chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-JAN-2019, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported)for prophylaxis (product storage error). No adverse effect was reported. The LIQUID PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950:
There is no report from patient, the company notified us of the event due to being administered after expiration date.
Extreme fatigue and terrible depression., 3 weeks after 1st shot.   Lasted over 3 months especially fatigue.
Pt reports she had pain at the time of injection. She noticed that on the AM on the 12th there was a lump and swelling at the site of the left upper arm. The lump continued to get harder and bigger, with redness increasing over the back of the arm, to the elbow. She reports it gradually got worse, and then she came into an appointment. After starting on ATB it was improving in 48 hours.
Diarrhea for 8 days and counting. Doctor said to expect it to last 10-14 days and that they are seeing this happen and lasting a typical 10 to 14 days. They recommended the BRAT diet and Imodium.
PT AND A CO-WORKER EXPERIENCED RASH ON 12-21-89. NO TREATMENT GIVEN. RECOVERED 12-28-89.
DEVELOPED FEVER, REDNESS AND SWELLING OF RIGHT ARM (6/10/08). PARENTS TOOK CHILD TO E.R. FOR EVALUATION. HAD OFFICE VIST 6/11/08, DOCTOR PRESCRIBED BENADRYL AND COLD COMPRESS TO THE ARM.
PATIENT RECEIVED MONVALENT MODERNA BOOSTER AFTER 08.31.2022.  PER OUR PROGRAM, I NEEDED TO SUBMIT VAERS REPORT .  PT WAS TRAVELING TO OUTSIDE COUNTRY WITH FIANCEE AND OTHER COUNTRIES ARE REQUIRING A BOOSTER PER PT.  SHE STATED THEY COULD NOT WAIT FOR BIVALENT BOOSTER DUE  THEIR TRAVEL PLANS.  PT HAD NO SIDE EFFECTS FROM BOOSTER AND IS DOING FINE.  SHE CURRENTLY DOES NOT A PRIMARY CARE PHYSICIAN SINCE SHE IS NEW TOR AREA WITH FIANCEE.
A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Dec-2010, the patient received FLUMIST. On 03-Mar-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Patient called in. Itchy rash to upper back & shoulders. States no SUA or any other sx. Rash does not go past mid back or above shoulders or on arms. Using BENADRYL creams & helping.
She experienced rash  in other parts of body; She experienced rash below the injection site; She did not feel good; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (She did not feel good), VACCINATION SITE RASH (She experienced rash below the injection site) and RASH (She experienced rash  in other parts of body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (She did not feel good). On 07-Mar-2021, the patient experienced VACCINATION SITE RASH (She experienced rash below the injection site). On 09-Mar-2021, the patient experienced RASH (She experienced rash  in other parts of body). At the time of the report, FEELING ABNORMAL (She did not feel good), VACCINATION SITE RASH (She experienced rash below the injection site) and RASH (She experienced rash  in other parts of body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
we got covid; we got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "we got covid"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "we got Covid". Therapeutic measures were taken as a result of suspected covid-19. The patient was treated with Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Blurry vision, severe sweating, weakness- passed out. Rapid breathing/wheezing- very weak- very itchy skin (on hands only). Pt started feeling a little better about 09:30pm on 11/20/2002. About 2 days ;later Pt was ok.
Redness an inch or two below the injection site; Swelling just below the injection site; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose, for tolerance refer US2020AMR072170).   On 24th April 2020, the patient received the 2nd dose of Shingrix. On 24th April 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 26th April 2020, the patient experienced erythema and swelling. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, erythema and swelling were unknown.   It was unknown if the reporter considered the injection site pain, erythema and swelling to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix on right deltoid. After receiving Shingrix, the patient had experienced pain at the injection site and also had redness an inch or two below the injection site on Sunday that was painful to the touch. The patient was taking Tylenol to treat the pain. The reporter consented to follow up. This case is 1 of 3 cases reported.
I began having a burning and tingling sensation around my ribcage on my right side. I attributed it to possible swollen lymph nodes as the result of the vaccine. I had tenderness there for about a week. It started getting better and on my right side in my waist area, I had a sensation on my skin with no visible rash or anything, but it felt like my skin was burning and tingling. I thought maybe I was getting shingles, but never broke out. The same pain then went to my inside upper arms, both of them and then it spread into my armpits. and down both my sides. At times, the sensation was across the top of my chest. There is no rash, there is no visible inflammation and my skin doesn't feel warm to the touch although it is burning and tingling to me. It has been going on now for weeks. I have taken naproxen to see if it was some kind of inflammation as an immune response and it has helped on some days but not on others. I feel stupid to make a Dr appointment because there is nothing to see, but the painful sensation is real. It feels like a really bad sunburn.
