chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Registered Nurse referring to unspecified patients of unknown age or gender. Information about medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patients were vaccinated with 5 doses of VARIVAX (dose, route and anatomical location were not informed) (Lot No. reported as L019454, exp date: 29-MAY-2017), which were exposed to temperature conditions below since 16-OCT-2015 until 17-FEB-2016. The storage temperature was between 2 degrees C and 8 degrees C. No previous temperature excursion was reported. Reporter was not aware of any adverse effect. Additional information has been requested.
Headache, Fever, Lethargy also/all symptoms resolved 02/6/2021 Narrative:
So, with the 100 + fever, that was the more severe side effect. it lasted for 5 days. I was in bed with low energy just like having the flu. Not able to do much because I felt so poorly due to the fever. I was out of work for 5 days. I also had soreness and redness. Also, the fever was still elevated even after taking the medication-TYLENOL. With the booster, I experienced hair loss. Still experiencing the issue now. A bit of thinning on my head and thinning of my eye lashes.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            Concomitant product record was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
strong tingling sensation in left leg; also had nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 11:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and radiographic stroke since an unspecified dates. The patient did not have any allergies to food, medications, or other products. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), statins (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN) for an unknown indications since an unspecified dates within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 15:00, the patient had strong tingling sensation in her left leg for about two hours. It felt like the patient had sat on her leg and it "went to sleep" - but she had not. The patient also had nausea. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events strong tingling sensation in left leg was resolved on 17Mar2021 at 17:00, whereas the event nausea resolved on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a health professional concerning an approximately 13 month old pt who on 08/28/2001 was vaccinated with one dose of varicella vaccine administered in the left. Concomitant therapy included one dose of Prevnar administered in the same leg. On an unspecified date, in approximately August 2001, the pt developed a local reaction of a knot on the leg and a non-tender pustule. It was noted that no prescription drug treatment was needed. Subsequently, the pt recovered. Additional info has been requested.
Information has been received from a physician concerning a female (demographics not provided), who on unspecified dates was vaccinated with first and second doses, respectively, of GARDASIL vaccine (yeast)(Lot #s not provided). It was reported that post vaccination of the second dose of GARDASIL vaccine (yeast) the patient fainted and "almost went into seizure". At the time of this report the outcome was unknown. No further information was provided. Additional information has been requested.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 70-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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved. For mRNA-1273 (MODERNA COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided.
Starting on April 6th, itchy hives starting under my right arm, then under my left arm; within 24 hours it had spread to both elbows and then traveled down my right forearm.  Under a nurse?s advice, I have been using topical cortisone cream and taking an antihistamine (benedryl) as needed.  The first area that the hives showed up in has started to clear up but the hives in the main sections are still red and itchy.  A few other small hives have popped up within the last two days.
Arm swelling from elbow to shoulder in L/arm where shot given. Arm very hot & firm in effected area. Dizziness when lying down. Upset stomach after eating. Rx: KEFLEX. Effects subsided on 1/15/00.
tired for a day or two; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EN6207) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "traumatic brain injury" (ongoing), notes: Verbatim: traumatic brain injury; "migraine" (ongoing), notes: Verbatim: migraines., uses compressed O2 for her cluster migraines.; "small concussion", start date: 2016 (unspecified if ongoing), notes: Major events 2003, 2005, 2011, minor one in 2016-small concussion. The patient's concomitant medications were not reported. Past drug history included: Flu vaccine , start date: Nov2020, stop date: Nov2020. The following information was reported: FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "tired for a day or two".  Additional information: When probing suspect product information, she reports she received both her Covid 19 vaccines in her left arm. She reports with the first dose she hardly noticed any symptoms. She was maybe tired for a day or two with the first dose. She experienced no problems with her arm. Second Covid 19 vaccine given on 20Apr2021 in the left arm, Lot# EW0162, NDC/Expiry not known. When probing medical history she reports she has a history of traumatic brain injury. She's had major events from this in 2003, 2005, and 2011. She had a minor event in 2016, a small concussion. She does report she uses compressed O2 for her cluster migraines. She reports she received the flu vaccine in Nov2020 because she thought if she got the flu vaccine then if she got the Covid 19 virus, the Covid 19 virus wouldn't be so bad. Prior Vaccinations (within 4 weeks) :no. AE(s) following prior vaccinations: no. Relevant Tests: No  No follow-up attempts are possible. No further information was expected.
