chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous consumer report (initial receipt 29-Jan-2013) concerns a 61 year old male patient. Concomitant medications included vitamins. On 14-Jan-2013, the patient received AFLURIA (batch P51208) in his right shoulder. On 14-Jan-2013, he noticed a cool sensation going 3-4 inches down his arm. During the same evening he couldn't move arm and needed the assistance from his left arm to accommodate his daily routine. He also had problems sleeping at night time. Two weeks later, the patient's arm is still sore. He states that it is annoying and very disturbing that this pain is still present. The event outcome is not yet recovered.
Per report of patient 1/26/21: Reports swelling of left cheek and dizziness. Visited an urgent care 1/26, given prednisone and instructed to take diphenhydramine.
shingles; She had two shingles episodes; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (1st Shingles episode at age of 32 years). Previously administered products included Zostavax (received on an unknown date years before date of reporting).   In April 2019, the patient received the 1st dose of Shingrix. In September 2019, the patient received the 2nd dose of Shingrix. In November 2019, between 6 and 8 months after receiving Shingrix, between 1 and 3 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported, but it could be 56 years old. The patient had she first shingles episode at the age of 32 years and it presented on her back under her bra strap. The patient  had a history of shingles 2-4 times a year since the first time.   Since it had presented sporadically over the years on her right hip only. The patient received both the doses on the left arm. 1st dose of Shingrix in April 2019.   She had 2nd dose of Shingrix in September 2019.   She had two shingles episodes.   One in November 2019 and the other in December 2019.   Both times it presented on the right hip and the entire area was the size of a half dollar.   The patient received acyclovir and it resolves within 7 days.   In February 2020, last month she felt it coming on and took acyclovir immediately and it did not present.   She also went 6 years without an outbreak years ago. The reporter consented to follow up.
I have fever of 104.  I had backaches, nausea, and vomiting.  I went to ER.  I was hospital 5 days first time and 4 days the second time. They did blood work, CT scan, and x-ray.   I was diagnosed with kidney infection.
Information has been received from licensed practical nurse, and a physician concerning an 11 year old male patient with asthma and no allergies who on 09Aug03 was vaccinated with a dose of varicella virus vaccine live. Concomitant medication included fluticasone propionate (-) salmeterol xinafoate (advair) and albuterol (therapy unspecified). On 26Aug2003 (also reported as yesterday) the pt developed chickenpox (also reported as rash). It was noted that he was seen in the office today, 27Aug2003 (also reported as same day) with about 20 poxes (also reported as 3 lesions on the face, 3 on the calf and 5 on the trunk). He was treated with calamine lotion (therapy unspecified), no other treatment was necessary and no fever. There was no product quality complaint involved. It was also noted that the pt had not recovered. Unspecified medical attention was sought. Additional information information has been requested.
Right arm swelling at site of injection. Red, swollen, warm to touch. Ranging 3 in by 1 in by 1 in. Encouraged mother to place ice pack, give appropriate dose of TYLENOL, and to take temperature and call back if still concerned.
7 days after vaccine I got a rash on left arm at injection site that was red itchy swollen hard and tender to touch. I looked it up and it showed it was covid arm and normal so I treated it at home.  Only other unusual symptom was aching   In the wrist on same left arm  the day after on Tuesday not sure if it was related to the vaccination or not.
Injection site become inflamed, swollen and bump appears right away. I called patient after few hours and patient said that he is fine with no inflammation or swelling .
At 2:27 pm patient c/o feeling dizzy. Vital - BP: 132/78. HR: 106. Nurse practitioner assessed and clear patient. Patient left in stable condition.
Vaccine given 1-28-21. Then on Monday the 8th of February swelling and redness was present when she woke up. Initially swelling was hot and about 2 inches in diameter. Over the next 2 days the skin around the swelling became red and increased the diameter of affected skin by 1 inch. Patient rated swelling about a 3 on a scale from 1-5. Patient went to the doctor on 2-11. Patient said doctor was unsure if patient had an injection site reaction, an allergy or an infection. Patient was started on an antibiotic and a steroid.
