chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker (also reported as an office manager) refers to three patient of unknown ages and genders. Their pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (which had a lot # of L042265 with an expiration date of 26-JAN-2017; however, the dose, dosage number, route of administration and anatomical location were not reported). Information regarding their concomitant therapies was not provided. Despite being vaccinated with an improperly stored vaccine, no adverse events were reported. The vaccine experienced a temperature excursion of -1 F for an unknown time frame. It had previously experienced an excursion of 21 F for a time frame of 108 minutes. The excursion was not called out due to the data logger and the total number of doses administered were reportedly three. Additional information has been requested.
Severe muscle pain; nonstop heartburn; nerve pain; severe headaches; severe migraine; extreme fatigue; myofascial pain syndrome; experience so much pain; that she could not walk; This non-serious case was reported by a consumer via sales rep and described the occurrence of muscle pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle pain (Verbatim: Severe muscle pain), heartburn (Verbatim: nonstop heartburn), nerve pain (Verbatim: nerve pain), headache (Verbatim: severe headaches), migraine (Verbatim: severe migraine), fatigue (Verbatim: extreme fatigue), myofascial pain syndrome (Verbatim: myofascial pain syndrome), pain (Verbatim: experience so much pain) and unable to walk (Verbatim: that she could not walk). The outcome of the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk were resolved.   It was unknown if the reporter considered the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk to be related to Shingrix.     It was unknown if the company considered the muscle pain, heartburn, nerve pain, headache, migraine, fatigue, myofascial pain syndrome, pain and unable to walk to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient received 2nd dose and had severe symptoms that lasted for more than a week. The patient had experienced severe muscle pain, nonstop heartburn that was not alleviated with any medication, nerve pain, severe headaches and severe migraine, and extreme fatigue. Reported that this messed up her whole system. The patient had myofascial pain syndrome and experienced so much pain that for first few days after vaccination was not able to walk. The reporter consented to follow up.
Donor reported when she stood up after 15 minutes had passed, that she felt that she felt some lightheadedness and some confusion. Donor sat back down and given a snack and drink. Donor stated that she felt better after she ate  and drank something.
She had gotten the rotavirus vaccine on 06/28/2010 and by 7/01/2010 she was very lethargic, she was hard to wake up an would not eat. She developed a fever around 10am it was 101, she also developed diarrhea and there was also blood in her stool. Was admitted to the hospital by 5pm on 7/01/2010. She stayed over night and was discharged 7/02/2010 at 1pm. She is still not herself, shes still has diarrhea and is only eating a one to two ozs ever 6 or 7 hours. She is also still sleeping most of the day.
After the second dose, she had a sore arm; After the second dose, little swollen; Low grade fever "you know like 100 for one night"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After the second dose, she had a sore arm), VACCINATION SITE SWELLING (After the second dose, little swollen) and PYREXIA (Low grade fever "you know like 100 for one night") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After the second dose, she had a sore arm), VACCINATION SITE SWELLING (After the second dose, little swollen) and PYREXIA (Low grade fever "you know like 100 for one night"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (After the second dose, she had a sore arm), VACCINATION SITE SWELLING (After the second dose, little swollen) and PYREXIA (Low grade fever "you know like 100 for one night") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100.   Patient is on Blood thinners.   This case was linked to MOD-2021-359904, MOD-2021-359939.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up contains No new information
On 09/21/09 at 5:30 pm received DT injection. Went home and an hour or two later he started crying with his arm hurting. Mom didn't see anything then. Repeated 3-4 times during night. AT 9:30 next morning still complaining of arm hurting, mom didn't see anything and went to school. That afternoon still complained after school. At 9:30 on Tuesday night mom was giving him a shower and saw his arm was swollen baseball size and was hot and hard to touch. C/o headache, called dr. Temp 100 degrees. Went to Children's, given Motrin. On 09/23/09 the size of his arm still swollen but lessened still warm to touch, slight fever but not complaining as much. Mom given prescription for bendryl.
