chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 5 minutes after receiving Pfizer COVID  vaccination, patient stated that she felt "drugged" and that she was having shortness of breath. Pharmacist began to observe patient for signs of anaphylaxis. After not seeing any, pharmacist alerted the patient that she would be calling the ambulance for further observation. Pharmacist checked patient's pulse which didn't reveal any concern. EMT arrived and checked patient's oxygen saturation which was 100%, BP and heart rate was normal. Patient was nervous about receiving the vaccine and didn't require any further treatment at the site. Patient was able to return home with her son and stated that she was feeling better.
Muscle break down; Loss of strength; Easy fatigue-ability of the muscles; A spontaneous report  was received from a Healthcare Professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of strength, muscle break down, easy fatigue-ability of the muscles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, after the first dose of mRNA-1273  patient experienced loss of strength, muscle break down, easy fatigue-ability of the muscles.  Treatment details received for the event was not provided Action taken with mRNA-1273 in response to the events was not reported.   The events, outcome of events include loss of strength, muscle break down, mild rhabdo, easy fatigue-ability of the muscles was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
A little bit spilled on her arm, once needle removed from her arm.; Has injection site pain but no side effects; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration dates were not reported) via an unspecified route of administration  on unspecified date at 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration dates were not reported) via an unspecified route of administration , on an unspecified date as 1st dose, single dose for Covid-19 immunization and experienced injection site pain. On an unspecified date, It was reported that patient was concerned that she did not get proper dose of vaccine because she did not have side effects after getting second dose of vaccine on the day of report (today). A little bit spilled on her arm once needle removed from her arm and she had no side effects at that time other than patient has had injection site pain. Patient declined to speak with safety. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient had blood sugar drop to 32 within 1.5hours of receiving vaccine: he has been diabetic for 30 years, so knows how to control his sugar
This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot # L041627 with expiration date: 20-APR-2017, therapy type rHA). The temperature excursion (-14 Celsius degrees) lasted 56 hours. There was also a previous temperature excursion which lasted 2 hours and 48 minutes (captured in MARRS# 1602USA006365). No adverse effects were reported. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
1:30pm Slight Headache started and slowly got worse 2:30pm Muscle Aches started. Especially in my lower back. 3:00pmTook temperature-100 There is no swelling on my arm, just a little achey Took 2 xtra strength Acetaminophen @3:30pm 500 mg each It is now 4:30 and I still feel symptoms but they are not as bad.
was stored in the refrigerator instead of the freezer since 01DEC2020 and has since then been administered to patients; It was also administered concomitantly with VARlVAX / intended to give MMRII but instead administered PROQUAD; intended to give MMRII but instead administered PROQUAD; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-DEC-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer. It experienced the temperature excursion of 44 degrees Fahrenheit for 1506 hours. There was no previous temperature excursion. The digital data logger was not involved. On an unknown date (reported as since then), the patient was administered with the incorrectly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter, lot # T025221, expiration date 19-JAN-2022 (route of administration was not reported) for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Additionally, on the same day, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
out of 188 injects: 1 w/palpable, visible swelling & extreme soreness; 1 w/palpable, visible swelling, extreme soreness & t102; 1 w/t102, h/a, nausea & stomach cramps; 6 w/extreme soreness;
February 12 stareted developing a strong headache,  numbness and tingling in arms and feet than it progressed to weakness on arms and legs in the next couple of days  Got diagnosed with Guillain-Barre syndrome and was hospitalized form February 16 to February 23. Received 7 treatments of IVIG and am now recovering
I have had throbbing, chronic pain in my skull for the past 2 days, in an area where I had a previous injury and scar tissue (10 years ago).  It has been dormant and painless for the past 8 years.  I believe there is a connection between the MRNA protein and my pain. I got my FIRST PFIZER SHOT on Tuesday April 20.
URI w/cough x 2 wk p/vax;chickenpox rxn in rt thigh in area of vax;
COVID breakthrough- Per patient, symptom onset 12/29/21. Came to the ED on 1/4/22 with SOB, cough, fatigue.
Red, swelling, hive light reaction localized at injection site, fatigue, sweaty, incoherent at times, lightheadedness. Started this AM, 24 hours, place ice pack locally on injection site, patient being sent to the emergency room.
