chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received call from School Nurse @ 8:30 a.m. on 5/13/08 stating Mom called her this morning that child was ill had Headache, Emesis and Temperature.  Reviewed shot records and contacted Mom @ approximately 9:00 a.m on 5/13/08 and questioned how son was feeling.  Mom was at work and stated that he called her complaining he didn't feel good, had headache all night, and vomited this morning.  Mom asked him to take his temperature with a digital thermometer and he told her it was 101.0 degrees.  She told him to take Ibuprofen and go back to bed.  I asked her if he had any stiffness in the neck, how many times he vomited and if he normally runs temperatures easily?  She stated he was sick with a stomach virus on 5/8/08 and 5/09/08 but seemed to be fine on 5/10/08 and 5/11/08.  She stated he did have a temperature of approx. 100.0 degrees during the stomach virus.  He had one emesis in the am per Mom.  She was not there with the child and he reported it to her over the phone.  I asked Mom if he was home alone and she said yes, " I think he will be fine and I am not sure this is even related to the vaccines".  I requested she continue to check on him hourly, contact her physician and to contact me with updates regularly.  Advised to go to ER if symptoms get worse.   I contacted Mom @ noon to get update.  She stated his temperature was 100.0 degrees, no further emesis, slight headache but feeling much better.  She is going to make him a doctors appt. if he continues to feel ill. She will leave work in the afternoon and take him to the doctor if she feels it is necessary.  I requested she contact me with update at end of day.
Pt rec'd 3/12/21 Jassen Vaccine and was to rec'd  her booster  dose  0.25 ml Moderna today but was given a full dose 0.5 ml  by this nurse.  Pt remained in observation area without incident prior to leaving facility.  Co-worker informed this nurse that pt should have rec'd booster dose of 0.23 ml.  Clinical Lead on duty made aware  and Doctor Medical Director made aware.  Doctor provided  contact information of patient.
1/2hr p/vax pt became faint, blurred vision & diaphoresis;2hr later also exp leg cramps, chills, fever 103 & muscular weakness & gen malaise;sx persisted for 24hr;
vomiting, diarrhea, severe chills, headache, high fever 103.8, no energy
This spontaneous report as received from a certified diabetes educator of unknown age who was reporting on herself, via a company representative. There were no concomitant therapies, concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not reported). On an unknown date (reported as "5 years later almost to the day"), the patient developed shingles. The outcome of shingles was not reported. The reporter did not assess the relatedness between the adverse event and the ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Severe joint pain / arthritic symptoms 12 hours - 36 hours post injection in hands (specifically within the knuckles and thumbs) and lingering pain in some joints; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 (at the age of 37-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29May2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 09May2021, the patient experienced severe joint pain / arthritic symptoms 12 hours - 36 hours post injection in hands (specifically within the knuckles and thumbs) and lingering pain in some joints. Not one to experience these symptoms usually and they did subside after 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the event severe joint pain / arthritic symptoms 12 hours - 36 hours post injection in hands (specifically within the knuckles and thumbs) and lingering pain in some joints was recovered with sequelae on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She is now 21 and has muscle weakness throughout her body. She has been tested for all genetic disorders and they have all come back negative. Has been seeing a Neuromuscular doctor for over a year and he still cannot determine what it is or what caused it. Is also seeing a holistic doctor and he feels there is some connection to the GARDASIL shots she received when she was 15 years old.
Arm was hurt; Arm was swollen; Left shoulder hurts really bad today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurt), PERIPHERAL SWELLING (Arm was swollen) and ARTHRALGIA (Left shoulder hurts really bad today) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00106950) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurt), PERIPHERAL SWELLING (Arm was swollen) and ARTHRALGIA (Left shoulder hurts really bad today). At the time of the report, PAIN IN EXTREMITY (Arm was hurt), PERIPHERAL SWELLING (Arm was swollen) and ARTHRALGIA (Left shoulder hurts really bad today) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient received Ibuprofen for treating these events.
Patient is a 31yo male ADSM with a hx of eosinic esophagitis, received Pfizer Covid vaccine #1 and had positive PCR to Covid-19 wild type infection day 9 after receipt. He experienced fatigue, malaise, ear pain, head congestion, fever day 1-3, followed by general improvement but development of a diffuse erythematous maculopapular pruritic exanthem, loss of taste and smell day 4, and episodic bloody diarrhea day 6 or 7. The exanthem has had limited (if any) response to steroid (day 5-9) and he has continued to self treat with Benadryl and atarax at home. He has just been released from quarantine. The dermatitis is improved but not resolved. CBC and CMP were normal.
