chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receiving Covid-19 booster; bilateral chilling of the  hands with whitening of the skin and purple discoloration; bilateral chilling of the  hands with whitening of the skin and purple discoloration; Patient measured temperature of hands at 93 degrees F; This is a spontaneous report received from a contactable Consumer or other non HCP.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Food allergies" (unspecified if ongoing); "allergic to cold" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, Unknown dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "receiving Covid-19 booster"; FEELING COLD (non-serious), SKIN DISCOLORATION (non-serious), outcome "recovered" and all described as "bilateral chilling of the  hands with whitening of the skin and purple discoloration"; TEMPERATURE PERCEPTION TEST ABNORMAL (non-serious), outcome "recovered", described as "Patient measured temperature of hands at 93 degrees F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling cold, skin discoloration, temperature perception test abnormal. Additional information: About 12 hours after receiving Covid-19 booster patient experienced bilateral chilling of the hands with whitening of the skin and purple discoloration. This occurred after ice was applied to the injection site which was described as feeling like there was a bullet in the arm. Patient measured temperature of hands at 93 degrees F. After applying gloves and a heating pad the hands returned to normal about 2 hours later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few minutes after vaccination, developed headache, fatigue and chest heaviness radiating to her back.  ST depression noted on EKG.  911 called. Aspirin and oxygen administered.  Attended to by onsite RN and paramedic.  At ER, significant hypertentsion with SBP>200, ST changes.  Normal troponin, no ACS.  Was monitored, treated with Norco and later discharged home.
muscle weakness in her legs; oxygen level was low; could not get up or walk; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (oxygen level was low), GAIT DISTURBANCE (could not get up or walk) and MUSCULAR WEAKNESS (muscle weakness in her legs) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Mar-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen level was low) (seriousness criterion hospitalization) and GAIT DISTURBANCE (could not get up or walk) (seriousness criterion hospitalization). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness in her legs) (seriousness criterion hospitalization). The patient was hospitalized from 14-Mar-2021 to 17-Mar-2021 due to GAIT DISTURBANCE, MUSCULAR WEAKNESS and OXYGEN SATURATION DECREASED. The patient was treated with Rehabilitation therapy for Gait disturbance. At the time of the report, OXYGEN SATURATION DECREASED (oxygen level was low), GAIT DISTURBANCE (could not get up or walk) and MUSCULAR WEAKNESS (muscle weakness in her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood test: normal (normal) Normal. On 13-Mar-2021, Oxygen saturation: low (Low) Low.         No concomitant medications were reported.  The treatment information included oxygen for 2-3 days.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
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), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "prolapsed hemorrhoids" (unspecified if ongoing); "abnormal weight loss" (unspecified if ongoing); "Latex" (unspecified if ongoing), notes: know allergies: Latex; "adhesive" (unspecified if ongoing), notes: know allergies: adhesive; "tape" (unspecified if ongoing), notes: know allergies: tape; "landed flat in my back" (unspecified if ongoing), notes: Previous fall 4 months prior to injections and landed flat in my back. Concomitant medication(s) included: ESTRADIOL; SYNTHROID; PRAMIPEXOLE; DULOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), for COVID-19 Immunization.The following information was reported: ANOSMIA (non-serious) with onset 14Aug2020, outcome "recovered with sequelae", described as "No sense of smell"; CHEST PAIN (non-serious) with onset 10Dec2021 12:00, outcome "recovered with sequelae", described as "Left side chest pain between the sternum and left nipple"; DYSPNOEA (non-serious) with onset 10Dec2021 12:00, outcome "recovered with sequelae", described as "Sharp, hard to breathe"; PAIN (non-serious) with onset 10Dec2021 12:00, outcome "recovered with sequelae", described as "dull non stop irritating pain, left side exact same spot". The events "no sense of smell", "left side chest pain between the sternum and left nipple", "sharp, hard to breathe" and "dull non stop irritating pain, left side exact same spot" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia, chest pain, dyspnoea, pain.The lot number for bnt162b2 was not provided and will be requested during follow up.Additional information: Ae treatment: Chest X-ray, physician eval, Take Ibuprofen.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal (normal) Within normal limits.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Race: H   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Updated patient demographics
Swollen, red, tonsils covered in white spots, that hurt, especially when I swallow
Vaccine Administration Error - pt received pfizer bivalent booster earlier than 4 month interval recommendation  pt reported to pharmacist that last dose was 4-2022 (monovalent pfizer). Pharmacist verified with pt that this was their fist bivalent booster and they responded yes.   pharmacist was scanning consent form after patient left and pt got first bivalent booster at pharmacy.  reported error to pts pcp on 4-27-2023. spoke with md office contacted pt on 4-27-2023 and 4-28-2023 to inform them - no response
pt recvd vax 3PM 29JAN96;7AM on 30JAN pt was found in full cardiopulmonary arrest by mother;911 called;attempts to revise failed;pt DOA @ ER:
This spontaneous report was received from a nurse practitioner, via agency (Ref # 2015US011074), referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route of administration, lot # and expiration date were not provided). No concomitant medications were reported. On an unknown date, four days after vaccination, the patient experienced diffuse rash, fever and emesis. The outcome of diffuse rash, fever and emesis was unknown. The reporter did not assess the relationship between ZOSTAVAX and the events. No product quality complaint was involved. Additional information will be provided if available.
