chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subject number: 01700084.  Initial report received on 31 January 2008 from an investigator participating in a trial under the reference number MTA37.  A 12-month-old female subject experienced a febrile seizure one day after receiving an intramuscular right thigh injection of Menactra (lot number U2172AA, dose two) and an intramuscular left thigh injection of Prevnar (Wyeth, lot number B53981A).  The subject received both injections during a well-child visit on 29 January 2008, and physical exam was noted to be within normal limits with tympanic membranes pearly gray and canals clear.  According to her parents she began experiencing a low-grade fever (100.5 degrees Fahrenheit, rectal), decreased activity, and several episodes of crying later that day.  Upon waking up from her nap, her temperature was noted to be 103.1, and it continued to be elevated throughout the evening and into the following morning.  Prior to her nap on 30 January 2008, the subject's temperature was noted to be 103.9.  After hearing a noise, her mother later checked on her and observed the subject having a seizure, which she reporting as lasting approximately three minutes.  She was taken to her physician's office, where her right tympanic membrane was noted to be red.  She was diagnosed with a febrile seizure and acute suppurative otitis media of the right ear, and a complete blood count (CBC) with differential was ordered.  Laboratory testing revealed the following: white blood count 11.1 THS/uL (normal 4.8-10.8), with absolute monocytes 1.0 THS/uL (normal 0.0-0.8); red blood count 3.73 MIL/uL (normal 4.04-4.85); hemoglobin 10.1 G/DL (normal 11.3-12.3); hematocrit 29.2% (normal 37-41); and MCV 78.3 FL (normal 80-95).  Treatment included a 500mg intramuscular injection of Rocephin, and Tylenol.  On 31 January 2008, the subject's temperature was 100.7, and her mother noted that her activity level was increasing.  The febrile seizure was considered to be resolved on 30 January 2008, and the subject continued in the trial.  According to the investigator, the event was related to Menactra and Prevnar.  Documents held by sender: labs, office notes.
Fever, chills, body ache, malaise, arthralgia I started to have these symptoms the night after I received the second dose of the vaccine. Tylenol and Advil helped. But symptoms recurred after 8 hours.
Heat, swollen & redness around injection site. Itchiness: arm, neck, ears. Redness: neck. Better with BENADRYL, but still present. I have been taking BENADRYL x3 days & still not completely resolved.
After 3 days still have no relief from swelling, itching, redness & "hot spot" on my arm.
Chills began night after vaccination-continued intermittently the next day dry cough. No fever, decreased appetite. No headache. No sore throat. Dry cough persisted to see PCP 1/28/15.
Person received vaccine at approximately 2:00 pm on 1/13/21.  Person has been on hospice but had been able to talk/communication.  The evening of 1/13/21 person declined to where they would no longer wake up and/or respond.  Restricted to bed.  We are unsure if this decline is just a progression of her disease or is a reaction to the COVID-19 vaccine received.
This spontaneous report as received from a Medical Assistant (MA) referred to a patient of unknown age. The patient was vaccinated with dose 1, 2, 3 and an extra 4 dose of GARDASIL on 29-JUN-2007, on 08-SEP-2008, on 30-APR-2012 and on 02-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. The patient experienced no known adverse effects. No treatment information was reported. The outcome of patient was unknown. The events were not related to GARDASIL. Additional information has been requested.
Had vaccine on Fri and sat AM woke up with abdominal pain. On Sun had excessive flatulance and belching in afternoon and mucous and blood and water as stool. Had urge to have BM but unable(This is a total change in BM pattern,Never experienced this before. This lasted through Mon and called Digestive Dr and goot in for an appt on Tues
Extra Hepatitis B given to patient. No adverse sxs - pt fine per mom - called CDC.
Pt reports bleeding outside of menses starting following her first moderna shot.  Pt had previously never had issues with her menstrual bleeding and had no changes in her OCP or other medications during the time of irregular bleeding.  Pt also had mild cervical irritation that was treated, but this did not improve her symptom of intermittent unscheduled uterine bleeding.  She has had her OCP increased in estrogen dose and reports moderate improvement of her irregular uterine bleeding.
