chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; dizzy/dizziness/lightheaded; chills; he is warm all of a sudden; a history of vertigo, so he thought he was having a vertigo attack; super sick on the 8th after his second dose; Fever; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 07Jan2021 at single dose on the left arm for COVID-19 immunization. Medical history included vertigo from Aug2019. There were no concomitant medications. The patient received the vaccine through the facility where he works (not a military facility). Patient received his first dose on 17Dec2020 (lot number: EL0140). Patient said that the symptoms started Monday, he was super sick Friday after first dose. Patient clarified to super sick on 08Jan2021 after his second dose. On 08Jan2021 after his second dose, patient had a fever of unknown temperature which he slept through it. He was tired the whole day on Monday (11Jan2021) and really dizzy and had chills from then to now, which is not stopping, he means the dizziness is not better, the chills come and go. He clarifies that he did take Tylenol to treat the fever and the next day he had no fever. He says that the dizzy, he still has it. Patient took 500mg once by mouth of the Tylenol. Patient stated that he also has a history of vertigo, so he thought he was having a vertigo attack, but he took his medicine and it did not help him. Patient stated that these were not serious for him, he just feels dizzy and lightheaded. He has no loss of balance. The patient reported that he had both doses of the COVID vaccine on the left arm. Patient had the second dose on 07Jan2021, and until now he has been dizzy, it started 3 days ago (11Jan2021), he has had chills and then after he was warm all of a sudden, he was concerned. Patient has had no new medications or other vaccinations recently. He last saw his doctor six months ago and he plans to see her tomorrow (15Jan2021). The events were assessed as non-serious by the reporter. Outcome of the event dizzy/dizziness vertigo attack, and chills was not recovered (ongoing), for fever was recovered on 09Jan2021 while for other events was unknown.
Sinus infection on 12/24/04- I subsequently began having back pain with tingling in arms (hands) and feet. The tingling is new in my legs- have had spasm, burning and joint pain throughout my hands/feet/back and other parts of my body- have never had these symptoms till I received flu shot.
normal adverse reaction to moderna--mild fever and chills,,mild headache,sore arm,some nausea...but developed a rash from day after shot-Saturday into sunday and Monday...allergic reaction rash over both arms and upper torso,,some itching..somewhat raised red rash similar to an antibiotic allergic reaction...breathing ok,,,no swelling in lips or lungs,,.
Suspected vaccination failure; had shingles, under left breast and back; Feel the pain/pain from my left side of my body till half of my back; blister under my left breast/noticed also at my back; sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had when was young).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had shingles, under left breast and back), pain (Verbatim: Feel the pain/pain from my left side of my body till half of my back), blister (Verbatim: blister under my left breast/noticed also at my back) and sickness (Verbatim: sickness). The outcome of the vaccination failure was unknown and the outcome of the shingles, blister and sickness were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister and sickness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, blister and sickness to be related to Shingles vaccine.   Additional Information: Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient's current condition was worse than chicken pox that the patient had when the patient was still young.  The patient never thought that they would experience it till yesterday since the patient had a shot for Shingles.  The patient went to urgent care because of the blister under their left breast and also noticed the blisters at back but the patient could not see it.  The patient felt the pain as if squeezing the left part of the patient's upper part and was not able to take the pain, as it was so worse.  The doctor looked at the blister and told that the patient had shingles.  The patient informed the doctor that he/she had a shot, so the doctor informed that there was no guarantee that they would not have it.  The doctor said, it was good that the patient had a shot because the situation would had been much worse if they did not have it.  On 06-March-2023, the patient began taking the tablet that the doctor had prescribed to take for a week, but the patient was still having pain from left side of the body till half of back. The patient was praying and hoping for everyone's survival during this kind of sickness. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting
Had vaccine on Thurs afternoon. Got up Fri morn to brush teeth, felt dizzy, things started looking blurry like I was going to faint. Very nauseous, had to sit on bathroom floor as felt I needed to vomit, plus I felt very weak.  Did not vomit, but stayed seated on bathroom floor . After 45 minutes I went into living room, stayed on couch and slept off and on all day. Ate very little, no appetite. Nausea feeling went away later in afternoon. Ate lightly, toast, soup. No fever but felt sick for a couple of days, very tired. Sat and Sun my legs were achy, took tylenol. Monday I felt myself.