Sore throat; Muscle aches; Joint pain; Febrile; Swollen lymph node in armpit; Cough; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Mar2021 at 15:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to penicillin, ibuprofen, bactrim and propofol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 16:30, after 1485 minutes of the vaccination, the patient experienced sore throat, muscle aches, joint pain, febrile, swollen lymph node in armpit of arm shot was given in and cough. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore throat, muscle aches, joint pain, febrile, swollen lymph node in armpit and cough was resolved on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain, inflammation, redness, heat in upper left arm. Pt went to after hours doctor.
fever, diarrhea, no appetite, vomiting, weight loss, dizziness, chills
"Hi I believe I read they want to track side effects of the vaccination for Shingles. 14 hours after I received the vaccination I awoke with fever and teeth chattering chills that lasted throughout the night. I took acetaminophen that helped reduce the fever. Tuesday I was not feeling quite right, but no more fever. I also have a 2 inch welt on my arm that's slowly improving. No need to reply, just sharing my experience post vaccination."
Heartache pain; Ocular migraine; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heartache pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Heartache pain) (seriousness criterion medically significant) and OPHTHALMIC MIGRAINE (Ocular migraine). At the time of the report, ANGINA PECTORIS (Heartache pain) and OPHTHALMIC MIGRAINE (Ocular migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details not provided.  Patient developed heart ache pain for 2 weeks and ocular migraine which the patient never had before in her life.  Treatment details not provided.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling, tenderness and sweing of the lymph nodes on the injection side Narrative:
he became somewhat like disorientated; Restless; He did not feel well; Nauseous; he was hot, he was cold and really disorientated; temperature was low; blood pressure was a little low; urinating quite frequently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid 19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: DISORIENTATION (non-serious) with onset 01Jan2022, outcome "unknown", described as "he became somewhat like disorientated"; RESTLESSNESS (non-serious) with onset 01Jan2022, outcome "unknown", described as "Restless"; MALAISE (non-serious) with onset 01Jan2022, outcome "unknown", described as "He did not feel well"; NAUSEA (non-serious) with onset 01Jan2022, outcome "unknown", described as "Nauseous"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 01Jan2022, outcome "unknown", described as "he was hot, he was cold and really disorientated"; BODY TEMPERATURE DECREASED (non-serious) with onset 01Jan2022, outcome "unknown", described as "temperature was low"; HYPOTENSION (non-serious) with onset 01Jan2022, outcome "unknown", described as "blood pressure was a little low"; POLLAKIURIA (non-serious) with onset 01Jan2022, outcome "unknown", described as "urinating quite frequently". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information; Concern: Reporter stated, "My husband received the booster yesterday afternoon around 2 O' clock at the, last night it was about 1 O'clock The patient became somewhat like disorientated, restless, he did not feel well, nauseous. The patient called EMS because the patient was hot, cold and really disorientated. The patient came to the house and his vital signs, his temperature was low and his blood pressure was a little low but they said, the patient did not need to go to the hospital. The patient had more water. The patient uses the bathroom not diarrhea but urinating quite frequently. Further probing could not be initiated as reporter hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 DAYS AFTER VACCINES PT DEVELOPED MILD URTICARIA TO CHIN AREA AS WELL AS MILD SWELLING TO UPPER EARS; NO RESPIRATORY DISTRESS NOTED.
