chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning after immunizations, child woke up with redness and swelling lt deltoid that progressed to neckline and down to elbow. Mother took child to PMD the following day Friday 7/28/06, Diagnosis allergic reaction. Treatment. Prednisone 3mg QD PO x 3 days. Resolved by 7/30/06.
Received Moderna vaccines on 2/28/21, 3/28/21 Tested positive for COVID by PCR on 10/16/21 Admitted to ICU at Hospital on 10/17/21 due to pneumonia due to COVID 19, ischemic right leg s/p right iliac thromboembolectomy/stenting on 10/18/21. h/o DM 2, HTN, CKD, PVD
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 07-OCT-2015 the patient was vaccinated with expired MMR II (strength, frequency were not reported) 0.5 ml (lot # not reported with an expiry date of 26-JUL-2015) subcutaneously. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
PT'S ARM WAS BLEEDING, HAD TO APPLY PRESSURE TO STOP .  PT C/O BURNING SENSATION RADIATING DOW TO WRIST.
patient inadvertently received undiluted vaccine at an estimated dose of 20mcg (twice the intended dose).   Patient does not have a valid phone number in the medical record; a letter was sent to her parents by the Clinic to notify them of the error.
The night of her vaccinations 4/6/17 - I awoke in the middle of the night to check on patient. She was extremely hot to the touch. Checked her temp 104-105 degree fever. The baby was lethargic and unable to really respond to me. I stripped her clothing down to a diaper and applied room temperature watered towel to her skin to help. My mother was calling EMS. Baby was still lethargic when EMS arrived - their thermometer did not read appropriately as it showed 98 something - when we arrived at the ER it was still 103-104 degrees having come down some with some skin to skin type intervention. The ER said that it was absolutely not the vaccines and that it was a viral or bacterial infection and sent us home with instructions to start an antibiotic and take TYLENOL/MOTRIN. We went to pediatrician the next day with some rash like bumps appearing on patient's trunk. Her pediatrician again claimed that there was no reaction to the vaccine but said it resembled HFM or Coxsackie virus. She did not have spots on her face, hands, or feet. Continually ran fever on and off for the next couple weeks. Then she broke out in blisters on her face which was later diagnosed as Eczema and cradle cap. She lost a lot of her beautiful hair at this point. I have multiple pictures of her before, during, and after treatment. The doctors recommended hydrocortisone and AQUAPHOR for treatment of her face and scalp leaving my baby in mittens.
Chronic daily next onset migrainous headache beginning 2 days after HPV #1. No PMhx of recurrent headaches.
On 01/29/18 patient came for well child exam. He had no fever or report of fever. He had conjunctivitis that day and was prescribed ophthalmic antibiotic drops. Closed Close to midnight the same day he had fever at home and had a tonic-clonic seizure. EMS called. Seizure lasted 20-25 minutes. Treated minutes, treated with medications, medications. Transported to ER. Head CT scan was normal. Patient was admitted for one day and discharged on only on DIASTAT in case of additional prolonged seizures. Initial temperature in the ER was 101.5. This was the highest temperature recorded.
Tested positive for COVID; Aches; Hair hurt; congestion; runny nose; cough; nausea; headache; hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over). On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with BAMLANIVIMAB (intravenous) on 26-Feb-2021 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported Patient said she is scheduled for second dose on 9Mar2021   This case was linked to MOD-2021-033480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up information received and contains significant information. Outcome of the events were changed from Unknown to Not recovered.
