chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at the site of injection following vaccine. 2 inch diameter. round shape; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the site of injection following vaccine. 2 inch diameter. round shape) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0317K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the site of injection following vaccine. 2 inch diameter. round shape). On 05-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at the site of injection following vaccine. 2 inch diameter. round shape) had resolved.        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 relevant concomitant medications were reported. Treatment for the event was Unknown.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) had resolved.        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.   The vial was stored at the facility on 07-Apr-2021 and kept in their fridge past the expiration date of 07-May-2021. The doses were received on 11May2021.   This case was linked to MOD21-089564, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089650, MOD21-089653, MOD21-089658, MOD21-089660, US-MODERNATX, INC.-MOD-2021-123137 (E2B Linked Report).; Sender's Comments:  MOD21-089564:Same reporter MOD21-089636:Same reporter MOD21-089642:Same reporter MOD21-089644:Same reporter MOD21-089646:Same reporter MOD21-089650:Same reporter MOD21-089653:Same reporter MOD21-089658:Same reporter MOD21-089660:Same reporter US-MODERNATX, INC.-MOD-2021-123137:crosslinked
pt recv vax;25feb94,devel aches & pains followed by fever;devel "extreme mono" & elev liver enzymes to "300+";a throat,mono & blood culture neg;2mar94,monospot pos,pt's SGOT peaked at 312;better on 12mar94;f/u pt recovered;related to vax;
Swelling at injection site was larger than most, was bright red for several days, and was hot (at least 4 days).  Developed two areas on left forearm that were raised and had clear blisters; this arm never had blisters from Celiac disease. A third area at the elbow was starting when everthing ended after day 6.  At the same time a swelling with blisters appeared on the right forearm, with a second area starting to appear about day 5. This arm has always had blisters around the elbow from eating wheat, but none above.  Nobody seemed to think much of it, except me. I was the one itching all the time.  I usually pop the blisters by pressing on them with a tissue. Once the liquid comes out, the itching stops.
Left deltoid area red with rash. Rash also present below deltoid to elbow and just below right scapula. Patient reports itching of entire upper outer arm and across midsection of his back. Lotion and hydrocortisone cream applied.
Approx 4 to 5 minutes after rcving the Gardasil shot (2nd dose) my daughter was seated on the exam table undergoing the rest of her physical. She suddenly became unresponsive to the dr she made a moaning sound, her eyes rolled back in her head she began to slide sideways down the wall. As I caught her her upper body became rigid and her arms made some jerky movements and her neck tensed up so she did not faint limply but actually tensed some of her muscles unlike normal fainting and more like siezure. Her color went out of her and she looked yellow. She came around in 20 to 30 seconds very upset and disoriented. She complained it was difficult to breathe at that point, she complained of neck pain, she complained of a tingling and painful sensation running up the arm the immunization was given in and into her neck. Dr checked her vitals and observed her prior to release from his office. Later in the day she complained of visual aura, was extremely fatigued and complained of discomfort moving the arm and strange tingling feeling in the arm and fingers for several hours which dissipated within 24 hours.
Pt started with Fatigue, nausea diarrhea, swelling of face, shortness of breath, rapid heart rate, symptoms have progressively gotten worse the soonest she can come in is on friday to see a provider.
Massive swelling of arm, hot to touch and red. ED staff diagnosed as Cellulitis and prescribed cephalexin. Continued to get worse and fear of cutting off circulation in hand due to severe swelling. Return visit to ED on 11/1/15 and then follow up with Physician on 11/2/15.
Child was given HPV and Flu shot. Child feet pain, starting crying, maculopapular rash developed on face and neck area. No resp. distress.
He got his vaccines, was OK on that day.  2-3 days later his arm on the right side was really sore, and when you rubbed the area close to the shoulder it felt like it pocked out.  Then after that on 11/7/22 he noticed that his mouth was drooping and he did not feel good.  He did not realize that it went to his eye as well.  He was at restaurant and eating lunch and when he was putting food in his mouth and trying to eat he was not able to eat really well, and realized that the food was falling down between his teeth and gums on the right side.   He asked his wife to look at his face and noticed that the right side of his mouth was drooping some.  His eye was very watery.  That evening about 5:30 he did not feel good at all and needed that he had to get some health.  He called a nurse on ask a nurse and explained what his symptoms were and the nurse called back and talked to her what was going on and she said that she felt that he was not having a stroke as he thought, and that he might have Bell's palsy.   On 11/8/22 he went to the ER and did a stroke evaluation and told him that she was 100% sure that he had Bell's palsy.  He had an EKG, a chest x-ray, CAT scan of his brain to rule out the stroke.  She then told him that he needed to see his eye doctor as his eye was involved too and to see his PCP as well.  He got home and the next morning he got his prescriptions filled and he started using that.  Two days later he called his doctors and set up those appointments.  His eye doctor told him that he was progressing well and that it would take some time for his eye to get back to normal.  His PCP also knew what was wrong and said that it was a relaxation to the vaccine, and that one of the side effects was Bell's palsy and that it would go back to normal, and to do some facial exercises to get it back to normal, and has a FU appointment for 6 weeks, and also has a FU appointment with his eye doctor next month too.  His PCP told him to call us and report the reaction.    He went to the ER at Hospital.
