chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of STENT PLACEMENT (I have had first moderna. Have heart stent and 79) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Stent placement (Have heart stent and 79.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STENT PLACEMENT (I have had first moderna. Have heart stent and 79). At the time of the report, STENT PLACEMENT (I have had first moderna. Have heart stent and 79) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants were reported. No treatment was reported.
Reporter indicates "significant failures in HB vax of employees (ages 30-50) p/switching fr Recombivax to Engerix-B were running approx 93% conversion w/Recombivax. Rate w/Engerix-B is estimated to be about 50%.
11/14/2022 I had a sore throat. I had a positive at Home COVID test during pregnancy. I went in to have an infusion. After recovering from COVID, I immediately got sick and was hospitalized for 10 days with Para- Influenza Type 3 and acute Respiratory Failure.
The employee wrote: "Needle not screwed in tightly enough to syringe, some vaccine sprayed out when vaccine administered."
sinus infection; really bad cold; right side of the face was swollen; COVID arm,/oval shaped in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen) and VACCINATION SITE REACTION (COVID arm,/oval shaped in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen) and VACCINATION SITE REACTION (COVID arm,/oval shaped in the arm). The patient was treated with AMOXICILLIN for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen) and VACCINATION SITE REACTION (COVID arm,/oval shaped in the arm) outcome was unknown.            No Concomitant use were reported She went to an oral surgeon and was advised to continue with the antibiotics.   This case was linked to MOD-2021-386034 (Patient Link).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored adult dose of VAQTA 50/1.0 U/ml injection (lot # L004745 with expiry date; 28-APR-2017; exact dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
CHEST DISCOMFORT STARTED 5 DAYS AFTER 2ND DOSE.  HEALTHY 64 YEAR OLD WITH NO HEALTH PROBLEMS
Unfortunately your medicine caused a stroke to my brain; Drug dose omission; Headache (hasn't gone away); Vomiting; Running nose; Diarrhea; Ache; Running temperature; Chills; Developed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Lasted for two weeks.) from 28-Mar-2021 to April 2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue) and VOMITING (Vomiting). On 29-Apr-2021, the patient experienced HEADACHE (Headache (hasn't gone away)). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) outcome was unknown, RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission) had resolved and HEADACHE (Headache (hasn't gone away)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received contains no new information. On 18-Jul-2021: Follow up received, new event cerebrovascular accident added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
28SEP 7AM pt woke up w/rt stiff neck; by 1:00 pt had a fine pinpoint rash over face & blotchy over anterior neck;29SEP rash had flared & became itchy; rx DPH
Fever > 101, painful joints, rash to face, trunk, arms, legs - swollen lymph nodes (cervical).
Received 1 st shot of Moderna vaccine on 02/20/21. On 02/28 in am right upper arm began to itch around inject site & was hard & lumpy.  By afternoon site was red & a large rash had formed. Did not apply any treatment or take anything. Understand from internet search this is a known side effect of the Moderna vaccine & may last up to a week. Will follow up with md if does not go away.
Fatigue, nausea, headache, soreness in arm, tingling in fingers of left hand
Elevated temperature and flushing of face within 15 minutes.  All over body and face rash within 24 hours of influenza vaccine.  Rash ongoing after 72 hours.  Person injecting the vaccine had trouble with the syringe and estimates that only 50% of injection was administered.
first dose, he had no symptoms other than a sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 29Jan2021 (at the age of 74-years-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  The patient's medical history was not reported. There were no concomitant medications. On an unspecified date, the patient experienced a sore shoulder. It was reported that the patient had no symptoms other than the sore shoulder. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented for scheduled WATCHMAN placement. Successful placement of a 35 mm WATCHMAN FLX device was performed on 1/5/22. Access for left atrial appendage closure was obtained via transseptal puncture. Hemostasis was adequately achieved postoperatively. Patient ambulatory and working with PT/OT with recommendations for discharge to home after 28 hours. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt experienced rash, itching. Tx'd Atarax, prednisone taper.
I started with mild tiredness on Sunday, March 7th and then Monday night I started feeling achy. I tossed and turned throughout the night switching from being warm to cold. Tuesday morning I woke up for work, but was very, very tired. I had mild body aches. The body aches continued to get worse throughout the day on Tuesday. I also started running a mild fever that morning. Most of the day my fever was around 100.3-.5, but I did have one reading of 101.1. I also had insane chills throughout Tuesday. I stayed under a sheet, blanket, bedspread , and electric blanket set to high. I felt too weak to get out of bed and when I did have to go to the restroom, it took every bit of strength I had to get out of bed to handle it.  On Wednesday all of my body aches and chills were gone. I still ran a temp of around 100 throughout the day and I was tired and unable to focus (brain fog). On Thursday, all of the symptoms were gone and I just felt as if I was just beaten with a baseball bat. I spent Thursday basically recuperating from this "beating". I did have a minor headache late Tuesday, but Tylenol quickly took care of it.
