chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administration, administered in arm left on Mar 2021 as single dose for COVID-19 immunization. Medical history included cardiac patient on meds. Concomitant medication included apixaban (ELIQUIS), atorvastatin, lisinopril and amlodipine. The patient had a historical vaccine of codeine and known allergies with codeine. The consumer stated, "I received my COVID-19 vaccine. Approximately, I think it was Tuesday or Wednesday of last week, probably Tuesday. Everything was fine but I noticed they didn't have a phone in case of any complications or issues. I took the vaccine, everything was fine, no problem but I guess it was 3 days ago (Mar 2021), I woke up with hives, swelled, hives and itchy. I thought it was bed bug bite or something. I didn't associate the vaccine and also reported as rash. It is red, swelled. In the front of my body, lower abdomen, my back and one on my foot, right on my ankle and I don't know why I got this adverse so many days later. Patient reported that he received the 1st dose of the vaccine on Mar 2021, roughly 48hrs later he developed hives and an itchiness of the skin. He also has concerns on whether he should receive the 2nd dose as a result of the reaction. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of rash/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle, hives/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle, swelling/it is red, swelled. in the front of my body, lower abdomen, my back and one on my foot, right on my ankle. The outcome of the events red rash, hives and swelling were recovered on an unspecified date and remaining all events were unknown. Information on the lot/batch number has been requested.
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering.   Additional information has been requested.
pt began crying 30min p/vax & cont crying for five total hours;motrin was given for 2 days & pt did well;
This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius) and another lasting for 72 hours, with the highest recorded temperature of 9 degrees Fahrenheit (also reported as 9 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient with no sleep walking for years, but with recurrence of sleep walking that resulted in disposal of numerous medications
Severe pain in injection site on 1/13/2022.  Started taking one 500mg Tylenol every 4 hours. Excessive swelling of left lymph node in armpit.  Used ice pack to reduce some of the pain.  Feeling of stiffness throughout body and uncoordinated. 1/16/2022 trouble taking deep breaths, extreme dizziness, uncontrolled muscle spasms.  Went to emergency room.  Blood pressure was extremely high (170/109).  Previous blood pressure (124/86).   1/24/2022 went to MD for a physical at 3pm.  Staff found blood pressure to be 220/120.  Sent me to the emergency room.  I was still experiencing tightness feeling in body and some muscle tightness.  No trouble breathing.  Went to emergency room.
Received vaccine in his left deltoid. Unable to move right extremities both hand and leg. When instructed to move right arm, he was not able to pick up arm. Unable to perform active ROM. He  was asked to pick up and move right leg. He was unable to perform the action. Sent to ER for further evaluation.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the recorded temperature of -1.66 to 1.11 degrees   degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia, Fever, NauseaVomiting, CHILLS/SWOLLEN GLANDS Narrative:
States day of vaccines very fatigued by next patient treated generalized itching.  Had hive on side of face again with fatigue enough to sleep during the day. The following day states ears "burning with blotches" on her face extreme fatigue-on 4th day post vaccine patient state felt normal.
One week after receiving  immunizations, pt developed a rash starting on face and neck and going down body, fever, sore arms, extreme muscle aches, a headache behind the eyes and felt sluggish with no energy. The pt was usually very active but felt he could only lie in bed. Over the next few days the rash progressed and was described as hundreds of spots all over his body with severe itching. Pt went to an Urgent Care and saw a PA who said the reaction was due to receiving too many vaccines at one time. The rash lasted approximately 12 days.
Nausea, migraines, dizziness, body aches, large red mark in arm at vaccine site .
coughing, diminished but still present Increase/spiking blood pressure, somewhat controlled now
3 days after vaccines given (DTaP, IPV, MMR, Flu shot), pt had fever 103, seizure, URI SX and mild RAD exacerbation. ER DR DX with pneumonia but radiology reading of CXR is normal. PT HX has frequent URI and RAD. Unclear as to whether the febrile seizure was from vaccines or illness although illness was not fairly mild. Treatment included antipyretics, antibiotics, breathing treatments, antihistamine and decongestant.
This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N029303 and expiration date 21-APR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). On an unknown date following the administration, the patient developed cellulitis. It was unknown by the reporter if the patient sought medical attention, if treatment was given for the adverse event or if lab diagnostics or studies were performed. The outcome of the event cellulitis and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. Upon internal review, cellulitis was considered to be medically significant. This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1802USA002517: US-009507513-1802USA002516:
15 year old received a "booster" dose (30mcg/0.3ml).
