chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, 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 experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 470 (High) blood sugar level was 470  and was still up did  not went down.         Patient had received first dose on the first week of March, received the second dose on 10 Apr 2021. No relevant concomitant medications were provided. Patient was a diabetic but was on no medication for the past year. Patient experienced a sore arm and a 470 blood sugar level and was still up and not going down. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD with lot # N023967 (expiration date unknown) (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis, reconstituted with MERCK STERILE DILUENT that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter.
Dizzy+woozy, couldn't driver/nauseous, Paramedics taking vital signs, Father coming to pick her up.
Per patient, started to have redness and inflammation at injection site between 5-6 pm on day of vaccination.  Rash and redness expanded next morning. She applied ice which seem to ease the pain and inflammation.
Heart palpitation; Nausea; She was very tired; Aches; She slept for many hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), HYPERSOMNIA (She slept for many hours), PALPITATIONS (Heart palpitation), NAUSEA (Nausea) and FATIGUE (She was very tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Aches), HYPERSOMNIA (She slept for many hours), NAUSEA (Nausea) and FATIGUE (She was very tired). On 10-Mar-2021, the patient experienced PALPITATIONS (Heart palpitation). At the time of the report, PAIN (Aches), HYPERSOMNIA (She slept for many hours), PALPITATIONS (Heart palpitation), NAUSEA (Nausea) and FATIGUE (She was very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
rash in multiple locations; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rash in multiple locations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (rash in multiple locations). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 60 milligram; HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (rash in multiple locations) outcome was unknown. Not Provided      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.   No concomitant medications were reported. No treatment related information has been reported.
Vaccine administer 11/23/09 around 7:30 pm at the Clinic.  When the lady placed the shot in my arm it was placed too high and she was unable to get the plunger to go in so she moved the needle around a little (while in my arm) and then pushed very hard on the plunger and the vaccine went in.  I thought to myself, that didn't seem right but didn't say anything at the time.  However, the nurse did make a comment that it was weird that the plunger wouldn't go in.  The next morning (11/24/09) I noticed pain in my shoulder joint and told my husband about it, explaining that it was not normal muscle soreness felt after a shot but rather pain in my joint.  I let it go a little more than a week and finally made an appt with PA at the Doctor's Office (12/03/09).  The pain had gotten pretty bad and I had limited range of motion in that arm. I explained what happened and she agreed that there was inflammation in the shoulder and that it sounded like the shot was administered in a tendon or the bursa sac of the shoulder.  Provider suggested ice, rest, and Ibuprofen.  I explained that my husband and I were trying to get pregnant and there was a chance that I might be pregnant, so we discussed Tylenol for pain instead of Ibuprofen since it's contraindicated in pregnancy.  The pain continued to worsen and that night I had difficulty carrying out tasks at my clinical site.  The next day I had trouble getting myself dressed and undressed and still had very limited range of motion that seemed to be getting worse.  I called The Doctor's Office that day (12/04/09) and attempted to make an appt for Saturday morning but they were closed for the weekend so I made an appt for Monday afternoon.  I called off work for the weekend (12/5/09 and 12/06/09) to allow my shoulder to rest.  By Monday my shoulder was a little better, so I cancelled my appt, hoping the pain would continue to get better.  Unfortunately, the pain has continued through the month of December and now into January.  I made another appt with the provider and saw her again today, 01/04/2010.  Provider xrayed my shoulder and ruled out a break but suggested I see an orthopedic specialist.  I have made an appt for 01/13/2010. The pain I am now experiencing is not unbearable but it is bothersome and is a nuisance. I have pain when completing everyday tasks like talking on the phone, driving, getting dressed/undressed, taking my coat off and putting it on, pulling the covers up while in bed, etc... I am also unable to sleep on my left side because if I am on that side for too long the pain becomes too great from the pressure on that shoulder. In addition, if I use that arm too much throughout the day I end up going to bed with a burning pain all over my shoulder area.  These are just some examples of the pain I am feeling from this injury and I'm scared becuase it doesn't seem to be getting all that much better with time.
