chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Infant received HIB #1, Prevnar #1, Pediarix #1.  Started to show sytmptoms of vasovagal response but then moved into very shallow, slow respirations.  Thready pulse by brachial check.  Become bluish purple.Infant then arched back and tremored slighty.  This RN immediately called for ER kit and 911 service.  MOC was obviously upset and crying "my baby isn't breathing".  This RN immediately began monitoring pulse and respirations asked staff to comfort MOC.  Pulse and Respirations started to return to more stable however color still extremely bluish gray.  Limp and not easily arrounsed.  B/P 82/64 and pulse back to 100 when paramedics arrived.  Oxygen provided and infant then transported to the hospital.
diarrhea that self resolved 18hrs after injection.  diarrhea exactly 7 days from injection that also self resolved.
This spontaneous report was received from a consumer, the aunt of the patient, refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot # were not reported). The patient was pregnant when she received GARDASIL. The patient LMP (last menstrual period) and EDD (estimated day of delivery) was not reported. The outcome of pregnant when she received the GARDASIL vaccine was unknown. Additional information is not expected because no reporter details were provided.
Nausea Patient brought in to medical screening for evaluation by medics. Left on stable condition at 09:59. Vital signs at 9:47 BP 81/54 at 09:55  HR : 64    BP: 100/59
Itchiness all over her body that lasted 18-24 hours, patient still wanted to receive the second series of Shingrix, so the second shot was administered on 12/30/2020 with 1 tab of Claritin 5 minutes before injection.
I lost my sense of smell. As of the date of this report I have not regained my sense of smell.
swollen right eye; warm; red spot; egg-sized lymph node on the right side of her neck where the clavicle bone is located; hard; headache; Patient says they are feeling achiness; chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swollen right eye), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red spot), LYMPHADENOPATHY (egg-sized lymph node on the right side of her neck where the clavicle bone is located) and VACCINATION SITE INDURATION (hard) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache), MYALGIA (Patient says they are feeling achiness) and CHILLS (chills). On 03-Feb-2021, the patient experienced EYE SWELLING (swollen right eye), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red spot), LYMPHADENOPATHY (egg-sized lymph node on the right side of her neck where the clavicle bone is located) and VACCINATION SITE INDURATION (hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (swollen right eye), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red spot), LYMPHADENOPATHY (egg-sized lymph node on the right side of her neck where the clavicle bone is located), VACCINATION SITE INDURATION (hard), HEADACHE (headache), MYALGIA (Patient says they are feeling achiness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
This spontaneous report was received from a registered nurse referring to a 48 year old male patient who on 29-MAR-2013, was vaccinated with a dose of PNEUMOVAX 23 (lot # H017759, expiration date 04-JUL-2014) 0.5 ml, subcutaneously. On 02-JUN-2013, the patient called the physician's office to report a high fever, redness and swelling at injection site and shortness of breath. Because of the shortness of breath, the physician's office advised this patient to go further information evaluation by the emergency room staff. It was unknown if the patient would be admitted to the hospital after the emergency room evaluation. The outcome of shortness of breath, redness and swelling at injection site and high fever was reported as not recovered/not resolved. Causal relationship between PNEUMOVAX 23 and shortness of breath, redness and swelling at injection site and high fever was unknown. Additional information has been requested.
