chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Certified Medical Assistant refers to an infant of unknown gender of 8 days old at the time of the report. Concurrent conditions and medical history was not reported. On an unknown date, the patient was administer4ed a dose of (Oka/Merck) VARIVAX (subcutaneous injection) (dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is cross referenced to MARR#1505USA009906, MARR#1505USA013644, MARR#1505US013646. Additional information has been requested.
rash on his leg/also got it on his arm; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age (59, units not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He received his 1st shot of the COVID vaccine and 2nd dose was scheduled 22 days after. About 1-2 days after the 1st dose, on an unknown date, he developed a rash on his leg which looked like poison ivy, it was on his inner thigh. He also got it on his arm, then it got better but the rash on his leg was the same. Second shot was due today. He did not get a rash at the injection site. He would like to know if he should get the 2nd dose of the Pfizer COVID vaccine. He would like to know if there was any benefit from the 1st dose of the COVID vaccine if he delays the 2nd dose. The clinical outcome of the event was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Severe palpitations lasted about 1:30 hours after 27 hours of the shot. Called the GP and was told to rest and relax. Had chills, fever and muscle aches later. Still having a mild fever everyday e joint pains on and off. Yesterday (4/11) had the same severe palpitations. Same time and same time course. Heart beats went over 140 both times. The palpitations stop for few seconds and starts over again. Just took homeopathic stress pills and back to normal after 1:40
cardiac issue; Chest pain; elevated troponin level; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), CARDIAC DISORDER (cardiac issue) and TROPONIN INCREASED (elevated troponin level) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (was in hospital for 6 days) on 23-May-2020 and Quintuple coronary bypass (Had five bypass, two arteries they took) on 23-Oct-2020. Concurrent medical conditions included Diabetes and Chest pain since 2020. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID for Anticoagulant therapy, AMLODIPINE, LISINOPRIL and METOPROLOL for Blood pressure abnormal, FISH OIL for Cardiac disorder NOS, ATORVASTATIN for Cholesterol, INSULIN for Diabetes, TIMOLOL MALEATE (TIMOPTIC) for Glaucoma, ISOSORBIDE for Heart disorder, PROGESTERONE (LUTEINA [PROGESTERONE]) for Retinal disorder NOS, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced TROPONIN INCREASED (elevated troponin level) (seriousness criterion hospitalization prolonged). On 25-Mar-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization prolonged) and CARDIAC DISORDER (cardiac issue) (seriousness criterion hospitalization). The patient was hospitalized on 25-Mar-2021 due to CARDIAC DISORDER and CHEST PAIN. On 27-Feb-2021, TROPONIN INCREASED (elevated troponin level) had resolved. At the time of the report, CHEST PAIN (Chest pain) and CARDIAC DISORDER (cardiac issue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Troponin: not elevated (normal) not elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time. Patient's advanced age along with underlying conditions and concomitant medications may have been contributory for the occurrence of the events. Further information has been requested.   This case was linked to MOD-2021-027718 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with underlying conditions and concomitant medications may have been contributory for the occurrence of the events. Further information has been requested.
I had a severe headache, fever and chills, my temperature went up to 100.4, muscle aches and pains and severe nausea in the solar plexus (upper G.I.) area. I felt sick all day Sunday and thought that I might be coming down with the flu. On Monday, October 1st I felt much better. My temperature is now back to normal and the other symptoms have also gone away. I'm hoping that pharmacy didn't get a bad batch of SHINGRIX vaccines. I think they are issued in batches of 10 by the CDC. The 1st vaccine on 6/18/2018 went fine.
Large (7cmx8cm), warm, area of redness covering much of upper portion of right thigh, with an obvious needle mark very high on the very upper thigh just below the hip; non-tender, normal gait; also, the whole R LE was swollen vs L including the lower leg (7 cm below patella R 21cm circ vs 20cm on LK); onset within 24 hours, late in the evening on the day that the vaccine was given.
