chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had first outbreak of shingles, refer case US2021AMR260214). On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was unknown. The reporter stated that, he/she had the Shingles vaccine and got the shingles terrible. About a year later, after first outbreak, they were there under the skin, not open blisters like before. They had been under the skin and itch like crazy all the time. The reporter stated that it was not fun, and they were not gone. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260214:same reporter.
swollen lymph node in his neck; This spontaneous report was received from an administrator (also reported as health business professional (HBP)) via company representative and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (reported as routine vaccination) (anatomical location, lot #, and expiration date were not reported).  On an unknown date, the patient experienced swollen lymph node in his neck. He sought medical attention (contacted primary care physician [PCP]), but no treatment was given for the event. It was unknown if any laboratory diagnostics or study procedures were performed. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
The first shot I only had muscle soreness; This case was reported by a consumer via sales rep and described the occurrence of muscle soreness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle soreness. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the muscle soreness was recovered/resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 60 or 61 years old. The patient had only muscle soreness which went away after a day or so. Other medications had taken since the shot included advil for muscle soreness. For tolerances of 2nd dose, refer case US2019AMR221110.
arm  swelled a little; Hot to the touch - injection site; Arm  hurt - injection site; Red - 80-90% gone - injection site; deep itching/itched severely - injection site; A little sore-injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site), VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site) and VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney disorder, Liver disorder and Heart disease, unspecified.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site), VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site), VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) and VACCINATION SITE PAIN (A little sore-injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 26-Jan-2021, PERIPHERAL SWELLING (arm  swelled a little), VACCINATION SITE WARMTH (Hot to the touch - injection site), PAIN IN EXTREMITY (Arm  hurt - injection site) and VACCINATION SITE PRURITUS (deep itching/itched severely - injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red - 80-90% gone - injection site) was resolving and VACCINATION SITE PAIN (A little sore-injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2021-014285, MOD-2021-017150 (Patient Link).
Myalgia, Fever, chills Narrative:  Received 2nd vaccine on 2/20/21 experiencing Fevers, chills  body aches, fatigue, on 2/21/21. He is taking motrin for body aches and reports feeling better will return to work on 2/23/21.  Other Relevant History:
3 days after the vaccine she started having pain in one side of her face. It is very painful.
pt had an immediate rxn following vax, consisting of a raised, red area @ inject site;
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On multiple unspecified dates, multiple unspecified patients were administered improperly stored GARDASIL 9 (Lot number L000610 was an invalid lot number for GARDASIL 9), expiration date 31-JAN-2017, strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effect was reported. There was no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Shortness of breath Itchy all over Diarrhea the next afternoon Definitely an allergic reaction
Pt begin feeling dizzy about 3 minutes after dose.  She was sitting down, I encouraged her to drink some water and sat with her.   Her dizziness became worse and I got the Epi Pen ready.   A few minutes later, she asked to lie down due to her dizziness.   I assisted her and had my tech call 911.   She had no trouble breathing but did develop tingling in her hands and a blotchy red rash on her chest.  The paramedics arrived and checked her vitals which they said were fine.  They took her out to the ambulance as a precaution.
PATIENT EXPERIENCED DRY HEAVES AND FEVER OF 100 DEGREES THE DAY AFTER VACCENATION, AND RED SWOLLEN ARM AT THE INJECTION SITE THAT HAS LASTED 2 DAYS.
Rash all over the front of my body. Recalled everything eaten and drank the past couple days and nothing makes sense. Got 2nd dose Sunday the 16th and saw a rash all over my body two days later.
Information has been received from the authors in a literature article concerning an unknown gender 21 year old patient with MMR (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Hospitalization: 12/22/2022 - 12/28/2022 (6 days) Presentation to the ED: Nausea and vomiting brown coffee emesis.  COVID + date: 12/22/2022 Treatment: no indication for additional steroids or antiviral.  Discharge to: SNF  Moderna 013L20A 2/16/2021 Moderna 027A21A 3/16/2021
High fever reaching 102.6 - fatigue and achy body - sore and swollen arms - big red patch on left arm hot to the touch - headache - itchy (3 days later/left arm).
