chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking with the chills; Shaking with the chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 at 09:30 as dose 2, single (Lot number: PF7140) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: PF7140, Location of injection: Arm Left, Administration time: 09:30 Am), administration date: 24Aug2022, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Headache", "Chills". The following information was reported: HEADACHE (non-serious) with onset 14Sep2022 at 21:30, outcome "not recovered"; TREMOR (non-serious), CHILLS (non-serious) all with onset 14Sep2022 at 21:30, outcome "recovering" and all described as "Shaking with the chills". Therapeutic measures were taken as a result of tremor, chills, headache. Additional information: No other vaccine in four weeks. No Other medications in two weeks. 12 Hours after the shot he started having Chills and the worst headache he had ever had. They lasted for about 3 days. After the second shot the same thing 12 hours after the shot he started shaking with the chills and the headache was there again also in 2 days into the 2nd shot and still have a terrible headache. treatment included Pharmacy told him to take Advil or Tylenol. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. No Hospitalization Prolonged.
An employee gave the daughter in law covid; Stuffed up sinus; Nasal burns; Lack of drug effect; Broke with COVID/Tired for a couple of days/coughing; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2, SINUS CONGESTION, NASAL DISCOMFORT, DRUG INEFFECTIVE, and COVID-19 in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced DRUG INEFFECTIVE. 13-Sep-2021, the patient experienced COVID-19. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2, SINUS CONGESTION, and NASAL DISCOMFORT. At the time of the report, EXPOSURE TO SARS-COV-2, SINUS CONGESTION, NASAL DISCOMFORT, DRUG INEFFECTIVE, and COVID-19 outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 13-Sep-2021, SARS-CoV-2 test) Positive.         No relevant concomitant medications were reported. Patient wears mask and was asymptomatic and as per reporter,  was vaccinated with both doses (manufacturer unknown) gave the patient COVID. From the patient, her own six year old daughter and husband got COVID. No treatment information was provided.  This case concerns a 35-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. Drug ineffective was considered an additional event. The events occurred approximately 7 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Difficulty breathing/retaining oxygen, chest pain, fast heart beat (at rest), anxiety, dizziness. About a month after the second dose on 05/28/2021 I developed sleep apnea. And chest pain still occurs regularly.
He tested positive for COVID on 13Jan2021. Since then, my 3 children have also tested positive for COVID. We did not isolate anyone once they were sick.; chills; body aches; This is a spontaneous report from a contactable consumer reporting for herself  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 11Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. The patient received first dose of BNT162B2 on 23Dec2020. Additional medical history or concomitant medications were not reported. On 11Jan2021 the patient experienced chills and body aches. Patient also informed that her husband started with symptoms of COVID on Sunday 10Jan2021. He tested positive for COVID on 13Jan2021. Since then, my 3 children have also tested positive for COVID. We did not isolate anyone once they were sick. (We realized this was a gamble). Patient informed that she was only person in the house who has not developed symptoms. She underwent SARS-CoV-2 test on 16Jan2021 which was negative. The patient recovered from chills and body aches on 13Jan2021.  Information about lot/batch number has been requested.
27 Aug2021- My allergies kicked in like I normally get . Next day it got worse, a terrible headache and cough. I was isolated because of Covid. I sent on the trip and in a hotel on Sat am to urgent care for covid testing and was negative and doctor was concerned about my wheezing . When test results came back - he said positive for chills.
Within 48 hours post vax, pt developed a severe injection site reaction characterized by swelling which extended to her elbow, pain and warmth.