This spontaneous report was received from a nurse via company representative refers to a 4 year old male patient. On 18-JAN-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) lot # K009473, expiry date 04-JAN-2016. No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
Woke from nap with a rash on face and trunk. Slight itch.  4 hours after vaccine given needed a breathing treatment. Mother says common occurrence this time of year.
Patient received Pfizer booster on 1/8/22, and had reaction  hours after injection, Pt broke out in hives on his face, chest, back, and arms. Hives were itchy in nature. Also reports Pt felt dizzy, shaky, short of breath and felt like his heart was racing.
-Cough  -Wheezing  -Tight chest -Hypoxia feeling  -Breathing difficulties  -HRV was off - High /sporadic HR compared to usual -Muscle spasms in chest  - Tight/pain left middle upper back - usual fatigue
Mother called and left message that son had been vomiting since after vaccine administered. Vomited approximately 10 to 12 times the day after. Called patient on Monday and he stated "I'm fine."
anxious, lightheaded , lost hearing, heard ringing that was not there, cold hands, numb legs, upset stomach, difficulty breathing started about 5-10 minutes post vaccination gave patient water, gave 1 dose of epipen due to trouble breathing EMT found  patient to have low blood pressure and advised to be checked up at hospital. Patient refused ambulance services but said he would go to ER to be checked out. Upon follow up several hours later patient said he felt better after getting outside and just went home
DIARRHEA; DRY MOUTH; URINE LEAKAGE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included malignant neoplasm of endometrium.  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. Non-company suspect drugs included: lenvatinib mesilate (oral, batch number: 9848179 expiry: UNKNOWN, form of admin was not reported) 20 mg, 1 time every 1 day, from 17-DEC-2020 for malignant neoplasm of endometrium. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 2021, the subject experienced dry mouth. On 2021, the subject experienced urine leakage. Laboratory data (dates unspecified) included: Positron emission tomography (NR: not provided) 2 masses gone, size of 3 reduced, 1 mass by lymph node raised but firm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 2021, and the outcome of dry mouth and urine leakage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000176991. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.
Information has been received on 12/19/2001 from a registered nurse concerning "several" adult patients who were vaccinated with a dose of hep A vaccine. Subsequently, the patients failed to seroconvert. There  was not further info available. The patients sought unspecified medical attention. Additional info has been requested.
C/O sore arm, redness/swelling, vomiting, temp 106.0 deg F two hours following immunization. 05/30/02, advised to take Tylenol, cold compresses to right arm. 06/05/02, pt states headache, vomiting, fever resolved 06/03/02.
Moderna vaccine given to patient under the age of 18, although not approved for that age.  Spoke with parent after discovery, and no side effects to report.
not the full second dose of the Moderna Covid-19 vaccine; greater than 36 days between COVID-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (not the full second dose of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between COVID-19 vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (not the full second dose of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between COVID-19 vaccinations). On 18-Nov-2021, ACCIDENTAL UNDERDOSE (not the full second dose of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between COVID-19 vaccinations) had resolved.            Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2021-406096 (Patient Link).   Reporter did not allow further contact
Severe flu symptoms for 5 to 7 days following the booster. Minor improvement after day 7. Shortness of breath, fatigue, brain fog are still persistent to this day. Cough was developed after day 12 of booster shot. Occasional chest tightness and pain throughout the day, sleep interupted due to tightness or pain.
Within 2 to 3 hours I started with lot of fever, I haven't been able to take it off; I am still sick; Sever body aches; Flu like symptoms; This is a spontaneous report from a contactable nurse (patient). This nurse reported information for two patients. This is the first of the two reports.    A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Jan2021 as first single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient reported as follows " within 2 to 3 hours I started with lot of fever, I haven't been able to take it off ", " I am still sick ", " sever body aches ", " flu like symptoms ", all on 02Jan2021.  Details were as follows: The reactions occurred immediately after the vaccination. Patient received the vaccine on a Saturday and immediately within 2 to 3 hours. The patient indicated that two reacted immediately like that and haven't been able to get any better.  The outcomes of events were unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015660 Same reporter/drug, different patient/event.
