chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (lot#, dose, strength and route unknown). On an unknown date the (Oka/Merck) VARIVAX was exposed to temperature excursions on 6F for 8 hours and/or 10F for 11.5 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Severe depression; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06May2021(at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On an unknown date in May2021, the patient experienced severe depression. The clinical outcome of the event severe depression was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red rash that goes from the injection site down to their elbow; tenderness; red rash that goes from the injection site down to their elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash that goes from the injection site down to their elbow), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE ERYTHEMA (red rash that goes from the injection site down to their elbow) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No concomitant medications provided.  Concurrent medical conditions included COPD, Blood pressure abnormal and Thyroid disorder NOS.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE RASH (red rash that goes from the injection site down to their elbow), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE ERYTHEMA (red rash that goes from the injection site down to their elbow). At the time of the report, VACCINATION SITE RASH (red rash that goes from the injection site down to their elbow), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE ERYTHEMA (red rash that goes from the injection site down to their elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included inhalers for COPD, blood pressure and thyroid medicine.  Treatment information was not provided. Patient had  first dose of the Moderna COVID-19 vaccine last week on Wednesday (10Mar2021) and still had a red rash on their arm that goes from the injection site down to elbow and there's still some tenderness. did not have any fever or anything else. Uses inhalers for their COPD and takes blood pressure and thyroid medicine.
I took the vaccine and I was sick as a dog; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient took shingles vaccine and was sick as a dog. The follow-up would not possible as no contact details were available.
Patient was checking out at reception desk, felt dizzy, started slurring words and fell. Patient hit her head on desk and floor. Also hit the side of her abdomen on floor. Patient was immediately brought back into office and evaluated by provider. Patient was given juice and crackers. Did state she did not eat before vaccination. Patient did start to feel better, and friend picked her up from office.
Hives and wheezing within 2 hours. Had itching redness also.  Very heavy period started within 2 days with severe cramping and large blood clots.  That lasted for several days then stopped then started again.  Still experiencing side effects one week later.  Also felt nauseous and tired.
Information has been received from a physician concerning a 17 or 18 year old female who was vaccinated with Gardasil. Subsequently, the patient experienced delayed menstrual cycle after receiving Gardasil. She underwent a pregnancy test which was negative. The physician advised the patient to contact her after one month if she still did not have a menstrual cycle. Additional information has been requested.
chronic hepatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: CHRONIC HEPATITIS (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Liver function test: Spiked. Clinical course includes, adverse event: 15-year-old of received 2 Pfizer COVID-19 vaccines. Her liver numbers spiked and she now has chronic hepatitis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a few minutes later she had tickling in throat after shot. told her to wait around pharmacy for 15 minutes after the shot and then husband came up and asked me which Benadryl was best...liquid or capsule.  I asked for allergies? and that's when she told me she was having the same reaction she has when she eats nuts...throat swelling shut.  administered one dose of adult epi-pen and called 911. the epi-pen took effect within a couple minutes and pt got better. advised her to see whoever her PCP was to get an epi-pen to have on her due to the nut allergy even though this was unrelated to the nut allergy. paramedics came and she was feeling much better by that time.  they walked out of the store with her.
After my first shot, I had a very sore left arm and  chills which were somewhat expected. The unexpected event was vaginal bleeding in the form of blood clots which  has happened before from a uterine polyp but hasn?t happened in over a year and has now stopped. Additionally, my abdominal area and overall body, to a lesser extent , were more swollen than usual. The bleeding stopped after a week and the swelling has finally gone down and seems back to normal now, 2 weeks after my second shot. I?m assuming that it sparked up my immune system, or perhaps it is all coincidental. I just wanted to share the information/communicate the experience.
After 6 days it started to get itchy red and it swelled and it was painful. The arm was huge and i went to the urgent care.
Redness and pain radiating to shoulder (cellulitis) and is on antibiotic for it.
had vaccine in my left arm which triggered my bursitis in my left shoulder for 4 days. Severe pain en both areas.
Started with headache... arm pain , sneezing and runny nose.  After work when I got home I started feeling achy and running a low grade fever.  Midnight the chills started and I couldn?t get warm. My fever has been up and down from 100 6 to 103.8.  Tylenol works to reduce it for about two hours and then it climbs back up and my body starts cramping in the joints and muscles.