Patient reported vaccine was given through outside source - not through vaccination facility   ACUTE RESPIRATORY FAILURE 10/2/2021 AMYLOIDOSIS, UNSPECIFIED
pt recvd vax 20JAN94 & the following day pt devel a severe local react w/ a 6 x 6 inch swollen, erythematous area on the injected arm; pt was seen by MD & treated w/DPH & cold compresses;
This spontaneous report was received from an unspecified source in a website via company representative, and refers to an adult female patient of unknown age (reported as "55 to 64 years old"). Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unspecified date in January 2012, the patient was vaccinated with a dose of ZOSTAVAX Injection, for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date were not reported). The reporter informed that on an unspecified date in 2012, 24 hours after being vaccinated, the patient experienced joint pain and flu-like symptoms. The patient sought medical attention, and received an unspecified treatment. The outcome of the events, and their relationship with the vaccination with ZOSTAVAX were not provided by the reporter.
Chills, fever, headache, nauseous, vomiting, shakiness, stomach pain
Within 15 minutes, patient reported severe nausea. The clinic then relocated the patient from the waiting room back to an exam room where they decided it was a good idea to place an alcohol wipe on her nose claiming it would distract her. It did nothing of use.  The next morning the patient woke up feeling itching all over her body followed that evening by all over pain.  Two days later, the patient was having her ears and throat checked by an ENT who reported her face and neck had an eczema reaction happening.  By that evening, the patient observed that her face had become splotchy, red, and swollen in places. The patient contacted her allergist?s office with some photos of the reaction in progress after which point they had her come in that Friday after the vaccine for a serum tryptase level check. It was at her highest ever.
Presented to ED w/SOB; admitted w/acute resp failure d/t COVID-19 pna; tx w/abx, remdesivir, O2, steroids, zinc; dc'd home w/O2.
Administered adult Td o.5cc instead of pediatric DTaP in right deltoid. County Health Department called. Advised that student get a temporary medical waiver from physician to enter school conditionally and get DTaP in 6 months. parents called. Given information.
Myalgia, Fever, SWOLLEN LEFT CLAVICLE LYMPH NODE Narrative:
Headache, Myalgia, Arthralgia, Fever, CoughWheeze,  fatigue Narrative
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 29-AUG-2013 (lot and expiration date not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Rash on back & muscle spasms. Hydroxyzine pamoate 25mg. Methylprednisolone acetate 80mg/ml office admin.
Long-term chronic nausea, chronic abdominal pain, face rash, anxiety, fatigue, depression, weight loss, loss of appetite, tremors, foaming of mouth...required visits to 3 different doctors with numerous prescription medications ordered with no relief. Additional medical records received 10/8/09 Dates of Service 8/4/08 to 9/2/09.  Assessment:  Contact pruritus, dermatitis, cellulitis, local infection, pyelonephritis, UTI, Influenza with other respiratory manifestations.  Assessment:  Presented on 8/4/08 with small red lesions on the left inner buttocks, diagnosed with pruritus, contact dermatitis and cellulitis.  On 11/15/08 presented with rash and itching of right inner buttocks;  diagnosed with cellulitis and a local infection.  6/17/09, presented with fever, lethargy, chills, lower abdominal pressure, and increased urination;  diagnosed with pyelonephritis.  Follow up on 6/19/09 c/o nightsweats, right lower quadrant abdominal tenderness; diagnosed with UTI.  Seen on 9/2/09 for cough, rhinitis, pharyngitis, fever, diarrhea, body aches and chills; diagnosed with influenza with other respiratory manifestations.  Presecibed Tamuflu.
2 year old with fever which developed within a few hours of vaccine. The next day, he developed swollen and red left arm. It was firm and tender. Continued fever X 8 days. On day 7, he developed blanching, red, maculopapular rash with coalescence on face.
This is a spontaneous report received from a contactable consumer. A contactable consumer (wife) reported for an 83-year-old male patient (husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 11Mar2021 through unspecified route of administration single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. he patient historical vaccine included first dose BNT162B2 through unspecified route of administration single dose for COVID-19 immunization. Immediately after the shot he developed reddish/blue like color around injection site on 11Mar2021. The reporter stated that "Soon after the second dose," he developed a rash on his arm and legs, described as itchy in Mar2021. He had no side effects after the first dose. The reporter also stated that he has not taken blood thinners in 2 years. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself.  A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020.  The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This is spontaneous report from a contactable nurse practitioner reporting for herself via a Pfizer sales representative. This  female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration at 0.5 ml single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced all over body aches on an unspecified date after the vaccination from which she recovered after 24-48 hours.