An itchy rash 4-5 inches around the administration site. Using Benadryl cream to help. Redness from rash is going down, itchiness has not changed.
Reported to our facility that was admitted to Hospital approximately 3 wks ago for Guillain Barre. Transferred this week to another hospital.
I had this really different cough; I was bringing up some phlegm. It was off color, it lingered. It was a 10-day period and constant at night. It was odd because it was independent. I did not feel too much pain, there was a little chest tightness.  I had a low-grade temperature of 100. My doctor thought it could be pneumonia, I had a chest x-ray, and it was not.  I was put on amoxicillin. It helped; I am immune compromised. I did test negative COVID-19. I had been vaccinated this 5th time. I had felt horrible with a temperature and chills. I felt awful.
my daughter had GARDASIL.  The next day became very sick with headache and nausea and very tired.  This is going on 3 weeks she is still sick from this.  has seen two doctors and can't find anything causing this.  They won't say it was the shot.  but she was very healthy when I took her for her yearly check up.  She has missed 3 weeks of school so far.11/5/2008 PCP records received OV 10/3/08 with c/o low back pain, abdominal pain, nausea, tiredness and feeling cold x 1 week. Abd pain is epigastric-(+) tenderness. Bland diet suggested. TC from parent re: nausea-phnergan prescribed. Pt extremely tired unable to attend school x 2 days. OV 10/10/08 F/U for stomach pain, queezy, night sweats. Assessment: Nausea, H/A, fatigue-possible viral etiology, doubts 2' to Gardasil. ER visit 10/15/08 for above sx-prescribed Nexium.
Quarter sized, red hive where injection was administered. Itching without burning.   Pregnancy- Fourth pregnancy, 0 living children, 2 miscarriages, 1 stillbirth. Gestation at injection 21 weeks, 5 days.
At about 9:00pm, my face began to feel hot. Within a few minutes I got the chills. Then fever set in at around 10:00pm.  I didn't have access to a thermometer but I estimate my temperature was 101. Fever lasted through the night.  At 6:00am I used a thermometer which read 100.6, and I also had a headache.  At that point I took a 325 mg Tylenol which resolved the fever in 30 minutes; the fever did not return.  The headache lingered but went away mid-afternoon.
I have been having headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (051529).  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "I have been having headaches".  Additional information: Patient reported "I have been having headaches." She also reported that she has not taken the medication for about 3 weeks now. This is because she received her COVID-19 booster just over 3 weeks ago and the doctor told her to not take her Xeljanz for about 3 weeks after receiving her booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
One day post shot #2 Awoke dizzy, had n/v X2,  then numbness/facial burning. All Symptoms resolved after 24 hours  excetp for Right sided facial numbness/burning- which              lasted until May 2022
Pt. returned to pharmacy and presented with redness below injection site, inner part of arm and on her side also had swelling and was very painful. Located on left side.
Patient stated she had a bruise approximately 3x4 inches in size around the injection site. She did not have any pain.
Patient experienced syncope after receiving FLUVIRIN, followed by ZOSTAVAX. (Approx. 10-15 seconds) reports this is "normal" occurrence for her.
Started with sore arm at site if injection.  Continues  with pain going down arm to wrist. Also loss of mobility. Cannot lift arm above shoulder without pain. Hurts and aches while at rest, at night in bed.
WHEEZING FEELING; WOOZY; HEAD FEELS TINGLY; LIGHTHEADEDNESS; FEELING OF PRESSURE ON HEAD; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Batch number was not reported. The company has requested follow-up for batch number. No concomitant medications were reported. On 24-APR-2021, the subject experienced wheezing feeling. On 24-APR-2021, the subject experienced woozy. On 24-APR-2021, the subject experienced head feels tingly. On 24-APR-2021, the subject experienced lightheadedness. On 24-APR-2021, the subject experienced feeling of pressure on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from wheezing feeling, woozy, head feels tingly, lightheadedness, and feeling of pressure on head. This report was non-serious.
