chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hands and feet swell and it feels more like at the joints.; Swelling of joints including fingers and elbows; Fatigued every day; High ringing in my both ears; Bruise at injection site; Soft bowels; Arm really hurt for 4 days; Had 4 by 3 red patch/ like a big raised hive/ hive started getting smaller and smaller; Hard in middle /raised; Queasy stomach; Red; Really bad headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021. The most recent information was received on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (High ringing in my both ears), VACCINATION SITE BRUISING (Bruise at injection site), BOWEL MOVEMENT IRREGULARITY (Soft bowels), PERIPHERAL SWELLING (Hands and feet swell and it feels more like at the joints.) and JOINT SWELLING (Swelling of joints including fingers and elbows) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (High ringing in my both ears), VACCINATION SITE BRUISING (Bruise at injection site), BOWEL MOVEMENT IRREGULARITY (Soft bowels), PAIN IN EXTREMITY (Arm really hurt for 4 days), VACCINATION SITE URTICARIA (Had 4 by 3 red patch/ like a big raised hive/ hive started getting smaller and smaller), VACCINATION SITE SWELLING (Hard in middle /raised), NAUSEA (Queasy stomach), VACCINATION SITE ERYTHEMA (Red) and HEADACHE (Really bad headache). On an unknown date, the patient experienced PERIPHERAL SWELLING (Hands and feet swell and it feels more like at the joints.), JOINT SWELLING (Swelling of joints including fingers and elbows) and FATIGUE (Fatigued every day). At the time of the report, TINNITUS (High ringing in my both ears), VACCINATION SITE BRUISING (Bruise at injection site), PERIPHERAL SWELLING (Hands and feet swell and it feels more like at the joints.), PAIN IN EXTREMITY (Arm really hurt for 4 days), VACCINATION SITE URTICARIA (Had 4 by 3 red patch/ like a big raised hive/ hive started getting smaller and smaller), VACCINATION SITE SWELLING (Hard in middle /raised) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown, BOWEL MOVEMENT IRREGULARITY (Soft bowels) and HEADACHE (Really bad headache) had resolved and JOINT SWELLING (Swelling of joints including fingers and elbows), NAUSEA (Queasy stomach) and FATIGUE (Fatigued every day) had not resolved.            No concomitant medication information were provided. No treatment medication information were provided.      Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Event outcome updated and new events added.; Sender's Comments:
Left upper back of arm red, warm to touch with slight swelling. Started today on Cephalexin 500mg TID x10 days.
This non-serious case was received from a health professional on 22 October 2008.  A 28-year-old male patient received a booster of IPOL (lot number A0169-2) on 02 June 2008.  A titer was subsequently drawn, and was negative for IPOL.  Per the reporter, the patient received two doses of IPOL as a booster, and had previously received three doses as a child.  At the time of the report, the patient had not experienced any adverse events.  Follow-up information was received from a health professional on 17 November 2008.  The patient received one intramuscular left deltoid dose of IPOL on 02 June 2008 and one intramuscular left deltoid dose of IPOL on 07 July 2008 (lot number for both doses was A0169-2).  Titers were drawn on 30 June 2008, 07 July 2008 and 28 August 2008.  Prior to 02 June 2008, the patient had received IPOL on 07 November 1979, 23 March 1980 and 03 June 1980.  In addition, the patient had previously received doses of OPV (oral polio vaccine) on 27 March 1981 and 15 October 1988.  Documents held by sender:  None
Patient sitting in observation area following 1213pm vaccine administration. At 1215, 2 minutes after vaccine, patient complained of chest pain and shortness of breath.  No hives or swelling of lips or throat noted.  + periorbital edema. No cough or wheezing or stridor. No local reaction noted on L deltoid.  Rapid Response called and pt transported to Emergency Department (ED).  Cardiac workup, CXR negative. Pt given IV Benadryl and IV fluids.  Symptoms resolved.  Pt discharged from ED at 2:50pm same day.
