chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "65-year-old male with a past medical history of hypertension and alcohol use disorder who presented to the emergency department as a level 2 trauma after falling down flight of stairs, EtOH level on arrival was 312.  GCS 14 on arrival, initially complained of neck and upper back pain, otherwise he was hemodynamically stable.  CT imaging of head and torso on intake was notable for left parietal fracture, trace acute subdural bleed, left zygomatic arch which fracture, type 2 dens fracture, sternal fracture and multiple bilateral rib fractures, with fractures in ribs 1 through 6 on the left and 1 through 5 on the right, rib 1 being fractured in 2 places.  There was also fracture in his right 5th finger. Also fra with greater than 50% vertebral loss, minimall displaced spinous fractures of T2-T4 and transverse fractures T4-T5. No solid organ injury in the abdomen.   patient was admitted the ICU with Trauma Surgery as primary service.  Neurosurgery, Orthopedics, and Cardiothoracic surgery were consulted for evaluation of his injuries.  Serial head imaging remained stable and his imaging and physical exam findings for his head and spine necessitated no surgical intervention per Neurosurgery.  The patient had no respiratory distress and no lung injury, necessitating no intervention per CT surgery.  For his R small finger fracture, splint was placed and patient is to follow up with Orthopedic Surgery in 2 weeks.  He has repeat imaging CT head and XR C and T-spine scheduled per Neurosurgery without outpatient follow up to be arranged after imaging.  The patient underwent PT/OT which he tolerated well.  He also demonstrated no signs or symptoms of alcohol withdrawal syndrome.    He was transferred to floor status without complication and care was assumed by the General Medicine team. The patient did test positive for COVID on screening, however he remained asymptomatic.  He had elevated blood pressures during his admission, for which lisinopril was increased to 40 mg daily and he was started on metoprolol tartrate 12.5 mg 2 times a day.  His hospitalization was prolonged due to COVID isolation in preparation for SNF, however the patient made the decision to return home over discharging to SNF. He otherwise remained clinically stable and was medically optimized for discharge home with plan to have LHC" PT/OT services arranged.
Temperature 102, 100.6 2 hrs after Tylenol 1000 mg, fatigue, neck pain, unable to walk, nausea, dizzy, feeling unwell
Information has been received from a health professional concerning a female patient with a history of pneumonia who on 11-AUG-2006 was vaccinated with a dose of Pneumovax 23 (lot # 650644/0004F).  Concomitant suspect therapy included lisinopril (manufacturer unknown) and simvastatin (MSD).  Concomitant therapy included SYNTHROID.  Subsequently, on an unspecified date, the patient developed redness, swelling and pain at the injection site.  The patient recovered from redness, swelling and pain at the injection site.  Additional information has been requested.
Patient had a syncopal episode after vaccine adminsitration. Normal reaction for patient after injections.
Pt developed a facial rash three days after receiving the vaccination.  The rash was a papular rash and was located on the right side of the face.  The patient was issued shaving restrictions.  By January 26, the rash had improved somewhat on the R side but had spread to the L side of the fack and the anterior neck.  The malar region of the face, chin and anterior neck are erythematous and there are scattered papules and pustules.
Severe arthralgia-difficult walking-disoriented, fever, headache-gradually improved over 48 hr period
Headache; fatigue; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient himself). A 75-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Lot Number: EN 5318; Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 24Jan2021, 12:00pm (at the age of 75-years-old) at a single dose for covid-19 immunization. Patient's medical history included type 2 diabetes mellitus, lymphoma and arteriosclerosis, all of which started from an unknown date and unknown if ongoing. Concomitant medications included metformin, sitagliptin (JANUVIA), enalapril, glyburide and clopidogrel bisulfate (PLAVIX). The start and stop dates and indications of patient's concomitant medications were not reported. The patient previously took losartan and amoxicillin and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Jan2021 at 2:30pm (14:30), the patient experienced headache, fatigue and soreness at the injection site which lasted for 3 days. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of these events was recovered on 27Jan2021 14:30.
Sore arm at injection site.  Intense itching on arms, head, legs beginning within 3 hours of injection and continuing.
administered Monovalent vaccine after the recall of this vaccine on 04/18/2023 Pt did not report any side effects
twitching at the injection site; twitching at the injection  site and on the muscle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "twitching at the injection site"; VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown", described as "twitching at the injection site and on the muscle".  Additional information: Reporter provided No patient identifiers were provided but the reporter has first-hand knowledge of the patient and was reporting on a specific patient. Below was the verbatim report. Reporter Want to know if the patient have received second vaccine or not. AE due to daughter having twitching after first vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 30 children ages range from five to seven years-old who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following patient demographics and outcome of the event.
That evening patient could not get out of his chair, the next morning he could not walk then by the evening all symptoms had resolved
Administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number n99p3, expiry date 19th October 2021) and (adjuvant batch number unknown, expiry date 28th February 2022) for prophylaxis.   On 17th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 17th February 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up. This case had been linked with case US2022029589, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022029589:Same reporter.