Patient experienced acute atraumatic rhabdomyolysis with paraspinal myositis as well as secondary AKI requiring dialysis. Patient initiated on dialysis 4/16 and continued onto discharge.
Patient was given an MMRV and Varicella on the same visit date 7/1/2022.
Within the first 24 hours of receiving the vaccine I felt swelling on the left side of my face, and the injection site was red, swollen, and painful. The swelling on my face subsided overnight and in the next 8 hours the right side of my face began to droop significantly. My primary physician's office saw me immediately and told me to immediately go to the ER to be checked for a possible stroke. The ER staff ran multiple tests as well as an MRI and diagnosed me with BELLS PALSY, possibly triggered by the Shingles vaccine.
My left arm is painful, red, swollen and bruised. The pain only lasted for one day but the redness, swelling and bruising is still here after 13 days but it has improved a lot.
2 days following inject pt c/o malaise, chills, arm sore, red, warm erythematous swelling 4cm-around site of inject w/papular rash; tx symptomatic=ice, APAP;
patient received covid19 vaccine and felt lightheaded 911 was called and paramedics released her home with mom
LEFT ARM WITH REDNESS AND SWELLING.  HARDNESS THE SIZE OF A "TENNIS BALL" ACCORDING TO SCHOOL NURSE.  CALLED LHD AT 9 AM ON 10/14/2015.  NO FEVER.
Information has been received from a physician concerning a 39 year old female with a pcn alergy who on 07/23/2001 was vaccinated IM with a first dose of varicella vaccine. There were no illnesses at the time of vaccination. On 08/03/2001, the pt experienced a headache which persisted and on 08/05/2001 the pt developed a "classic varicella rash." Other symptoms included coryza. The pt did not develop a fever. The pt sought unspecified medical attention. Follow-u info from a physician indicated that the pt experienced a "chicken pox breakout" two weeks after vaccination given. The rash was located over the entire body. On an unspecified date, the pt recovered. No further info is available.
Client was under 18 and had not gone 6 months since last dose of primary series.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 2, single (Lot number: EN8727, Expiration Date: 31Jul2021) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diagnosed about 15 years ago. It is under control with medication.; "asthma" (unspecified if ongoing), notes: She has had bouts of asthma usually once a year. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose Pfizer Covid-19 vaccine: 06Mar2021 , NDC: 59267-100-2 , Lot: EN6199 , Exp: 30Jun2021), administration date: 06Mar2021, when the patient was 64-year-old, for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset 2021, outcome "recovered", described as "She had flu symptoms"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown", described as "2nd dose Pfizer Covid-19 vaccine: 31Jul2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had flu symptoms that lasted 12-24 hours and then she was fine. She would never had lost her doctor if she would have never got the vaccine and was in the study. She had to go back to the study the next day because she had severe flu symptoms. She said that they ran blood tests and a chest x-ray and everything came back normal. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was None. No family medical history relevant to AE.
While patient was sitting in observation area after receiving her vaccine she said she began to feel faint and was seeing black spot across her vision. She was given a bottle of water and cold compresses for her neck and wrists and was feeling back to normal by the time the ambulance arrived. Patient said that she felt as though it was a panic attack and not directly related to the vaccine administration. EMS checked her vitals and they were within range so she drover herself home.
Moderna vaccine administered to patient under minimum age. No adverse effects at time of vaccination up to follow-up on 4/12.
Client received vaccine at 1:10 pm.  Client complained of "foamy mouth and burning in throat" @1:30pm.  Client has history of allergy to decongestants and antibiotics, reports hives and swelling of face with these medications.  Client denies shortness of breath, difficulty breathing, or difficulty swallowing.  RN offers client Benadryl for symptoms, client declines, states Benadryl makes her sleepy.  Vitals signs are stable, client is able to drink water and reports this helps, foamy mouth has resolved.  At 1:53 pm, client states she feels completely better, symptoms have resolved, vital signs remain stable.  Client is able to leave observation area with family member, walking with steady gait @ 2:00pm.  Client made aware to follow up with primary care physician and when to call 911.
The morning after receiving the first vaccination dose, a small (almost 1 cm) hard, non-tender, immobile lump appeared on the right-outer area of my hard palate. It has been 8 days and the lump is still present; however, it is smaller in size. To be seen by my ENT for follow-up if lump remains persistent after 2 weeks.