LOW ANTIBODIES AGAINST COVID VIRUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, and cancer survivor, and other pre-existing medical conditions included: The patient did not have drug abuse or illicit drug usage. The patient experienced drug allergy when treated with inosine, lisinopril, and sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the patient experienced low antibodies against covid virus. Laboratory data included: Antibody test (NR: not provided) Showed less than 50% antibodies (Negative). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
urticarial local rxn, rash-shoulder to elbow, 5 days post vax w/TD:marked improvement w/in 2hr w/DPH;
Patient was sitting in chair when he started feeling dizzy and noticed his vision was blurry. Patient fell to floor and hit back of head on the floor. Syncopal episode lasted for 5-10 sec. Patient awakened A/Ox3. Vitals obtained with BP 146/96, HR 75, O2 99%. Given water and cold compress to neck and head. Denies feeling bad at time. Vitals obtained again with BP 136/62, HR 68, O2 99%. Kept patient an additional 15 mins. Patient refused ambulance and EMS service. Patient left after sitting 30 mins total.  Mentation still A/Ox3.
Fever 99.7 F.                                                                                                                                                                                                              Began around 11:30 PM on 11/07/2020 and continuing at time of this submission 6:25 AM 11/08/2020
Fever CHILLS; ARM SORENESS; NAUSEA; FATIGUE; BURNING EYES Narrative:  Other Relevant History:
(Low temp). Left arm swelled size of baseball, hot & red. Severe headache, pain up left side of face & up & over left eye which swelled & pained. Broke out in blisters & itched. I am left with red "dots" across brow that itch daily now. I also suffered with severe sinus inflammation for months.
progressive patch, raised rash on scalp,  face, neck upper extremities and upper torso
Patient was to get DTaP, Polio, MMR, Varicella. By mistake we administered Pediarix (DTap,Hep B, Polio) for the DTaP and we administered Polio. Patient received two doses of polio. Contacted dad 7 days after injections and he stated child was great and the injections didn't slow her down.
At approx. 1100 PT was evaluated, cleared for and received both anthrax and typhoid vaccinations in the right deltoid muscle. No immediate issue was noticed, PT was sent to wait in another area with others to wait for a provider. At approx. 1130 it was noticed that patient may be losing consciousness by a coworker and a medic was notified. PT was immediately moved to a nearby stretcher and joined by an LVN, the Immuz acting clinical staff. PT was found to be AOx3, GCS15 but had a graying pallor and stated he felt as though he was passing out. PT was moved to a private room where his VS were taken and found to be WNL, (144/87 HR91 spo2 RR20 100RA) but elevated compared to his pre immunization state (132/84 HR69). PT began shivering and degrading emotionally to a near panic stating he was cold and could not breath. NP was notified and saw the PT. PT reveled to the NP he had had seizures in high school and had a HX of substance abuse. NP decided to have the PT transported to the main ED via EMS. EMS was notified by staff member. PT was transported via EMS to ED.
Pt had a temp of 102F on 9/27/12 at 8PM. At 2AM on 9/28 Pt had a febrile seizure that last 10 minutes. He fell back to sleep and woke up at 6AM and had a seizure that lasted 5 minutes went to ER.
This spontaneous report as received from a pharmacist via a company representative refers to a 64 year old female patient. On an unspecified day in January 2012 (year confirmed to be 2012) the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported). On an unspecified day in April 2013 the patient developed recurring sores on her head that look like ringworm. Pharmacist reported that patient had been referred to an unspecified dermatologist for treatment. Patient sought medical attention by contacting the pharmacist. At the time of report, the outcome of event was reported as not recovered/not resolved. Additional information has been requested.
11hrs after the vaccine I experienced numbness and tingling in my right eye, face, neck and tongue in which I took already prescribed antihistimine medication for that.  I developed a migrane the following day which lasted about 7 days and I alternated Ubrelvy and Sumatriptan to manage the migrane.  I reached out to my allergist who monitored me vitually for a few days and finally all symptoms finally subsided.
Pt had h/o sulfa allergy (hives).  She was premedicated for 1 week with Zyrtec and Pepcid prior to first JEV vaccine.  The day after the vaccine she developed a few hives on her torso which spontaneously resolved.  The JEV series was stopped.  No further problems.
She is experiencing chills and she got a 102.7 temperature; She is experiencing chills and she got a 102.7 temperature; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 27JAN2021 as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On JAN2020 on unspecified date the patient was experienced chills and she got a 102.7 temperature. The patient underwent lab tests and procedures which included body temperature: 102.7 on an unspecified date. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Patient has had fever and extreme fatigue since getting the High Dose Flu vaccine.  Doctor has run many tests and cannot find out reason.  Patient thinks it may have something to do with getting the flu vaccine, even though it took 2 months for the symptoms to occur.