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck  Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness.  Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night,  nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma  I have not been able to work since 01/08/2021
Information has been received from a licensed practical nurse concerning a child between the age of 4-6 years who in first week of May 2007 was vaccinated SC with second dose of Proquad (Lot # 657262/0295U). It was reported that within 5 minutes to 12 hours after vaccination, the patient developed swelling, redness and warmth at injection site. The child was treated with KEFLEX. At the time of report the patient recovering. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Patient developed chest pains, shortness of breath with tingling to her extremities about one hour after injection. Seen at ER, diagnosed with panic attack.
had a sore arm for about 48 hours; fuzziness that started which eventually went into fatigue; fuzziness that started which eventually went into fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 12:00 (Lot number: EN6199) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6201, Vaccine administration time: 14:00 pm, Anatomical location: Right arm), administration date: 14Feb2021, when the patient was 73 years old, for COVID-19 immunization, reaction(s): "sore arm", "heavy chills". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Mar2021, outcome "recovered" (10Mar2021), described as "had a sore arm for about 48 hours"; FEELING ABNORMAL (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), FATIGUE (non-serious) with onset Mar2021, outcome "not recovered" and all described as "fuzziness that started which eventually went into fatigue". Therapeutic measures were not taken as a result of pain in extremity, feeling abnormal, fatigue.  Additional information: The patient did not have any family medical history relevant to the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose on 08Mar2021 and had a sore arm for about 48 hours and fuzziness that started which eventually went into fatigue which he thought was something normal but it got heavier to the point that to make coffee in morning it was tough and to do anything during day he could only sit and stated taking 2 to 3 naps a day for over a hour a piece. Fuzziness ended a couple of weeks after but was not enough that he started wondering what the heck was happening until the fatigue kicked in at the end of March. The adverse events did not require a visit to Emergency Room or Physician Office.  No follow-up attempts are possible. No further information is expected.
flu; Product supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of flu in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis.   On 17th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced flu and product supply issue. On an unknown date, the outcome of the flu and product supply issue were unknown.   It was unknown if the reporter considered the flu to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd Shingrix dose. The pharmacist reported that she had a patient who had not been able to get the 2nd Shingrix dose due to availability and health issues.  The patient inquired if she would get the 2nd dose or she would need to restart. The pharmacist probed further to see what health issues the patient had, and the patient confirmed that she had multiple sclerosis, but had it prior to receiving the vaccine.  The pharmacist stated that the patient contracted the flu sometime during the winter after receiving the vaccine.  It was unknown whether the two (multiple sclerosis and flu) were related. The pharmacist preferred not to leave the patient's initials.
pt states pain, heat, swelling & redness started 1MAR97;arm swelled to size of a grapefruit during the noc;heat only was relieved temp w/APAP;swelling started going down later 2MAR97;arm remains red & warm to touch w/swelling & knot 2
Pt fainted, fell off his chair onto the floor where he was convulsing. He then regained consciousness shortly after. Sweaty, clammy, pale, did not remember what happened. Asked "what happened?". 911 was called, the paramedics came. Took vitals. They administered IV fluids and wheeled him out on a gurney in a neck brace.
warm at injection site; itchy at injection site; Arm at injection site is red; Swelling at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE ERYTHEMA (Arm at injection site is red), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE ERYTHEMA (Arm at injection site is red), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (itchy at injection site). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE ERYTHEMA (Arm at injection site is red), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed with "Nethyl Prednisolone" 4 mg for her hip. Treatment medication was not reported.
Patient passed out in dad's arms. Once conscious, sucker and ice pack given. Patient was able to identify parents and walked steady before release.
Case number PHEH2015US000688, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 49 years old male patient. Medical history and concomitant medications were not reported. On 31 Oct 2014, the patient received FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLUVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed as non-serious. No adverse event was reported following this medication error.
6/7/2023 - 6/9/2023 (2 days) Presented to the hospital after experiencing neurologic symptoms such as diplopia and difficulty speaking.  She also had chest discomfort concerning for acute coronary syndrome  EW0153 4/6/2021 EN6208 4/27/2021 330308D 11/29/2021 FM0173 6/4/2022