w/in 1hr of vax rt thigh became red & tender to touch;by 3 1/2 - 4hr p/vax pt began to cry uncontrollably for  up to 1hr in duration;woke up during the noc & would have crying spells lasting up to 1hr in length;sl temp 100;
pt recv vax 9AM & w/in seconds p/vax pt stated felt sleepy;turned extremely pale w/dark arches under eyes & became cold & clammy;pt put head on mom shoulder & closed eyes;pt given coca cola & mom stated pt had not eaten this morning;
Night of 2am Very painful arm; whole body sore; next am, 100 degree temp, rise to 102, stayed all day; felt really bad; have hives; itchy ears, face, head, neck, constant; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN6205), via an unspecified route of administration, administered in left arm on 03Mar2021 15:00 as dose 1, single (at the age of 69 years) for covid-19 immunization. Medical history included restless legs syndrome (RLS), hypertension, coronary disease from unknown dates and unknown if ongoing. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), losartan, clonidine, furosemide, metoprolol taken for unspecified indication, start and stop dates were not reported. The patient previously took pantoprazole sodium sesquihydrate (PROTONIX) and experienced allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. On unspecified date, night of 02:00 AM patient experienced very painful arm, whole body sore, next AM 100-degree temperature, rise to 102 stayed all day and into evening, felt really bad, next AM gone, now have hives, itchy ears, face, head, neck, constant. On unspecified date, the patient underwent lab tests and procedures which included body temperature: 100-degree Fahrenheit and 102-degree Fahrenheit. The patient was not received treatment for adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
& tingling in hands Narrative: Pt received his 2nd dose of covid vaccine on 2/26/2021 at approx. 14:00. After 15 minutes of waiting in the parking lot pt experienced dizziness and tingling in bilateral hands. Pt reported to covid vaccine clinic with reaction. Pt was monitored for an hour in the clinic. Symptoms subsided. Pt was able to walk around and able to leave. No treatment medications were given.
DTaP was ordered but the MA mistakenly gave KINRIX. She read Dtap on the box and failed to note it was Dtap-Ipv. The child also received IPV. Patient's mother was contacted when the mistake was discovered on 1/25/19. Patient's mother stated that she did not note any reaction at the site of injection or any other reaction up to that point.
Pain/soar/redness within back of upper right arm. Lump on area where shot was given. Pain inside the arm (armpit) to chest (right side).
SWELLING AT INJECTION SITE, RADIATING PAIN IN THE LEFT ARM, FOR A FEW DAYS, RASH ABOUT 1-2 INCHES DIAMETER, REPORT BODY ACHES AND FEVER.
Following administration of the HPV vaccine, patient fell back on the exam table-started shaking. She was breathing very fast and crying. Then patient stated that her arm/hands felt numb. She was treated for hyperventilation with paper bag rebreathing. Pt regained sensation in her arms/hands and was able to leave clinic about 30 mins following vaccinations.
Narrative:  8 yo female who presents to the ER for evaluation of possible allergic reaction after her 2nd Moderna COVID vaccine. Pt reports she had her second vaccine approximately 15 minutes before coming to the ER and started to  feel dizzy/lightheaded, have severe hot flashes and chest pain. Pt reports she is having severe "hot flashes" and pain in her chest. She did not have this issue with the first vaccine. Required treatment with IV benydral, pepcid, medrol and IV  fluids
(1) local swelling  (2) dizzy presyncope (3) nausea and vomiting.  12/14/07 Reviewed hospital medical records which reveal patient experienced recurrent hypotension & syncopal episodes.  Admitted 10/23-10/24/2007.  Later on day of vax, patient became pale, dizzy, fever, nauseated & had worsening injected right arm pain.  FINAL DX: reaction to pneumococcal vaccine and presyncopal episode, likely related to pneumococcal vax reaction w/presumed vasovagal episode.
pt stated she woke up next day after taking her vax with chills, headache, pain behind the eyes, running nose, muscle pain, joint pain and loss of appetite.  Most of these symptoms lasted about 3 days but still has pain behind her eyes, headache and joint pain so she will contact her PCP today regarding this.  She has taken Tylenol to help with pain.
This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding her granddaughter who suffered from pneumonia after getting vaccines. The patient received a dose on an unspecified date. On an unspecified date in 2008, the patient's grandmother reported that her granddaughter suffered from pneumonia after getting vaccines, resulting in surgery on 06-May-2008. The patient's outcome was unknown. No additional information was available at the time of this report.
Patient is too young to receive vaccine. DOB on administration form was given as 2016, when it is 2017 according to the registry.
This initial spontaneous case, was received from a pharmacist on 21-Nov-2017, concerns a male patient of unspecified age. On an unknown date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch no. and expiry date: not reported). It was reported that the patient received the flu vaccine twice: one at the hospital and other at the office which was explicitly coded as inappropriate schedule of vaccine administered and at the time of this report the reporter did not have further information. The reporter wanted to know if there was anything the patient should watch for. The reporter assessed the report as non-serious.
101 degree fever, arm pain, visibility noticeable swelling above left collarbone with pain.
Information has been received from health professional concerning an 85 year old white male with penicillin allergy hives who on Jan 25 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649695/0512P), intramuscularly. There was no illness at the time of vaccination. Subsequently the patient experienced pain, redness and swelling at the injection site. The patient was treated with rest, moist heat and cephalexin (Keflex) (x 7 days). Subsequently, the patient recovered after 72 to 96 hours. There were no relevant diagnostic test or laboratory data performed. it was noted that the patient and the patients sibling did not experience any adverse symptoms following prior vaccination. It was noted  that four other patients had a similar reaction (WAES0502USA00745, WAES0503USA00537, WAES0503USA00538, WAES0503USA00540). No further information is available.