Feb 3, 2021 (day 8) delayed reaction -large over bright red, hard, hot to touch; took tylenol and Benadryl and iced arm; on Feb. 4, the oval was slightly better; on Feb 6 oval was almost faded but still red; Feb 8 slight ring around ova reaction Also, I felt very tired and tended to sleep during the day
I woke at 3:00 am the morning of the booster with a stiff neck.  I went to work, then around 11:30, I began to feel as if I could not turn my head (left side only)  I was shaking, began to feel hot and col and had difficulty walking, my muscles were very weak. I left my job (I work in a public school) I went to see the school nurse, and she was very concerned.  I was crying and very upset. Something felt very wrong.  In hindsight, I probably should have gone to the hospital.  I am reporting this as I have never experienced anything like it.
PATIENT RECEIVED VACCINE. ABOUT 18 MIN LATER SHE WAS DISORIENTED, COLD, CLAMY, SWEATING. PATIENT REPORTS NOT KNOWING HOW SHE GOT ON THE FLOOR. 30 MIN AFTER VACCINE PATIENT WAS FEELING A LITTLE BETTER. HOUR AFTER RECEIVING VACCINE PATIENT LOOKED BETTER, WAS NOT FEELING 100%, BUT REPORTS FEELING BETTER
Had soreness in all muscles .  Throat felt full 6/26/2021.  6/27/21 inside mouth/gums sore and slight fever... 6/28/21 gums still sore on upper left mostly hard to eat.   did
high fever to 104 starting morning p/immun irritability; was seen in ER noc p/vax; hospitalized 30JUL for septic work-up; all cultures neg; p/eval & ped consultation felt to have a viral syndrome;
On 3/23/01, the pt presented with facial swelling, hives, itching and the feeling of burning.
Information has been received from a consumer concerning her 15 weeks old son, who on an unspecified date was vaccinated with the first dose of ROTATEQ, 2 ml, oral (lot number not reported). The reporter stated "my son didn't get his first ROTATEQ vaccine until he was 15 weeks old. I see he should have gotten it by 12 weeks old". No further information is available.
Client complained of numbness/tingling to left arm, unable to move,  weak grips, resp even unlabored, skin cool, clammy, pupils reactive, EMS called, reassessed with weakness moving to right arm.  Vitals stable 120/80, HR 76.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-FEB-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had four temperature excursions one of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)), the other one of 72 hours with a highest recorded temperature of 9 F (9 C), the third one of 48 hours with a lowest recorded temperature of 0 F (0 C) and the last one of 24 hours with a lowest recorded temperature of -1 F (-1 C). The storage criteria and the type of excursion for this vaccine was refrigerator (R). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited report received from a Physician on 05 February 2016  This case involves 28-year-old female patient who was vaccinated with a dose of ADACEL (batch number not reported) intramuscularly on left deltoid on 12 January 2016. The patient's medical history includes vaccination with pneumonia vaccine and had experienced axillary and breast lymph node swelling (at some time ago). On an unspecified date and pre-existing physician diagnosed allergies, birth defects, medical conditions includes cyclic vomiting syndrome, allergic to Reglan causes dystonia. The patient's illness at time of vaccination was reported as unknown. The patient's concomitant medications was not reported. On an unspecified date, few days following the vaccination, the patient had experienced swelling in the lymph node area on the left side of the head and neck. The patient was diagnosed with lymphadenopathy of the left head and neck. The patient required ER/doctor visit. Laboratory data includes complete blood count and X-ray was performed and was in normal limit. The patient's corrective treatment was not reported. The patient was not recovered from event. List of documents held by sender: none.
Vaccine administered while pt was deployed to Saudi Arabia. Pt was itching at the site of injection.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Details surrounding his death are not clear. He was 89 with CDK stage 4 and was obese. He died at home surrounded by his family.
My eyes Swelled within two hours. Headache within 24 hours. Benadryl helped with the swelling. Still swollen after 48 hours
Prolonged constant pressure headache. Intensity varies between mild and severe but the headache is always present.
Numbness of small area of left cheek. Felt similar to numbness from dental work as it?s wearing off. I could still move my face. Started right after the 15 minute mark and Was slightly numb until the next day. Resolved with no treatment. Did not report to a doctor.
Light headed, fever of 102, body aches and chills, vomiting and diarrhea all night, dehydration
pregnant after administration; This spontaneous report was received from a nurse referring to a currently 33 years old female patient.    The patient's medical history, concurrent conditions, and drug reactions/allergies were not provided. The concomitant therapy included tizanidine hydrochloride.  On 26-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602284, expiration date not reported but upon internal validation established as 26-SEP-2021) (dose, unit not reported), intramuscular for prophylaxis. Pregnancy test was negative upon administration of vaccine.  The patient became pregnant after administration. The last menstrual period (LMP) was reported as 24-JUN-2019 and estimated date of delivery (EDD) was 30-MAR-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 4 weeks. The patient sought medical attention. The pregnancy outcome was pending. The outcome of the event was unknown.