Left arm is very sore, lifting arm above shoulder height is extremely painful. Unable to lift 5 lb weight with out pain and not able to lift above shoulder height. Muscle is very sore, even to the touch right at the injection site. In the morning after sleeping arm is extremely stiff and painful to move, after moving it muscle seems to relax and is not as painful, but sore most of the day. I have been using it to see if things will get better but after 3 weeks it is not getting better. I do not feel like this is a reaction to the actual flu but the way it was injected, possibly?
Extreme swelling on left arm, elbow to shoulder. Large red sun burn looking patch the is radiating heat. The feeling of the area is itchy, sore, skins feels like  a bad sunburn,(dry and scratchy)  This all began about 11 a.m. on day of vaccine. Also very tired for 72 hours after the vaccine.  I have taken benadryl tablets at bedtime, applied Ice to the area and anti-itch creams.  No real improvement to speak of.
Right upper arm with redness, swelling and warmth.  Size of area 9cm x 7cm.  Immunizations administered 2 days ago.
Swollen lymph nodes above clavicle.  Golf ball sized swollen nodes behind ear.  Pt visited urgent care for evaluation and will follow up with doctor if swelling gets worse or doesn't resolve in 72 hours.
Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WRINKLING (Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 030A21A and 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN WRINKLING (Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly). At the time of the report, SKIN WRINKLING (Skin all wrinkled up in his injection arm/wrinkled up skin then went to the other arm/all wrinkly) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. The treatment information was unknown. The patient experienced skin wrinkly was started in the injection arm and about a week later went into the other arm. It was started the day after the shot and is still ongoing. This case was linked to MOD-2021-017366 (Patient Link).
Patient took dose or oral typhoid. After using this had some itching of medial right eye.  Prior to this had not noticed any problems.  Then used Zomig as pt awoke this am with migraine headache (has tolerated for several years).  Began to feel itchy around left lip, then began to swell. This began around after having coffee and toast. Pt had used vaccine 1/2 hour before breakfast.   Sense of lip swlling; puffiness.  Flu vaccine given 5 days ago; Hep A vaccine (2nd dose) 5 days ago. DX: Angioedema -  new onset angioedema after using oral typhoid vaccine this morning.
Infant received vaccine at approximately 1400. She began running fever up to 103 deg w/in the next 12 hrs and continued to have fever for 47 hrs as well as periods of crying. She developed a rash on 2/10/03 - macular over trunk, extremities.
3 inch long 1 inch wide raised redness at injection site.  Not itchy painful  when touched with light pressure.
Got COVID-19 from a new strain even after being vaccinated; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got COVID-19 from a new strain even after being vaccinated) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19 from a new strain even after being vaccinated). At the time of the report, COVID-19 (Got COVID-19 from a new strain even after being vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that a woman that the reporter knew and the husband of that woman (both were vaccinated), along with other people who went to a graduation, got COVID from a different strain than the previous ones. Reporter was not having any additional information about this case, the reporter only knew that the woman and the husband were older adults. Treatment information was not provided.  Company comment: This spontaneous case concerns an adult female patient with no medical history information reported, who experienced the unexpected non serious AESI of COVID 19. The event occurred on an unknown date after a dose of mRNA-1273. As reported, the patient got COVID-19 from a new strain even after being vaccinated. No information about vaccination schedule or dose number was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-630497 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult female patient with no medical history information reported, who experienced the unexpected non serious AESI of COVID 19. The event occurred on an unknown date after a dose of mRNA-1273. As reported, the patient got COVID-19 from a new strain even after being vaccinated. No information about vaccination schedule or dose number was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-630497:Wifes case
Day 1 after vaccine day - Woke up next morning at 5am with chills, diarrhea, 102.8 fever, nauseated. Took 2 Tylenol. Fever 100-101 throughout the day. Day 2 after vaccine, no fever and I felt good.
pain at injection site, bruising at injection site, inability to lift right arm/move shoulder, sharp shooting pain in right arm/hand, localized redness/swelling, fever of greater than 100.4 for more than 4 days, rash to right arm from injection site down to bend of arm with localized edema
Patient was given shot (ADACEL) on 8-14-17 (Mon) developed bruise at night, 2 days later (elbows, knees (joint pain)), by Thursday terrible back pain (can't sleep). Took TYLENOL, pain becomes manageable. Still experiencing tingling.