I had a really bad headache, ached all over. It felt like the flu. I had terrible chills and couldn't warm. This lasted about 12 hours.
There is a large, swollen itchy lump on my left arm where I got the vaccine.  It just showed up today (3/27/2021), even though I got the vaccine on 3/19/2021.  The lump is hard and swollen,  and looks and feels similarly to the reaction I get when I get a mosquito bite, I.e. hard, swollen, itchy, and red.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. No concomitant medication reported. On an unknown date, the patient experienced redness at the injection site after receiving ZOSTAVAX. The outcome of redness at the injection site was not reported. Causality between ZOSTAVAX and redness at the injection site was not reported. Product quality issue was not reported. Additional information has been requested.
pt recvd vax;soreness in joint muscles  & soreness at inject site;30oct95 rash raised devel around inject site;skin very tender to touch & extended to arms pits;feels T slightly inc and chills & weakness;
No other adverse events reported; Expired MMR II vaccine given; This spontaneous report has been received from a medical assistant (also reported as "office manager") via Agency concerning a 57-month-old (also reported as "4 year and 9 month old") male patient.  The patient's concurrent conditions, concomitant medication, historical drugs, and pertinent medical history were not provided.  On 09-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (rHA) 0.5 milliliter (lot number T013724 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), expiration date reported and confirmed as 21-APR-2022) (route of administration was not provided) administered into his right arm as prophylaxis. After the vaccine was given it was discovered that it was expired (Expired product administered). The vaccine did not experience any temperature excursions. No additional adverse events were reported.
BLOOD CLOTS; ISCHEMIC STROKE; This spontaneous report received from a consumer concerned a 60 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, which occurred on 16-OCT-2020. At that time, the patient was found on the floor in the morning at 06:30 and the stroke took out patient's left side and the bleed took out the right frontal lobe. The patient needed to relearn how to do everything from putting on clothes to brushing teeth. Concurrent conditions included: penicillin allergy, hay fever, abstains from alcohol, and non-smoker. The patient had no history drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included daily consumption of acetylsalicylic acid, apixaban, atorvastatin calcium, baclofen, diltiazem, escitalopram oxalate, and methylphenidate hydrochloride (not daily, depending on the day). On 27-AUG-2021, the patient experienced ischemic stroke and blood clots. The patient went to the emergency room on 27-AUG-2021 and did not initially find anything on the Magnetic resonance imaging but was called back on 28-AUG-2021 and then the patient was hospitalized and was released on 30-AUG-2021. The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ischemic stroke, and had not recovered from blood clots. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210905634- covid-19 vaccine ad26.cov2.s-Ischemic stroke . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210905634- covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
C/o soreness to deltoid right S/P ADACEL injection. Pain occ. persists rated 4-5/10 esp. point tenderness. Tx'd with Ibuprofen 600mg q 8 hours. Pain continues today.
