chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an 81 years old patient (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due wrong vaccine administered. No information about any adverse event reported. 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.
This case was reported by a consumer via call center representative and described the occurrence of corneal inflammation in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included corneal abrasion (30 years before the reporting date). In July 2018, the patient received the 1st dose of SHINGRIX. On 1st August 2018, 14 days after receiving SHINGRIX, the patient experienced corneal inflammation and eye dryness. On an unknown date, the outcome of the corneal inflammation and eye dryness were unknown. It was unknown if the reporter considered the corneal inflammation and eye dryness to be related to SHINGRIX. Additional details were reported as follows: The patient asked if she could have corneal herpes without a rash and was asking could she get other symptoms. The patient developed right eye corneal inflammation and severe dry eye 2 weeks after vaccination with SHINGRIX. Since 1st August 2018, the patient had these problems. The ophthalmologist said if it was a corneal issue caused by a dose of SHINGRIX the patient would have a rash. The patient had a corneal abrasion 30 years ago and was told that area of the cornea was weak causing patient to have this problem. It might be just a coincidence, but the patient was leary about getting 2nd shot of SHINGRIX. The patient would be seen by the physician the next week of reporting. The patient's left eye was fine. The patient was asking, if corneal herpes could be adding to this. The patient was asking, whether ophthalmologist should be able to tell the difference between a herpes virus or a corneal scar.
Redness and swelling at injection site 2 days following injection  fever, nausea and fatigue 1 day following injection
10/4/99 dizziness, sensitive skin on trunk, balk of arms, middle back;10/11/99 dizziness great J reduced, sensitive skin persists;10/19/99 sensitive skin persists;
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Nurse RN gave patient 0.5 ml second dose Moderna vaccine on 10/30/21. Patient was originally afebrile, alert, and oriented. He reported feeling slightly nauseous after receiving vaccine and after few minutes, patient presented with syncope episode and signs of seizure. EMS came after he came to and patient was okay after vomiting a few times. He left store after about 30 minutes.
Redness at injection site. MD wants pt to ice site TID. Ibuprofen OTC TID. Contact MD in 5 days.
Acute fever, diarrhea, vomiting, x 7 days. (temp. 102 degrees Fahrenheit)
Client was 19 years and 4 months at the time adult Hep B was given. Adult Hep B is approved for those 20 and up. The vaccine is countable, and client left the clinic without complications.
Started  light bleeding/spotting after 19 months of no period and being in menopause
Hospitalized with weakness and falls, non productive cough, rhinorrhea. Remdesivir 3 day course.  discharged to home.
Patient was admitted to hospital on 9/25/14 with acute onset of bilateral upper extremity weakness, which progressed to involved lower extremities as well as weak cough. He had cough and congestion about 2 weeks prior to these symptoms. CSF at the time of admission showed 129 white blood cells (82% lymphocytes) with normal glucose and protein of 123 mg/dL. MRI showed abnormal T2 hyperintensity along the spinal cord. He was treated with IV steroids and plasmapheresis with some improvement. I am the pediatric infectious diseases fellow who was consulted on this patient at admission. At the time of the report the patient is still admitted.
Fever of 102.1 (went down to 100.3, but then back up to 102), body aches, headache, lethargic, difficulty sleeping, sore arm where injection occurred. 24 hours later (and after taking Tylenol and Ibuprofen) still have headache
pt recvd vax;p/ dose 1,exp burning sensation in groin;p/ dose 2 pain in hips(heads of femurs);approx 16 mo p/ dose 3 was found to have bilateral avascular necrosis of the hips; unresolved
aches; I felt like all my teeth were going to fall out; muscular pain; severe mouth pain; tooth pain; This is a spontaneous report from a contactable consumer (patient). A 41-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0217), dose 1 intramuscular, administered in Deltoid Left on 26Aug2021 around 3-4 pm after work (at the age of 41-Years-old)  as DOSE 1, SINGLE for covid-19 immunisation. The patient received vaccine at Pharmacy or Drug store. The patient's medical history included S/P R thyroidectomy for papillary CA with partial thyroidectomy of Right thyroid from 2007 to 2008, Hypothyroidism which is ongoing. Family medical history included hypertension both sides, gout in father, CKD in mother. Concomitant medication included levothyroxine sodium (SYNTHROID) oral taken for hypothyroidism from 2008 and ongoing. Prior vaccinations were reported as none. On 26Aug2021, the patient experienced severe mouth pain, tooth pain at night-time but especially worse on the right upper side. Visual assessment with minor without any indication of inflammation. Persisted for the next 2-3 weeks with reduction in duration from 20-22hr to 6-12 h, kept up at night to sleep. On 26Aug2021, patient had immediate muscular pain as expected.  On an 27Aug2021, patient had aches and felt like all my teeth were going to fall out. It was reported that every now and then patient will have it. The reporter assessed the event as serious (Persistent/ Significant disability/ Incapacity). Dental visit on 16Sep2021 without findings. The patient underwent lab tests and procedures which included dental examination with no acute findings on 16Sep2021. Therapeutic measures were not taken with respect to severe mouth pain, tooth pain. At the time of this report, the outcome of severe mouth pain, tooth pain was recovered with sequel, aches, I felt like all my teeth were going to fall out was not recovered and muscular pain was unknown.  Follow-up attempts are completed. No further information is expected.
