chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; The patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005505: US-009507513-1905USA005504: US-009507513-1905USA005507: US-009507513-1905USA005503:
The injection site is swollen and hot to the touch. The size of the swelling is the size of my palm and protrudes about 1". It is very tender to the touch. Fever, chills, body ache and headache. Improved with Tylenol. Experienced some dizziness. In the evening,  Vomited, but after the initial episode, it ceased.
Arm is killing her this morning; A spontaneous report (United States) was received from  a nurse on 28 Dec 2020 concerning an adult female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm is killing her this morning with the use of mRNA-1273.    There was no medical history or concomitant medications provided.  On 27 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient, experienced the non-serious event of arm is killing her this morning. There was no treatment information provided.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of arm is killing her this morning was not reported.   The outcome of the event was unknown,.; Reporter's Comments: This case concerns a female patient, who experienced event of arm is killing her this morning. The event occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 5 year old male patient. On 16-JUL-2014 at 12:46 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
911 called to patients house for trouble breathing and abdominal pain. Patient coded, wife presented DNR paperwork. Patient presented to Hospital DOA at 0958.
Student was given Hep B #2 at school. Several hours later she noticed her lips were puffy and burned the next day there were several sores around her mouth. Saw physician who advised not to have hep #3.
For about 8 hours on the day after I received the second shot, I experienced sweats (no chills) and (possibly) a fever.  I felt slightly achy and tired. I did not have pain at the injection site or any difficulty lifting my arm.
05/18/18 6:09pm. Per patient lump on left arm about 2 inches in size, a little redness, no red streaking. Per nurse advised take Ibuprofen, use cool compresses for 20 min at a time. No improvement or new symptom to call next day. 06/18/18 Pt. came to office for 2nd dose. Per Pt. to nurse had long lasting reaction to vaccine site red, swollen, warm to touch. Advised to come following day. 06/19/18 Pt seen today. Site warm, dry approx. 3/4 inch hyper pigmented patch, smaller sq pea sized firm knot.
8:35 AM  Throat felt tight, heart pounding (continue allday) 8:45 AM  Headache continued until 4/6/21 9:00 AM Nausea & lightheaded   Sore@ injection site 1:30 PM fatigue-continued thru 4/8 fever up to 100.2 continued thru 4/5 chills, Abd. cramping -muscle aches- joint pain very loose bowels 4/6-8.
Continues Chest Pain , sharpness . Have gone to ER and made appts with Dr. They say it's notmal for teen boys to have chest pain.  It's not normal
Pain in shoulder, unable to lift above the waist.  Fever, chills, headache, body aches, fatigue, sleepiness  All occurring 24 hours after vaccination. No treatment.   Most symptoms passed by day 4
This case was reported by a nurse and described the occurrence of elevated creatinine kinase in a 36 year old female pt who received Lyme disease vaccine recombinant (Lymerix). On an unspecified date the pt received a dose of Lymerix (dose number not specified). The nurse did not state that the pt had been a clinical trial participant. At an unspecified time after receiving the vaccination, in 2004, laboratory evaluations revealed an elevated creatinine kinase level. The nurse stated that, the pt does not have lab values prior to recent work up no way to know when creatinine kinase was first elevated. The outcome of the event is unk.
20 MINUTES AFTER RECEIVING THE VACCINE EXPERIENCED FACIAL NUMBNESS ON THE LEFT SIDE (SAME SIDE RECEIVED VACCINE ON). NUMBNESS PERSISTED FOR SEVERAL HOURS. NUMBNESS FULLY SUBSIDED OVER 12 HOURS AFTER ONSET. PRESCRIBED OTC ADVIL TAKEN ORALLY EVERY 6 HOURS.
Injected full dose of Pfizer vial (1.8 mL) into patient instead of correct dose (0.3 mL). Unknown adverse effects.
Within minutes of receiving injection blood pressure dropped, lost consciousness, and experienced muscle spasms in left arm (injection site) which was witnessed by spouse.  Woke moments later with nausea and cold sweat/chills.  Tended to by EMTs and left facility after 45 minutes of observation.
This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA, intramuscular after being improperly stored at 33F. No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 27-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Severe pain in lower back/pelvis area shooting down around hips to legs. Starting around March 23rd which increasing got worse. Unable to use 2 aleve and tylenol along with stretching, ice packs and epsom salt soaks to ease pain. Went to see primary on 4/8. Ordered blood work after initial exam. Blood work came back inconclusive. Xrays of the lumbar and spine were ordered. Showed extensive scacroilac inflamation/mass on the left side. Was ordered prednisone for 14 days which starts today.