After immunization, rash developed within 5-10 minutes. Hives developed within 10-15 minutes after injection. 30 minutes after vaccine, felt throat closing, wheezing, and stridor. Immediately went to ER. Received BENADRYL, SOLU-MEDROL, PEPCID, and epinephrine. Admitted for observation overnight.
I went to the hospital, because I had shortness of breath the night before. When I got to the hospital, I was put on an IV and underwent bloodwork. A routine COVID-19 test was done, and the result was positive. I was then admitted on COVID-19 precautions. They gave me one dose of IV remdesivir and treated me for heart failure. I was also given a diuretic to get rid of the fluid buildup. I was discharged the next day. After that, everything was fine.
Swollen lymph nodes under left armpit.  Noticed tenderness on 4/15 and swelling on 4/16.  Still swollen on 4/19 (today).
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reaction/allergies were reported. On an unknown date, starting on or after 13-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L050560, expiry date: 14-DEC-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 10.67F for 12 hours. There was no previous temperature excursion. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
RED INFLAMED CIRCLE WITH SLIGHT ELEVATION ON THE SITE OF INJECTION. PATIENT WAS SEEN AT THE URGENT CARE CLINIC AND WAS GIVEN INJECTABLE DECADRON IM ON 1/24/16 PER HER DISCHARGE PAPER.
Visitor and mother came for their first doses of Moderna Covid-19 vaccine.  Visitor had registered online with the birth date of 7-20-2002 but actual date of birth is 7-20-2004. Visitor and mother were processed through front registration table, through secondary screening , and visitor was administered vaccine. Visitor proceeded to fifteen minute monitoring area and was questioned why he was not wearing visitor pass. Visitor stated that he didn't need a pass from security because "my mother said I didn't need to go through security because I'm only sixteen". Mother was vaccinated first and refused fifteen minute monitoring and left vicinity. Several attempts were made to contact mother as soon visitor disclosed he was sixteen. Mother did not answer any of the three calls. Visitor did not experience any adverse effects during fifteen minute monitoring.  Visitor was educated on potential side effects and verbalized understanding.
Narrative:  Patient received dose #1 of MODERNA COVID vaccine 2/6/2021, monitored for the appropriate 15 minutes and left without incident. Patient hospitalized 2/7/2021. Patient with recurrent UTI history and was recently diagnosed with UTI and was treated Bactrim which was started 3 days prior. Since then, patient's mental status has been declining progressively as per husband and today morning she was lethargic and unresponsive therefore, she was brought into the ED. As per husband, the current episode is not different from her previous episodes of UTI as she always presents with altered mentation when she has urinary tract infection. In additional to that, as per PCP advice, she started limiting sodium intake in her diet 2 months ago. Found to have a sodium of 117 (which is decreased from Na 134 1/28/2021). Medications identified that could cause hyponatremia include desipramine (initiated 10/1/2019) and sulfamethoxazole/trimethoprim (initiated 2/4/2021; although has tolerated in the past without incident). Patient was intubated on 2/7/2021 for increased FiO2 requirement and diagnosed with sepsis secondary to UTI and SIADH related hyperosmolar hyponatremia. Potential ADR for sulfamethoxazole/trimethoprim and/or desipramine being evaluated.   Other Relevant Hx:  Symptoms:  Confusion, Sedation & hyponatremia Treatment:   SODIUM CHLORIDE 20ml/hr x 5 hours. No more than 100mL total ,LEVOFLOXACIN 750 MG EVERY DAY
10/10 lower back pain. Intense pain resulted in not being able to walk by Friday and multiple doctor's appointments. I was referred for MRI as well as physical therapy and chiropractic care. I was advised that i had significant inflammation in my spine, neck and joints. I am still experiencing lower back pain and continue chiropractic care since April 2021. I also experienced high Fever of 102.4 for 24 hours, chills,  and fatigue.
pain after the 1st dose of the vaccine; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started to feel pain after the 1st dose of the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old male patient who received a 0.5 ml of vaccine FLUBLOK QIV (lot number: QFAA1824, expiry date: 30-Jun-2019) via unknown route in the left deltoid on 20-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given to the patient. It was a case of actual medication error due to inappropriate age at vaccine administration because safety and efficacy does not establish in that age group to revaccinate with age appropriate flu vaccine. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Muscle aches, weakness, fever, fatigue, headache, shortness of breath at times. Shooting pains throughout body which started on 11/4 continuing through today 11/8.
Patient reported nausea (which is common to known vaccine effects) and dry mouth (which has no evidence at this time that is attributed to vaccine).
