions to the vaccine to her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (ongoing); "lymphoma" (ongoing); "leukemia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "allergic reactions to the vaccine", "rash". The following information was reported: RASH (non-serious), outcome "unknown", described as "rash in her biceps"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "some allergic reactions to the vaccine to her arm".  Clinical information: Caller is a cancer patient with lymphoma and leukemia. Her oncologist is recommending cancer patients to get the Pfizer Bivalent Vaccine. Caller wants to know if it's okay for her to take it. She wants to know more medical information about the vaccine. She had her 2 shots vaccine from Pfizer and she had some allergic reactions to the vaccine to her arm. Resolution -1st and Last name phone number Gathered -Read ISI -Provided PMI Phone Number and HOO -Created. Manual AE Form since the caller mentioned that she had a rash in her biceps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tuesday, April 20, was fine. Wed had expected chills, fatigue, body ache, headache . Thurs felt even worse with less chilling, less headache, but felt nauseous and did vomit a few times. Had some dizziness or light-headedness. Something off. Unable to read my phone or computer. Some buzzing and other sounds in my head. (I know, it sounds crazy) Friday, nausea gone, but had some sudden diarrhea. Dizziness continued. Noise continued. I was barely eating, but trying to drink water. Saturday, some improvement, but occasional headache, dizziness continued.  Sunday finally was up for quite a while in the afternoon. Just feeling flu-hangover. This week has been on and off. I have had to keep a couple of work appointments  and was able to do so, but exhausting. Much better than last week, but nausea returned today. Less dizzy finally. And I just lie around when I can. Tired still.
3 weeks after vaccination, Patient presented with mild rash all over her body starting at the head and running down to her body over the course of 5 days. At the end of 5 days, the rash disappeared.
PATIENT RECEIVED PFIZER DOSE OUT OF AN UNDILUTED PEDIATRIC VIAL.  PT DID GET CORRECT DOSE SINCE THE VIAL WAS NEVER DILUTED.   CALL ED PATIENT TO INFORM HIM OF THE ERROR, BUT THAT THE CORRECT DOSE WAS RECEIVED. NO INDICATION FROM HIM OF ANY SYMPTOMS OR REACTIONS TO THE VACCINE.
Information has been received from a physician concerning a male patient who was vaccinated with varicella virus vaccine live. The physician reported that about a year ago (approximately 2004) the patient appeared to have a case of full blown wild varicella. No testing was done. Subsequently, the patient recovered. No further information was available.
Yesterday, 8 days after I got my first dose of the Moderna vaccine, I developed a large itchy hive at the vaccination site. It persists today, day 9 post-vaccination.