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, Pain/redness/swelling@injection site Narrative:
I received the 1st shot of the Moderna's Covid-19 vaccine on 1/23/21 at the Pharmacy. Three days later I started experiencing sharp abdominal cramps with gas that I couldn't expel and abdominal bloating. I am still experiencing this 6 days later from when it started. I feel better when laying down but when I stand up I have this really heavy feeling in my lower abdomen. I also experience abdominal cramps not long after eating. I am not constipated. In fact, I've been having a lot more bowel movements which is not normal for me. Also, on Sunday, 1/31, eight days after injection, I developed a red patch that was very warm on my left arm where I received the injection and a headache. The red patch is still there. I'm concerned about this and wonder if this may be related to one of the ingredients in the vaccine, i.e., polyethylene glycol.  I have reported this to my M.D. this morning and they are asking me to come in.
Pt. reported 11/23/99 at 14:00 w/swollen & warm right deltoid with pain/aching rt. arm, shoulder & clavical. Also, c/o numbness in rt. hand. Pt. states unable to move arm without increased pain. Dr. told pt. to take Tylenol & ice on area.
Rash broke out on chest, stomach, back of neck and under arms, swollen eyes with welt under right eye.
got Covid after getting 3 doses of Pfizer Covid vaccine; got Covid after getting 3 doses of Pfizer Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), on 09Apr2021 as dose 2, single (Lot number: EN6206) and on 12Oct2021 as dose 3 (booster ), single (Lot number: FE3590) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 14Jul2021, outcome "unknown", VACCINATION FAILURE (medically significant) with onset 14Jul2022, outcome "unknown" and all described as "got Covid after getting 3 doses of Pfizer Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was reported that the patient had a rebound case after treatment of Paxlovid. On 14Jul2022, first tested positive for Paxlovid. Started Paxlovid on 15Jul2022, finished the treatment on 20Jul2022. Tested positive again for COVID last night 03Aug2022. She stated that she did receive the Pfizer Covid vaccines. She also stated that she had the metallic taste in her mouth and felt like she was sweating out a fever while on the medication, clammy and sweating, exact dates unknown.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and experienced Shingles. Till the time of reporting patient had an active episode of shingles. The Vaccine Administration Facility is the same as Primary Reporter. No further details were reported.
This spontaneous report as received from a other health professional refers to a patient of unknown age.  On an unknown date the patient was vaccinated with ROTATEQ lot # M040270 for prophylaxis.     On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to ROTATEQ.; Sender's Comments:  US-009507513-1707USA000533: US-009507513-1707USA000534: US-009507513-1707USA000535: US-009507513-1706USA005754:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On an unknown dates the patients were vaccinated with doses of M-M-R II that underwent a supported temperature excursion (dose, dose number, lot #, route and application sure were not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported aches, chills, pain and fever 1 hour after vaccine administration. Symptoms resolved within 24 hours without treatment.
got the shot and it gave him the shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The patient got the Shingles shot and it gave him the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Received the vaccine in my left arm on Aug. 5. My arm was hurting severely within 30 minutes and continued until sudden easing of pain around 8 p.m. Aug. 6. I was achy, had a severe headache and had a runny nose on Aug. 5. Got up the morning of Aug. 6 dizzy, with a low grade fever that climbed through the day to 102 by 8 p.m. Had cold symptoms. I experienced two heart palpitations. Both of my arms were hurting and I kept experiencing spasms in my lower right arm and hand. I was weak all over and felt like I had the flu. This would improve suddenly at times, but the severe left arm pain, headache and fever were continuous. I had odd pains in my legs and backside, painful enough I thought I was being bitten by a spider or something. My eyes were extremely sensitive to light. I laid around most of the day because walking  jar my arm too much, though I did try to move my arm and work it out. By the morning of Aug. 7 I was fever free and mostly headache free. My left arm continues to just slightly hurt as of today but similar to after getting a flu vaccine if you don't work your arm out. I continued to have the spasms and pain in my right arm until the evening of Aug. 8. I am continuing to randomly have sharp very short headaches, just very bad pain for about 20 seconds. My legs and arms have been weak and achy. I returned to work on Aug. 9 with the backs of my lower legs having sharp pains in them all day. I do not know if my arm and leg pain is connected but I have done nothing else to cause this and feel like I have the flu when it comes to this weakness and pain.