I was present to witness a man who received the monkeypox vaccine a few minutes beforehand briefly lose consciousness while in the observation area. I observed him slowly fall to the ground from being seated in a chair. I rushed over to the individual, where for the first few seconds he did not respond to verbal stimulation. He then was quickly arousable and was able to sit upright on the ground. He was aware of his surroundings without any evidence of injury, and remained for an additional 30 minutes to be observed. An emergency department RN came out to evaluate the patient, and did a brief exam. The patient was offered but declined evaluation in the emergency department. They stated that they had passed out from needles in the past. He was accompanied by a friend to their place of residence.     MD
Patient reported that within an hour had tingling in left pinky and right hand. Patient has continued pins and needles in both arms and tingling on the tongue. Patient reports a sensitivity to heat an; has continued pins and needles in both arms and tingling on the tongue. Patient reports a sensitivity to heat an; sensitivity to heat; difficulty when moving extremities; difficulty when moving extremities; tingling on the tongue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jul2021 12:00 (Lot number: fa7484) at the age of 52 years 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: PARAESTHESIA (non-serious) with onset 29Jul2021, outcome "not recovered", described as "Patient reported that within an hour had tingling in left pinky and right hand. Patient has continued pins and needles in both arms and tingling on the tongue. Patient reports a sensitivity to heat an"; PARAESTHESIA (non-serious) with onset 29Jul2021, outcome "not recovered", described as "has continued pins and needles in both arms and tingling on the tongue. Patient reports a sensitivity to heat an"; TEMPERATURE INTOLERANCE (non-serious) with onset 29Jul2021, outcome "not recovered", described as "sensitivity to heat"; MOVEMENT DISORDER (non-serious), DYSKINESIA (non-serious) all with onset 29Jul2021, outcome "not recovered" and all described as "difficulty when moving extremities"; PARAESTHESIA ORAL (non-serious) with onset 29Jul2021, outcome "unknown", described as "tingling on the tongue". The events "patient reported that within an hour had tingling in left pinky and right hand. patient has continued pins and needles in both arms and tingling on the tongue. patient reports a sensitivity to heat an", "has continued pins and needles in both arms and tingling on the tongue. patient reports a sensitivity to heat an", "sensitivity to heat", "difficulty when moving extremities", "difficulty when moving extremities" and "tingling on the tongue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of paraesthesia, paraesthesia, temperature intolerance, movement disorder, dyskinesia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that within an hour had tingling in left pinky and right hand. Patient has continued pins and needles in both arms and tingling on the tongue. Patient reports a sensitivity to heat and had to adjust water heater in order to shower. Also reports difficulty when moving extremities that does not appear to be resolving. Patient had an appointment with a nurse practitioner and was prescribed meloxicam with little to no resolution of symptoms. Patient received treatment of Meloxicam.  No follow-up attempts are possible. No further information is expected.
Welts appeared 1/19/2022 on arms, back, neck, buttocks, legs and hand. This continues to come and go with the use of Benadryl to alleviate the welts and itching. Have not sought medical treatment yet.
Severe lower leg pain that lasted at least 12 hours. Pain subsided after about 12 hours.
Started running a fever of 100.4 the day of the shot. the fever would go up and down but never below 99.4. Arm very painful  and running fever for 2 days now. I just now noticed a knot on the right side of my neck,(this was also the side of the injection). I called the Pharmacist and my family doctor about the fever and chills because I thought I may have caught the flu but they both told me it was a reaction to the shot. They are both closed for the day so I could not call them to tell them about the swelling in my neck.  I don't know if this is usual in the Shingle shot but I didn't have this reaction with the first injection back in May,2019.
Headache, body aches, high fever, pain in entire arm on side of injection (left arm), unable to move arm due to extreme throbbing pain, gradually regained use of arm over the next four days, pain radiated into shoulder and upper neck area, felt extremely sick and nonfunctional for about three days. Applied heat to sore arm and took Tylenol for fever and pain.
1st on 3/4/2019 and 2nd on 2/6/23; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KR4T, expiry date 21st May 2024) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on 4th March 2019 from lot number 7L355 and expiry date 28th August 2021).   On 6th February 2023, the patient received the 2nd dose of Shingrix. On 6th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: Pharmacist called to inquire and asked how to proceed. The reporter stated that the it had been long between first and second dose of the Shingrix vaccine. The reporter wanted to know does the patient need to restart series. Did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended time frame, which led to lengthening of vaccination schedule.
This spontaneous report was received from medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # M001578 with expiry date: 21-NOV-2018, (dosing details not reported). No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt states  05/22/2021 ER visit,  mult-pulmonary clots in both lungs, also blood clot found in left leg. Hemoglobin 6.2, blood transfusion, 75 O2, 06/04/2021 ER visit 4 days of observation hospitalized. Per Dr. 2 months out of work.