Complains of right hand pain, the meat part of the thumb.  Says it is difficult to pick up heavy items and do daily activities.  Aleve helps relieve the pain as does soaking the hand in warm water.  He does take medication for Gout and also has arthritis in his back.  Has not gotten any worse but not necessarily better.  Has not seen a medical doctor.
Client passed away 8 days after being vaccinated.  It is unknown if it occurred from the vaccine or other comorbidities.
Injection site - right deltoid received at 1630 on Friday, October 21, 2005.  Parents noticed entire right arm swollen, reddened and child scratching at injection site.  Mother began giving Benadryl for age to treat symptoms.  Right arm continued to swell with erythema & itching.  Parents brought child to ED for evaluation & treatment.
Soreness in arm (severe); spiked fever of 100.7 F.  Fever subsided 1.5 hours later without medication after sleeping.
I developed a red itch rash on my arm  4 days after I received the 2nd dose of the Moderna Covid-19 vaccine.  I treated it with topical antihistamine lotions and cortisone creams.
A rash developed on the arm of the injection soon after receiving vaccine, similar to a heat rash. Approximitely 8 days later, my entire body broke out in what looked like measles & hives. It was extremely itchy and sensitive; it was treated with steriod pack via Urgent Care, where the Dr. confirmed that this was an allergic reaction to COVID-19 vax.
Developed mild arm soreness shortly after immunization near injection site.  Most of upper arm, outer aspect was moderately to severely sore within a few hours and remained so for several days.   Mild headache experience in the evening after receiving the vaccine but was not experienced after that -- no other symptoms besides arm soreness was experienced.  The left arm ached and was sensitive to pressure (sleeping on that side) for about 4 days and moderated after that.  Raising arm out to side or over head also exacerbated pain.  Pain/ache resolved fully within about 1 week.
Syncopal episodes. With arched back & all body stiffened. Eyes rolled up. Episode almost 15 secs. Pale & diaphoretic.
Hives face and genital area, thick secretions c/o throat swelling site became red and sore 24 hours. 7/19/04 - Mother reported after receiving DTaP, IPV and MMR vomiting mucous sore throat, itching 10 minutes after giving immunizations.
Received vaccine 2pm.  I woke at 3am with a headache and Fever of 101 (max taken).  Very tired, flushed.    Treatment:  Rest, Advil  Symptoms stayed with me 3am through that afternoon.  Fever varied from 99.5 to 101.
Numbness in rt eyelid reported by pt to nurse approx 4.5 hrs p/hep B vax injection; lasted approx 56 hrs;
Menveo given on 7-1-20, went to ER on 7-2-20 due to swollen & red L.D. ER Rx'd Medrol dosepak & Keflex 250mg QIDx7 days. Followed up in office on 7-6-20 RNX improving--complete abx & steroid
Information has been received from a registered nurse concerning a 5 year old female patient who on 31JUL1998 was vaccinated with a first dose of varicella virus vaccine live. On 10JUN2003, the patient developed "itchy red spots" on her "entire body". Subsequently, the patient recovered. No further information is required.
First three toes turned bright red two days after receiving the vaccine. Patient reports redness dissipated after 24 hours.