Numbness in toes, ascending numbness to hip level. Shooting pains from toes to hips. Numbness of fingers moving up forearms and hands. Loss of muscle control in legs. Slow onset of numbness and pain in toes in late August. Rapid progression up to hips, arms and hands in late September. Treated in hospital for Guillain Barre 10/02/2012 to 10/07/2012. Has not fully recovered.
Having adult onset severe asthma I am prone to lung inflammation from a number of sources including some foods and allergens as well as viruses and smoke of any kind. I had been doing fine that week until the day after the second shot. I had severe shortness of breath, bad enough to keep me home and using my rescue inhaler several times that next day. This also occured when I had Covid in November 2020. It took me longer to test negative, 3 weeks. I believe that the shot caused an immune reaction, like it should, but also triggered an asthma attack that lasted several days but progressively reduced as time went on. Last week I had dizziness and heart palpitations. I have no idea if it was the shot still or the meds for my asthma, but I thought I should include it.
The nurse administering the patient vaccine booster shot administered a 0.25 ml dose of Moderna intramuscular to a patient that was under the age of 18.  The patient that received the dose was 14 years of age.  The patient was observed for 20 minutes following administration of the vaccine and no adverse reaction was observed .
A report has been received from a Health Professional concerning a 4 month old, Male subject, who had been receiving FLUMIST (intranasal). FLUMIST started on 13-Dec-2013. It was reported that FLUMIST was given to four months old which started on 13-Dec-2013. The outcome of the event of FLUMIST given to a 4 month old is unknown. The report was considered to be non-serious.
From initial information received on 6/28/04 from the patient regarding an adverse event occurring in the USA, it was reported that the female patient (age and date of birth not reported) received a FLUZONE vaccination on 10/8/03. The lot number, site and route of administration were not provided. Two days later, on 10/10/03, the patient experienced a raging fever, chills aching all over and a pain in her spine from the neck down, which she described as feeling like someone had hit her in the back with an axe. She was seen by her primary care physician, who treated her for pulmonary problems. On 11/30/03, the patient was admitted to the hospital and told by a cardiologist that she had congestive heart failure. The patient's recovery status was not provided.
Right shoulder - upper arm swollen warm tender bruising 15 x 18 cm after Tdap vaccination 2 days prior.
Vaccine administered on 6/9/05. Pt reports having developed lymphadenopathy on 6/19 and stiffness, pain and swelling of both knees on 6/22. SX resolving by 6/26.
Began having severe joint pain/back pain  5 days after 1st dose. Unable to lift legs to step up and unable to get up from seated position without assistance. I did already have joint pain before but it became unbearable after vaccine.   After second dose I began having chest discomfort 2 days later. Joint pain still continues .
Developed headache, ears burning, hives on trunk, neck and head with itching. Felt hot and difficulty taking deep breath. Rx Famotidine 20 mg Atarax 50mg / Solumedrol 125 mg.
pt stated vomiting 1hr vax-vomiting lasted approx 24hr;had fine rash the following day according to pt;exam by MD the following day;no rash, c/o lingering nausea;
Patient reported having trouble closing left eye, left facial weakness, and left facial drooping Patient was treated in ED and given prednisone and acyclovir
5/20 33y.o. w/ a PMHx significant for roux-en-y gastric bypass and laparscopic reduction of internal hernia who presented with abdominal pain and was found to have a SBO for which she had diagnostic laparoscopy, reduction of internal hernia and repair of mesenteric defect x2 on 5/20.
Headache and arm soreness first day.  neck issues day 2. very stiff and sore.
Itchy hives covering the entirety of my body.  Currently on day 4 of the symptom
Patient received TDaP that was unneeded. Had previous TDaP vaccination on 3/14/11. Patient was not pregnant. Age of patient at time of event: 61 years.
At 12 PM I got my annual flu vaccine in my left arm at 11:50 AM and only symptom was injection site soreneds prior to COVID-19 Comirnaty vaccination  At 3:30 PM, I got my COVID-19 Comirnaty vaccine and before I even left the facility at 4:00 I became cold to the touch (hands, fingers, wrists arms, toes, feet, ears, nose, lower legs, around the eyes, cheeks) and skin turned pale and a purple hue in these regions. It has almost been a week and I am still cold to the touch in these areas just 30 min after vaccination and a sore arm on that side too.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, at the age of 12 years the patient was vaccinated with GARDASIL (dose, route, batch/lot# unknown) as first dose in the Human papillomavirus vaccination series for prophylaxis. On an unknown date, at an unknown age the patient received GARDASIL 9 as second dose (dose, route, batch/lot# unknown) in the vaccination series (Interchange of vaccine products). On an unknown date, at an unknown age the patient was in the reporter's office to receive the third dose in the vaccination series with GARDASIL 9. No adverse effects were reported. Product quality complaint was not involved.