Local skin reaction- large raised hard lump at injection site, skin is itchy, and red.  Started 3/24/2021, ongoing,
Pt recvd 2nd dose of MMR; Lab eval revealed a positive titer for rubella & a neg titer for measles; pt's titer for mumps was not tested;
This spontaneous report as received from a registered nurse regarding an unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with one dose of GARDASIL (dose, route, indication, lot # and expiration date not reported). The reporter stated that the patients were administered with improperly stored GARDASIL for the past 3 years at the office. She stated that she wasn't aware of the recommend label storage temperature of GARDASIL being 36 F to 46 F, and noted that over the past 3 years their GARDASIL doses have had an unspecified number of low temperature excursions (as low as 30F-31F) and unspecified number of high temperature excursions (as high as 48F-54F) for unspecified time period on unspecified dates. No adverse effects were reported. Additional information has been requested.
Pt began feeling throat scratching  and coughing 30 minutes after vaccine administration. Pt was given Benadryl 50 mg orally per MD order and symptoms started to resolved 22 minutes after Benadryl administration.
At 1024, RRT was called to the post-vaccine recovery area for a 29 y/o F that c/o feeling ?hot? after receiving the vaccine. She also complains of pain to her left arm radiating to her neck. She was initially light-headed, cool, and clammy. Head-to-toe assessment completed. Vitals ? BP: 100/56, RR: 18, HR: 100. No PMH, NKA, did not take any medications. Not pregnant. Throughout monitoring period, client?s status improved. Client given a cool compress to improve condition which client states, helped. Pain to left arm decreased, client?s skin warm, and she had no complaints of dizziness before she left home. The feeling of feeling hot went away. Client opted to go home after monitoring/evaluation period. Client left facility at 1100, accompanied by her girlfriend. Girlfriend stated she will be driving home. Client left in stable condition, AA0x4, in no acute distress, breathing even and unlabored.
RASH BROKE OUT ON BACK/ARMS AND WAS ACCOMPANIED WITH ITCHINESS; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy. The patient had no pertinent medical history. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series 01, 01 in total, administered on an unspecified date in APR-2021 for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 01). The patient stated he did not have any problem with the first dose. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 855794, expiry: unknown) dose was not reported, dose number in series 02, 01 in total, administered on an unspecified date in OCT-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in OCT-2021, 6 days after vaccination, rash broke out on his back and later rash also started showing on his arms, the patient also stated that the rash was accompanied with itchiness (dose number in series 02). The patient had been seen by 3 different doctors including an allergist and dermatologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash broke out on back/arms and was accompanied with itchiness. This report was non-serious.
Hematuria with red blood cell casts ALP 237, AST 169Z, ALT 1250 WBC 19.4 with left shift all clearing rapidly in 2-3 days. Child was not ill clinically. Brought in because of hematuria. Still following.
Information has been received via complete pregnancy questionnaire from a registered nurse (RN) concerning a male baby who was born from a currently 21 year old, female previous smoker patient with type 1 diabetes mellitus since age of 13 and an obstetric history of 1 elective termination (because of health reasons: kidney were failing) (date unspecified), who on 23-MAY-2011 was vaccinated with the first dose of GARDASIL (route not specified, lot number 666595/0992Z). Other concomitant therapy included DEPO-PROVERA, HUMALOG, LANTUS and PHENERGAN. On 28-DEC-2011 the mother delivered a premature, male baby. The baby's weight was 5 pounds 5 ounces, length 18.5, apgar score was 5 (1 minute) and 8 (5 minutes) and head circumference was 31cm. The RN reported that complications during pregnancy included pre-eclampsia. The patient had ventricular septal defect. There were no other congenital anomalies or complications during labor/delivery and no illness or infections during pregnancy. Upon internal review, ventricular septal defect is considered a congenital anomaly. The mother's experiences were captured in WAES#1109USA01051. Additional information has been requested.
Ten to fourteen days after I recovered from COVID-19 I discovered that my middle toes on both feet the nails were dark and the toes up to the knuckle were white. I discovered this when I went to get a pedicure after recovering from having COVID-19 when the nail technician took the nail polish off. It is going away, I can see my normal nail coming back. It does not hurt, I will consult with my physician at my annual physical.