Headache, Fever (100), body aches, cold chills.  Lasted about 24 hours no treatment
Swollen Lymph node in the armpit (4/2/1) starting the night of the vaccine shot and last for 24 hours; Swollen Lymph node in the armpit (4/2/1) starting the night of the vaccine shot and last for 24 hours, some inflammation after that for a couple more days.; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via intramuscular route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, etonogestrel (NUVARING) for unknown indication on unknown date and unknown if ongoing. The patient previously took clavulanic acid (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced swollen lymph node in the armpit which measured 4inches/ 2inches /1inch, starting the night of the vaccine shot and lasted for 24 hours and some inflammation on an unknown date in Apr2021 after that for a couple more days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node in the armpit which measured 4inches/ 2inches /1inch, starting the night of the vaccine shot and lasted for 24 hours was resolved on 15Apr2021, while that of some inflammation after that for a couple more days was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Noticed lips, chin and inside of mouth beginning to swell, all on left side of face. Swelling later went to eye, also on the left side, and swelled shut.   Skin was red and puffy both around my mouth and eye. Took Allegra and went to local urgent care.  Facility was so full of COVID patients that we felt uneasy there and left to come back home, as swelling was resolving itself after about two hours near my mouth.  Eye is still somewhat swollen.  Clearly an allergic reaction of some sort.  I felt a lighter version of the same thing, also on the left side of my face after the first vaccine, but convinced myself that it was nerves and so I didn't mention it to the nurse before getting the 2nd vaccine.  Clearly, I should have, as it was probably the same problem I experienced today.
Immediately after administering the vaccine, she relaxed her body and leaned forward into mom's arms. She then fell back onto the exam table and lost consciousness for approximately 10 seconds. I attempted to lay her flat and raise her legs, but before I could do so, she came to and I sat her up on the exam table. She opened her eyes and looked pale; while her heart rate was rapid, she had normal pulse oxygenation and her heart rate returned to normal within another minute. Her color returned by now. I got her water. She stayed for total approximately 5 minutes after event. She was walked out of clinic w/ mine and mom's assistance. She had no further events per parents. She was very anxious leading up to the administration of the vaccine.
FEVER; VOMITING; MUSCLE WEAKNESS; HEADACHE; SORE THROAT; A spontaneous report has been received from a consumer via the regulatory authority concerning a 10 year old female patient with height of 148 centimetres and with weight of 32 kilograms.    No medical history was reported. No concomitant products were reported.    On 27-Nov-2019, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) 0.2 ml unknown, via nasal route, for flu vaccination.     On 30-Nov-2019, the patient experienced sore throat (preferred term: Oropharyngeal pain) and headache (preferred term: Headache). On 01-DEC-2019, the patient experienced fever (preferred term: Pyrexia), vomiting (preferred term: Vomiting) and muscle weakness (preferred term: Muscular weakness).     At the time of reporting, the event of fever, sore throat, vomiting, muscle weakness and headache was ongoing.     The events were considered serious (disability and important medical event) by the reporter.; Sender's Comments: Oropharyngeal pain, vomiting and muscular weakness are not listed in the company core data sheet for Q/LAIV (Fluenz Tetra). Pyrexia has been associated with use of LAIV in children but not in adults.  Due to limited information on concurrent diseases, concomitant medication, relevant medical history, risk factors (respiratory infections), etiologic and diagnostic workup, it is not possible to make conclusive assessment of causal relationship of events with suspect drug.
lt sided numbness early demyelinating disease likely secondary to vax; severe h/a, early diabetes;
pt recvd vax & 1oct94 had HA like beginning migraine; 2oct94 muscle aches (back, neck, legs); fever 101; tx w/ apap; stomach dis; 4oct94 sxs resolved xcept for muscle aches; 6oct94 rash devel on face & neck; red blotchy skin; raised nodules
Patient stated she felt 'weird" and confused with tingling in left arm. Stated she felt clammy. patient felt better after 1 liter of IV fluids at 17:36pm
Left knee pain; Headache; Much pain in the lower part of her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Much pain in the lower part of her back), ARTHRALGIA (Left knee pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     The patient's past medical history included Varicose veins, Clot blood and Surgery (Surgery for blood clots 12 years ago) in 2009. Concurrent medical conditions included Pain and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced BACK PAIN (Much pain in the lower part of her back) and HEADACHE (Headache). In August 2021, the patient experienced ARTHRALGIA (Left knee pain). On 29-Jul-2021, HEADACHE (Headache) had resolved. At the time of the report, BACK PAIN (Much pain in the lower part of her back) and ARTHRALGIA (Left knee pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant product use included medications for pain.   Patient also treated with steroids to treat knee pain.  Patient experienced headache that went away that same day and in the night had much pain in the lower part of back. Four days ago received an injection of steroids in left knee to treat pain.   The patient was scheduled for second dose on 26-Aug-2021 and wanted to know if should take it given that had this steroid injection before.