Within approximately 5 minutes patient doubled over in pain and said something was wrong, she grabbed her chest/upper abdominal region. She said something is wrong, and stated the pain was radiating all the way to her back. She appeared to be in quite discomfort. I called 911 as it did not appear to be an allergic reaction, I took her blood pressure which was 127/66, pulse 73.  When the paramedics arrived they took her vitals, and everything appeared normal.  She declined going to the hospital as the symptoms subsided in about 20-30 minutes and you could tell she was feeling better. EMS advised if she started feeling worse to call them again or go to ER
pt recv 2 doses of vax jan96, lab evaluation on 06jun96 revealed a lack seroconversion ELISA=0.05);
PATIENT HAS NO MEDICAL PROBLEMS AND IS VERY ACTIVE , GOES TO THE GYM REGULARLY AND DEVELOPED NAUSEA AND EPIGASTRIC PAIN ON THE 3/17/21 , 3 DAYS AFTER RECEIVING MODERNA SHOT . HE SAID HIS PAIN  HAD BEEN PROGRESSIVELY GETTING WORSE. HE SOUGHT CARE AT THE HOSPITAL ON 3/27/21 AND WAS DIAGNOSED WITH PANCREATITIS AND SENT HOME . RETURNED TODAY, 4/1/21 WITH SAME AND CONSTANT ABDOMINAL PAIN. LAB WORK  AND EXAM SHOWED FINDINGS CONSISTENT ACUTE PANCREATITIS.  PT DOES NOT DRINK OR USE DRUGS. ONLY SMOKES 3 CIGARETTES A DAY. I HAVE ADMITTED HIM TODAY AND WILL BE FOLLOWING HIM
pt recvd vax 19JAN94 in the afternoon & 6PM started w/an elevated temp, reaching 104.8; states pt was fussy et "legs" sore; father states that pt spiked 104.8 temp the next noc; fluid behind 1 eardrum;
started breaking out at 3:30 - noticed this when patient came home from store at 4:05.  Has rash on arms, fac red and slightly warm.  Rash has started on back 4:10 Benadryal 4:15 rash started to fade.  4:20 instructed patient on use of benadryal. Will follow up with patient next day.
-Nerve or muscle pain/tingling in left arm -happens approx once per week but is becoming less frequent as time goes on. -Joint pain (shoulder and elbow) -soon after receiving the vaccine, lasted approx 2-3 days. -Extreme headache approx 10 hours after receiving the vaccine, lasted 1 day. -Extreme chills approx 10 hours after receiving the vaccine. -Approx 45 days after the shot I experienced extreme shoulder joint stiffness and loss of motion (could not move left arm above head or behind back) -which lasted about 3 to 4 days.
Have the nearly constant metallic taste and smell. Started day after vaccine. 7 days later, still the same, maybeslightly lessened but quite noticeable.
Died of aspiration pneumonia due to  Diaphragmatic inflammatory myopathy/myositis Systemic inflammatory response  Found and pronounced days after the actual death, which probably occurred approximately 5 days after the first shot.
Low grade headache. General muscle aches in entire body. Tiredness. Pain where shot was given.
It started in my right wrist about 6 weeks after 2nd dose. I felt a bump on top center of my wrist when I bent my wrist. After about a month of not getting better, and the coincidental growth of one in my left wrist and right ankle. I went to the doctor. They did X-rays and said it could be cysts. By the end of its development, I was limited to 20-30 degrees of motion in my wrists. I was helping my parents cut some trees which seemed to have ruptured the cysts internally. The ones in my ankle and wrists have gone down. The one in my right wrist has gone.
Swelling at the injection site / has not resolved; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA438A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Menveo.  Additional details were provided as follows: The patient received Menveo and had only adverse event that was seen was some swelling at the injection site.  The swelling had not resolved and the parent of the child had not reported any other adverse event. The reporter did not consent to follow up. This case linked with US2021030543, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030543:Same reporter.
April 14th high, severe acute asthma attack felt like I was going to black out lasted 24hours, asthma medication didn't work.   I used 2 nebulizer treatments that also didn't work. April 17th went to ER with chest pain and had electrical shock pain down to pelvis. ER doctor said I was having an Esophageal spasm.
fever around 100 degrees, heart beat high over 110 shivers, body aches, and headache (she described aching in her bones) no injection site reaction other than a little bit of soreness  She took Tylenol on 05.03.19 at night and will take Tylenol again throughout today. May try Ibuprofen and alternate with Tylenol. Refused to go to urgent care when recommended
Pt presented in ER at 17:02 hours with hives,itching and nausea since noon today (11/02/2004). Was started on IV with Benadryl and Solumedrol and monitored. She was DC on Medrol pack and Benadryl. To follow-up with family MD.