returned home from work due to fatigue - 27 Feb 2021; warmth at injection site- - night of 26 Feb 2021; knot on injection site size of tennis ball - night of 26 Feb 2021; redness at injection site- night of 26 Feb 2021; low grade fever 99.7F- evening of 25 Feb 2021, fever of 101.0F - night of 26 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site- - night of 26 Feb 2021), VACCINATION SITE MASS (knot on injection site size of tennis ball - night of 26 Feb 2021), VACCINATION SITE ERYTHEMA (redness at injection site- night of 26 Feb 2021), PYREXIA (low grade fever 99.7F- evening of 25 Feb 2021, fever of 101.0F - night of 26 Feb 2021) and FATIGUE (returned home from work due to fatigue - 27 Feb 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (low grade fever 99.7F- evening of 25 Feb 2021, fever of 101.0F - night of 26 Feb 2021). On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site- - night of 26 Feb 2021), VACCINATION SITE MASS (knot on injection site size of tennis ball - night of 26 Feb 2021) and VACCINATION SITE ERYTHEMA (redness at injection site- night of 26 Feb 2021). On 27-Feb-2021, the patient experienced FATIGUE (returned home from work due to fatigue - 27 Feb 2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warmth at injection site- - night of 26 Feb 2021), VACCINATION SITE MASS (knot on injection site size of tennis ball - night of 26 Feb 2021), VACCINATION SITE ERYTHEMA (redness at injection site- night of 26 Feb 2021), PYREXIA (low grade fever 99.7F- evening of 25 Feb 2021, fever of 101.0F - night of 26 Feb 2021) and FATIGUE (returned home from work due to fatigue - 27 Feb 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 99.7 (High) Body temperature was 99.7 degree Fahrenheit. On 26-Feb-2021, Body temperature: 101 (High) Body temperature was 101 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
an expired dose of Daptacel administered to 18 month old; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old patient (gender not reported) who was vaccinated with a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Exp. Date 15-May-2019) via unknown route and administration site on 30-May-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post 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.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report as received from a physician refers to unknown number of patients of unknown age. On an unknown date the unknown number of patients vaccinated the third dose later than recommended in the prescribing information for GARDASIL (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This case was reported by a healthcare professional (nurse) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX Quadrivalent (unknown details). In 2014, within weeks of vaccination with FLUARIX Quadrivalent, the subject experienced arm pain at injection site, inflammation of arm at injection site, and injection site pain radiated to rotation cuff of shoulder. This case was associated with a product complaint as the "doctor's office wanted feedback on this specific lot number" regarding other "reports of people experiencing adverse events from this lot number." The subject had received flu shots in the past with no reactions. Per the nurse, the subject "had flu shots for years and never had trouble before." Per the nurse, "after 2 weeks" after receiving FLUARIX Quadrivalent, the subject reported that they are "still experiencing inflammation and pain in the arm it was given. The patient radiates up in to their shoulder." At the time of reporting the events were unresolved. Per the nurse, "after 2 weeks" the subject reported that they are "still experiencing" the events. The nurse reported 2 other cases with FLUARIX Quadrivalent. See A1050672A and A1050680A for details on the other cases. According to product complaint investigation results reported by GSK quality assurance on 13 December 2013, the product complaint was assessed to be unsubstantiated.
Everything Tasted Or Smelled The Same and just now is things starting to taste or smell properly but only have a immediate Taste or Smell as it was when everything Tasted & Smelled the same
Almost immediately after vaccination patient started feeling poorly. Lightheaded, dizzy, "just felt weird".   Able to drive home but continued to worsen, looking back should not have driven but was not thinking clearly.   Feeling terrible once home, throwing up violently,  Within an hour of injection started hallucenating, making strange uncontollable noises, "lost touch with reality", reports not being able to move.   Wife called 911 and they arrived within 15-20 minutes. Wife reported to EMS that patient had just been vaccinated. EMS administered epinephrine and IV Benadryl.  Transported patient to hospital
pt recv vax JUN94 & 17OCT94 pt was pricked by a needle from a dialysis pt;a blood sample was collected on 17OCT94 & was test on 18OCT94;lab eval revealed anti-HBc positive;antibody for australian antigen positive,HBsAg negative
A 15 year old patient received the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient received the moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient received the moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient received the moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   Reporter did not allow further contact.
