chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered 0.5ml instead of 0.25ml of booster 3rd dosage, letter was sent to patient informing her of dosage given
29 year old Hispanic man developed large local reaction within 24 hours of receiving 2nd in Anthrax series. Previous shot (lot number FAV080) had been 15 months earlier and produced only a small transient "knot". This 2nd shot (lot number FAV086) was given on September 23,2004 into upper triceps region of his right arm. The patient describes the ensuing rash as follows: "After a couple of hours, around 4 or 5 hours later, I felt a big knot and the area was red. I did not think anything of it because that's what they tell you upon receiving the shot. That night, I noticed the area was warm to the touch and small dark red ring starting to form around the site and looks like a rash in the middle. The site itched. The next morning around the site was getting bigger and looked like a rash. On Sept. 25, 2004 the rash ring was about 4 inches long mid biceps. Arm was still red and warm to the touch and itched. On Sept 26,2004 the ring was bigger and redder almost to the elbow. On the 27 of Sept, 2004 I went in to sick call and was evaluated. The site was the same red ring and warm to the touch with redness size measured by the physician was 5.5 cm x 11cm, The redness by now was slowly turning pink, and was no longer warm to the touch. The 28 Sept, 2004 the ring of rash let up little by little. The physician who evaluated him on Sept 27,2004 described an "erythamatous patch 5.5cm x 11 cm with mild tenderness". The patient denies any systemic symptoms (fever, arthralgia, remote rash, etc.). Patient Description- At first it was a big red swollen area with a darker ring around the solid red spot. When the rash started to go away and spread to the elbow and beyond it was just a ring. The inside was light pink almost normal coloration.
10 day wchair. 10 day walker. In nursing home 1 month. Paralyzed, waist down for 1 month.
36 hr later, awoke from sleep, tremulous, hypo responsive, pale face, blue lips and hard (1/2 hr). ER normal exam.
Extreme body aches after sundown  Menstruations heavier and longer than normal  Night sweats  Headaches persisting for 5 weeks  Chills High fever  Cough persisting to this day  Hives on back  Swelling of right side lymph nodes on neck
Moderna COVID-19 VaccineEUA Fever Chills small rash on legs cough rash at injections sight along with swelling on arm and big knot, headache, overall fatigue for a little over 24 hours
24 hours after vaccination administered right arm became red, swollen, warm, and sore down into her elbow.
pt exp rxn to vax stated arm turned red the day of inj & devel a rash sometime later;pt had hot arm for 3 days & itches & felt like was coming down w/flu;
Patient was given 0.2ml of non-diluted vaccine. No reactions or symptoms and no concerns.
Mother called next am said child had 102 degree fever during night. This am 101.6 degrees. No redness or swelling around site. Will call family Dr. this a.m.
No adverse event; Infant received their first dose 10 days earlier than 6 months; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months) and NO ADVERSE EVENT (No adverse event) in a 5-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Infant received their first dose 10 days earlier than 6 months).    No Concomitant medication were reported. Vaccines were stored in freezer. Reporter stated that seeking guidance if the Moderna vaccine (6months-5yrs) was administered earlier than 6 months of age. It was stated that a 5 months and 20 days infant received their first dose 10 days earlier than 6 months and had no reactions. Reporter stated that the doctor said the child should be fine, but wanted to confirm with the infant's mother how the patient was.     No treatment drug were reported.   This case was linked to MOD-2022-644921 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2022: Live follow-up received on 14-Sep-2022. patient information (initial and date of birth) and date of vaccination were added.
gen rash over entire body, face & neck;eyes itching-started about 11AM 7JAN98;h/a;to MD 7JAN98 2:30-sent to ER given DPH & steroid;
I started feeling sick the evening I got the shot. Chills, body aches, fever, headache. sweating, fatigue. Today I am having severe diarrhea and nausea. Fatigued and dizzy. Very scared.