12/26/22 presents to ED for "SOB". PMHx of "invasive squamous cell carcinoma, ESRD on HD MWF, DVT, Hepatitis C, CAD s/p cath, lung nodules, depression/anxiety, hypothyroidism, paroxysmal Afib on amiodorone"
Patient received the covid vaccine on 12/30/2020.  Tolerated the vaccine without problem. c/o new onset of "stomach pain" at the RLQ.  Unable to walk starting on Jan 3rd. Pain persists today. Denies fever, HA, Dizziness, cough, nausea, vomiting, diarrhea, or constipation. She has reached out to her rheumatologist.  She noticed the pain occurred after she self administered the Taltz injection on 12/31/2020. She is concerned about the drug-to-drug interactions with the vaccine.    Covid test on 12/23/2020 was negative.
screamed inconsolably for 3/12 hrs starting @ 5PM on day of vax; mom gave APAP every 4 hrs for 3 or 4 doses; fever of 100; slept well @ noc; inject sites both sore;
Runny nose; Tested positive for covid19; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and COVID-19 (Tested positive for covid19) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RHINORRHOEA (Runny nose) and COVID-19 (Tested positive for covid19). At the time of the report, RHINORRHOEA (Runny nose) and COVID-19 (Tested positive for covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  The patient did not take any treatment.
Information has been received from a registered nurse concerning a 10 year old female patient who on 15-MAY-2008 was vaccinated with the first dose of GARDASIL.  On 29-DEC-2008 the patient was vaccinated with the third dose of GARDASIL (Lot # 660620/0571X).  It was reported that the patient developed a rash 6 hours after the third dose of GARDASIL was given.  The patient was recovered.  It was reported that patient's mother called physician's office.  Additional information has been requested.
The evening after receiving the flu shot, the night after, and the following day, the guest had fever, severe chills and body aches, and respiratory symptoms (coughing).  He said that the same thing has happened to him the last couple of years that he received the vaccine, but it seems to keep getting worse each year.  Patient received Fluzone High Dose vaccination.
Information has been received from a health professional concerning a 22 week old male who on 17-JUN-2007 was vaccinated with a first dose of Rotateq.  It was reported that, on 30-AUG-2007, the patient was in the office for the second dose.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Arm - shoulder to elbow swollen by 24 hrs after shot 2/3 of length. 1/4 width red, warm. RX with claritin 5mg, motrin, and cool compresses.
Bells Palsy affecting left side of face as per doctor  due to stress; stress; chills; body aches; 102.2 fever; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy affecting left side of face as per doctor  due to stress) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells Palsy affecting left side of face as per doctor  due to stress) (seriousness criterion medically significant), STRESS (stress), CHILLS (chills), MYALGIA (body aches) and PYREXIA (102.2 fever). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy affecting left side of face as per doctor  due to stress), STRESS (stress), CHILLS (chills), MYALGIA (body aches) and PYREXIA (102.2 fever) outcome was unknown.            Patient states she woke up last woke up last Wednesday with drooping left face "I thought I had a stroke". Went to doctor was diagnosed with Bells Palsy and as per doctor it is "due to stress". Says it is affecting left side of face and caller states  she was injected in left arm also, same side of body.  1st dose 5Aug2021 Lot # 088D21A Expiration not on vaccine card. Left arm  2nd dose 2Sep2021 Lot # 020F21A Expiration not on vaccine card. Left arm  Reports after 1st dose she had fever, chills, headache and left sore arm.  Reports after 2nd dose she had body aches, 102.2 fever, and chills. Treatment: Was prescribed Prednisone, antiviral valacyclovir 3x a day  Concomitant : blood pressure medication  Company Comment : This case concerns a 36 year old female who experience serious expected event of Bell's palsy on unknown date. Second dose was given on 02Sep2021. No relevant medical history.The benefit-risk relationship is not affected by this report for Moderna Covid 19 vaccine.   This case was linked to MOD-2021-325463 (Patient Link).; Sender's Comments: This case concerns a 36 year old female who experience serious expected event of Bell's palsy on unknown date. Second dose was given on 02Sep2021. No relevant medical history.The benefit-risk relationship is not affected by this report for Moderna Covid 19 vaccine.