Within 30 minutes I experienced the worst hot flash ever, I had to go to the pharmacy to just make sure everything is okay. The same day I had diarrhea, fever, pain all over body.
Chills Fever 100.3 Body and Joint Pains Heartrate of 115 Irregular heartbeat
Initially, both eyes just itched. I found myself rubbing them a lot. So, I started using eyedrops, thinking it might be pollen. Around 3 days after the 2nd booster, I saw a red streak going across my right eyelid. within a week, the red line became more pronounced and a lump. I started using warm compresses (just like I had with Booster #1's reaction). But it just kept getting larger. The difference with this one is that the chalazion is on the outside of the Right Lid, versus after Booster #1, it was underneath my eyelid of the Left Lid.  The bump continues to enlarge, making it more and more difficult to see. Everything  blurs. I saw Dr. today; she went ahead and injected the chalazion with cortisone in the outside lid. We are hoping the injection will reduce the size of the lump, and perhaps it will begin to drain.
Guillan-Barre syndrome after Shingrix; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that she was diagnosed with Guillan-Barre syndrome after taking the Shingrix vaccine. The reporter did not consent to follow-up.
Vomiting, nausea - started 2hrs. after the shot. No treatment - did not see Dr. Still sick 48 hours later. Called Dr. Dr will give anti-nausea med on 10/28/11 if still needed.
right eye has like a broken vessel in it; Like a just one part closes to the nose is like bloody red; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the right deltoid on 01Oct2021 (Batch/Lot Number: FF8841) (at the age of 73-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included blood pressure abnormal and he had two stents in his heart. Concomitant medications included blood pressure medicine, and he takes blood thinner because he had two stents in his heart. The patient previously received the first dose of BNT162B2 on 21Jan2021 (Lot #: EL9261) and the second dose on 13Feb2021 (Lot #: EN6201); both received by the patient at the age of 72 years old for COVID-19 immunization. It was reported that on 01Oct2021, the reporter and the patient received the third COVID vaccination shot in the morning at the (pharmacy withheld) and in the evening, his right eye has like a broken vessel in it, like a just one part closes to the nose was like bloody red (as reported). The reporter further stated, "It's white part of his right eye from the color part over towards to the nose, now if you look that the white part of his eye towards his ear. It does not have the blood, it's more saline in the coroner and right under the lower lid, he could just regular saline eye drops (Treatment) in it you know they do like refresh or something like that he 'spell' that how many time, one time and it does seem to help some so." It was reported that the patient put eye drop in his eye called Blink tears lubricating eyedrops. The patient went to his primary care physician approximately two months ago (Aug2021) and had lab work (unknown results). The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient (age and gender not reported), who was vaccinated with an expired dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used because expiration date is listed as 24Jun2018 and PENTACEL was given today. It was also reported that the reporter would like to know what adverse events to look for and what expiration date should she follow on 24-Jun-2017 or should she assume the expiration date is the last day of the month. It was unknown if any adverse event was 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.
coughing; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0162; Expiration Date: Jul2021) via an unspecified route of administration on 19Apr2021 as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, he takes medication for a heart condition, but he has taken them for a long time. The patient concomitant medications were not reported. On 21Apr2021 the patient experienced coughing and fever. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Hard and enlarged red circle appeared at injection site 7 days after receiving vaccination.  Looks like a bug or mosquito bite.  Slightly painful if pushed, like pushing on a small bruise.  Slight itchiness around area of injection site.  No other side effects or adverse events at this time.
Vaccine was administered after the BUD of 2/18/23.- no symptoms reported at this time.
Hives all over body 1 hour after vaccine administration. No anaphylaxis.  Tx: oral loratadine.
Fever-3 days. Inability to raise or use injected arm-4 days. Incapacitating fatigue-2 days.
This spontaneous report as received from a consumer refers to a 56 year old female patient with allergic reaction and rheumatoid arthritis (ra). The patient's medical history included peripheral neuropathy. History drug included methotrexate, leflunomide, sulfathalidine and doxycycline. On 12-APR-2013 the patient was vaccinated with ZOSTAVAX, injection, 19400 PFU for Prevent shingles. Concomitant therapies included vitamin d and thyroid pills. On approximately 13-APR-2013 (one day after receiving the vaccination), the patient experienced injection site reaction. The patient did not seek medical attention. No treatment was given for event. On an unknown date the patient was recovered from the event (on therapy). Additional information has been requested.
Varicella - Information has been received from a registered nurse concerning a 7 year old caucasian female patient with an allergy to carbofed hyperactive and congestion including a stuffy nose.  r otitis media, and sore throat at the time of vacccination who on 09 Dec 1998 was vaccinated with a first dose of varicella virus vaccine live (lot 628243/1340H) sc in the left arm.  there were no concomitant medications.  On 22 May 2000 the patient developed 6-10 lesions but no fever.  The patient sought unspecified medical attention.  Follow up information from a registered nurse indicated that on 22 May 2000 the patient was diagnosed with varicella.  Subsequently the patient recovered.