C/O HA, NECK STIFFNESS, T-99 DEGREES FAHRENHEIT, LIGHT HEADINESS, LETHARGIC WITHIN 24 HOURS OF RECEIVING VACCINES.  NO VISION PROBLEMS. NO REDNESS OR SWELLING AT INJECTION SITE.  MOTRIN GIVEN.  ADVISED IF HA WORSE OR TEMP GREATER THAN 101.5 THEN GO TO ER.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 25-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 09:15 (Lot number: EN6207) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Moderate-severe asthma" (unspecified if ongoing); "Only animal allergies" (unspecified if ongoing). Concomitant medication(s) included: SPRINTEC; WELLBUTRIN. Vaccination history included: Tetanus shot (I am feeling similar to how I did the day after getting my tetanus shot this summer, where my lower body was in extreme pain and even temperature changes or wind would cause pain in my legs.), administration date: 2021, for Immunisation, reaction(s): "lower body was in extreme pain", "pain in my legs". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: The patient had no reaction after the first vaccine other than sore arm. She was feeling similar to how did the day after getting my TETANUS shot this summer, where her lower body was in extreme pain and even temperature changes or wind would cause pain in her legs. She had known allergies to only animal. Other medical history included moderate to severe asthma. She had no other vaccine in four weeks. Other medications in two weeks: SPRINTEC, WELLBUTRIN XR 300 milligram. She did not have COVID-19 prior to vaccination. Post the vaccination, was not tested for COVID-19. No treatment was received for the adverse event.  No follow-up attempts are possible. No further information is expected.
Got shot within the year got shingles / Suspected vaccination failure; Got shingles; shooting pain on the right side of my skull; Pain; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot within the year got shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles), headache (Verbatim: shooting pain on the right side of my skull) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, headache and pain were not reported.   The reporter considered the vaccination failure and shingles to be unrelated to Shingles vaccine. It was unknown if the reporter considered the headache and pain to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. It was unknown if the company considered the headache and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient was vaccinated for shingles.  Within the year the patient got shingles and he/she did not believe it was the result of the vaccine. The patient wondered if he/she had a brain tumor being, had shooting pain on the right side of the skull.  The patient honestly did not even need to take Tylenol. The pain was very mild.  The patient suggested to get vaccinated today, and stated it was one of the best things he/she ever did. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Flu-ish/ Feel flu like a couple of days ago/ I thought I was coming down with flu; Sharp pain in his stomach/ stomach hurt very bad/ stomach felt like it's going to come out of me/ really bad for about 5 or 6 hours; nausea; muscle pain; headache; Joint pain; fatigue; chills; Cold; Sick; I don't feel well/ Hasn't been feeling good; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3240, Expiration Date: Unknown), via an unspecified route of administration on 19Jan2021 at 11:00 (at the age of 71 years-of-old) as a single dose for COVID-19 vaccination. Relevant medical history included hypertension. Concomitant medication included Enalapril maleate (ANAPRIL) (MANUFACTURER UNKNOWN) for High blood pressure from an unknown date and unknown if ongoing.  On an unspecified date, the patient experienced "Flu-ish" a couple of days ago with sharp pains in his stomach, nausea, muscle pain, headache, fatigue, and chills, cold. Thought he was coming down with flu. Nausea. Sick; dint feel well. Hasn't been feeling good. Reporter stated, yesterday he had a really bad day. He got the shot about week ago and all day long hurt really badly, his stomach. Reported stated he did not have diarrhea or not like that. Had chills, joint pain, nausea so, was that kind of normal after a week was the query. Reported stated really bad for about 5 or 6 hours, really bad, stomach felt like it's going to come out. No investigational assessment, lab test in the past two weeks. The outcome of all the events was unknown.
Pt reported severe vertigo, dizziness, and nausea worsened by riding in a car. These symptoms started 2 days after the vaccine was given. No hx of this in the past.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 12-MAY-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot# L008997, expiry date 04-DEC-2020; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second one lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This lot number expired in refrigerator on 1/17/2022, the vaccine was given after that date
Developed headache, arthralgias, myalgias, malaise, nausea and dizziness which lasted 2-3 weeks. Symptoms were reproduced with each subsequent anthrax dose. Since dose 2008 has had migratory arthralgias.
pt recv vax; crying; apap given;pt is spitting up a little;warm tab water & warm cloth used;to drs if sz or lasts past 3pm;no inflam at site; pt calmed down w/ tub, apap cont;
Complaints of having a fever, sore throat and bodyache/weakness 3 hours after getting Influenza vaccine. Treated with Acetaminophen 325mg 2 tabs every 6 hours as needed for fever.
Moderna Bivalent booster was due, 12 and older Monovalent was given, no reaction.
The patient presented a day or two after receiving the vaccine with injection site reactions - warmth, redness, pain, swelling past the injection site, almost looked like hives.
Within 12 hours of vaccine she became feverish and developed headache, body aches and severe nausea.  Vomited several times.  Symptoms resolved in about 24 hours.
Partial paralysis of last two fingers and palm of right hand...like it was "asleep" and insensitive...very odd.  Went away with recovery in a day or so.