Soreness/discomfort injection site. Swelling of left upper arm, warm to touch. Pink discoloration of upper left arm. Cellulitis at injection site.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient reported that 1st SHINGRIX shot was much more painful than other vaccines she has received. The pain began within a couple of hours after receiving SHINGRIX, the patient experienced pain which resolved after 2 days. The patient planned to receive the 2nd dose. The patient consented to follow up. The healthcare professional details were not asked.
3 days subsequent to receiving one dose of varicella virus vaccine live the pt experienced bumps on her chin, chest, lower back and arms. Additional information has been requested.
NAUSEA/VOMITING, HEADACHE. Evaluated by EMS-Cleared
Hives, pruritus left arm 2 days after injection treated with cool compress, Benadryl, lotrisone cream.
the entire left side of her body was numb; Daily headaches; bodyaches; fatigue; posterior cervical lymphadenopathy; dizziness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Dec2020 10:30 (Lot number: EL8982) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing); "covid prior vaccination" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPOAESTHESIA (disability) with onset 29Dec2020, outcome "not recovered", described as "the entire left side of her body was numb"; HEADACHE (disability) with onset 29Dec2020, outcome "not recovered", described as "Daily headaches"; PAIN (disability) with onset 29Dec2020, outcome "not recovered", described as "bodyaches"; FATIGUE (disability) with onset 29Dec2020, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (disability) with onset 29Dec2020, outcome "not recovered", described as "posterior cervical lymphadenopathy"; DIZZINESS (disability) with onset 29Dec2020, outcome "not recovered", described as "dizziness". The events "the entire left side of her body was numb", "daily headaches", "bodyaches", "fatigue", "posterior cervical lymphadenopathy" and "dizziness" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: covid-19: unknown results. Therapeutic measures were taken as a result of hypoaesthesia, headache, pain, fatigue, lymphadenopathy, dizziness.  AE treatment: MRI, muscle relaxers, still continuing to seek treatment. AE resulted in: Doctor or other healthcare professional office/clinic visit Disability or permanent damage. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient received the second dose of BNT162B2 (lot number: EL1284) intramuscular in the arm left on 20Jan2021 at 04:45PM for COVID-19 Immunization. The patient had no covid tested post vaccination.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
A single clump of hair loss noticed for the first time 10 days after 1st Moderna vaccination, hair loss increased dramatically after 2nd dose on 4/23, saw an internist who drew blood work and eventually a dermatologist, lab work showed hypothyroidism which progressed to being symptomatic , TSH continued to increase and put on thyroid replacement
Pt. had DTAP, Hep A (L) deltoid 12/05/2012. 12/06/2012, Mom states he had a small redness in the area. 12/07/2012 the work area that had grown to 5 cm area that was hot to touch. Ice was applied to area. Patient started on Prednisone 5mg/5ml 2 tsp. once a day for 3 days.
slurred speech, difficulty putting thoughts  into words, difficulty completing a whole sentence when talking occurred almost immediately after receiving the vaccine (within 15 minutes or so) lasted for about 8 hours
This spontaneous report as received a registered nurse refers to a 58 year old male patient. Patient's pertinent medical history included psoriasis. Drug reactions or allergies were reported as none. On 12-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (Lot# L038669), route, dose and strength were not reported. No concomitant medications were reported. Lab tests were reported none. On 13-FEB-2016, 2 days after vaccination, the patient developed swollen hard mass at the site of injection. The reaction was red, warm and painful to touch. The patient sought medical attention and was prescribed warm packs to the affected area, as well as alternating doses of ibuprofen and TYLENOL. On 15-FEB-2016, the patient recovered from the events. The reporter did not provide causality between the events and the suspect therapy. Additional information is not expected as reporter did not give consent for follow-up.
Symptoms first noticed were elevated heart beat with arrhythmia. Heart palpitations and skipping beats. Signs were elevated heart rate, light headed, noticeable arrhythmia, especially when prone. Symptoms have been consistent since first exposure to COVID after booster shot. Did not contract COVID-19 until the month following symptoms, but was exposed at same time of family member. Treatment has been ongoing...daily medication, EKG, ECG, EKG w/stress test, MRI, Holter monitor, etc.