Fever, chills, and general flu like symptoms for 48 hours  For fist 24 hours, severe muscle cramps throughout body
Diagnosed with left breast cancer; Chills; Headache; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Diagnosed with left breast cancer) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 15-Mar-2021, the patient experienced BREAST CANCER (Diagnosed with left breast cancer) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Lumpectomy) for Breast cancer. At the time of the report, BREAST CANCER (Diagnosed with left breast cancer), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.      No concomitant medication was provided.  04Jan2021: The patient got the 1st dose of the Moderna Covid-19 vaccine. Her arm hurt at the injection site.  01Feb2021: The patient got the 2nd dose of the Moderna Covid-19 vaccine. The patient had chills, headache, joint pain, & fever.  15Mar2021: The patient was diagnosed with left breast Cancer.  07Apr2021: Lumpectomy  The patient had radiation treatment the 1st 3 weeks in May 2021.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event of breast cancer, an association appears unlikely, however with regard to the remaining events, a causal relationship cannot be excluded   This case was linked to MOD-2021-305824, MOD-2021-305900 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of breast cancer, an association appears unlikely, however with regard to the remaining events, a causal relationship cannot be excluded
lymph nodes swelling, pain (LEFT) and has pain at injection site; lymph nodes swelling, pain (LEFT) and has pain at injection site; lymph nodes swelling, pain (LEFT) and has pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling, pain (LEFT) and has pain at injection site), VACCINATION SITE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) and LYMPH NODE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling, pain (LEFT) and has pain at injection site), VACCINATION SITE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) and LYMPH NODE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site). On 19-Jan-2021, VACCINATION SITE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) outcome was unknown. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling, pain (LEFT) and has pain at injection site) and LYMPH NODE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided
(11/5/2021-ongoing) Sudden onset sharp pain in upper right arm with movement, rotation, daily activities,  etc. Unable to keep arm elevated for more than a few seconds as the pain does not go away.  When movement/activity is  discontinued, residual pain is still  present.  Pain has disrupted daily life, unable to perform some activities due to fear of pain. No new or strenuous activities were started before or after onset, and  no injuries. Pain scale ranges between 7-9 out of 10. PCP was contacted 11/15/2021, I was told to monitor pain and take ibuprofen As needed and make appointment after one month if pain persists. PCP was seen on 12/7/2021. Ibuprofen 600mg 3/day with meals for 5 days and flexeril 10mg at night. This did not help with pain and pain is still ongoing with no improvements.
My arms have been  going numb and i have a lump in the upper right side of my chest that has lately become a bit concerning makes me feel like i stress my body out. My doctor appointment is 12/23/21
Patient woke with pain from the injection site up to base of neck.  Pt also reports sinus pressure and sinus headache.
appendicitis/abdominal pain; This is a spontaneous report from a contactable consumer (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in arm left on 12Mar2021 09:00 as a single dose (at the age of 27-years-old) for covid-19 immunization. The vaccine was administered at the clinic. The patient's medical history and concomitant medications were not reported. On 12Mar2021 at 6:00 pm, she started with abdominal pain that continued through Saturday (13Mar2021), and Sunday (14Mar2021) morning she went to clinic, they told her that she had appendicitis and she should go to hospital for a test. She went to the hospital, they ran a contrast test and she was diagnosed with appendicitis on Mar2021. She had the operation on Monday (15Mar2021) and she was recovering. The reported event resulted in doctor or other healthcare professional office/clinic visit and  emergency room/department or urgent care. The patient needed operation. The patient was hospitalized on Mar2021.
wants to be registered in teh Moderna pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (wants to be registered in teh Moderna pregnancy registry) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-May-2021. On 20-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (wants to be registered in teh Moderna pregnancy registry). On 20-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (wants to be registered in teh Moderna pregnancy registry) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not reported.  No treatment information was provided .
PT RECEIVED GARDASIL, MENACTRA AND ADACEL IMMUNIZATIONS ON 01-12-09.  AFTER INJECTIONS, PT GOT DIZZY AND PALE WHILE SITTING UPRIGHT IN CHAIR IN EXAM ROOM.  PT SLUMPED DOWN, HAD A BRIEF LOC WITH MILD IRREGULAR JERKING OF EXTREMITIES THAT LASTED APPROX 10 SECONDS. + URINARY INCONTINENCE.  PT WOKE STARTLED AND SURPRISED ASKING "WHAT HAPPENED?"  THE EPISODE WAS WITNESSED BY DR.  DR. DOCUMENTED "THIS SEEMS TO HAVE BEEN A VASOVAGAL SPELL WITH A SUPERIMPOSED HYPOXIC SEIZURE."