This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm at the age of 15 years old on 30Jul2021 11:00 (Batch/Lot Number: FA7485) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies. Concomitant medications included CLARITIN taken for an seasonal allergies start and stop date were not reported; VITAMIN C taken for an unspecified indication, start and stop date were not reported. On 31Jul2021, the patient experienced hives that spread to her entire body. The hives spread on her thigh to left calf, to entire body except her bottom but stated they may have been there too. The patient stated she felt like she had been bit by bugs however she had not gone outside. On Sunday, she had one episode and today, she had one episode. It also started around 11:00. The patient also reported that the palms of her hands were getting very swollen and tight to the touch started on Sunday (01Aug2021) and it was also around 11:00. Since the hives were so itchy, burning, and painful, she called the doctor, the office was so overwhelmed that they called a nurse, that told her to give her Benadryl, Pepcid, and Calamine Lotion. It seemed to work, she gave Benadryl 15 ml the second time, the 3rd time, and her hives started to dissipate but other places pop up, she woke up and 10 minutes after again with the hives, she started takin Benadryl. The last time she took Benadryl was until yesterday, but today she had an occurrence, at 11 o' clock an hour ago, the Clorox wipes swelled up her hands. The patient recovered from the event the palm of her hand swollen and became tight to the tough. The outcome of the event urticaria was not recovered, while the outcome of the event swelling of hands was unknown.
This spontaneous report was received from a healthcare professional referring to a male patient of unknown age. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine experience was unknown. The reporter did not assess the relatedness from vaccine adverse experience to GARDASIL. Additional information has been requested.
Pt. developed injection site tenderness, fever, aches & chills day after vaccination w/HD course of symptoms lasted 24 hrs.
sugar blood increased; condition aggravated; This case was reported by a nurse via call center representative and described the occurrence of blood sugar increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 15th July 2019, the patient received the 1st dose of Shingrix. On 15th July 2019, unknown after receiving Shingrix, the patient experienced blood sugar increased and condition aggravated. On an unknown date, the outcome of the blood sugar increased and condition aggravated were unknown.   It was unknown if the reporter considered the blood sugar increased and condition aggravated to be related to Shingrix.  Additional detauils were provided as follows: The age group was not reported, but selected as an adult as per vaccine indication. The reporter reported that, after receiving dose of Shingrix, the patient had  large increase in there blood sugars.
I started noticing when I was going to the gym I was getting short of breath. In late February it was mild by early March it had increased to the point that I went to the cardiologist. I had to have a pace maker put in on April 13, 2022.
Lyme symptom flare up including, fever, swollen throat/lymph glands/parotid glands, headache, eye ache, joint inflammation, nausea,  malaise, dizzy, lightheaded, shortness of breath.   Came on within the first two days, left me bedridden for 5 days.  Ran low grade fever off and on and symptom flare ups for the next 20 some days until I began to feel better.  Went in to get scheduled 2nd vaccine and was turned away.  Asked to return with epi pen in hand and feeling strong.
Brain fog.  My wife asked me to change the battery in a smoke detector.  Went downstairs to the kitchen to get a battery but forgot  why I entered the room.  Several times at work I have struggled to find the word I want to use.  I have forgotten the name of coworkers I have worked with just a couple of months ago.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 years old male patient who received an unknown dose (0.5 ml reported as the content of the syringe) of the vaccine TYPHIM VI (lot N1K81, expiration date 19-Oct-2019) via intramuscular route in unknown administration site when it was reported that the barrel goes down may be a hole and when the nurse went to push there was leakage from lower part of needle (syringe issue). It was reported that the product emptied during administration, unclear how much went inside or leaked out on to patient (underdose), the fluid shot out sideways, before reaching the lure lock adaptor. Fluid was all over the patient during administration while needle was in patient skin (exposure via skin contact). On the next day 26-Oct-2018, the patient was vaccinated with a dose of the same vaccine with an unknown batch number via unknown route in the left thigh (extra dose administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to exposure via skin contact, syringe issue, underdose and extra dose administered. It was not reported if the patient had any adverse event. 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Discussion:  Pt reports she received the pneumonia vaccine on 10/18/22 and  when she went home from the appt, she reports she had purple welts on her  face. She reports she 50 mg of Benadryl, waiting one hour, took another 50 mg  of Benadry and pt. reports within 3 hours, the areas lightened. Pt reports  she washed her face "really good that night".  Pt reports when she woke up  the next day, the welts were gone. In addition to the purple facial welts, pt.  reports she was SOB, but just that night, diarrhea, 2 bouts today so far.  She  reports yesterday she did have an accident as she was unable to get to the  bathroom.  She reports she had a cramping feeling under the breasts, stating  "it felt like something was being pushed against my chest". Pt reports this  sensation lasted until midafternoon yesterday.  It is gone today. She reports  she has no appetite and states she she tries to eat something, she becomes  nauseated and is only able to take a few bites.  Pt reports "I'm hardly  eating anything".  She reports she is  feeling weak and having difficulty with  her balance, which she just noticed this morning while in the shower.  She  denies any dizziness or blurry vision. Pt reports she has body aches and a  lump under the left axilla although she is unable to tell me any other  symptoms associated with this lump as she is "not home".   Pt was advised when she began SOB, she should have proceeded to the ER for  evaluation. The weakness, body aches and lump under the left axilla could be  the body's reaction building immunity due to the vaccine, but I will address  with provider for recommendations.   Pt reports she had a fever when the vaccine was administered.  I advised pt.  her temp listed in the chart is 99.8.  A fever would be 101 or higher.   She had not other cold/flu symptoms at the time of the vaccine.