Patient is fully vaccinated.  COVID + on admission to hospital. 86-year-old male patient, who presented with a history of CKD, CAD, diabetes mellitus 2, hypertension, hyperlipidemia, secondary to altered mental status.  The patient is alert and oriented to time and place, though he is confused as to why he is in the hospital and is not able to provide history this current condition.  The patient apparently has been progressively fatigued and altered over the past couple of weeks and has a home care nurse and lives at home with his wife. Metabolic/Toxic encephalopathy CT head: IMPRESSION: No acute intracranial process. COVID + CXR: There is no radiographic evidence of acute cardiopulmonary disease.  No indication for steriods, remdesivir, or oxygen.  Elevated troponins. Cr 3.51. elevated D dimer.  Discharged home after a long hospitalization.
developed it (blood clots) and died; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed it (blood clots) and died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: developed it (blood clots) and died
Pt's right leg with redness and swelling in area DTaP was given. Pt is also screaming. Pts mother was told to give him instant Tylenol and use cold packs to helps reduce swelling.
Received injection PNEUMOVAX 10/3/2017 at Pharmacy. The next day and 48 hours temp 103. Went to ER1 10/4...left too sick to wait. Went to MD 10/5 temp; WBC = 27,500. Started generic LEVAQUIN 10 days ending 10/15. Recheck at MD showed WBC normal at 10,500. Adverse discomfort began the day after the shot; fever lasted 48 hours. Everywhere, every bodily joint hurt, but excruciating pain in right arm and elbow (the arm that got the shot). I need to add that I received a flu shot in the left arm (opposite) the same day.
This spontaneous report as received from an other health professional refers to a male patient od unknown age. On 01-MAR-2013 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular (lot no reported as 1537aa, exp 21-JUN-2014). It was reported that the patient may have received a GARDASIL dose that had previously been exposed to -4 for 24 hours and -2c for six days. The reporter was unsure if the patient received the GARDASIL due to discrepancies in their documentation, but it was stated that no adverse events were documented. Additional information has been requested.
Expired vaccine used (expired drug administered) A non-serious spontaneous report of administration of expired FluMist was received from a nurse concerning an adult male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FluMist vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product complaint investigation results.
Systemic: Headache-Medium, Systemic: Nausea-Medium.
Achy muscles/joints about 12 hours after shot, lasted about 48 hours Fatigue started about 16 hours after shot, lasted about 48 hours Pain in muscle at injection site for 72 hours
Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Right arm is sore; Headaches; Body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20May2021 12:30 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "Right arm is sore"; HEADACHE (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "Headaches"; PAIN (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 20May2021 14:00, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of pain in extremity, headache, pain, chills.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Would consider myself someone extremely healthy without any disease. My symptoms included intermittent migraines with rainbow halo around lights for two weeks, myalgia that I have never experienced. Vaginal breakthrough bleeding with period ( have IUD placement x2 years and haven't had bleeding  since).   In addition I experienced the normal fever, malaise and fatigue for the first three days following but wanted to report the extended symptoms that continued. Feel great now and am thankful, but thought it would be useful for research  purpose.
Patient received Fluarix vaccine, which is not approved for those under age 18.  No apparent side effects according to Mom.
Erythema and swelling over Left Deltoid region 11 cm tall 7 cm wide.
Case number PHHY011US69372, is an initial spontaneous report from a nurse received on 29 Jul 2011: This report refers to a patient with unknown age and gender. This patient was inadvertently received a intramuscular dose of only MenA lyophilized conjugate component of MENVEO (batch number M10059) that was reconstituted with a sterile diluent on 26 Jul 2011. The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration.
Initial report was received on 22 January 2014 from a health care professional. A 17 year-old male patient with no known allergies and no medical history had received the following vaccines on 21 January 2014: a dose two intramuscular left deltoid injection of MENACTRA, lot number U4657AA, an intramuscular left deltoid injection of FLUZONE, lot number UH900AE (number of previous doses for FLUZONE was reported as several) and dose three right arm injection of Hepatitis B, lot number J006511 (manufacturer not reported) and an unspecified amount of time later after the patient received MENACTRA vaccination "slumped over but caught by nurse and returned to position". The patient was observed for 15 minutes and no other symptoms were noted and the patient left facility for home. The next day patient reported experiencing nausea, increased salivation and shortness of breath. The patient was to be evaluated by a physician assistant. Outcome was not recovered. Documents held by sender: none.