tingling in arm at the time of admin down into fingers which faded over 15 mins and then soreness in arm
Commencing at 7:00 pm on vaccination date numbness in mouth and metallic taste, nausea, dizziness. At approximately 9:00 pm extreme headache, extreme nausea, excruciating pain at injection site spreading down to hand. Threw up repeatedly. Temperature of 102. Chills and shaking , pain in lymphnodes, unable to arise from prone position. Diarrhea commenced around 1:00 am. Major symptoms subsided by noon following day and by 7:00 pm symptoms largely resolved.  Had Covid in March 2020 no test as not available at time. Tested positive for antibodies for several months. ER visit in May 2020 severe inflammation and pain during menstration. Had to have hysterectomy on March 9,2021. Daughter in ER week after me with alleged HSP but confident she had MIS-C. I am Rh negative.   I truly hope this helps with future care for others.
Information has been received from a physician concerning a 33 day old female who on 06-FEB-2007 was vaccinated with an oral dose of Rotateq (Lot# 653981/0411F). Later that same night, on 06-FEB-2007 the patient experienced colic. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Within 3 days of my first dose I had pain in my left thumb. It felt swollen and I could barely bend it at the first knuckle. I put it off as a carpal tunnel flair up, even though u have never experienced pain & swelling in my thumb before. However, this pain has not gone away, I still have this pain and I'm convinced it has to do with my injection. After my second dose of Moderna lt # 017C21A the pain got worse. That's when it occurred to me, that this could be a side affect to the Covid19 Moderna Vaccine.  My son encouraged me to report my symptom on this site and to speak to my doctor after he read an article of other patients reporting this odd symptom.
01/26/11 - 0.1cc tetanus toxoid administered intradermally (L) volar forearm instead of PPD. 01/28/11 - large area erythema from several cms. below antecubital fossa to midway down forearm almost entire width of forearm, central induration at injection site 01/31/11 decreased erythema.
arm pain; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and RASH (Rash) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 021B21A) for COVID-19 vaccination.     no medical history was provided by the patient.  The patient's past medical history included Eczema. Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), DULAGLUTIDE (TRULICITY), METFORMIN, ATORVASTATIN, TESTOSTERONE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), TADALAFIL (CIALIS) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and RASH (Rash). At the time of the report, PAIN IN EXTREMITY (arm pain) and RASH (Rash) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
11MAY92 started w/rash; bumps on back of knees & finger; no fever, cough, runny eyes or malaise; 12MAY92 mom phoned rash going into eye advised to ER; ER dx hypersensitive to MMR; given meds;
I had shortness of breath and now have chronic tackycardio that in now on meds for and have to see a cardiologist for.
"severe reactions"; very weak; Felt Bad; shortness of breath; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION ("severe reactions") and ASTHENIA (very weak) in a 71-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.     Reporter stated that the patient had a history of "health problems."  No specifics were provided.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MELATONIN for an unknown indication.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION ("severe reactions") (seriousness criterion death), ASTHENIA (very weak) (seriousness criterion death), FEELING ABNORMAL (Felt Bad), DYSPNOEA (shortness of breath) and PYREXIA (Fever). On 06-May-2021, FEELING ABNORMAL (Felt Bad), DYSPNOEA (shortness of breath) and PYREXIA (Fever) outcome was unknown. The patient died on 06-May-2021. The cause of death was not reported. An autopsy was not performed.            Patient had no symptoms or side effects after the 1st dose. Patient was never hospitalized for the reported events.  A 71-year-old male patient who received mRNA-1273 experienced Pyrexia, Feeling Abnormal, Dyspnea, Asthenia and Vaccination Complication and died on an unknown days after the second dose of vaccine.  Patient had a history of unspecified health problems which may confound the event. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.; Sender's Comments: A 71-year-old male patient who received mRNA-1273 experienced Pyrexia, Feeling Abnormal, Dyspnea, Asthenia and Vaccination Complication and died on an unknown days after the second dose of vaccine.  Patient had a history of unspecified health problems which may confound the event. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death
chills, cough, chest tightness, SOB, chest pain, abdominal pain, constipation, weakness
FEEL LIKE HIT BY A MACK TRUCK; FEELING CLAMMY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, 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 feel like hit by a mack truck, and feeling clammy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like hit by a mack truck and feeling clammy was not reported. This report was non-serious.