Headache, Fever, NauseaVomiting, fatigue, chills Narrative:
Needle popped out and vaccine leaked, most of the vaccine was not administered; A spontaneous report was received from a nurse concerning a 68 year old female patient who was participating in the mRNA-1273 vaccine program and the needle popped out and vaccine leaked, most of the vaccine was not administered [Incorrect dose administered].  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 20 Jan 2021 the patient received their second of two planned doses of mRNA-1273 (lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection.    At the time of vaccination the needle popped out and vaccine leaked. Nurse states that most of the vaccine was not administered.  No treatment was provided for the event.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, needle popped out and vaccine leaked, most of the vaccine was not administered, was resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered (Nurse states that most of the vaccine was not administered) for mRNA-1273.  There were no reported adverse events associated with this case.
Headache, Myalgia, Arthralgia, Fever, Chills, Fatigue, Erythema, redness and bruising in the legs Narrative: reported redness/bruising in the legs that worsened over 10 post-vaccination. Understanding is that this has since resolved.
Blood sugars, normal before, are now extremely high (220-295) no matter what I do to lower them.
Exactly 9.5 hours after receiving dose 2 extreme body aches began, followed overnight by a headache, fever that reached 101 degrees, and nausea.  The next day I called my doctor about the fever, we elected home treatment with Tylenol.  Tylenol kept the fever below 101 for the duration of 48 hours.  I was bed-ridden during this 48 hours.   48 hours after onset of symptoms, they all rapidly disappeared and I was able to resume normal activity.
The patient began to have tingling in her mouth then sense of swelling in her mouth and throat about 5 minutes after vaccine was given
four hours after vaccination, pt started with hives on that arm that spread to the other arm and both ankles over night
Death Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was hospitalized in 02/2021 at facility for unknown reason until his passing on 3/7/2021. He had dx of HCV in 01/2021 that was cured but left him with cirrhosis s/p TIPS procedure. Was not liver transplant candidate due to home O2 needs. Other major comorbidities include COPD and diabetes.
An expired booster dose was administered to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was administered to a patient). On 13-Nov-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. Pharmacist reported that a booster dose was administered 10 hours after it expired. Pharmacist wanted  to know about stability of that dose so that they can decide whether to repeat the dose or not. Dose was administered 22 hours post puncture.
6cm area of erythema and swelling approximately 5 cm at site of varicella. Benadryl/cool compreses, Tylenol prn.
Chickenpox, rash onset 9/21/99, about 200 lesions and fever for 2 days.
immed following flu vax pt exp a flushed feeling radiating from the chest, to the neck to the jaw, a funny taste & palpitations;pulse was 120 to 120 BP 150/90;pre flu vax was 40yr ago;no problems;
Patient developed rash on torso. Patient contacted her personal physician and took BENADRYL according to doctors instructions with follow up appt on 10/7/12. Dr. provided steroid shot. Patient took ALLEGRA then BENADRYL with no relief.
This spontaneous report as received from a registered nurse refers to three patients of unknown gender aged between 12-15 months old who on an unspecified date were inadvertently administered both PROQUAD (dose not provided), subcutaneous and VARIVAX (dose and route not provided) at the same office visit. No adverse effects reported. Additional information has been requested.
Headache; muscle ache; dizziness; fatigue; This case was reported by a consumer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced headache, muscle pain, dizziness and fatigue. On an unknown date, the outcome of the headache, muscle pain, dizziness and fatigue were unknown.   It was unknown if the reporter considered the headache, muscle pain, dizziness and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was reported by patient's husband. The patient had immunization with Shingrix 36 hours ago prior to the reporting date and still experiencing headache, muscle ache, dizziness, and fatigue. The reporter asked If a person is having side effects from Shingrix, how long should they normally last. The reporter consented to follow up.
Pt complained of arm pain, and claimed skin was "blotchy". Advised pt if she had chills or if symptoms got worse see a physician.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. From on unknown date in February 2014, the patients were vaccinated with GARDASIL (strength, dose, route of administration and lot # were not reported). This vaccine was exposed to unsupported storage temperatures. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
felt tremendous energy for a week, as if she were 15 years old; had a few headaches; the migraines that she usually suffers were gone; This spontaneous case was reported by a physician and describes the occurrence of ENERGY INCREASED (felt tremendous energy for a week, as if she were 15 years old), MIGRAINE (the migraines that she usually suffers were gone) and HEADACHE (had a few headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (the migraines that she usually suffers were gone). On 10-Apr-2021, the patient experienced HEADACHE (had a few headaches). On an unknown date, the patient experienced ENERGY INCREASED (felt tremendous energy for a week, as if she were 15 years old). At the time of the report, ENERGY INCREASED (felt tremendous energy for a week, as if she were 15 years old), MIGRAINE (the migraines that she usually suffers were gone) and HEADACHE (had a few headaches) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.