Sore arm, swollen arm unable to lift, fever of 102, chills, swollen glands, extreme body aches. Dealt with the symptoms at home. Could not work. Sick for 4 days
Migraine headache; nausea; Lymph nodes in the arms and neck swollen; Tingling in fingers; chills; arm swelled up pretty good; Got sick to her stomach; Slept for 3 hours; Then went to bed that night, slept for 12 hours; slept for 4 or 5 hours; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Got sick to her stomach), SOMNOLENCE (Slept for 3 hours), SOMNOLENCE (Then went to bed that night, slept for 12 hours), SOMNOLENCE (slept for 4 or 5 hours) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Got sick to her stomach), SOMNOLENCE (Slept for 3 hours), SOMNOLENCE (Then went to bed that night, slept for 12 hours), SOMNOLENCE (slept for 4 or 5 hours) and PERIPHERAL SWELLING (arm swelled up pretty good). On 18-Apr-2021, the patient experienced NAUSEA (nausea), LYMPHADENOPATHY (Lymph nodes in the arms and neck swollen), PARAESTHESIA (Tingling in fingers) and CHILLS (chills). On an unknown date, the patient experienced MIGRAINE (Migraine headache). On 18-Apr-2021, PERIPHERAL SWELLING (arm swelled up pretty good) had resolved. On 19-Apr-2021, ABDOMINAL PAIN UPPER (Got sick to her stomach), SOMNOLENCE (Slept for 3 hours), SOMNOLENCE (Then went to bed that night, slept for 12 hours) and SOMNOLENCE (slept for 4 or 5 hours) had resolved. At the time of the report, NAUSEA (nausea), LYMPHADENOPATHY (Lymph nodes in the arms and neck swollen), PARAESTHESIA (Tingling in fingers), CHILLS (chills) and MIGRAINE (Migraine headache) outcome was unknown.        Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Left thigh with 4 x 3 cm area of redness induration and some warmth.
tested positive 16 days after dose 2, requiring admission; tested positive 16 days after dose 2, requiring admission; This is a literature report. The full publication has been requested.  A patient of unspecified age and gender received first and second dose of BNT162B2, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing cancer.  The patient's concomitant medications were not reported.  The patient was tested positive 16 days after dose 2, requiring admission. The patient underwent lab tests and procedures which included COVID-19 (C19) test: positive.  The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of the lack of efficacy of the vaccine.
Bruise at injection site. Pain on 2nd day unable to move arm w/o intense pain. Starting to get better today (10/13/15). No fever, no inflammation otherwise okay.
My brother died 1-2 weeks after receiving his second Moderna vaccine.  Outcome was death.  The coroner marked an enlarged heart as a significant contribution to his cause of death along with a combination of prescription drugs for back pain and depression.  There was no previous awareness of an enlarged heart in his life.
Right after vaccine while in 30 minute observation- numbing of hands & feet, tingling, lump in throat, hand swelling,  and itching   Was told to take Benadryl as soon as I got home.  I took 2 Benadryl pills and went to sleep. Woke up  a few hours later from a nap with foot numb, tingling, muscle aches, shivering  and itchy.   5/16/2021- skin feels like fire was touching it. Still tingling, muscle aches, fatigue   Monday 5/17/2021-  right foot still numb on right side, muscle aches, skin feels like it is on fire, hives all over face. I emailed my Dr. with pictures and she told me to schedule an appt.   I scheduled my appt for 4:20pm and saw my Dr around 4:35ish.   Hives had gotten  bigger, more red and more itchy.   My Dr prescribed me a epi pen refill, muscle relaxers for my right muscles, and prednisone for my hives.   5/18/2021- Hives are much more red, swollen and itchy. Also have severe headache on 2 sides on my head that literally feel like I was struck with a hammer. I?m a migraine sufferer and this is much worse. I?m lethargic, itchy all over,  skin still feels like fire is touching it, or it was just burned and now my thigh muscles are feeling super week and painful.  Muscle relaxers not really helping.
Dosing error, this was the patients second dose of the one-dose Janssen Covid19 vaccine. First dose was more than one month earlier (3/11). Patient indicated on the questionnaire that they had not previously received a COVID19 vaccine. No adverse outcomes and patient was ok, with no unusual adverse reactions.
p/vax pt exp 10cm diameter redness, 2cm bluish in center;it was reported that pt recovered from this exp;
8cm x 6cm erythema, sl induration, warmth tender-seen on 25AUg94; t99.3 o
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 16-SEP-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 528 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Received Hep B and VARIVAX vaccines on 040213. 040413 c/o redness, soreness, and swelling. Went back to HU and was told to take OTC pain reliever and apply warm compresses. 040513 c/o not better and was instructed to see PMD.
