chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a school nurse and physician office nurse concerning a 13 year old male with no known allergies, a blood transfusion in June 2006, sickle cell anaemia, and asthma, who on 10/3/06 was vaccinated SC in the left arm with a one time 0.5ml dose of varicella virus vaccine lot (654129/0919F). Concomitant therapy included folic acid, penicillin V potassium (PEN VEE K) and amoxicillin. The pt had cold symptoms for two weeks prior to vaccination. On 10/5/06 the pt presented to the ER with knee, ankle pain, abdominal pain, vomiting, nausea, and decreased appetite, he had been taking Tylenol with codeine 3 and was admitted to the hospital for sickle cell crisis. It was reported that this was the pts normal presentation and were the symptoms for his sickle cell crisis and that the pt is frequently (monthly) admitted to the hospital in crisis. During the pts hospital stay, on 10/8/06, he received a blood transfusion. The pt also received fluids, a morphine drip for pain and unspecified antibiotics, he was treated with nothing out of the ordinary. The pts chest X ray was fine and his pertussis swab was neg (the nurse reported that there was a pertussis outbreak in the area. The pt was discharged on 10/9/06, though an actual recovery date was not reported. The pts discharge diagnosis was asthma and sickle cell crisis. There was no product quality complaint involved. It was reported that the sickle cell crisis may have been triggered by stress, the pt had been suspended from school on 10/4/06. It was also reported that the pt may have been hospitalized with a sickle cell crisis from 9/19/06 to 9/22/06, again after being suspended from school and that the pt was frequently hospitalized when he had problems at school. The pts events were considered to be other important medical events (OMIC) and serious for hospitalization. Additional information has been requested.
A 29 year old female patient, received on 14 June 2007 first subcutaneous dose of JE VAX (lot# EJN228A) into the right arm.  The patient experienced on 15 June 2007 localized reaction of redness and swelling that resolved after 2 to 3 days.  The patient had recovered.  Treatment was not reported.  On 05 June 2007, the patient received RABAVERT (NOVARTIS, lot# U12011A) intramuscular first dose into the left deltoid.  No illness at vaccination time.  No pre-existing physician diagnosed allergies or medical conditions.  The patient did not receive any other medications.  Follow-up information received on 01 October 2007 from a health care professional.  The case was reviewed, and there was no additional information at this time.
11/15/21 presents to FBC for "scheduled late term IOL", "G1P0 at 41w3d".  PMHx" asthma, CIN III, hypothyroidism, psoriasis".
Localized reaction on (L) thigh, red, swollen area approx. 5".
Patient who was pregnant was inadverdently administered a dose of GARDASIL 9; No adverse effect; Patient was supposed to be administered the influenza vaccine to prevent flu, but was administered with GARDASIL 9; This spontaneous prospective pregnancy report was received from a registered nurse refers to a 27-year-old female patient. The patient's concurrent conditions, medical history, historical drugs, drug allergies and concomitant medications were reported as none. On 18-MAR-2019, the pregnant patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose/frequency were unknown) (lot # 1581027, expire date: 03-JUN-2021, route: intramuscular) instead of a dose of influenza vaccine (manufacturer unspecified) for prophylaxis. The last menstrual period was reported as 34 weeks and estimated date of delivery was not known.The patient was supposed to be administered the influenza vaccine to prevent the flu, but was administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The reporter reported that this was not a product confusion. No adverse effects were reported. There was no treatment rendered for the events. No lab tests were performed. The pregnancy outcome was unknown. The patient did not seek medical attention.
24-48 hours after patient received vaccines, Patient was found dead in crib, no clearly identifiable cause of death.
Constant ringing in the left ear after the 2nd Vaccine. Went to an ENT who confirmed this most likely was a result of my covid vaccines
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for less than a minute.  She hit the right side of her head.  It was red but no bruising.  Observered for 30 minutes. She stated that she had a history of fainting in relation to blood
Employee described the event as swelling, redness, and pain two days after injection given. Stated that is lasted for approximately 2 days.  Employee did not report event until time to complete the second series.
Severe muscle aches, chills, back pain, nausea, vomiting for 4 days
Patient states area of/around flu shot was immediately itchy and has continued to itch intensely since vaccination. Patient has used hydrocortisone cream on area and has not beet seen by MD.