6 month old child received Hepatitis A # 1 at 6 months instead of 12 months, per standard, in error. In follow up with the parent, child has had no adverse symptoms. Patient seen in the clinic on 3/20/09. Health status stable.
Patient hospitalized after testing positive for COVID-19 on 5/22/2021. Hospitalized on 5/22/2021 due to COVID. Patient has been fully vaccinated.
Beginning the morning after my second vaccine dose, I experienced body aches, joint pain, nausea, diarrhea and fatigue.  By 24 hours post-vaccine, I developed a fever of 100.8, a headache, and swollen lymph nodes.  By 36 hours, my fever broke, diarrhea discontinued, and the headache subsided.  The body aches, nausea, fatigue, and swollen lymph nodes continue to inhibit my ability to perform ADLs and I was unable to work today.
Headache; muscle pain; fatigue; pain at injection site; This is a spontaneous report from a contactable nurse.  A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19. Vaccine location was left arm. Concomitant medication included topiramate (TOPAMAX), bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), escitalopram oxalate (LEXAPRO), clonazepam (KLONOPIN). The patient experienced headache, muscle pain, fatigue, pain at injection site all on 09Jan2021. The events outcome was recovering  Information on the lot/batch number has been requested.
Approximately 8 hours post-vaccination, the patient was lethargic for 5 minutes, then fussy, and excessive crying for 3 hours, temp 102.6. Treatment was cool compresses to the site, Tylenol and Motrin. The patient fell asleep after 3 hours of crying.
Pt vax w/3 times usual dose; devel flu-like sx (fever, malaise).  Tx w/ APAP & augmentin & recovered w/in 24 hrs.  Reporter stated that sx may have been caused by an infection.
first dose of Gardasil in early 2019 and has yet to get additional doses; no additional AE information provided; This spontaneous report has been received from a consumer referring to himself, a currently 44-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies, concurrent conditions or concomitant medications was provided.  On an unspecified date in 2019, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) as prophylaxis. The patient was unsure if he received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was reported that the patient had yet to get additional doses (inappropriate schedule of product administration).   No additional adverse event was reported (no adverse event).
TINNITUS BOTH EAR , OTALGIA A Narrative: added the following symptoms on 2nd dose of Pfizer mRNA covid 19---left ear pain, bad dreams, night sweats sleep disorder (initiation)
Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Patient of age 46 received a partial dose of Fluzon HD due to the dose leaking out around the hub at the luer lok with no AE.; Initial information regarding an unsolicited valid serious case was received from a Pharmacist via Agency (Reference number- 00353849) and transmitted to Sanofi on 10-Nov-2020.   This case involves a 46 years old female patient who received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ517AA and expiration date: 30-Jun-2021) via unknown route at an unknown administration site for prophylactic vaccination due to the dose leaking out around the hub at the luer (product administered to patient of inappropriate age, Inappropriate dose of vaccine administered and syringe issue) on an 10-Nov-2020.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration, Inappropriate dose of vaccine administered and syringe issue.  At the time of report, no adverse event was 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.
blisters form after she eats and when they pop they bleed for a while; blood blisters in mouth worse; blisters pop and it hurts; rash gotten worse; 45 days between the administration of the 1st dose and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) in an 87-year-old female patient who received mRNA-1273 (batch nos. 032M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No previous medical history was provided).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose). On an unknown date, the patient experienced HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (blood blisters in mouth worse), PAIN (blisters pop and it hurts) and RASH (rash gotten worse). At the time of the report, HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while), PAIN (blisters pop and it hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose) outcome was unknown and ORAL MUCOSAL BLISTERING (blood blisters in mouth worse) and RASH (rash gotten worse) had not resolved.            No concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-079482 (Patient Link).; Sender's Comments: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt. was given a series of vaccines on 3/7/11 HepA, MMR, MENACTRA, polio & DTaP. Pt. was to have received Tdap & not DTaP. Pt. will return in 4 wks to receive Tdap vaccine.
Woke up on the second day with pain In right shoulder and right wrist and right hand areas.  I originally thought I slept on the shoulder wrong. The pain in the right wrist lasted for about 5 days. It has lessened through today but can still be achy. Shoulder pain persists. It is acute pain if I raise the shoulder while keeping elbow and hand parallel to the ground above shoulder height. I read today these symptoms could result from vaccination and the timing fits.