mild fever; Nausea; Chills; Brain fog; Sleepy; Aches; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613), via an unspecified route of administration in the left arm on 17Mar2021 at 15:45 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, depression, obesity and irritable bowel syndrome with constipation. The patient had known allergy to Dilaudid. Concomitant medications included Losartan (MANUFACTURER UNKNOWN), Duloxetine (MANUFACTURER UNKNOWN), Omeprazole (MANUFACTURER UNKNOWN), Potassium (MANUFACTURER UNKNOWN), Chlorthal (MANUFACTURER UNKNOWN); all for unknown indication, from unknown dates and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 08:00, the patient experienced mild fever, nausea, aches all over, chills, brain fog and sleepy. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.The patient did not receive any treatment for the adverse events. The clinical outcome of the events, mild fever, nausea, aches all over, chills, brain fog and sleepiness were recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
Sore arm immediately following vaccination. Lasted approximately 24 hours after onset and then resolved. Headache approximately 3 hours after vaccination. Laid down periodically and took ibuprofen; neither improved headache. Headache lasted approximately 24 hours after onset then resolved.
Pt recvd 2 doses of Engerix-B & 2 wks p/2nd dose devel elevated triglycerides, SGO & SGPT; pt seen by MD;
I started to feel a tingling sensation on my tongue about 2 hours after the injection. It did not get worse and has remained constant. I fell asleep and woke up with the sensation of my tongue tingling. It has been almost 24 hours since the injection and it still tingles.
Fever 101, onset within 8 hours of injection for 24 hours.  Papules erupting on head, neck and trunk on 02/29/08 (72 hours after injection).  03/03/08 rash resolved on face, legs and stomach.  Skin peeling on upper thighs.
In December 2022 I began to have pain in my elbow on the right side. In February I went to another country to have a cortisone injection. It lasted about 3 weeks, but the pain came back. I had an MRI in March and a 3mm intra substance tear and some mild tendinosis. I am waiting for the surgeon to get back with me about a plan going forward.
Patient received first dose of Covid-19 vaccine on 03/08/2021 and while waiting the 15 min period after getting the vaccine the patient stated they felt their tongue swelling. Patient was still able to breath, but felt more like a panic attack. Patient was given 25 mg of Benadryl, and after waiting the patient felt fine and said he no longer felt any symptoms. Patient left the pharmacy.
Moderna rash from shoulder to elbow- presented like cellulitis.  APRN prescribed Amoxicillian 500 mg x 7 days and Trimcinolone 0.1% cream 2X day.  Received information from friend about this "moderna rash" after I had taken the last dosage of antibiotic.  This rash didn't start until 11 days after injection.
I experienced acute, sharp pain in lower abdomen  throughout two days following my a day after my second dose of the Pfizer vaccine (first dose is the same  vaccine).  Following this, my menstruation cycle  slowed, had abnormal flow, then stopped for seven months.  The menstrual cycle started and returned to normal again in the 8th and 9th month post vaccination.
pt recv vax;localized rxn to tetanus;c/o pain/swelling to deltoid area of shoulder; sl erythema noted; tx w/ local applications of cold;
Patient had swelling and redness from shoulder to elbow with a lump and itch at injection site. Patient treated with oral Benadryl and Tylenol. Sore at injection site for 2 days.
He was feeling restless, clammy, and dizzy and appeared pale during his 15-minute waiting period after vaccine administration.   I had him lie down on the floor with his feet up for about 10 minutes until he felt confident to sit in the chair for another 10 minutes or so.  As he was lying on the floor, We brought him a bottle of water.  His color came back shortly after lying down on the floor.  He stated that he has previously had panic attacks after shots, blood draws, etc.  He stated he was no longer dizzy when he stood up to leave.