herpes zoster; Information has been received on 09-APR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a healthcare provider at a pain management center for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.   Additional information has been requested.
Dizzy, "feels like throat is swelling up" .Refused oral BENADRYL - verbal order from OBGYN. Refused to go to ER.
Felt overall sickness; Pain down her back and arm; Pain down her back and arm; Woke up feeling like ball in armpit, got an ultra sound and discovered there were four oversized lymph nodes.; Muscle area where received the shot with sore with some tightness; Brain fog; Fever; Fatigue; Malaise; A spontaneous report was received from an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle area where received the shot with sore with some tightness (vaccination site pain), woke up feeling like ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes (lymphadenopathy), felt an overall sickness (illness), fatigue, malaise, brain fog (feeling abnormal), fever (pyrexia), and felt pain down her back and arm (back pain/pain in extremity).  There was no medical history provided. There were no concomitant medications provided.  On 21 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient experienced muscle area where received the shot was sore with some tightness. On 26 Dec 2020, she woke up feeling like there was a ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes. It was noted the largest lymph node was 5cm and was very painful. On unknown dates in Dec 2020, the patient felt an overall sickness, fatigue, malaise, brain fog, and fever, and the symptoms have been slowly dissipating. On 28 Dec 2020, described as the worst day, she felt pain down her back and arm. There was no further treatment information provided.  Relevant laboratory on unknown date in December 2020, included an ultrasound which showed four oversized lymph nodes.   Action taken with mRNA-1273 in response to the reported events was not reported.   The events of felt an overall sickness, fatigue, malaise, brain fog, fever were reported as recovering at the time of this report. The outcome for the remaining events, woke up feeling like ball in armpit, got an ultrasound and discovered there were four oversized lymph nodes, and felt pain down her back and arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 20 year old female who on 08-MAR-2007 was vaccinated with a 0.5 mL dose of Gardasil. On 10-MAR-2007, the patient experienced excessive vaginal bleeding and her period was a week early after receiving Gardasil. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
lt arm shoulder & deltoid area of red & warm, hard area around immun site;T100.8R;placed on keflex;
Patient reported an adverse event; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient reported an adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient reported an adverse event). At the time of the report, IMMUNISATION REACTION (Patient reported an adverse event) outcome was unknown.     Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. The patient did not receive second booster of Moderna Covid-19.
Over the course of a week, initially had vomiting, diarrhea, and hives. Hives returned the 2nd week after vaccination AND for 2 days on the 3rd week after vaccination.
Fatigue and decreased appetite for two days.  No specific treatment necessary.   Back to normal after two days.
No adverse reaction was seen 15 mins after vaccines were administered. Child has a 2 week follow up appointment.
The day after I got the 2nd dose I was feverish, tired, and achy all over. I also was dizzy and nauseous if I stood for more than a few minutes. At about 30hours after I got the 2nd dose, my eyes began burning and swelling. I woke up the next day with one eye nearly swollen shut, but the swelling has almost entirely gone down after 8 hours.
Arm soreness after COVID 19 vaccine; This is a spontaneous report received from a contactable consumer via a Pfizer colleague. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness after COVID 19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DTaP vaccine administered intramuscularly to pt on 2/2/15 by LPN. Parents noted swelling and pain of site, on the same date. Parents brought child to clinic for assessment. Pt. afebrile and cold compress applied for swelling. Will continue to monitor. Pt education provided.
pt was seen @ clinic on 5FEB98 d/t rash on body;dx on 5FEB98 dermatitis;seen again on 18FEB98 for fever, rash & soreness in both upper arms;pt referred to dermatologist;had red papular rash on arms;progressed to plaques as large as 0.5cm;
mom reports temp of 104 & 105 on 23JUL94 & 24JUL94; did not go to MD or ER; pt given cool baths & APAP; diarrhea cont since a/vax given; 26JUL94 pt has fine rash over trunk of upper body, has croupy cough by report;