Nausea; Dizziness; Weakness; Fast heartbeat; High blood pressure; Injection site pain; Low grade fever; Fatigue; Headache; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 09:00 (Batch/Lot Number: EL3249) (at the age of 25-years-old) as single dose for covid-19 immunisation. Medical history included endometriosis, known allergies to most antibiotics, Guaifenesin, Venlafaxine, peanuts and eggplant. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 05Jan2021 09:00 (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Concomitant medication(s) in two weeks included escitalopram oxalate (LEXAPRO), levocetirizine dihydrochloride (XYZAL) and levonorgestrel (MIRENA) taken unknown indication from unknown date. No other vaccine was taken in four weeks of time. Patient did not have COVID prior to vaccination and was not tested post vaccination for the same. On 26Jan2021 at 20:00 patient experienced dizziness, weakness, fast heartbeat, high blood pressure, injection site pain, low grade fever, fatigue, headache, muscle aches, chills and nausea. No treatment was taken as a result of events and outcome of all the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
no additional AE at time of call; patient was inadvertently administered a dose of ROTATEQ after the product's labeled expiry of 4/29/2021; This spontaneous report was received from a medical assistant who refers to a 4-month-old patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 03-MAY-2021, the patient was vaccinated inadvertently with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, orally, for prophylaxis, lot # 1660993, expiry date 29-APR-2021 (formulation, concentration, dose number and frequency were not reported). No additional adverse event was reported. No product quality complaint (PQC) was involved.
Vivid dreams, sleepy. Stated vaccine made in Canada. Provided second manufacturer for Box 13. Manufacturer - BioMedical Corp of Quebec.
dry cough, which seems to be aggravated whenever he lays down; patient had headache which is close to a migraine; This is a spontaneous report received from a contactable consumer (patient).   A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 19May2021 (at the age of 21 years), as second dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. On 20May2021 (the following day), the patient had headache which is close to a migraine. When he woke up the next day (21May2021), he started experiencing dry cough, which seems to be aggravated whenever he lays down. The cough never went away even up until this day. Caller wanted to know if the adverse events that he experienced is among the commonly reported adverse events following the Pfizer BioNTech Covid-19 Vaccine administration and wants to get some treatment recommendation. Outcome of the events "patient had headache which is close to a migraine" was reported as unknown and cough was reported as not recovered.  Information about Lot/ batch number has been requested.
pt recv vax 31JUL96 & exp fever, malaise & did not feel well for 1-2 days;
The day of and the following day, flu like symptoms- fever (102 at highest) chills, sweats, headache, fatigue, restlessness (had to sit and sway at night because my body could not stay still. loss of apatite, nausea, injection site pain. tightness in head, upper back/shoulder and neck on the side of the injection (left). Everything but the soreness of the injection site and tightness in the muscles on that side lasted about 48  hours. The tight muscles and soreness lasted about a week.  *** THREE WEEKS AFTER THE SHOT**** Sunday, 4/12/2021 I woke up and stepped out of bed and my left ankle gave out when I stepped down. Internal rotation, weakness in left ankle. It happened again as I walked shortly after. That day I tripped many times due to weakness in that ankle. When I showered and shaved my legs I realized that I had absolutely no feeling in the left lateral part of my lower leg. It felt like I had a novocaine injection in my leg. I could not even feel a pin prick there. By Friday 4/9/2021 I started to have some sensation, but still decreased sensation and weakness in my left ankle even at this moment.  ****4 WEEKS AFTER THE SHOT**** My period started Monday, April 5th, 2 days early. By Friday, 4/9/2021 and through the day and night Saturday 4/10/2021, I had such a heavy period that I kept soaking through tampons, pads, and 2 pairs of jeans. I have never blead like that and could not keep up.
Information has been received from a physician concerning a female patient between 14 and 16 year old who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL. After receiving the vaccine, the patient experienced vomiting. The patient recovered. Medical attention was sought. This is one of two reports received from the same source. Additional information has been requested.
Muscle aches, skin sensitive to touch, feeling of burning throughout body, fatigue, upset stomach, flu like symptoms on 2nd day.
Immediate violent pruritis, 8 cm erythema with swelling and 6 cm white center just below site of SQ injection of Proquad MMRV.  No other symptoms noted.