Janssen COVID-19 Vaccine EUA     Approximately 37 hours after I got the J & J vaccine, I had all this black floating down my left eye.  At first I thought it was some bug/spider and then realized it was my eye.  Some shiny effects happened as well.  I didn't know what was happening to my eye.  I was able to finally see an eye doctor on Monday, March 15, 2021.  She examined my eye and said that they were floaters.  She tried to say that it was because of my age but I have never had anything wrong with my eyes.  PLEASE NOTE:  I have never been to an eye doctor, so this was the first time I had ever seen this type of doctor.  I asked her if she had any other patients that had this effect after the Covid vaccine and she said, yes.   The eye doctor siad that another patient around my age came in to see her after 2 weeks of getting a Covid 19 vaccine( it was not the J & J) and had floaters.  The doctor  dismissed this again as an age issue.  I found it deeply disturbing that this would not be reported.  How does the eye doctor know with certainty that these floaters that happened to me and any other patiients were not caused by the vaccine?    I called the number on the sheet after this first happend to report it, only to be told that a form needed to be filled out.   I was hoping that the floaters would be gone by now but they  are not completely gone.  It is much better than it was when it happened on  March 10, 2021 but it is still not completely better by this time.  I am reporting this because if this has happened to other people that have gotten the same vaccine as I did, that it can be looked into and studied more.  Plus,  I do not want this to happen again or to anyone else.
Bowel movements turned green & mucousy for 4 weeks, became very frequent (sometimes >1 per hour); child began waking in the night with discomfort/grunting to have bowel movement; three episodes of inconsolable crying and refusal to eat within week of vaccine (had never happened before) - longest episode resulted in not eating for about 7 hours during daytime/evening hours.
Within minutes of vaccination, after walking about of exam room, patient had a syncopal event in the hallway, caught by father. Immediately awakened, pale, mild bradycardia. Recovered promptly. Patient had not eaten anything for greater than 12 hours prior to episode.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007393: US-009507513-1806USA001032.
Day of vaccine Fever up to 101.6, chills, headache, lethargy, arm pain radiating to neck chest & back. Following day fever 99-99.7 all day. Headache, lethargy.
WEAKNESS, MALAISE, DIAPHORESIS, RESIDENT THEN FELL OUT OF BED AND BROKE RIGHT HIP
Headache; chills; Body ache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 11:45 at 53 years old (Lot Number: EL3247) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination. No other vaccine were administered in four weeks. The patient previously received the first dose of bnt162b2 administered in Arm Left on 29Jan2021 01:30 PM at 53 years old (Lot Number: EL3247) as single dose for covid-19 immunization. The patient experienced headache, chills, body aches on 20Feb2021 02:00AM. No treatment was received for the events. The outcome of the events was recovering. COVID was not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Starting at 9 hours after injection, felt dizzy and achy.  15 hours after injection had VERY SEVERE flu like symptoms , extreme body pain, dizziness very muddled thought processes and unable to walk more than from bedroom to bathroom for at least 24  hours .  Had to take 800 mg ibuprofen every 6 hours for 3 .5 days.
Systemic: Fainting / Unresponsive-Mild, Additional Details:  fainted, muscles in arms went stiff.  Called 911, retrieved epipen in case she stopped breathing.  She spontaneously woke up after about 60 seconds unaware of what had happened.  Paramedics arrived, checked her bp and ekg. bp was low, 95/55. ekg was normal.  Father refused transport to hospital.
At the time of administrtion, patient stated," My god, this hurts a real lot" She states she made that statment as the vaccine was being administered.  At approximatel 6pm or 5 hours after vaccine administered, patient experienced vision problems...problem seeing, "blurry", thought I must be getting an infection in my eye, felt nauseous and even when I put on my glasses it did not help. Blurry vision started out of the blue on that evening and continued for several days until Saturday when it got better. Nausea started at the same time, was able to eat lightly; lasted until Saturday. No vomiting. Just wanted to sleep; ended up leaving work early approximately 24 hours after vaccine administered...so tired; too exhausted to work on Friday; felt better by Sunday.
Slight redness at injection site, size of 2"-3" diameter, tenderness/supersensitive area size of softball, warm to the touch. > delayed hypersensitivity reaction.