Child seen in office 12/22/09, side visit - cough; congested no fever. Child behind on immunizations, had only had 1 Hep B. Immunizations given at this visit, no other contact from parent until 12/28/09 - parent called office to inform us of death of child.
11/23/21 Following vaccination patient was observed and asked was he okay. The client status became altered. He was unable to answer questions, unable hold his head up. 911 was called. EMT arrived Patient assessed and within minutes patient was able to communicate. Patient states, "He experiences anxiety to needles".
Night Sweats, bad dreams, fever, disorientation, loss of balance, fainting, difficult for me to get the energy to wake up early. No energy for about 2-3 weeks afterwards.
swollen; red; itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches). At the time of the report, VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Post menopausal spotting: light in color/watery , vaginal discharge, daily to once in a few days; occasionally, slight, rust colored discharge with increased activity.  In the past month, or so, especially ...becoming more infrequent to almost nonexistent now.  Since I started menopause over 15 years ago, I have NEVER had any other spotting!
Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it passed within another 30 minutes. A few hours later, pain in upper arm got pretty intense. Then around midnight, the pain in my upper arm had grown so severe that it was spreading into my shoulder and neck. By 2:00 a.m., I woke up in sever pain in my face, not able to open my mouth because my jaw hurt so much. I went back to sleepI was not able to open my mouth until I repeatedly coaxed it open, around 8:00 a.m. By 10:00 a.m., my eyes itched like crazy and were red.  My jaw getting stuck shut and my eyes itching insanely are why I'm completing this form.
10 minutes after receiving vaccine patient reported to nurse a "sensation of her throat closing."  Patient had taken 100 mg Benadryl at home before appt.  Patient injected own epi pen.  Smartwatch showed normal sinus rhythm and heart rate in the 70s.  Lungs were clear and no edema noted to mouth or facial area.  Patient refused EMS to be called.  Was observed for 30 minutes without further incident.
I got my second Pfizer shot on 05Oct so it''s been about 16 days now since I got my second shot and my body still feels weird it still feels weak.; I am getting headaches every day.; I do have little blood pressure which sometimes make me dizzy.; I have just been really weak and dizzy infect last night I could barely walk and this is 16 days after I got the shot.; I was getting chest pain.; I have just been sleeping a lot.; I do have little blood pressure which sometimes make me dizzy.; This is a spontaneous report from a contactable consumer or other non hcp.   A 48-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05Oct2021 as dose 2, single for covid-19 immunisation. Medical history included hypotension: Low blood pressure, migraine, anxiety disorder. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 for covid 19 immunization. It was reported that, Consumer stated, "I got my second Pfizer shot on 05 Oct, so it's been about 16 days now since I got my second shot, and my body still feels weird it still feels weak and I am getting headaches every day. Consumer stated, "I have just been sleeping a lot. I do have little blood pressure which sometimes make me dizzy but when I went to my cardiologist, he said my blood pressure has been perfect. The day that I got the shot my blood pressure was still perfect, but I have just been really weak and dizzy infect last night I could barely walk and this is 16 days after I got the shot or since I got the shot and it just doesn't seem to be letting up now and it starting to scare me because I got it on 5th and it's already been 19th.The event The events my body still feels weird it still feels weak and I am getting headaches every day, chest pain, sleeping a lot, weak and dizzy infect last night I could barely walk, low blood pressure .The outcome of the events was unknown on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: little blood pressure on blood pressure measurement: perfect on when I went to my cardiologist he said my blood pressure has been perfect , blood pressure measurement: still perfect  on 05Oct2021 The day that I got the shot my blood pressure was still perfect , laboratory test: negative on Lab Test performed recently: Consumer stated, "Nearly lab work they did was they took blood to make sure that it didn't get any blood clot from the Pfizer medication. I mean from the Pfizer shot because I was getting chest pain. But it came back negative. Thank-goodness." (Further not clarified hence tab left unchecked). The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of , i do have little blood pressure which sometimes make me dizzy. (hypotension).