6 hours after vaccine developed itchy rash/hives on both arms and chest. No dyspnea or other sign of significant anaphylaxis. Resolved with Benadryl
24 hours after the vaccine I had  uncontrollable chills, fever, headache,  body aches, fatigue, burning eyes and runny nose. The next day  Friday was better but still body aches and a slight headache.  My injection sight started turning red and the red rash moved down my arm. Still tired but better, symptoms letting up.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: extremely hot but temp was not taken during event-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Mild, Additional Details: Patient warned of probable fainting.  He fainted after his flu shot.  He was fine immediately after shot then 6-7 minutes later patient passet out leaning against his father.  Within 10 seconds patient began to seize (arched bac and arms and legs drew up.  This lastes only a few seconds and patient was immediately able to speak coherently but stated he was very light headed.  Patient was very warm.  He was given bottle of cold water and an ice pack which was placed on his neck.  ems declined
immediately after injection: CDC grade 3 effects -- myalgia, fatigue, headache, shivering, fever (no GI upset) -- begin, last ~3 days Jan 29-30, 2019: flu-like symptoms -- myalgia, fatigue, headache, shivering, fever; last ~2 days Feb. 22: second Shingrix dose;  CDC grade 3 effects as after first injection begin immediately after injection, last ~3 days March 28: awake with moderate to severe pain at base of neck and at lower back and waist, worsening and radiating over next few days; pain persists through July 1 [see below] April 1: blood work shows slightly elevated CRP (1.3; < 1.0 optimal); Cervical and lumbar x-rays show findings, but Drs. consider them unrelated to reported pain  April 23: myalgia, fatigue, headache, shivering, fever; lasts ~2 days May 1: labs show mildly elevated sed rate (27; 0-20 normal) and CRP (6.4; 0.0-5.0 normal) and significant presence of anticardiolipin AB IgM (31; 0-10 normal; 11-13 equivocal) About May 13: myalgia, fatigue, headache, shivering, low body temp (96.5); lasts 1 day June 12: myalgia, fatigue, headache, shivering, fever (101.0); lasts 1 day June 27: lab work shows sed rate just normal (19; 0-20 normal) normal CRP (7.6; ref. range 0-8.0) [different lab used from May 1, hence different ranges], presence of Phosphatidylserine AB IgM (41; > 35 positive), cardiolipin AB IgG (20; 12-20 indeterminate, 21-80 low to moderate positive), and cardiolipin AB IgM (16; 12-20 indeterminate, 21-80 low to moderate positive): Rheumatologist's working diagnoses is (mild) polymyalgia rheumatica (PMR), prescribes 20mg/day prednisone July 1: pain gone; remains so through present July 10: prednisone reduced to 17.5 mg/day  Symptom monitoring and lab work will continue with goal to tapering prednisone to 0 as labs indicate and symptoms allow  Related note: Lab tests done 12/21/05 (at time of SMA embolectomy): Antibody screen:negative; Cardiolipin AB IgM negative (4.0; neg. < 10.0);                           Cardiolipin AB IgG negative (<4.0; neg. < 10.0)      Query doctors could not answer: Could Shingrex have precipitated immune reaction that lead to the monthly flu-like symptoms and the presumed PMR?
Erythema, 2" red circle at injection site with white 3.5" white circle, hardness of area, itching at site. 10:p.m. itching of both arms & thighs. Benadryl 25 mg taken with resolution.
severe itching; has a severe rash under her armpits and went on for a day or so; swollen lymph nodes; had the, one injection on March the 12th/they can give me you kow, some further information and with I can get the second shot; This is a spontaneous report from contactable consumer (patient). A 77-year-old female patient received BNT162B2 (Pfizer-BionTech Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 12Mar2021 as dose 1, single and supposedly received her second dose of BNT162B2 (Pfizer-BionTech Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on April2021 for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced on an unspecified date in 2021, severe itching, she mentioned that they may be related to lymph nodes. She never saw the swollen lymph nodes. The night of the injection at 2:30 in the afternoon and about 1:30 at night she had a severe rash under her armpits and went on for a day or so. She wanted to know how long these symptoms would last? Is it okay to take the second shot? She also wanted to know if she could have the second dose longer than 3 weeks & 6 weeks after the first dose? She wanted to know if the antibody testing would determine if she had developed antibodies from the vaccine. If the antibodies that she has would be enough not to get the second dose of the vaccine. How long would she get antibodies after getting the dose? The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
This initial spontaneous report was received on 03-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 04-JUN-2013, at a pharmacy, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract the varicella virus and a host of painful and life-altering complications. On or about 14-MAY-2015, the female patient began treatment with a physician at a medical practice, for painful burning, swelling and tingling in her feet and legs, which was diagnosed as severe peripheral neuropathy, secondary to varicella zoster infection (shingles). Peripheral neuropathy is a chronic condition of permanent damage to the peripheral nervous system that can affect and impair every part of the body, including causing internal organs to fail. Peripheral neuropathy also causes abnormal sensitivity, or lack of sensation that results in excruciating burning and pain. The patient has been prescribed valacyclovir (VALTREX) and gabapentin in continued and incrementally increased dosages for management of her ongoing symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was not resolved.  The lawyer felt the events were related to ZOSTAVAX. Upon internal review, diagnosed as severe peripheral neuropathy, secondary to varicella zoster infection (shingles) were determined to be disabling. Additional information has been requested.
Presented to ED w/cough x 1 month; recently dc'd x 1 wk from hospitalization for pna; admitted w/COVID pna; tx w/abx, remdesivir, steroids, zinc; pt did not require O2 therapy; DC to home in stable condition.
Patient received the covid-19 vaccine instead of shingrix.  He had already gotten his covid-19 shots 2 months ago according to the patient.  This was his third covid-19 shot.  He went ahead and got the shingrix vaccine shortly afterward the same day once he was aware of the mistake.  The patient has not experienced any adverse events so far.
I received the covid vaccine and my arm is extremely red swollen hot to the touch and feels like a big knot . hard to move with out pain . I am taking ibuprofen every 6 hours . and did anticipate some soreness but this is a bit much . I do get flu shot every year
patient is dead but doesn't confirm if this was related to a Pfizer medication.; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 37-year old female patient received bnt162b2, via an unspecified route of administration on an unspecified date at age of 37-year old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported the patient was dead but doesn't confirm if this was related to a Pfizer medication. The patient died on an unspecified date. The event was fatal. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: patient is dead but doesn't confirm if this was related to a Pfizer medication