She passed away six weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "She passed away six weeks later". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)).  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: She passed away six weeks later
pt recv vax;jaw was clenched & fists were clenched; had glazed expression on face;
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), FEELING COLD (ice cold), FEEDING DISORDER (not able to eat) and PYREXIA (temperature of 101F) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), PYREXIA (temperature of 101F) and CHILLS (chills). On 03-May-2021, the patient experienced FEELING COLD (ice cold) and FEEDING DISORDER (not able to eat). On 03-May-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweat), FEELING COLD (ice cold), FEEDING DISORDER (not able to eat), PYREXIA (temperature of 101F) and CHILLS (chills) had resolved. Not Provided
2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date
temp since 18NOV91 102.5 ax; 21NOV91 temp 101 ax, mom states pt is irritable & has diarrhea; denies cold sx;
Blurred vision; Sensitivity to light; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 19Apr2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced blurred vision and sensitivity to light. The events resulted in doctor or other healthcare professional office/clinic visit. 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 blurred vision and sensitivity to light was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Within seconds of receiving vaccine RN asked client if she was feeling fine as she appeared pale. Client stated "I feel lightheaded". RN signaled lead PHN  assistance. RN set up anti-gravity chair and client was able to transfer self without assistance. Client reported medical history of acute psychosis and schizophrenia, no current medication and allergies to Cipro. PHN  took first set of vitals at 1402: blood pressure 104/70, pulse 65, oxygen sat 99%. PHN observed client start coughing to clear throat and asked client to elaborate new onset. Per client no shortness of breath, denied throat closing, but felt "heaviness over throat, like when you eat popcorn". PHN did not note any swelling or redness on face or neck area, no tongue swelling and client able to speak in full sentences. Client declined blurry vision, headache, or chest pain. PHN offered client Benadryl and client declined due to not having a ride and taking public transportation, per client would wait a few more minutes for symptoms to improve. At 1405 client reported throat feeling not improving and wanted Benadryl, per client "does not like shots and wants oral". At 1406 PHN  gave client Benadryl 50mg PO. Vitals at 1407: blood pressure 100/60, pulse 50, oxygen sat 99%. Per client dizziness same and "throat itch improved". Per client swallowing saliva just fine. Per client had no breakfast this morning, RN brought client juice and client begin to take small sips. At 1410 PHN took pulse manually, 53. Per client is aware pulse and blood pressure run low, and has not followed up with primary provider, but has been seen at ER when she felt chest pain 2 weeks ago. PHN advised client to make appointment with provider. Vitals at 1413: blood pressure 97/73, pulse 54, oxygen sat 99%. Per client dizziness and throat discomfort resolved and stated "I feel tired". PHN Ivonne gave client ER precautions and advised client to follow up with provider. At 1415 PHN reminded client of possible side effect of drowsiness with Benadryl, client verbalized understanding and stated "I live close, bus stop is right in front of my house." Vitals at 1419: blood pressure 110/69, manual pulse 48, oxygen sat 99%. Per client "feeling fine". Denied lightheadedness, headache, blurry vision, shortness of breath or chest pain. Per client wanted to leave. Client left facility with steady gait against medical advice at 1424.
Fever, 102.7 fatigue, nausea, blood (probably myoglobin) in urine Treated with D5 and zofran in primary care office (treatment for any illness where oral intake cannot be maintained or if febrile and unable to maintain calories at home)
For the past few months I've had persistent extreme muscle tightness in my legs.  i walked every day prior to Covid and continued to go for daily walks.  While I have had sciatica problems previously, this is different and now requires that I do consistent stretching at least three times a day to manage.  Even so, the tightness persists, and has become somewhat disruptive of my life/abilities.
Immediate pain and reflex arm jerk as the needle was inserted. After the pain remained and was unable to rotate arm fully. The pain decreased over time but arm is still unable to rotate fully even months later. Unsure when/if arm rotation will return to baseline.