mom stated pt had shrill crying episode about 1- 1/2 hrs long p/2nd DTP; pt given APAP t103.7 & had shrill crying, mom had trouble comforting; pt taken to ER & given APAP;
About a month after receiving the booster, my head started filling up and I could not breathe, or sleep. It started draining by Friday. I was getting a little bit of a sore throat up at the top of my throat. I went in and saw the doctor last Monday and he gave me an antibiotic, nasal spray, and pills for congestion. I did take Nyquil at night, because that helped me go to sleep for at least 3-4 hours. They swabbed me and took my temperature. I cannot remember if they took any blood. I was tired on Saturday. I think it is just a cold.
Pt tolerated MCV4 well and was given TDaP approximately 1-2 minutes after the first vaccine. Pt was feeling a little nervous about getting vaccines. Pt started to slump over, convulsed approximately 5 seconds with eyes closed, arm extended and stiff.  Pt then abruptly sat up with eyes open and pupils dilated and then (what i think was purposefully) laid back down. Pt was immediately awake and alert. Speech was normal. neurological exam was normal, eyes- PERRLA. Pt was pale. We kept her here for 30 minutes and she recovered completely and left the office.
Pt called to report reaction post covid vaccination. Pt experienced increasing rash 7in + at vaccine site and itching. Pt contacted Dr and was prescribed medication including a steroid at her local pharmacy for the reaction.
Pt recvd vax 10FEB94 & 2 days later pt was seen in ER for cellulitis; pt was treated w/Erythromycin & recovered; No further details were provided;
Approximately two weeks after receiving my second COVID vaccination on March 15, I developed tinnitus in both ears. I experience a constant, high-pitched ringing in both ears. Now, two months later, the condition has not changed.
This spontaneous report was received from a physician referring to a 30 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated at unappropriated age with a dose of GARDASIL 9 for prophylaxis (strength, Lot # and expiration date were not reported). No adverse effects were reported.
Patient had tingling sensation to her right arm and right arm heaviness and dizziness that started approximately 1-2 minutes after receiving vaccine. She was also dizzy so sent to ER.   She was given juice and monitored in the ER.  Sensations come and go in different areas of the right arm. The lightheadedness resolved after a couple of hours in the ER.  She was told to rest, increase fluid intake, alternate Tylenol & Motrin every 4-6 hours as needed for pain control and follow up with her PCP in 1 day.
Systemic: 6th Cranial Palsy-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Double vision starting 11/14/21 and progressively worsened 11/15/21 and 11/16/21. Diagnosed with 6th cranial palsy on 11/15/21.
Blood in Stools-Pt was seen in ER to R/O Intussusception.  5/22/07 Received hospital medical records which reveal patient experienced blood in stool & was seen in ER on 5/7/07.  Based on CBC, given 1 dose IV antibiotics after cultures & d/c to home.  Admitted to hospital 5/12-5/15/07 for  + cultures.  Remained afebrile & playful but w/sporadic bloody stools for approx 1 wk.  Started on IV antibiotics.  GI consult obtained which revealed dx: cow's milk protein sensitivity. FINAL DX: Bacteremia, melena, anemia, sickle cell trait. 5/25/07 Received medical records from PCP but no vax records included.  T/C to PCP to request same.  No new info in PCP records, patient had mild nasal congestion & GERD otherwise healthy & developing well.  6/19/07 Received vax record from PCP which provided RO lot & dose #.
Fever 103, vomiting & dehydration seen in ER & APAP given;
I started having bad chills and a fever of 102. The next day, I woke up and didn't feel any better. I took a rapid test on 12/6/22 and tested positive. I called the doctor, and they prescribed 5 days' worth of PAXLOVID. I have been feeling better up until today. I have had the metallic taste in my mouth that everyone talks about. Since lunchtime today, I have been feeling a little nauseated.