This spontaneous report as received from a physician refers to a patient of unknown age. In June 1996 (17 years ago), the patient was vaccinated with ROTATEQ could not be ruled out at the time of the call) oral administration (dose and lot # not reported). The physician reported that the patient developed intussusception following administration of a rotavirus vaccine 17 years ago. The physician stated that the intussusception was reported at the time it occurred (17 years ago). The outcome of intussusception was reported as recovered on unspecified date. Additional information is not expected.
Cellulitis of bilateral deltoid areas, started on Keflex (po antibiotics) for 10 days. Follow up on 08/21/2003: "Resulted in doctors visit to pediatricin for localized cellulitis."
Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fever (37.8C), muscle pain, body joint pain for 3 days, left arm pain (3 days), sweating (2nd night), fatigue for ~2days, and most importantly: for over 9 days/nights swollen nymph knot under left arm, was as big as a full hand full (like a full bar of soap), has meanwhile improved daily, but I can still sense a small (wallnut size) under the arm now, 9 days after the shot. It's important to inform because the media and the doctors are not reporting how bad and lasting the side effects are and it is important to be transparent to patients what to expect, otherwise trust is eroded and people stop getting vaccinated.
My injected arm was quite sore during day 2 - I could not sleep on that side that night.  It was much better the next day and soreness gone by day 4.  On 2-15-2021 I developed a rash very similar to Hives over approximately 10% of my upper torso between my waist and neck.  Was very itchy so I applied an itch stopping cream which eliminated most of the itching.  By the next morning some much reduced rash remained but virtually no itching.  As I write this at 9 PM 2-16-2021 the rash is still evident.
From District Pharmacy Manager: Patient fainted after getting into the observation area (maybe about 3-5 minutes after receiving vaccine). Fire Dept was called. She did not go to hospital and did go home with her husband who was driving.
just tested positive for COVID; just tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "just tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (2023) Positive. Clinical course: the patient tested positive for COVID using the Abbott at home test and had most recent vaccine on 03Oct2023. The patient returned from two weeks of work related travel in on 27Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
After the morning shot I felt extremely groggy and sleepy for the rest of the day.  Napped a lot.  The next day I was back to normal except for left arm was sore at the injection site.
8-27-21 noticed rash around injection site, as of 9-1-21 the rash has expanded to 5" x 5", noticeable swelling, heat and mildly itchy. Treating at home using benadryl and calamine lotion. Ongoing - will continue to monitor
Patient was sitting in her car seat, and her hands started trembling. Her eyes were half open to closed. Her legs were 'fidgety'(trembling, but somewhat restricted maybe because of rear-facing seat). She had a vacant stare. She gradually started to look around more, stopped trembling but still was very vacant and not saying anything. We headed towards the hospital. She gradually came around, but still very quiet. Roughly 30 minutes later, she was back to herself. She had a slight fever (about 100F) and red spots on her back when examined at the hospital. She was kept overnight for observation, as they suspected a seizure. 6/13/08-History and Physical report for DOS 1/27/08 received-presented to ED after episode of staring off into space, not entriely responsive with twitching of left hand and arm. Did not respond to calling of name. Postictal period.PE: scattered lymphadenopathy neck area.  Temperature spike 100.4. Firsat time nonfebrile seizure.  6/20/08-records received for DOS 1/27-1/28/08-Seizure admitted for overnight observation, uneventful.
This spontaneous report as received from a physician via a field representative refers to an over 80 years old male patient. In July 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, frequency and route not reported). Approximately on 06-NOV-2013 (reported as a week ago), the patient made a phone call to the physician and reported having blister on his head that were painful. The physician had not yet seen the patient and had made no diagnosis. No treatment was given for adverse event. No lab diagnostics studies performed. The patient still had the blisters on his head but he was no longer in pain. Additional information is not expected.