Body tremors that are sumitro seizures doctor says they are not seizures but that?s the best way to describe
MOC noted redness to the leg the afternoon after administration, worsened through night.  At time of assessment in office these were the findings: LEFT UPPER THIGH 7CM X 9 CM ERYTHEMATOUS (SPLOTCHY) SLIGHTLY RAISED AREA, NOT HOT TO TOUCH , MINIMALLY TENDER, NL GAIT, NO LIMP , RIGHT UPPER LEG CIRCUMFERENCE 10.5 INCHES VS LEFT UPPER LEG 11.25 INCHES.
Patient has cellulitis in left arm from shot- area is red and hot to the touch.  Patient currently taking antibiotics for infection.
Rash on left arm (injection site) appeared one week after injection and hives on neck and right foot. Rash at injection site is painful and itchy. 2 inches wide
complained of malaise and prolonged headache.  Had several ED visits.  Treated with Dilaudid, Toradel, and flexeril.  Prescriptions given: vicodin, motrin, and flexeril, ativan
Initial non-serious report received from a health care professional on 18 September 2007. A 24-year-old female with history of diabetes and allergy to codeine received a left deltoid intramuscular injection of IMOVAX (second dose of a post-exposure series; lot number Z0877-2) on 15 September 2007 and two days later complained of facial flushing (lasting 48 hours), nausea, vomiting and diarrhea. She was afebrile and had no complaints of symptoms at the injection site. Needle length for IM injection was reported as one inch, 25 gauge. The patient had no illness at the time of vaccination other than a reported "bite". The event was treated with PHENERGAN. Recovery status was reported as "not recovered". On 12 September 2007, the patient had received the first dose of IMOVAX (right deltoid intramuscular injection; lot number not reported) in addition to a left gluteal intramuscular injection of IMOGAM (lot number not reported). No additional information was provided at the time of this report.
30 seconds after vaccines, child felt=faint and looked pale. P60 BP110/58. I placed him in a supine positn & he improved immediately. Dad states he always feels faint with shots.
Second time in 3 weeks to menstruate.  Also menstruate shortly after first dose.  Fairly heavy. I have not had period in the last few months and never menstruated so close together.  Low degree fever and body aches.
Elevated heart rate for 2-3 hours 6:00 PM day of injection. Swelling, lump and rash at injection site from 5/12/2011 for 5 days. 95% cleared up by 5/21/2011. Mild to moderate Joint pain increase to present.
Within a week after getting vaccine, I started with a prominant heart beat in that arm.  It would actully wake me up it was so strong.  I went to a walk in clinic at day 10 because I was worried.  They sent me for an ultrasound of that arm and arteries to make sure there wasn't a blockage on day 11 after vaccine.  They didn't find anything.  I then made an appointment with my family doctor who did bloodwork and didn't find anything.  I also went to my cardiologist who did an EKG and didn't find anything.  All of my physicians think this is just my bodies reaction to the vaccine.  Over the months since getting the vaccine, the heartbeat issue has lessened but I'm now having tingling  and light numbness all down the inside of that same arm into my thumb, forfinger and middle finger.
headache, body ache, lethargy, fever; headache, body ache, lethargy, fever; headache, body ache, lethargy, fever; headache, body ache, lethargy, fever; This is a spontaneous report from a contactable other health care professional (Patient). A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:00 as dose 2, single for Covid -19 immunization at Nursing Home/Senior Living Facility. No Covid prior to vaccination. The patient medical history was not reported. No known drug allergies reported. Concomitant medication(s) in two weeks included fluoxetine (FLUOXETINE). No other vaccine taken in four weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number), via an unspecified route of administration, administered in Arm Left on 12Jan2021 09:00AM as dose 1, single for Covid -19 immunization. On 03Feb2021 06:00, the patient experienced headache, body ache, lethargy, fever. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: unknown results on 05Feb2021 [{covid test type post vaccination-Nasal Swab, covid test date-05Feb2021, covid test result-Pending}]. No treatment received for the events. Outcome of events was not resolved.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Felt like a very strong flu without high temperature,; Whole body was sore and in pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like a very strong flu without high temperature,) and MYALGIA (Whole body was sore and in pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INFLUENZA (Felt like a very strong flu without high temperature,) and MYALGIA (Whole body was sore and in pain). On 24-Apr-2021, INFLUENZA (Felt like a very strong flu without high temperature,) and MYALGIA (Whole body was sore and in pain) had resolved.            Patient transferred from Customer Care (case#00163238) got both doses of the Moderna vaccine and wants to know if it safe to take prednisone for poison ivy after receiving the vaccine. First dose was on 20Mar2021 and second dose was on 23Apr2021 (lot#045B21A), both on the left arm. Patient mentions after getting the first dose the had a sore arm, with a little pain for 12 hours. after getting the second dose the felt like a very strong flu without high temperature, and their whole body was sore and in pain, for about 12 hours. Patient provides consent for Safety to follow up.   This case was linked to MOD-2021-118176 (Patient Link).