pt recv vax 5MAR98 & 20MAR98 pt exp stiff fingers & rash (red spots on arm);also exp swelling of hands, pain hands & feet;
I have always had mild ectopic heartbeats. However, after receiving the shot starting about 15 days afterwards and continuing through the beginning of August I started having preventricular contractions that used to be around 10-50 per day that increased to around 1500 on some days. These ramped up from May 17th eventually I visited the ER on July 3rd, 2021.   I am now on beta blockers, they help with symptoms and most of the palpitations subsided in August, however they have returned. I had a breakthrough case of Delta confirmed on November 13th and now I am having another bout of palpitations similar to those after the vaccine. I do not know if they are related or not, however I am reporting them as we continue to investigate.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who experienced tired and couldn't get out of bed through the weekend, some itching at site and rash at injection site 4 inches wide, flat while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious tired and couldn't get out of bed through the weekend, some itching at site and rash at injection site 4 inches wide, flat, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was rash at injection site 4 inches wide, flat, some itching at site and tired and couldn't get out of bed through the weekend. The patient was recommended Hydrocortisone cream as corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
During PM bath noted to become quite pale followed by limpness & appeared "glassy eyed"; was responsive; fever then noted; No vomiting; No respiratory distress; Difficulty cleared spontaneously; Normal exam later in ER;
Rec'd PENTACEL, PCV7 and Rotavirus 1/12/2009 - developed fever to 106 1/11 per mom, Occ crying. Temp on and off throughout day 101-102 per parents, 102 on visit 1/14/09 - behavior better - drinking well, vomited X 2 yest.; Sl. diarrhea 1/11. Affect gd on visit 1/14/09- happy + playful
Chest pain unrelated to pregnancy --found out newly pregnant when assessing symptoms, PCP told me in was common for chest pain after vaccination and that she has others patients that have experienced the same.
very tired/tiredness; had a need to sleep it off /went to bed earlier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172250). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: her experience with testing positive from COVID-19. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "very tired/tiredness"; SOMNOLENCE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "had a need to sleep it off /went to bed earlier". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was not pregnant at the time of vaccination. It was reported that, the patient had Pfizer COVID-19 vaccine-both doses-experienced mild symptoms; both times only lasted for 24 hrs and the symptoms reminded patient of her experience with testing positive from COVID-19 as she was very tired and had a need to sleep it off. Stated that, second dose was supposed to wait until the 30th, but patient had conflict and asked nurses whether she could take the second dose two days earlier. Stated that, mild symptoms consisted of tiredness and went to bed earlier.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110  muscle ache, fatigue, weakness
Starting a week after his 12mo visit and injections, he came down with  bronchiolitis for 4 whole entire months. He'd get real sick for 2 weeks, start to recover, only to get worse for another 2 weeks, etc. By his 15 mo check up (12/06/2017) he was finally feeling better only to get sick again and is still currently sick with bronchiolitis. I refused any shots for that visit as his immune system was still overloaded. He is now on plumicort daily until further notice (I was told at least until spring starts) and Albutoral when needed to help him breathe. This all started when he got RSV back to back last dec (2016) which severely weakened his lungs. After which I was told vaccines were still safe to give so I listened. I have so much regret. He was also saying several words prior and now only says 1 word and started flapping his hand near his face.
Pt began feeling faint. We sat her down. She drank some water and cool rag placed on neck and forehead.
"...felt like truck ran over me." At 4 AM on 10/17"...felt my upper body on fire with pressure inside head and face. BS 322, took meds. At 7AM BS 176, felt "horrible." At 1300 woke up, shaky and weak BS 140. At 1800 felt normal."
Child pulled away from the needle while injecting.  It appeared that some of the flu vaccine may have entered the subcutaneous space.  Area around injection became red.  Child kept rubbing the area.  The mother asked the child to stop rubbing so as to see the extent of the redness, but it was difficult to tell.  The mother said she would keep an eye on it.