Information has been received from a currently 34 year old female pharmacist referring to herself. The patient was allergic to sulfa drugs. The patient's concomitant meditation and pertinent medical history were unknown. On an unknown date (reported as a child), the patient was vaccinated with M-M-R II (dose, route, lot number and expiration date unknown) for routine vaccination. Other suspect therapies included sterile diluent (MERCK). On an unknown date in "August of 2017", the patient had titers drawn while she was pregnant (Vaccine exposure before pregnancy) which showed she became no longer immune to MMR. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was lost to f/u. There was no treatment given for the event and not seek medical attention. The outcome of no therapeutic response was reported as not recovered. The causality assessment was not provided by reporter.
Information has been received from a nurse practitioner who on 03-APR-2008 was administered a first dose of GARDASIL vaccine (yeast) (lot #655327/1287U) to a patient. During administration of the vaccine, the vaccine leaked out of the syringe and ran down the nurse practitioner's arm and hand. The nurse practitioner indicated that she put the needle on the syringe properly and she looked at the syringe after vaccination and didn't notice anything unusual. At the time of the report, the patient's outcome was unknown. The SR# is 1-2829187985.
Information has been received from a medical assistant concerning a female who on 25-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). The patient, along with her husband (WAES# 0711USA01697) were scheduled to receive zoster vaccine live (Oka/Merck) 25 OCT 2007. The medical assistant reported that during charting documentation, that same day, it was noted that only diluent was given to one of the patients, and the other patient received zoster vaccine live (Oka/Merck). The medical assistant did not know which of the patient's received zoster vaccine live (Oka/Merck). It was noted that the female patient did experience burning at the injection site. The patients were contacted, and both patients returned that same day and were re-vaccinated with zoster vaccine live (Oka/Merck) (lot# 658209/1085U). The records were not available from the first Lot number. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
Symptoms started around midnight sweats chills nausea aching joints severe headache temp 101.9 he did go to facility they swabbed him for covid which was negative and his viral panel was negative. If I can be of any further assistance please let me know.
vomited 7 times w/in 1 day p/vax;weight 3lb 14SEP98 @ MD office;weight 29.5 on same scale 15SEP98;
mom reports 3" diameter welt distal to inj site w/single vesicle;resolved w/warm compress;
Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.
In the middle the night after my second dose I woke up with a severe headache, muscle aches, and feeling very hot. I felt achy and like the flu the next day with nausea.  Severe headache.  The worst part is my arm.  Arm is very painful since the evening of the shot and now has a hot, hard, red bump under the injection site.  It?s painful to touch and hot to touch. You can see it.
After 2-3 days. hands and feet began to itch  at night and turn red, this progressed every night for about 10 nights to include generalized itching and redness with bumps on torso, chest, head, ears, neck  and face.  Also hands and feet.  Somewhat acutely relieved with hydrocortisone and benadryl.  Visited my internist this morning after bring unable to sleep at all due to itching.  Received a steroid shot and am hoping for the best!  She thinks it must be the shingles shot as I take no meds, have no dietary changes and no new soaps, detergents, etc. that could be irritants.
Initial report received from a consumer on 16 Feb 2011: The patient had no medical history and no allergy.  The patient did not smoke, drink and did not take illicit substance and practiced regularly body building.  The patient's vaccination status was up to date and had scheduled DTP vaccine before the end of 2011.  The patient was vaccinated with MENVEO (meningoccal groups A, C, W135 and Y conjugate vaccine, batch number: 360379-1) on 12 Feb 2011.  On 13 Feb 2011, the patient experienced hot flushes, nausea, vomiting, headache, coated tongue and loss of appetite.  At 3.00 pm the patient developed severe chills with chattering teeth, and the body temperature increased to 38.8 and then at 39 degree Celsius.  During fever, the patient also experienced delirium and hallucinations, the patient developed muscular pains on thighs, calves, loin and back and flu like symptoms that lead to walking difficulty.  At 9.00 pm, the patient went to emergency room.  The tension was normal, fever was 40 degree Celsius and urinary tests were normal.  Thoracic and abdominal percussions, knees/feet control were done (no details provided).  The patient was treated with paracetamol every six hours.  The outcome for muscular pain in thighs, calves, loin and back, flu like symptoms, walking difficulty, nausea, headache and dizziness was reported as condition improving whereas the outcome for increased body temperature, delirium and hallucinations was reported as recovered, the outcome for loss of appetite was reported as condition unchanged and the outcome for nausea was not reported.