Admission Date: 8/20/2022 Discharge Date: Aug 31, 2022  PRESENTING PROBLEM: Paroxysmal atrial fibrillation (HCC) [I48.0] Sepsis (HCC) [A41.9] Atrial fibrillation with RVR (HCC) [I48.91] Septic shock (HCC) [A41.9, R65.21] COVID-19 [U07.1] Bacteremia due to Enterococcus [R78.81, B95.2]   HOSPITAL COURSE:   Patient is a 67-year-old female with a history of chronic obstructive pulmonary disease, CKD3 (baseline creatinine ~1.5), atrial fibrillation on warfarin, bicuspid aortic valve s/p bioprosthetic AVR, CHF with ejection fraction of 44% who presented with altered mentation, hypotension and wide-complex tachycardia on 8/20. Given 80 mg lidocaine by EMS en route to ED.  Hypotension and tachyarrhythmia persisted on arrival to ED (Afib with LBBB); attempt at cardioversion was unsuccessful and was started on an amiodarone gtt. Remainder of ED work up significant for BUN 59 creat 3.5, lactate 2.8, WBC19k, COVID positive. Found to have Enterococcus bacteremia. Given total 3 L IVF then started on norepi, vasopressin and stress-dose hydrocortisone. 8/20 ECHO showed LVEF 45%, bioprosthetic AV mean pressure gradient 22 mmHg, mild MR and moderate TR (limited visualization). Dark stool noted 8/21 night concerning for melena, CBC noted Hgb drop on serial draws overnight - trended from 11.2 on 8/21 AM to nadir of 7.7 overnight 8/21 along with recurrent mild hypotension - 1u pRBCs transfused with follow-up Hgb to 10.8  (suspect Hgb of 7.7 inaccurate). EGD showed a hiatal hernia, grade A esophagitis and mild gastritis. TEE 8/23 - bioprsthetic valve appeared normal, no AR, moderate MR, mod-severe TR, no clear evidence of endocarditis, but difficult to rule out   She has Enterococcus bacteremia -4/4 cultures from 08/20/2022 positive.  Positive blood cultures on 08/21/2022 for GPCs.  Enterococcus isolate is pan susceptible.PET was done.  Showed possible aortic valve graft infection, right cervical lymph node could be reactive, new small bilateral pleural effusions and a new small amount of ascites. CTS was consulted and no acute surgical intervention and recommended outpatient follow-up and to continue IV antibiotics. Infectious disease recommended continue Ampicillin and Ceftriaxone for a total of 6 wks with end date of 10/4/22.    Endocrinology was also consulted for the elevated TSH despite being on levothyroxine and they adjusted the dose.   The patient was discharged home in a stable condition. She is instructed to follow up with PCP, and ID.
she said she developed a red rash around her neck...like she had been strangled...she went to the doctor and he thought it looked like a fungal rash but wasn't sure.
This spontaneous report has been received from the doctor's office manager refers to a 35 years old female patient. The patient was vaccinated with the three dose of 0.5 ml GARDASIL but since had been diagnosed with HPV. The vaccine had been administered by the patient's family doctor, whose name was unspecified. The patient sought unspecified medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
seen by PMD for ear infect evening p/vax;rx w/amoxicillin;26APR(7 pink superficial rash noted-fever-99-99.3;26APR-27APR97 small spit-up, not vomiting;1MAY97 t100.3, scratching head, rash, itchy & possessing;lack of appetite;little sleep
I woke up and went to brush my teeth and noticed my eye was swollen badly. Within a week my lip started swelling badly. I went to urgent care because my allergist was on vacation. They gave me a steroid shot and then after a week it started swell again. In the past when I had swelling it would normally subside with medication after medication but this time it has not subsided. Now going on 8 weeks, the swelling has not subsided and now have itching. I have not been able to get off of the medication completely. I feel like my nervous system is not responding.
Patient received injection and within seconds said that she felt unwell. I asked her to stay in pharmacy to monitor her within a few minutes patient said she was feeling worse. I called 911. The medic arrived and monitored her vitals. Medic said no swelling of throat or tongue. Airways were clear. She was given an injection of 25mg diphenhydramine and transported to hospital. Medic thought vasovagal symptoms of psychosomatic reaction to shot.