Rash, redness, itchy, swollen, hot and soreness. Felt fine otherwise
Upper arm and shoulder were sore from hours after the injection.  Seemed muscular.  The muscular soreness seemed to get better over the next 7 days but on Friday night I noticed that the injection site felt like a bruise and it was getting warm, also my arm was tight, like from swelling to move.   By Saturday morning, I put ice on my arm and took 3 Advil, 600mg .   By Saturday night the redness and hard area over the upper part of my arm developed.  Also am very tired.  During the night the swelling of my arm increased, took 600mg of Advil again.  Redness is about 3 inch in diameter, watching to see if it increases over the next few days.
Pain branching out into my left shoulder; Bit of swelling branching out into my left shoulder and upper chest; Pain branching out into my left shoulder and upper chest; Palpitations occurred during the night, waking me up.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EWO158) via an unspecified route of administration in the left arm on 18Apr2021 at 14:15 (at the age of 45-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: WO1832) via an unspecified route of administration in the right arm on 09May2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and intestinal trouble. 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 levothyroxine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) on an unknown date for unknown indication and unknown if ongoing. On 19Apr2021 at 01:00, on the following night, the patient felt pain and a bit of swelling branching out into her left shoulder and upper chest. Palpitations occurred during the night, waking her up. She took 2 Acetaminophen. It happened again the next night. The branching pain and swelling occurred off and on for about a week, even during the day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with 2 Acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt pain and a bit of swelling branching out into left shoulder and upper chest and palpitations were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Daytime and Nighttime Hypoxia - Low Blood Oxygen Saturations.   Ranging from 96-88 days to  as low as 72 while sleeping. Extreme fatigue, cloudy thinking, at times - overall malaise
Patient reported significant adverse effects with the SHINGRIX. She had her shot on Wednesday afternoon, 2/21/2018. She reported waking up around 6am on Thursday feeling like she had the flu. She had a 102F temperature that she treated with TYLENOL. Patient also reported feeling tired, achy, had a headache, and had to leave work early at 1pm. Her arm was red and also swelled up significantly. All issues resolved the following day, but she felt tired and run down for several days. She was back to normal today, 2/26.
pt recvd MMR vax 18JUL90 & on 19JUL91 rubeola titer was performed & no anitbodies were detected; 2nd test on 28AUG91 yielded the same results; pt recvd addtl inject of MMR 13SEP91; no further details were provided;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with a dose of ROTATEQ (lot# was unspecified, 2 ml, oral) and a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which both underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
rash on his forehead; This case was reported by a consumer via call center representative and described the occurrence of rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash spread on his face to his cheeks. The rash was unresolved. This case has been linked with case US2020AMR249090, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249090:same patient
Normal adverse events:  Some fatigue, chills, mild fever for short period of time.    Then after approximately 24 hours developed extremely severe hives/welts over entire body including face and head.  Also, experienced severe almost intolerable itching.  Applied hydrocortisone several times but did not help whatsoever.  Next morning went to walk-in clinic.  Was prescribed a z-pack of Methylprednisolone and Hydroxyzine for the itching.  All hives gone within the next 24 hours and most of the itching.   No wheezing, shortness of breath,  heart racing or swelling of tongue or mouth.
INJECTION GIVEN AFTER  ALLOWED TIME  AFTER FIRST VIAL PUNCTURE
Hives and swelling.  Still uncomfortable in feet and ankles.  Fingers are still kind of tight. Patient noticed itching and swelling on fingers, hands, feet, toes, ankles, and knees on Sunday (2/7). Had hives, went to urgent care, thought it was allergic reaction to vaccines received. Received influenza, meningococcal, and HPV on 2/2. Given prednisone and famotidine at after hours clinic and have been taking since then, swelling has gone down, still has pain in joints. Also taking benadryl and claritin. Hives come back at night, when steroids wear off. No new foods recently, no new products, not going anywhere.
Immediately after inject a large red lump appeared at injection site. Meassured 20mm in size.
I received my 1st dose on 4/28/2021, I was fine for the rest of the day, next day I woke up the next day 4/29/2021 feeling achey and sore all over. My arm was tender at vaccination site. These all went away towards the end of the day on 4/29/2021. I had no marks, or redness on my arm. On 5/9/2021 I woke up feeling incredibly sore, and my vaccination side became visibly red. It looked like a red spalsh mark (I have photos). ARound 1:30/2 my gums became incredibly tender, almost as if my teeth were going to fall out. I took a nap, and this feeling went away. As of 5/10/2021 this rash /redness is gone.
throat swollen, v, 103 fever started w/in 2hr of vax;swollen throat & vomiting for 5 days then just vomiting for 2 more;Gatorade or juice p/ day 5;throat practically closed because of the swelling & fever was down to 102;throat infect;