Patient said was sore and a little swollen on Sunday evening after shower.  She put alcohol on it. She said today it had a rash, swollen to elbow, hot and painful. I recommended she contact her doctor.
migraine headaches/jr. migraine headaches; This case was reported by a consumer via interactive digital media and described the occurrence of migraine headache in a child patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced migraine headache. On an unknown date, the outcome of the migraine headache was recovered/resolved.   It was unknown if the reporter considered the migraine headache to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had DTP as a child, the patient was diagnosed with jr. migraine headaches at age 7.  The patient reported that the event didn't resolve until about age 25 when the patient used an elimination diet of food additives food colorings, vitamins, herbs, yoga, and chiropractic treatments. The patient asked if the vaccine could cause migraine in children.
radiation recall phenomenon; Flared up after vaccination; This is a literature report.  A 67-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing); "edema of the laryngeal mucosa" (unspecified if ongoing); "radiation therapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ramucirumab, reaction(s): "induced RRP", notes: flared up after vaccination. Vaccination history included: Covid-19 vaccine (Unknown manufacture, DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: RECALL PHENOMENON (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "radiation recall phenomenon"; CONDITION AGGRAVATED (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "Flared up after vaccination". The patient underwent the following laboratory tests and procedures: Positron emission tomogram: Unknown result.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events RECALL PHENOMENON , CONDITION AGGRAVATED  and suspect drug BNT162B2 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.
Severe diarrhea, anorexia, irritability, fever 100.2, runny nose
Lymph node in my right arm pit swelled and ached; Lymph node in my right arm pit swelled and ached; Fever; Chills; Body aches; I had a migraine all day; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 320308BD) via an unspecified route of administration in the right arm on 12Nov2021 at 18:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously 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 22Oct2021 at 18:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 13Nov2021 at 05:00, the day after, the patient experienced fever, chills, body aches. The patient had migraine all day. On 14Nov2021, 2 days later, the patient experienced lymph node in her right arm pit swelled and ached and still had for 2 additional days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event fever, chills, body aches, migraine all day and lymph node in her right arm pit swelled and ached were not resolved at the time of this report.
Chills for 45 min ( felt like a seizure) . injection site was warm. low grade temp for 2 days
Information has been received from a certified medical assistant concerning an over 8 month female who on 06-APR-2009 was vaccinated with the initial dose of ROTATEQ (lot number and route not reported). Since vaccination, the patient developed roseola on 28-APR-2009, and on 19-MAY-2009 experienced cellulitis due to insect bites. The patient had sought medical attention at the office. The patient's outcome was unknown. Additional information has been requested.
By 10:30 of day received, slight fever. Overnight, developed high fever, aches and pains, and muscle spasms. High fever persisted through the first 24-36 hours. Then developed (and am currently experiencing) tingling in the face and headache.
On friday evening (exactly one week from the date of the shot) I felt a sensation on my upper left arm and then an immediate itching feeling.  My upper left arm, around where I received the shot was  hot/sort of painful to the touch and itchy.  The itching/pain was relatively mild, and sort of came and went.  Before I went to bed I put aquafor on it.   The next day (Saturday) I noticed that the area (which still had that off and on itch/pain feeling) had developed a rash of sorts that was red, oval shaped (maybe 3 inches long, 1.5-2 inches wide) - it was just one big red patch, and maybe the rim of the oval was a bit more red, sort of like a ring.  I washed it and put a hydrocortisone cream on it.  Again the itch/pain sort of came and went throughout the day and was more noticeable when something rubbed on the area.   Overall, it was very mild - I could easily resist scratching/touching because it sort of hurt to touch it.  When I woke up on sunday, the redness of the rash was mostly gone and any itch/pain was very very faint to non-existent.
Patient was observed for 30 minutes in the office after administration of Havrix.  No immediate skin reaction or symptoms observed.  One week later he reports having a mild rash on his arms later in the day after administration of Havrix, on 5/8/08.  Resolved after 48 hours.
Seen at ER, medical center on 10/13/08 and diagnosed with chickenpox for rashes that appeared on her face and body that day.  No medication given but advised to get oatmeal bath.
Per parent of pt, pt woke up next day with redness around injection site and pain to upper arm, parent observed and by Saturday morning, pt's rt arm was swollen, red and warm to touch. parent took pt to an emergency clinic where he was dx with cellulitis and rx Cephelexin 500 mg tid. Pt continued to complain of pain in arm with radiated pain into his neck, n/v. Mom followed up with PCP the following day and pt was rx an new abx d/t the inability to hold orriginal rx down. Per parent, he had a lowgrade fever Saturday. Parent reports improvement upon follow-up on 09/01/2020.
History of passing out on vaccines, lab work, "any needles" phobia c/o lightheadedness
Dizziness, rolling pain throughout the body, cold sweats, fever, nausea for approximately 15 hours. Approximately a few hours later that same day facial pain on the right side of the face became swollen around the eye and check.  The swelling lasted approximately 30 hours before subsiding.
Site: Swelling at Injection Site-Mild, Systemic: Lymph Node Swelling-Medium, Additional Details: pt states he has a large lump under left arm and sore throat
Patient had pain, swelling and redness at injection site. Patient received vaccine on 10/11/16. Patient was fine when I contacted her.
Information has been received from a physician regarding to a 5 years old patient of an unknown gender. Patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with two doses of VARIVAX (dose, route and lot number were not provided) within a 2 month period (dates unspecified). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.