Redness in the left eye; Itchy left eye; Achy all over; Tired; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, OCULAR HYPERAEMIA, EYE PRURITUS, PAIN and FATIGUE in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (When she has allergies she gets red eyes).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY, PAIN, and FATIGUE. On 17-Feb-2021, the patient experienced OCULAR HYPERAEMIA and EYE PRURITUS. At the time of the report, PAIN IN EXTREMITY, OCULAR HYPERAEMIA, EYE PRURITUS, PAIN, and FATIGUE outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medications included eye drops for her allergies  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
babysitter checked on baby-was napping longer than usual-found in crib-had vomited, was unresponsive-felt hot to touch;in ER limp, unresponsive, t41.8R, pale, periods of apnea
Swelling of limb. Inguinal lymphadenitis. Initial non-serious report received from a consumer, who is also a physician, in the United States on 10 November 2009. A 55-year-old male patient developed swelling of a lymph node in the groin, with swelling from that point to his foot in the right lower extremity, 14 days after receiving an intramuscular left deltoid injection of FLUZONE SV (lot number not reported). The patient underwent a full range of testing (including Doppler Flow Test) to discover the cause; all results were negative. Treatment included tetracycline, which was due for completion on 10 November 2008, to be followed by treatment with Keflex. At the time of the report, the patient had not recovered. Documents held by sender: None.
Three weeks after my second shot of the Covid Vaccine I became pregnant with an ectopic pregnancy.  I am 31 years old and have never been pregnant in my life or had a pregnancy scare.  I believe there is a direct correlation between the vaccine and what happened to me.  I received my 2nd vaccine on Saturday 6/5.  On Monday 8/23 I went to the hospital and ended up having emergency surgery.  They said I was 9 weeks pregnant, which puts my conception date 3 weeks after the last vaccine.
confusion; extreme weakness; Sore arm; unable to put words together; dizziness; headache; injection site redness; fever; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion), ASTHENIA (extreme weakness), PAIN IN EXTREMITY (Sore arm), SPEECH DISORDER (unable to put words together) and DIZZINESS (dizziness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (confusion), ASTHENIA (extreme weakness), PAIN IN EXTREMITY (Sore arm), SPEECH DISORDER (unable to put words together), DIZZINESS (dizziness), HEADACHE (headache), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CONFUSIONAL STATE (confusion), ASTHENIA (extreme weakness), PAIN IN EXTREMITY (Sore arm), SPEECH DISORDER (unable to put words together), DIZZINESS (dizziness), HEADACHE (headache), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever) outcome was unknown.            concomitant medications were not reported.  Patient gave consent to safety for Follow-up.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
1 day p/vax pt devel a fever of 103 & a 5inch by 3 inch area of redness @ the site of vax;4 days post vax pt devel swelling @ vax inj site which extended below the elbow;the swollen area was also red & squishy;tx w/APAP, Pediapred & Lorabid
Injection site was red, warm, tender and swollen. Pt was fatigued. Symptoms started 24 hours, post vax and resolved with Zyrtec 10mg, once a day.
Vague headache; little chill (no fever); Vague dizziness; feeling unbalanced (walks to the left); Nervousness; Fast heartbeat; A spontaneous report was received from a 51 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experience vague dizziness, feeling unbalanced (walk deviated to the left), patient got nervous, her heart beats fast, vague headache and little chills.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient stated that she was experienced vague dizziness, when she stood up, feeling unbalanced, walk deviated to the left, patient got nervous and her heart beats fast.   On the morning of 01 Jan 2021, the patient mentioned that she feels better and ease off but vague headache and little chill (no fever) as evident, but she said that she could function normally. No treatment was information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of vague dizziness, feeling unbalanced (walk deviated to the left), patient got nervous and her heart beats fast, were resolving.   The outcome of events, vague headache and little chill, were unknown.; Reporter's Comments: This case concerns a 51-year-old female who experienced with NS events of unexpected dizziness, balance disorder, nervousness, heart rate increased and expected headache, chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Based on 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.
My arm and shoulder were sore throughout the day and that evening it was really sore. I woke up at 3:00 in the morning and my head hurt very bad, and I woke up and I took two Tylenol and waited 20 minutes and then took alleve, drank four cups of coffee and half floreset and that helped a little bit and this morning I woke up with a terrible a headache and stiff neck and shoulder, and its only my left shoulder where I got the shot.
Began having fever, high fussiness on 07/30/2003.  Seen in urgent care advised bilateral OM and heat rash.  Started on Zithromax.  No improvement.  Continued fevers to 103F, difficult to control with Tylenol/Advil.  High irritability.  Seen here 08/01/03 with fever 105, morbiliform rash difficult to console but otherwise normal exam.