Continuous pain on site of injection. Reduced range of motion. Patient's physician has recommended physical therapy.
needle broke up and patient had half the dose; Vaccine was administered after 36 days from first vaccination; needle broke up and patient had half the dose; This spontaneous case was reported by a medical assistant and describes the occurrence of NEEDLE ISSUE (needle broke up and patient had half the dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered after 36 days from first vaccination) and ACCIDENTAL UNDERDOSE (needle broke up and patient had half the dose) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 061B22A and 927B21A) for COVID-19 vaccination.     It was reported that patient had no allergies, not had COVID  test or diagnosis, no acute and chronic illnesses at the time of vaccination.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 15-Sep-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .25 milliliter. On 15-Sep-2022, the patient experienced NEEDLE ISSUE (needle broke up and patient had half the dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered after 36 days from first vaccination) and ACCIDENTAL UNDERDOSE (needle broke up and patient had half the dose). At the time of the report, NEEDLE ISSUE (needle broke up and patient had half the dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered after 36 days from first vaccination) and ACCIDENTAL UNDERDOSE (needle broke up and patient had half the dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient administered 0.5ml (Intramuscular) dose of Moderna Pfizer Johnson and Johnson. No treatment medication were provided.
Pulsatile tinnitus in left ear that began shortly after getting vaccinated. Increased in intensity. I did seek care with an ENT physician and ultimately got an MRI and CT to look for an anatomical cause of this.
the side effects just other than and pain and stiffness in the arm; the side effects just other than and pain and stiffness in the arm; Chills; fatigue and tiredness; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for two patients. This is the second of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Feb2021, four days after vaccination, it was reported that the patient experienced chills, fatigue and tiredness and it better overnight. It was also reported that the reporter want know the side effects just other than pain and stiffness in the arm after four days which started on an unspecified date. The outcome of the events chills, fatigue and tiredness was recovered overnight on 02Feb2021 while for the other events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147760 same reporter, suspect vaccine, events; different patient
Flucelvax flu vaccine given to 17y.o. patient.  Approved age for Flucelvax is 18 and older.
Approximately 8 hours after vaccination patient reports onset of mild body aches, strong chills, dizziness, and extreme fatigue with a lasting duration of about 24 hours.  At approximately 36 hours body aches lessened.  At 36 hours mark - pt reports less body aches, while dizziness, chills and extreme fatigue continued.  Patient also reports an incident of sleepwalking, ( did state that she did this as a child up to around age 10.  As of 04/04/2022 @ 8:30am - pt stated " I don't feel normal", but no further chills or body aches reported.  Reports some dizziness, mostly c/o "weakness".
began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face
HEADACHE, FATIGUE, ACHIE,FEVER,CHILLS,TIRED.FOR THE PASS THREE WEEKS HAD TO GO TO MD STATE FEEL REAL WEAK. CLIENT WENT TO MD.FOR LAB. WORK
Came in 3-9-09 with 101-102 degree fever for 5 days previous r. nose cough & 15 "spots" on torso. Mother called 3-10-09 to report at least 100 more "spots" that itch - no fluid in pustules. DX: Atypical Chicken Pox
Symptoms: Severe chills, sweating, extreme fatigue, headache, bizarre dreams, restlessness, and wheezing.  Treatment by doctor: Rest, albuterol, acetaminophen and ibuprofen.  Outcome: Symptoms diminished 80% after 48 hours.
Information has been received from a licensed practical nurse concerning a pt in their mid 60's who was vaccinated IM into the deltoid muscle with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (649914/0578P). On approx 19Jul05 over this past week, the pt experienced localized redness and localized swelling that looked like cellulitis from the deltoid area down to the elbow and inner arm. The pt was seen in the clinic and was treated with cephalexin (Keflex). In about 4 days, the reaction resolved. No product quality complaint was involved. Additional information has been requested.
The patient felt lightheaded and fainted. Quickly brought him in to sit down and checked his blood pressure and gave him a cup of water. BP was 106/66. The patient looked a bit pale so orange juice was given to him. The patient was observed for about 15mins before his parents picked him up.
Immunizations given and pt observed x 15 mins after shots. S/S of adverse reaction. Mom states later, one day developed hard red nodule on right thigh at injection site of Varivax. Child also received Comvax and PCV in same leg and did receive Wyeth Flu vaccine.
Rash - first noticed on stomach area and back area. Then began to travel to neck, under arms, legs and feet. Also on hands as of late Sunday afternoon.