Raised, Painful and Hot Red 2in Injection site, swollen in a 4in diameter. Monster Headache Severe Right Hip Joint Pain Severe Vertebrae Pain Muscle Pain Constant Urination Day two only Major Fatigue Chills than Sweats Day three and still have symptoms
I felt fine all day until 11:00 at night. Then I started having a sore throat, blowing my nose as it was congested, I had a low-grade fever. The next morning, I had a fever of 100.2F the ADVIL was helping to bring it down. The sore throat was not hurting as much, but I felt awful. I took a home COVID-19 test on Monday, it immediately came back positive. I called the doctor and had a virtual appointment on Tuesday and was prescribed PAXLOVID and went to pick it up at my local pharmacy. I started taking it immediately and the next day I was feeling better, yes, some of my symptoms were still there but I was on my way to feeling better. By day 5 I thought I was going to be ill again but no I was not, I recovered.
Tingling and throbbing from the injection site; Tingling and throbbing from the injection site; Itching at injection site; feels kind of like her arm fell asleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6202) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease stage 3" (unspecified if ongoing), notes: Verbatim: Chronic kidney disease stage 3; "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol abnormal (ongoing); IRBESARTAN/HCTZ GA taken for blood pressure abnormal. The following information was reported: VACCINATION SITE PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 03Mar2021, outcome "not recovered" and all described as "Tingling and throbbing from the injection site"; VACCINATION SITE PRURITUS (non-serious) with onset 03Mar2021, outcome "recovering", described as "Itching at injection site"; FEELING ABNORMAL (non-serious) with onset 03Mar2021, outcome "unknown", described as "feels kind of like her arm fell asleep".  Additional information: Caller was a consumer. She reports she received her first covid vaccine exactly a week ago, on 2Mar2021. She initially stated that she developed tingling, but later clarified she also feels throbbing from the injection site, all the way down to her fingertips: feels kind of like her arm fell asleep. She reports this has been going on since the day after the vaccine,3Mar2021. Caller reports it comes and goes maybe about 6-7 times an hour. Caller stated that she does not know if he hit a nerve when he gave her injection or if this is from the vaccine itself. She thinks a week is long enough to worry. Reports it itches at the injection site and it improved slightly. Caller stated the Bottle number/Lot number is EN6202. It is hard to read his writing, but she thinks that is an N. Caller stated the person who gave her the vaccine told her he gets 6 doses out of a bottle. She sees a date of 03Sep2020, on the bottom of the card, that is the only date she sees.   No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing), notes: Thyroid disease; "Osteoporosis" (unspecified if ongoing); "Parathyroid disease" (unspecified if ongoing); "Knee and hip Replacements" (unspecified if ongoing), notes: Knee and hip Replacements; "Knee and hip Replacements" (unspecified if ongoing), notes: Knee and hip Replacements; "Back surgery" (unspecified if ongoing); "known allergies:Latex" (unspecified if ongoing); "known allergies:adhesives" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL; OXYCODONE, start date: 05Oct2022; TYLENOL, start date: 05Oct2022. Past drug history included: Gluten, reaction(s): "known allergies: gluten", notes: Latex and adhesives, gluten sensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 from 14Dec2022 to 19Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This clinic was to administer Tdap as a follow up booster from the original DTaP but administered a DTaP to my child in error.  They realized the error in noticing the lot number did not align with the correct vaccine and a supervisor followed up with me explaining that DTaP can be given in place of Tdap if Tdap is not available. The instance of administering the DTaP was an error due to negligence at the clinic. Though there is unlikely to be a safety risk to my child due to this error, a clinic administering the wrong vaccine on accident should be reported.
massive headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "massive headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient said she felt "typical soreness" in the injection area for about 5 days after the flu shot. She said it then turned into "a pinched nerve feeling", along with "muscle spasms". She also stated that she has trouble lifting her arm over her head.
A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 6-year-old male subsequent to the administration of FLUMIST. The patient's medical history and concomitant medications were not reported. On 22-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. No later occurring adverse events were reported. Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
My COVID started off with a sore throat, sneezing and runny nose. It was heavy pressure on my chest. It was about 10 days I was told I was not contagious but I did develop a productive cough. It lasted about 3 weeks.
Vaccinating nurse did not dilute vaccine. Patient received 0.3ml dose from undiluted vial.  Mistake was discovered after she asked for more vials. Patient was contacted and counseled to watch for more pronounced side effects. At the time of the call, patient had no symptoms yet.