pt recvd vax; noted rash on 19mar95 on both forearms, itching; seen in student hlth by MD; tx w/ dph, afebrile;
Initial report received from a patient's parent on 9/2/05. An 18 year old male patient with no significant past medical history, had received an IM injection of Menactra, lot number U1656AC, on 8/4/05. 28 days later the patient woke up and was unable to move the left side of his face or close his left eyelid. He also had pain behind his left ear. The patient was seen by a neurologist and was diagnosed with Bell's Palsy. At the time of this report, he had not recovered from these events. (OMIC)
pain in upper arm and shouder-lt, severe pain in rt-could not move arms, fever
Bat in house 2/3. Called 2/5-received rabies series. Received RIG + Rabavert on 2/5, then Rabavert alone 2/8, 2/12, 2/19. Day after last dose lymphadenopathy (resolving) with headache (gone) and fatigue persisting. I am aware all can occur after vaccine. However, has dyspnea on exertion too (stairs, singing) despite being very physically fit.
1 day p/inj pt noticed redness & pain rt deltoid findings rt deltoid 2-3" round, red, firm, hot, tender, 2 days p/inj;referred to hosp dx inj cellulitis;
PATIENT RECIEVED PFIZER 1/8/2021. HE COMPLETED SERIES WITH MODERNA ON 4/30/2021. LOCATION DOES NOT OFFER PFIZER.
At least once a month I experience COVID like symptoms (minus congestion) for 24-72 hours.  Joint pain, headache, fatigue, and shortness of breath. This has been going on since May.
Pt c/o myalgia, upper left arm since 2nd Moderna vaccine administration.
Pt reports he had an extreme headache, severe chills, pain at injection site & nausea.
18JUL98 started running temp, not feeling well;22JUL had rash on cheeks that subsided p/2 days;devel gen non-raised red rash;felt hot all over x 4 days;did not check temp;saw MD on 26JUL98;stated it was from shots;
Information was received on 13-JUL-2017 from a medical assistant who was reporting on a female patient of unknown age. No concomitant medications or medical history was reported. On 13-JUL-2017, the patient received a dose of MMR II (lot L024268, expired 01-JUL-2017) (dose, route and site not reported) for prophylaxis, that was expired and was reconstituted with sterile diluent (lot M028330, expires 24-FEB-2019) that was not expired. No adverse effects reported. No other information was provided. Additional information has been requested.
Weakness in legs. This occurred during the 1st and 2nd dose to the point of unable to stand. Symptoms disappeared within 24  hours.  Please be advised that patient had previously tested positive for Covid.
positive COVID test; positive COVID test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: EW0171) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW051), administration date: 14Apr2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: Mar2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "recovering" and all described as "positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Pt received AFLURIA vaccination on Tues, Oct 12 at about 11:00 am along w/six other patients. She called & reported: shaking, lightening bolts up my arm thru my head, "had" fever & face look like someone punched me.
Right arm swollen, tight, red at injection site. Tx: ice packs, Motrin
muscle joint pint in the fingers on left hand; Feeling shaky and cold; Feeling shaky and cold; HR 100s; SBP 147; left arm started to have tingling sensation. the sensation got worse as the minutes passed/tingling on right side of the face below eye; This is a spontaneous report from a contactable Nurse. A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular (left arm, dose 1) on 05Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks.  The patient previously took rocephine and experienced rash. On 09:03, patient received vaccine. On 09:07, left arm started to have tingling sensation. the sensation got worse as the minutes passed. On 0930; vital signs were taken (SBP 147, HR 100s). On 09:40, second set of Vitals (SBP 117, HR in the 80s). On 1028, tingling on right side of the face below eye. On 10:38, tingling on the face got better. Feeling shaky and cold. On 11:15, muscle joint pint in the fingers on left hand. On 13:30, most of the symptoms disappeared. Tingling on left arm still present mostly on in the tip of fingers and inner aspect of the forearm that comes and goes. Symptoms are not as bad as the first 50 minutes into the vaccine. Events occurred on 05Jan2021. No treatment was given. Since the vaccination, the patient has not been tested for COVID-19. Event outcome was recovering. The reporter considered the events as non-serious.
shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to an approximately 72-year-old (also reported as 70-year-old, conflicting information) male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis, at medical center. As a result of his receipt of zoster vaccine live (ZOSTAVAX), on an unknown date in 2015, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. He was informed and believed and further alleged that he will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, he requires and will continue to require healthcare and services. He has incurred and will continue to incur medical and related expenses. The patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. He has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter determined the shingles to be disabling.