Patient states that a week after receiving Pfizer Covid vaccine her leg started feeling uncomfortable while driving  and progressively got worse until she couldn't hardly walk. She went to the doctors office 3/2 due to the leg pain and was diagnosed with a DVT patient was placed on Apixaban 5mg  BID & after taking 3 doses wound up in ER  3/2 due to new onset vaginal bleeding.   Patient will f/u in ER today 3/8 for follow up with their provider for repeat eval and possible testing.
I experienced extreme fatigue and exhaustion after receiving the vaccine. I had a visit with my doctor and she said that my symptoms were side effects.
Breakthrough case admission after 2 vaccines  Moderna 11/9/21 Lot# 013F21A;  Moderna 4/26/22 Lot# 005M21A
Numbness in right arm. After 2nd shot I had numbness in right leg. I received shot in my left arm but right arm is numb.
Within a couple of hours, my arm was sore. About 24 hours later - body aches, chills, muscle aches and fatigue and that was gone the following the day and the arm soreness was gone the following day.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 09-NOV-2016, the patient was vaccinated with an expired dose of VAQTA 25/0.5, intramuscularly, lot # L032749 with an expiration date of 04-NOV-2016. Furthermore, no adverse event was reported and no product quality issue was involved. Additional information has been requested.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. There were two vials that were punctured and used some time between June and November 5, but  can't back track those dates, they were written on the vials themselves, which were disposed of. It just came to their attention that the vials were being used past the recommended 12 hour post puncture time. It was reported that vial was punctured on 11-NOV-2021 and dose given then kept in refrigerator after puncture.   This case was linked to MOD-2021-418964 (Patient Link).
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 02-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479:  US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Initial misuse report received from a healthcare professional on 13 February 2013. A patient had received ACT-HIB and PENTACEL on same visit in September 2012. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
FLU LIKE SYMPTOMS/MUSCLE ACHE/BODY ACHE/HEADACHE/FEVER/CHILLS/COUGH WITH PHELGM/FATIGUE; WEIRD TASTE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On 03-APR-2021, the subject experienced flu like symptoms/muscle ache/body ache/headache/fever/chills/cough with phelgm/fatigue. On 03-APR-2021, the subject experienced weird taste. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms/muscle ache/body ache/headache/fever/chills/cough with phelgm/fatigue, and weird taste. This report was non-serious.
States he broke out in hives all over his arms/legs/torso about a week and a half after he received his first Moderna vaccine (got vaccinated on 7-30-2021). States happened two afternoons in a row. One afternoon, he broke out in hives and within an hour of taking Benedryl, the hives were gone. The next afternoon, the same hives popped up and he took another Benedryl and within an hour, the hives were gone. States began itching these two days and used Goldbond anti-itching cream and it helped. Client states he never got tested, but his wife tested positive for covid-19 a week after he got his first vaccine. States he had bad headaches and muscle aches/fatigue for 1-2 weeks after receiving the first vaccine.
Swollen lymph nodes in both armpits; Swollen lymph nodes in both armpits that are painful; Whole body pain and aches; Fever up to 100.8; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm right on 21Apr2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included possible inflammatory autoimmune disorder. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the arm left on 31Mar2021 at 14:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 10:00, the patient experienced swollen lymph nodes in both armpits that are painful, whole-body pain and aches fever up to 100.8. On an 22Apr2021, the patient underwent body temperature test and the result was fever up to 100.8 F. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes in both armpits that are painful, whole body pain and aches fever up to 100.8 F was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Myalgia DVT Narrative:  Employee developed and was diagnosed with a DVT on 1/11, however of note, had knee injury to same LLE prior to vaccine, and had prior history of DVT on the same LLE. Need to consider other risk factors for DVT. At this time, working from home, on po Eliquis.
9cm indurated area at injection site that patient first noticed on 2-14-15. Also reports diarrhea. Seen in office on 2-17-15. Treated with topical steroid cream and oral antihistamines.