3 hours after vaccine- sore arm 15 hours after vaccine, woke up with chills, fever of 101.3, and 1inx2in hive that was hard when palpated. 17 hours after vaccine, hive spread down arm, stiff and hard took benadryl, hive stopped spreading. cont benadryl q6 hours until fever broke at 330pm 2 days after vaccine. diarrhea and nausea started 1 day after vaccine and continues at day 3
I had ischemic stroke 2 days later. I was in the hospital for 4 days, I had to go to speech therapy. The doctor did a thrombectomy. I was out of work for 2 months and had to work part time.
Lymphadenopathy - onset about 24 hours post injection.  First - soreness and swelling of lymph node in left armpit that worsened over the course of approximately 12 to 24 hours and required ibuprofen.  Second - same soreness and swelling in lymph node at collar bone, onset approximately 10-12 hours after armpit.
Patient's mom called nurse advice line on 2/25/2008 and stated patient had a one inch, red, hard, swollen area on Left outer thigh.
Received his 1st dose of the Moderna vaccine on 3/3/2021 Lot # 002A21A PCP: Dr. (name)  Employee was alerted to the pt?s condition on 3/31/2021. Employee placed call for further information. On the same day of the vaccine the pt reported nausea and vertigo for about 7 days. Pt reports on day 4 his legs were hurting him. Day 10 his legs became weak and numb, day 17 pt reports losing all sensation in legs and losing sensation in his hands and arms. Trouble throwing a ball, using a toothbrush, etc. Pt went to the ED. Pt had a normal CT scan and MRI of brain and neck. Pt stated he recently started having some intermittent issues with swallowing, feeling like there was a lump in the back of his throat. Pt states his PCP is fully aware of all of his symptoms. Pt is scheduled to see a neurologist next week. Pt notes he experienced anaphylaxis to sulfa for the first time this past summer that required the use of an epi pen. Pt states he has a lung issue but otherwise is healthy. Pt reports no neurological symptoms prior to the vaccine.  Patient was advised to continue to monitor his symptoms and keep his PCP up to date. Discussed precautions in great detail. Pt does not feel like he needs to seek emergency care again at this time.
Patient reports twitching starting the next day.  She states has continued since the shot.  Occurs 2-3 times a day for about 5-15 seconds.  Occurs all over diff areas of the body (legs, arms & neck mostly
First dose at 12:15pm  arrived observation, at 12:20pm c/o feeling unwell, nausea, felt anxious, appeared pale and diaphoretic.   Patient place in WC, placed in supine position in Med Eval area, drank water.  Patient recovered well, BP 110/78, P 82, R 20.  Left with husband clinically well.  Likely vasovagal reaction without syncope.  CSyta NP
fever, chills: aching bones, exhaustion;dizzy, earache;went to bed;drank fluids & took Bufferin;lasted through 3DEC tired very quickly during past week;
Patient received flu vaccination in office at office visit. That night her arm started bruising and very painful. Bruising was from injection site down to elbow. Patient is currently on COUMADIN. INR that day was 3.4.
After vaccines (04 10 07) the baby had 1 seizure. Then on 06-05-07, the patient had 4 episodes of Grand Mal. Follow up by a pediatric neurologist - treatment not started yet.
12/19/2020  in the evening Started with  frequent flatus . Then stomach cramps early in the morning of Sunday 12/20/2020  at 4am following with diarrhea.  Took Imodium 2 tablet after first loose stool. Then  another 1 tablet  with the second loose stool.  Diarrhea continues intermittently. Took another anti-diarrheal medication: Pepto-Bismol Liquid form.  Since then diarrhea slowed down.
2-3 days following 2nd dose of Moderna, (I)/patient complained of muscle aches in major muscles all over body (arms/legs/chest). These were localized to one spot in the muscle and not soreness overall.  The pain would pulsate and relax and was maybe a 2-3 out 10 scale.  At worst maybe a 5.  Enough to notice it for sure. This lasted for about a week.  Same pain returned a few days later and similarly went away.  A few days following that,  similar but different pain returned and localized to abdomen and ribcage largely.  From there, the pain continued and was/is present in numerous areas of the body (abdomen, legs, arms, chest, back).  Pain is both muscular in feeling but also feeling "under skin" in some ways.  Pain is better with sleep and increasingly worse during the day.    I have never felt like this before, even with rheumatoid arthritis which has been solely impacting hands.
Information has been received from a physician concerning a 71 year old female with no pertinent medical history and no drug reactions/allergies who in May 2008, was vaccinated with VARIVAX vaccine (Oka/Merck) instead of vaccination of ZOSTAVAX vaccine (Oka/Merck) because the person administering the vaccine confused the VARIVAX vaccine (Oka/Merck) with ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included LEXAPRE. The patient had no adverse event reported. No lab or diagnostic studies were performed. It was reported that the patient sought unspecified medical attention. Further information has been requested