See attached progress notes. 12/29/2009 MR received for 2 office visits.  Pt presented 11/6/08 with c/o bilateral extremity weakness, weakness of the hands and feet and ataxia, difficulty walking and numbness to the abdomen. Recently tx for Community Acquired Pneumonia 11/2/08. PE (+) for rhonchi, decreased strength in arms, legs and hips, weakness both ankles, ataxic gait and diminished or absent reflexes. Assessment:  Muscle weakness-hands and feet x 2 days with truncal numbness.  No resp issues.  Sent to Er to r/o GBS.  Community acquired pneumonia. Labs and Diagnostics: CXR WNL. CBC with Hgb 36.6.  Hct 12.6.  Platelets 445. F/U visit for DX: Guillain-Barre Syndrome 11/25/08.  Pt reports still feeling weak, having trouble walking, paresthesias in legs, facial numbness. Unable to open mouth or close R eye. PE (+) for mild R peripheral VII paresis. DX:  Bell's Palsy. F/U 12/2/08 Sx improving but not completely resolved. 2/11/09 MR received for DOS 10/29-11/2/2008, 11/7-12/2008 and 11/12-20/2008 with initial DX of Pneumonia then Guillain Barre Syndrome. Pt initially presented with 5 day hx of worsening cough with yellow sputum, nasal congestion, vomiting and chills. DX with pneumonia and treated with abx.  Also reported knee and ankle pain. Infiltrates improved with abx and d/c on 11/2/08.  Returned 11/7 with c/o numbness/tingling  in his fingers and feet progressing to the thighs and difficulty walking.  Admitted and tx with IVIG with improvement. Able to walk with cane. Transferred for further rehab 11/12/08.
headache; experienced flushing; light headed; This is a spontaneous report from a contactable Consumer (Patient). A 51-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown single Solution for injection, Lot number EN6203) via an unspecified, route of administered in Left arm on 27Feb2021 11:15 AM (at the age of 51-years-old) at a single dose for COVID-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included asthma, Known allergies cephalosporins, erythromycin, sulfa and concomitant medications included Allegra, Symbicort, Nexium, Flonase (medications in two weeks). On 27Feb2021 11:30 Within 10 minutes patient began to have a headache, began feeling light headed and experienced flushing. EMT checked and O2 was 97, heart rate 82, BP was 132/78. No wheezing or swelling. Patient had no treatment. Patient did not test the COVID-19 test prior vaccination and Not tested covid post vaccination.  Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Fever, chills, tingling in the lips, throat swelling, hives, high blood pressure, coughing, asthma attack.   The lip tingling was within 30 minutes of my vaccine, and continued for 2 weeks.  Throat swelling lasted the first week.  Hives lasted 1 week 4 days. Coughing started on day 3 and lasted 3 days. Asthma attack happened one time, during the coughing phase.  High blood pressure started the evening of the vaccine and has continued. Doctor has prescribed a low dose of blood pressure medication to help combat it. Fever and chills started on the first day and lasted through the second day.
Headache swelling at injection site. Diaphoresis.  Narrative: Per supervisor report: "took his 2nd injection on Monday 3/1/2021 experiencing headache, sweating, swelling at injection site."   Other Relevant History:
The same day as the injection I experienced severe pain a few hours after in my bicep rather than my shoulder where I experienced pain during the 1st vaccine dose. I also experienced the common fatigue. However, at 12:13a.m on May 25th, I was woken from sleeping to what can only be described as either the most severe case of the shakes that have ever been experienced, or convulsions. I was unable to move, speak, and could hardly breathe. The effects of this lasted well over an hour and a half. It was only after what I was experiencing stopped, that I suddenly became burning hot, but did not have a fever. 98.7° was what was read at the time I started to feel hot. Since then I have experienced severe joint and knuckle pain on my left hand, still bicep soreness, pain in my left forearm, again joint and knuckle pain in my left hand, and headaches.