pt recv vax 24AUG95 & 2OCT97 pt devel a papular rash on trunk;It was noted that there was no fever or illness;
chills; severely achy; headache the back of my head; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PAIN (severely achy) and HEADACHE (headache the back of my head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     no medical history is provided and concomitant drugs are provided.  Concomitant products included BENRALIZUMAB (FASENRA).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (chills), PAIN (severely achy) and HEADACHE (headache the back of my head). At the time of the report, CHILLS (chills), PAIN (severely achy) and HEADACHE (headache the back of my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Tylenol On 27-Jan-2021
2 hrs p/vax pt exp a seizure; no elevated temp or other problems; pt taken to MD seen & released;
On December 30 I developed a sore arm along with a raised red rash at the injection site only. This last about 2-3 days and went away. Then on January 6 the red, raised rash at the injection site returned for approximately 2.5 days. The site felt slightly itchy like a mosquito bite. I reported it to my doctor who advised me to use Benadryl cream and/or benadryl
Left arm injection site was red and painful, arm movement was limited due to pain. 36 hours post injection pt became hot, sweaty, nauseated and passed out for 10 minutes. Paramedic transported pt to ER because of low BP.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-AUG-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 33 Fahrenheit (F) Degrees (0.555555556  Celsius)for a total of 1560 hours and also at 34 Fahrenheit (F) Degrees (1.111111111 Celsius)for a total of 336 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Approximately an hour after vaccination, she reported lightheadedness, dizziness, severe headache, Warmth (isolated to the head), Fatigue and burning nose w/bleeding when blown. V/S B/P 122/86, Pulse 120, Temp. 98.8. TYLENOL 1000 mg given at 5:45.
Patient was given a Moderna Vaccine but was under the age of 18 years old. When the patient returned for their second dose, the technician noted the age and vaccine they were given for the first dose. The pharmacist on duty spoke to the family to inform them that Pfizer is the recommended vaccine for under 18 and the family would look for a Pfizer vaccine since it was unavailable at the pharmacy.
Red, swollen, fever in arm. Over half way around her arm. Flu given in bottom of left arm, pneumonia in top left arm. Pt went to the MD. he told her it was an allergic reaction. She stated that he gave her antibiotics and that she will get the flu shot again because it will beat getting the flu. (The reaction beats getting the flu). The doctor also stated, acc to her, that it would be ok for her to get the flu shot again. On Tuesday, yesterday, she told employee, that it was alot better.
Mom states "red swollen warm size of baseball" took to PP next day when swelling started (7/26/03). Advised Motrin and Benadryl and cold compresses.
Initial report was received on 16 October 2014 from a consumer who is also the patient. A male patient (date of birth not reported) had received on an unspecified date an intramuscular INFLUENZA VACCINE (manufacturer, lot number and site of administration not reported) and an unspecified amount of time later developed compartment syndrome. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
Enlarging indurated area on left thigh, red, warm to touch. NON tender 15cm x 8cm. Large hive
Pain and itching near injection site.  Blotchy red spots. Intense headache with stabbing feeling.  Headache only one day. Arm pain and splotching continue
Fever, muscle aches, swollen Axillary lymph nodes and subcutaneous swelling over ribs on right side
Moderna not to be given to patients under 16 years of age, this patient is 14
Arrived with GI symptoms, tested positive for COVID. Fully vaccinated. Ileus vs gastritis likely 2/2 COVID infection, no respiratory symptoms. Discharged home.
12/19 erythema, warmth. TX: Prednisone; Ranitidine.
Patient received monovalent Pfizer as a booster instead of Bivalent Pfizer
After first dose of vaccine on 4/23 complained of fatigue and tiredness.  After second dose on 5/26 complained of fatigue, dizziness, nausea and body aches.  Expired on 5/28.