Information was received on 30-JUN-2017 from a medical assistant who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The medical assistant reported that multiple doses of improperly stored (31 degrees F or lower (29F) for 7 hours 55 minutes) VAQTA (lot L017757, expires 08-APR-2018) were administered to multiple unspecified patients on unspecified dates. No previous temperature excursions. No adverse effects reported. No further details available. Additional information is not expected, no additional information is available. This is one of several reports from the same reporter.
brain is not clear; Asthma; headache; body ache; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain is not clear), ASTHMA (Asthma), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Gastritis and Drug allergy (Aspirin). Concomitant products included PROBIOTICS NOS for Gastritis.  On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced FATIGUE (Tired) and PYREXIA (Fever). On an unknown date, the patient experienced FEELING ABNORMAL (brain is not clear), ASTHMA (Asthma), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, FEELING ABNORMAL (brain is not clear), ASTHMA (Asthma), HEADACHE (headache), MYALGIA (body ache), FATIGUE (Tired) and PYREXIA (Fever) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-092588 (Patient Link).
Pt diagnosed with COVID-19 infection on 1/8 in ER.  Returned due to diarrhea, weakness, altered mental status, and poor PO intake.  Admitted due to acute encephalopathy.
Swollen glands under left armpit lasted 5 days   Frequent headaches for a few weeks   Terrible dreams for a few weeks   Significant hair loss  started a few days after vaccine, still experiencing this 4 weeks later.
5PM lightheadness & dizziness, h/a, vomiting; 8PM localized area size of orange, red, hot, sore, now bruised;
Moderna vaccine was inadvertently administered after the 30-day use by date.  Moderna company was contacted and case ID CEA-1917 given.  NO reports of any sign and symptoms at this time.
pt recvd flu vax 20OCT93 & on 21OCT w/in 24 hrs devel h/a & fever, myalgia; visited ER on 30OCT; spinal tap 61-69 WBC/ml, protein 76 inc; dx aseptic meningitis;
Received Moderna Booster vaccine on Friday afternoon around 4:30 PM. Woke up Saturday morning around 7:30 AM with intense pain in upper stomach. Pain came in waves and did not seem to be related to food or drink intake. Pain was intermittent throughout the day, and often caused doubling over because of intensity. I tried to go to urgent care facility near my home, but they were closed for the holiday. I returned home and waited it out. Pain continued into the night, but subsided by the next day and has not returned.
PAIN AND SORENESS WHERE THE BAND AID WAS, ARM SORNESS THROUGHOUT THE NIGHT.
24hrs after taking the booster his lungs started hurting. He was having chill, hot & cold flashes. Headaches
tunnel vision; blurry; vision impairment; Vein was bulging out (about 8mm long, 3mm wide, 2mm thick. upper cheek-bone very tender to touch; Area below eye remained puffy; cute pain in area of sternum; 3/12/21 Acute pain in vicinity of left shoulder blade; pain in right lower-outer eye area at cheek-bone; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 12:30 (Batch/Lot Number: EN6199) as single dose, dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation  .  Medical history included none.  There were no concomitant medications. Patient did not have Covid prior to vaccination. The patient experienced "acute pain in area of sternum. Felt like heart attack. Pain dissipated in 6 hours. Minor pain for a couple more days" on 14Mar2021 with outcome of unknown , tunnel vision on 01Apr2021 with outcome of recovered , blurry on 01Apr2021 with outcome of recovered , vision impairment on 01Apr2021 with outcome of recovered , acute pain in vicinity of left shoulder blade on 12Mar2021 22:00 with outcome of unknown , pain in right lower-outer eye area at cheek-bone on 12Mar2021 22:00 with outcome of unknown,  vein was bulging out (about 8mm long, 3mm wide, 2mm thick, upper cheek-bone very tender to touch on 01Apr2021 with outcome of unknown, area below eye remained puffy on 01Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included 02Apr2021 eye exam: all was normal; 05Apr2021 Full blood work was done: normal; 15Apr2021 Partial Physical Examination, EKG and Chest x-ray: All normal; 20Apr2021 Carotid Artery Ultrasound: normal. No treatment was received. The outcome of events tunnel vision, vision impairment and blurry was recovered while outcome for other events was unknown.  Patient was not tested positive for Covid post vaccination.
Red swollen arm/flyu like symptoms pain around shoulder and inj site. for 5 days.
cellulitis on vax site;pt was seen 15SEP97 & rechecked on 15SEP97 on 15SEP97;tx w/Keflex recovered;
After getting pneumonia shot, patients left arm began to swell, turn red, & itch. Went to immediate care clinic where prednisone was prescribed.