Headache, Myalgia, Arthralgia, NauseaVomiting, Chills, fatigue Narrative:
No symptoms or additional adverse effects reported.; patient received unspecified dose in PROQUAD that was improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 06-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, as prophylaxis (lot number S021328 which has been verified to be valid, expiration date reported and validated as 05-JAN-2021) (dose, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of 67 degrees Fahrenheit, during a time frame of 17 hours, as recorded by a digital data logger. There was no previous temperature excursion. No symptoms or additional adverse effects were reported in the patient.
Injection site is hot to the touch; Can barely walk because his entire body hurts; Body aches that progressively worsened; Has no appetite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is hot to the touch), GAIT INABILITY (Can barely walk because his entire body hurts), PAIN (Body aches that progressively worsened) and DECREASED APPETITE (Has no appetite) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hot to the touch), GAIT INABILITY (Can barely walk because his entire body hurts), PAIN (Body aches that progressively worsened) and DECREASED APPETITE (Has no appetite). At the time of the report, VACCINATION SITE WARMTH (Injection site is hot to the touch), GAIT INABILITY (Can barely walk because his entire body hurts), PAIN (Body aches that progressively worsened) and DECREASED APPETITE (Has no appetite) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.1 (High) 100.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Ibuprofen, Acetaminophen.
shingles; Rash has developed since receiving the vaccine; Feeling quite sore; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A 47-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as an unknown dose number, at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. It was also reported that rash has developed on an unspecified date since receiving the vaccine and that the patient was feeling quite sore. The patient was due to attend her physician on 13May2021.The outcome of the events was unknown. The event shingles was considered as medically significant.  No follow up attempts needed.  No further information expected.
Exhaustion  Headache Lightheaded/dizzy  Nausea Fainting
Starting pretty soon after my vaccine, my arm became tender and I started experiencing mild joint pain. By that night the joint pain in the shoulder where I?d received the injection, the pain was severe and my mobility was impacted drastically. The pain has not really decreased (48 hours later). My mobility is extremely limited and I can?t bear body weight on my arm without very intense pain.
generalized malaise, fatigue, intermittent abdominal pain, nausea, vomiting, diarrhea.  Her GI symptoms happen occasionally.
dizziness, lightheadedness, flushing to chest and face, pre-syncope, BP 190/100
The injection was administered intramuscularly in the right deltoid using a 1 inch needle. The acromion process was palpated as site reference and injection given below acromion in dense portion of deltoid muscle. The site was visualized when patient presented to clinic today and was unremarkable. Patient reports pain and discomfort in right upper arm upon pressure and position changes. Pt relates discomfort to injection and has sought medical attention through two physcians. The initial provider was seen approximately one month ago and patient was treated with anti-inflammatory medication that produced no relief per patient. The second provider offered her a shoulder x- ray of which she declined.
Pt. states that after receiving the 3rd dose of Moderna 01/19/2022, started experiencing symptoms that evening of slightly raised rash with itchiness located on the abdomen. Primary  visit 01/20/2022 with recommendations of use of Benadryl.
covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 09:00 as dose 1, single (Lot number: EN6200), in left arm, on 12Apr2021 at 09:15 as dose 2, single (Lot number: EP7588), in left arm and on 11Nov2021 at 09:15 as dose 3 (booster), single (Lot number: 8020) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Meniere's" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim"; Levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: Took paxlovid 29May2022 for covid.and tested negative one week later; (12Jun2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: No other medication in 2 weeks. Took paxlovid 29May2022 for covid. She took paxlovid on 31May2022 till 04Jun2022 and tested negative one week later. 12Jun2022 tested positive again.  No follow-up attempts are possible. No further information is expected.
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6205, Expiration Date: not reported), via an unspecified route of administration on 04Mar2021 at 09:15 (at the age of 40 years old) as first dose, single for COVID-19 immunisation in a Pharmacy or Drug Store.Medical history included high blood pressure from an unknown date. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines in 4 weeks, has no known allergies and prior to vaccine the patient was not diagnosed with COVID-19. On 04Mar2021 at 14:00 (reported as 02:00PM), the patient experienced sore arm. No treatment was received for the adverse event and since vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.