The patient received third/booster dose of BNT162B2; After fourth dose of Pfizer vaccine patient developed fever of 103.1F recorded on oral thermometer in ED; Chills; Tachycardic to 125bpm; Patient received 4th dose of BNT162B2; This is a spontaneous report from a non-contactable physician. A 55-year-old male patient received fourth dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Nov2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The medical history included intellectual disability, supraventricular tachycardia (SVT), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD) and allergy to penicillin which caused reaction of shortness of breath (SOB). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine in four weeks which included influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) on 08Oct2021. The concomitant medications were multiple including paracetamol (TYLENOL) and unspecified NSAIDs, all from unknown dates for unknown indications and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021(at the age of 55-years-old), second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 (at the age of 55-years-old) and third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Oct2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 23:00, after fourth dose of pfizer vaccine, the patient developed fever of 103.1 Fahrenheit (F) recorded on oral thermometer in the emergency department(ED), chills and tachycardic to 125 beats per minute (bpm). The reporter stated that the patient had no prior Pfizer COVID-19 vaccine reactions reported. On 05Nov2021, the patient underwent body temperature test and pulse rate and the result was 103.1F and 125 bpm respectively. On 06Nov2021, the patient underwent SARS-CoV-2 test (Flu/ respiratory syncytial virus (RSV/ polymerase chain reaction (PCR)) and the result was pending. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events included treatment with ketorolac tromethamine(TORADOL), paracetamol (TYLENOL) and unspecified fluids(unknown route of administration). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 103.1F, chills and tachycardic to 125 bpm were resolved on an unknown date in Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After second dose "off the wall" rapid heartbeat.; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heartbeats increased and premature ventricular contractions. Previously administered products included Metoprolol (received on an unknown date, had metoprolol for PVC and slight rapid heartbeat) and Shingrix with an associated reaction of heart rate increased (1st dose received on an unknown date refer case US2020AMR192310).   On 22nd September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 7 hrs after receiving Shingrix, the patient experienced heartbeats increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the heartbeats increased was unknown.   It was unknown if the reporter considered the heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself. The reporter did not have LOT or EXP date. Caller reported that she got her 2nd dose of Shingrix yesterday from the date of reporting. On 23th September 2020, 7 hours later the patient experienced off the wall rapid heartbeat. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR192310:SAME PATIENT (1st dose)
Patient pregnant, last menstrual date: 13May2021, administration date: 22Oct2021; Rash all over face,arms,and chest.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 11:30 (Lot number: FH8027) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 13May2021. The patient was 23 weeks pregnant at the time of exposure to bnt162b2. The patient was 23 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 17Feb2022. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2587, Location of injection: Arm Left, Vaccine Administration Time: 11:30), administration date: 01Oct2021, when the patient was 22 years old, for Covid-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Patient pregnant, last menstrual date: 13May2021, administration date: 22Oct2021"; RASH (non-serious) with onset 22Oct2021 13:00, outcome "recovering", described as "Rash all over face,arms,and chest.". Therapeutic measures were not taken as a result of rash.  Additional information: The patient had past drug history included: (unspecified) drug name and reaction(s): "Allergy".
This spontaneous report was received from a medical assisstant and refers to a 17 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-OCT-2017, the patient was vaccinated with GARDASIL 9 injection (strength, dose, frequency, route of administration were not reported, lot # N017697, expiration date 21-JAN-2020) for prophylaxis. On an unknown date in October 2017 (reported as after vaccination with GARDASIL 9 the patient experienced syncope, abnormal pain, vomiting and fever. The patient was seen at the hospital on an unspecified date in relation to syncope, however hospitalization was not asssessed as serious criteria for the event. The outcome of the events was reported as recovered on an unknown date in October 2017. The causality between the events and GARDASIL 9 was not reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA012280: US-009507513-1710USA002338: US-009507513-1710USA012279:
pt recv vax & devel redness @ the inj site;no tx was necessary;pt recovered;
Hx of increased redness, warmth, "streaks", felt bad night of injection, vomited once, rash.
back pain; abdominal pain; scrotum pain; dehydration of the kidneys; Fatigue; headaches; dehydration; Constipation; This is a spontaneous report received from a contactable  health care professional. A  report on behalf of her 66 years old husband who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at single dose at right arm for COVID-19 immunisation on 14Mar2021 at 14:00.  Relevant history included high blood pressure, Atrial fibrillation and memory problems. No family history.  Relevant concomitant drugs included ongoing Diltiazem at 120 mg once daily for high blood pressure and Atrial fibrillation,  ongoing Losartan at 25mg once a day for high blood pressure and Atrial fibrillation, ongoing Aspirin at 81mg at night.  The reporter stated her husband had severe side effects. Her husband was having low back pain, scrotum pain and abdominal pain and constipation. She did not know if this had anything to do with the vaccine. Her son was a doctor and thought that her husband may have been a passed kidney stone. She took him to the doctor and did an X-ray which showed dehydration of the kidneys. They were pumping him full of water.  She stated that the dehydration and constipation could have been self induced. This started about last week and was home all week. It may have been around 29Mar2021, about 2 weeks after the vaccination. On day 3, her husband had headaches and fatigue on 17Mar2021. The patient was taking Tylenol pretty much every four hours for a week because he was in so much pain. The patient wear APAP machine at night. No history of all previously immunizations. No additional vaccines administered on same date. No prior vaccinations within 4 weeks.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: The events was considered related to suspected vaccine BNT162B2 based on temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions 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 RAs, Ethics Committees, and Investigators, as appropriate.
PATIENT BECAME SHORT OF BREATH, NAUSEAUTED, TIRED, AND WENT TO BED BUT THEN WOKE IN THE ER.
pt recvd vax & 28FEB93 & states felt ill all over muscle in body-hurt; has erythema/edema @ inject site; advised APAP, cool compress to site & DPH;
CRAZY DREAMS; SHORT OF BREATH; HIGH FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced abnormal dreams, short of breath, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, abnormal dreams and short of breath was not reported. This report was non-serious.