On 05/30/2023,, while I was at work in the ED, within seconds of taking the SULFAMETHOXAZOLE-TRIMETHOPRIM DS, I immediately went into anaphylaxis, starting with with severe itching, followed by sob, wheezing, diarrhea w/o blood,  vomiting w/o blood, then a brief bout of unconsciousness. I was treated IM epinephrine 0.3 mg, IV dexamethasone 10mg, IV diphenhydramine 50mg, IV famotidine 20mg and IV ondansetron 4mg and immediately responded. One and a half hours later, I biphasic re-reacted, with intense itching, and was re-medicated with IM epinephrine 0.3mg,  IV diphenhydramine 50 mg, IV famotidine 20 mg immediately responded again, was admitted to hospital for a one night stay w/o further incidence
Moderate pain/ Feeling achy; stiffness in left arm/ stiff neck; small cough; headache; This is a spontaneous report from a contactable consumer. This 57-year-old (non-pregnant) female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: En6202) via an unspecified route of administration into the left arm on 05Mar2021 16:45 (at the age of 57-year-old) as single dose for COVID-19 immunisation. The patient medical history included known allergies to Erythromycin and had breast cancer. Concomitant medications were not reported. On 05Mar2021 at around 20:00, the patient reported of moderate pain and stiffness in left arm. Tender to touch and cannot lift more than a few inches. She was feeling achy, had small cough, headache and stiff neck. Facility type vaccine was a school or student health clinic. No other vaccine in four weeks. No treatments received for the adverse events. No Covid prior vaccination nor Covid tested post vaccination. Outcome was not resolved for all the events.  No follow-up attempts are possible. No further information is expected.
Client called clinic to report that she started having leg cramping (5 out of 10 reported severity) for "a number of hours" starting at approximately 11:00 PM. She also reported that she has a continued low-grade fever the morning after. She stated she did not feel the need to seek medical attention, and reported no medications taken for relief.
Edema (R) axilla started 10-21-12 edema (R) collar bone started 10-21-12. No treatment.
In my left temple, it is like a sharp, stabbing pain for a second then it goes away.  It comes and goes on someday and somedays I might not have any.  These symptoms has been going off and on for about 3 months now.
pt recv vax may96, 8AUG96 pt devel chicken pox; devel 15-20 lesions on his abd and trunk.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 31-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.      No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
11/21/22 presents to EC ED for "decreased output from her Foley catheter". PMHx of "anemia, hypertension, GERD, gastric ulcer, diverticulosis, NSTEMI and SBO"
Rash on legs, trunk and arms, itching started 7/29/07 when awoke. Used Benadryl 7/29 and 7/30 but rash was spreading. Saw provider on 7/31/07. Instr. to con't Benadryl 12.5mg q 6-8 hours PRN. Calamine lotion and oatmeal baths. Follow up if not improved.
sore leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore leg pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Vascular disorder NOS.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore leg pain). At the time of the report, PAIN IN EXTREMITY (sore leg pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.  No concomitant medication provided by Reporter
0n 7/7 - patient started to have fever, dizziness, chills, neck stiffness, body ache, swollen arm. Went to PCP and was told it was reaction from vaccine was given ibuprofen.
This spontaneous report was received from a registered nurse via a company representative concerning a male patient of unknown age. On an unknown date in December 2010 (almost two years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On unknown date in December 2012 (almost two years after receiving ZOSTAVAX), the patient experienced shingles on the torso. It was unspecified if the patient sought medical attention. The outcome of shingles on the torso was unknown. Treatment information was unspecified by the reporter. Additional information has been requested.
Redness and heat on R foot, left after 15 minutes. Upset bowel system.  Have always had opposite problem.
Employess states that she developed mild itching for 3 days after getting typhoid vaccine. No medications taken. She flushed it out by drinking extra water. Itching resolved after 3 days.
SYMPTOMS OF VACCINE ~ SAME DAY SITE SORENESS TO THE TOUCH & ARM HURT, BODY ACHES, FELT TIRED, SLEPT ALL DAY. TWO DAYS AFTER, I FELT TOTALLY DRAINED & MY THOUGTHS WERE/ARE (STILL TO DATE 5/11/2021) EXTREMELY 'OFF' & 'FOGGY', NOT THINKING STRAIGHT, FOCUS & CONCENTRATION ARE BOTH WAY OFF. NOT AT ALL FEELING LIKE MYSELF.