Pt is a 49 YO Female presented with severe anxiety upon initial contact with medical observation physician.  After some coaching and sitting with physician pt decided to get the vaccine and physician gave approval.  Pt then proceeded to booth 9 and a paramedic gave pt her 1st does of the Pfizer vaccine.  Pt was still very anxious but agreed to continue with the vaccine injection. After injection was given pt stayed in booth for an addition 10 minutes with the paramedic.  Pt was coached to take slow deep breathes in order to get her breathing under control.  After pt started to calm down, she was asked if she was ready to proceed to medical observation for her 30 preset time. Pt agreed and we walked to the observation tent.  Pt was transferred to the observation unit team for the next 30 minutes. At approximately 1410, the paramedic was alerted that pt was having an adverse reaction and needed to be medically assessed. The paramedic immediately proceeded to patient with medical equipment given by facility.  Upon assessment pt presented A&OX4, very anxious, skin flushed, complaining of dizzy, lightheaded, and a headache. Pt was speaking normally and vitals were assessed.  Vitals are as follows: At 1418- BP 186/110, HR102, RR26, SPO2 99% Lung sounds clear in all fields, Skins: hot, flushed, moist; At 1427- BP 196/116, HR 99, RR 24, SPO2 98% Lung sounds clear in all fields, Skins hot, flushed, moist. PT was then assessed for possible stroke and was negative slurred speech, negative arm drift, pt had symmetrical smile, and equal grips bilaterally. The decision at that point was made by the paramedic to activate the EMS 911 system for further evaluation and possible ALS ambulance transport to the hospital for further evaluation by emergency physicians. After EMS arrived and assessed the patient, they agreed the patient should be transported to the ER and pt was transported to local hospital, Pt care was transferred to responding paramedics and pt contact ended at that point. Report was given to responding paramedics.
Patient experienced chills, hot flashes, weakness, diarrhea for two days. These symptoms have now stopped but have an itchy rash that appears intermittently. Patient was instructed to get immediate medical attention from her PCP. 12/27/01 Patient stated that she received an injection-type unknown, Medrol dose pack and Ativan from her PCP.
Woke up unable to breathe, had horrible chest pains and a burning sensation and time I tried to breathe. I checked my heart rate on my watch and it was at 124-133 all day on Saturday. I could not lay on my side or sit up without it getting worse.
Received the first dose on 16Jan2021 then tested positive for COVID on 30Jan2021; Received the first dose on 16Jan2021 then tested positive for COVID on 30Jan2021; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 16Jan2021 as single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported.  The patient received the first dose on 16jan2021 then tested positive for COVID on 30jan2021. The reporter wanted to know when the patient should receive the second dose. The outcome of the event was unknown.  Information about Lot/batch number has been requested.
Received vaccine 3:40 afternoon of March 15.  Woke up 6 AM March 16 with hive-like rash on legs, arms, buttocks.  Took Benadryl and by 3 pm in the afternoon, rash was gone.  Developed sore arm, hot, itchy, swollen lasting 9 days after vaccine and spreading daily from injections site around to inside of arm.  Used ice.
Information has been received from a nurse practitioner concerning a patient who on approximately 02-NOV-2007 "sometime last week" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On approximately 02-NOV-2007 the patient experienced a localized adverse experience at the injection site that involved pain and a lump. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
The day after the first vaccine, I had a sore left arm. After the second vaccine, I had sore left, lower back pain, and fatigue for a few hours the day after the injection. On 4/12/2021, I started having pretty strong heart palpitations. It felt like fluttering. The next day, the palpitations were extremely strong and I couldn't get a good breath. I had difficulty talking and concentrating. The symptoms continued the next day. That Thursday, 4/15/2021, I went to the emergency room. They did a second EKG, which showed premature ventricular contractions (PVC). They did a chest X-ray to make sure I didn't have pneumonia; everything looked fine there. They checked my electrolyte levels in lab work; they were perfect. They sent me home. I did another EKG at my PCP's office later on; it also showed PVC. She ordered me a halter monitor. I had the halter monitor 4/26. I wore it from 4/25 til 4/27. It showed 49,000 PVC; that was considered extremely frequent and necessitated an echocardiogram, which I was scheduled to undergo 5/21/2021. The result of that echocardiogram was normal/clear. Everything has been back to normal since then.
Patient's wife called the physician's office with increasing SOB.  MD advised that the patient go to the ED.  While dressing, the patient became unresponsive, 911 called.  Patient expired in ED.