DEVELOPED CONTINUOUS CHEST PAIN WHEN BREATHING IN. WAS SENT TO THE EMERGENCY ROOM. WAS SEEN IN ER AND DISCHARGED AFTER OBSERVATION PERIOD. ER PROGRESS NOTE: Patient is a 37 y.o. male who arrived by Home presented to the emergency department for Chest pain.  Patient states that approximately 15 this morning he received a Covid vaccine and approximately 1 hour later he started to have chest pain.  Patient describing chest pain as sharp, left-sided, nonradiating, nonexertional, only occurring with taking a big deep breath, has never had similar symptoms before, not improving with home baclofen, currently a 3-4 out of 10, not occurring at rest only with deep breath.  Patient states that he became concerned that it was a side effect of the vaccine and came to ED for further evaluation.  Patient just denies any associated shortness of breath, nausea or vomiting.  Patient states he has history of bipolar, takes no mental and has been taking as prescribed.  Patient states he is otherwise healthy. Patient works at a healthcare facility, has a weekly Covid antibody test which is was been negative, denies any other associated symptoms today.  Patient is a daily smoker, no history of blood clots, no recent travel or surgeries. Patient denies any headache, change in vision, nausea, vomiting, neck pain, back pain, fever, chills, shortness of breath, abdominal pain, flank pain, change in urination, diarrhea, constipation, rashes, lightheadedness, dizziness, or any other associated symptoms.
Expired vaccine was given. HAB was given on 02/22/2022 and the expiration date was 02/08/2022. Client was notified on 03/01/2022. Mfg. consulted on 03/01/2022 with the understanding that the vaccine was viable 30 post expiration date. Client was given the opportunity to revaccinate.
I was not pregnant at the time of the first vaccine, but was pregnant at the time of the second vaccine.  I had a miscarriage on 2/24/2021
My son received the vaccine at 12:35pm and he was fine for the reminder of the day and did not have any soreness in his left arm. Around 8:40pm he came to me after using the bathroom and discovered blood in urine. He wiped himself and their was red blood on the toilet paper. He used the bathroom again around 10:00pm and saw red blood in the toilet as well as on the toilet paper when he wiped himself. He also experienced stinging pain when urinating both times.
Localized reaction on day three 2 x 2cm localized redness and 10-11 cm area of pain.
Pt had injection of vaccine in left deltoid on 5-18-16. Yesterday 24 hours later arm soreness 3 red bumps with swelling inside left arm.
Woke up at 2 am  with extreme pain in my chest and shortness of breath.  Then my stomach started burning and burned all the way up to my chest and then throat until I had to throw up. I threw up a bunch of green liquid that really burned my throat. I took to Tylenol and tried to go back to sleep but it was hard because my whole body hurt and it felt like I was being repeatedly stabbed over and over again in my armpit.  This lasted for 2 days
Large rash spreading outwards from injection site on left leg. Spread upwards toward hip and groin. Bright red rash/hive developed on hip bone of right side. Low grade fever for multiple days. Swelling of injection site. Lack of appetite for multiple days (ongoing lack of appetite). Some communicative regression for 2-3 days.
Headache, Arthralgia, Fatigue, injection site red and swollen Narrative:
Diffuse hives, swelling about 8 hours after vaccines MMR and Varicella given, Prompting ER visit given Benadryl and Decadal
Patient doesn't recall when symptoms started; just over time. States her arm where shot was given and shoulder is weak now with decreased ROM. She says she has to help lift her arm up if it is any higher then her nose. She kept thinking it would get better but it hasn't. It also hasn't gotten worse since gradual onset
Low level fatigue; This spontaneous case was reported by an other and describes the occurrence of FATIGUE (Low level fatigue ) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FATIGUE (Low level fatigue ). At the time of the report, FATIGUE (Low level fatigue ) outcome was unknown. Not Provided          Concomitant product use was not provided  by the reporter.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2021-060412 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-060412:dose 2 (crosslink)
Starting the day after receiving the tetanus vaccine on 12/29/2021 to today (2/18/2022), experienced progressive shoulder pain near site of injection of right arm. Patient describes getting vaccine "too high" on upper deltoid region. Now, he's unable to fully move right shoulder, with greatest difficultly rotating his right arm towards his back.  Complains of achiness and unable to sleep on right side. Was evaluated by urgent care clinic on 2/1/2022, who recommended physical therapy.  Started physical therapy on 2/7/2022 and attended 4 sessions so far - has at least two more sessions scheduled. Reports marginal improvement.