chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Pt's wife contacted telephone triage nurse today requesting advice. States Patient had a covid vaccine yesterday, and developed "severe" swelling in the arm. States she is not sure if it's red or not, "I'm visually impaired, I can't tell." Not sure if he is running a fever or not. Wife also expresses concern re: confusion. States Patient woke up today, "just a little off", but confusion has progressed throughout afternoon. States Patient has been taking his clothes off, walking into rooms for no reason, "just acting odd, this is not like him." He is currently sitting on living room floor with only a T-shirt and underwear on, "Not sure why." She is expressing a great deal of anxiety over situation, "I don't know what to do" - crying. Advised her to call 911. She denied at this time, states " I just called my daughter, she lives next door - she is on the way over - she will help me get him to the ER now." (Please see disclaimer, below). States she "will" call 911 if they are unable to get him into vehicle for any reason.
heart would start beating really really fast; like someone was pouring air in my chest like my chest was going to explode; a hard time breathing; getting sick "really sick; tremendous anxiety; having insomnia; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 22Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and was sick. Patient reported that following administration of her first Pfizer Covid vaccine dose on 22Feb2021, she experienced a terrible reaction, with tremendous anxiety and insomnia that started 3 days after getting the vaccine in Feb2021. Patient reported feeling fine for the first 2 days after the vaccine but then on the 3rd day in Feb2021 she started getting sick, really sick, when she ate all the sudden heart would start beating really really fast like someone was pouring air in her chest like her chest was going to explode, even with a tiny bit of food. Patient went on to report that, she had an oximeter in the house that tests oxygen and counting heart beats and her heart went from 83 to 104 so heart was beating fast then was having a hard time breathing the first time and tremendous anxiety and been having insomnia. Patient reported that she did go to the doctor and they took an electrocardiogram which was fine. Then she went to a cardiologist yesterday and they planned to do an echo an electrocardiogram, stress test and heart monitor. Reportedly, consumer was asking, what happened when you have a reaction to the vaccine or an ingredient in the vaccine, does it create antibodies, is there a blood test to find out if I have antibodies after a reaction. Patient also was asking how long does PEG stay in the body and should she get the second dose after having a reaction. Patient reported that the only other time she had experienced this type of reaction was when she took Cipro antibiotic which has a common ingredient of PEG. Stating 3 years ago patient got very very sick from a product, Cipro, the only ingredient that the Pfizer vaccine has that Cipro has, the only common ingredient is PEG. Caller reported that she initially didn't want to get the vaccine reporting that she was supposed to have it on Feb 3rd but when she arrived she left because she was scared. She reported that she got different advice from her doctors 2 said to get it and 2 others said no. She reported that she has followed up with her doctor after her reaction but can't get any answers about her reaction or how long PEG will stay in her body. The patient underwent lab tests and procedures which included electrocardiogram: 0.83/1.04 seconds on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
soreness and redness at site.  Fever for 48 hours of 100.5, headache for 48 hours.
Experienced ringing in my right ear which turned into ?pulsating? noise in sync with heart beat. My PCP recommended taking an allergy pill 1x/day and OTC allergy nasal spray 2x/day for one week. Symptoms persisted and I was referred to see an ENT. Completed a hearing test which showed diminished sense of hearing in my right ear but within normal limits. ENT recommended to monitor symptoms and to get an MRI if symptoms persist or worsen.
Narrative:  75 yo male with end stage renal disease on dialysis, cardiomyopathy, HTN, HLD, cognitive impairment living in long term care facility died on 7/29/2021 at REHABILITATION facility. Pt had received covid vaccines on 2/4/21 & 3/6/21. Death appears not related to vaccines due to comorbidities, age, and length of time from vaccine administration.
Started noticing a red, raised pinpoint rash on my chest on Tuesday, 2/5/2019. By Thursday, 2/7/19, the rash was itching and had spread to my arms, face and back and multiple large painful lymph nodes swelled all over the back of my head and behind my ears. Went to a clinic on Friday, 2/8/2019, where the doctor confirmed it was due to the MMR and prescribed Hydroxyzine HCl medication for it. By Monday, 2/11/19,  the rash and itch had mostly faded, but the lymph nodes remained swollen and painful. Friday, 2/15/19, rash gone but intermittent itching returned and lymph node sites, some are gone and a few are tender to touch.
This is a spontaneous report from a contactable nurse. A 4-month-old female patient received the second dose of PREVNAR 13 (Lot# 917242) via the intramuscular route in her left thigh on 20Mar2012. The patient medical history was not reported. Concomitant medications included PEDIARIX, HIB, and ROTATEQ all administered on unspecified dates. The patient was previously immunized with PREVNAR 13 on her right thigh and experienced a large red bump with yellow greenish drainage. On an unspecified date in 2012, the patient experienced a large red bump in her left thigh, injection site swelling, and redness. Relevant lab data included culture and sensitivity on 19Apr2012 and 23Apr2012 showing no growth. Therapeutic measures were taken as a result of the events and included treatment with antibiotic ointment. The outcome of the event large red bump was unknown at the time of the report. The outcomes of the events injection site swelling and redness were recovering. Follow up (15May2012): New information reported by the contactable nurse included product lot numbers, dosage regimens, concomitant vaccinations, relevant lab data, outcome information, and treatment details. Follow-up (31MAY2012) Follow-up attempts completed. No further information expected.
Donor reported to Center staff after returning from the rest room that she felt sweaty.  Snacks provided and assisted into Booth to monitor vital signs.  At her worst discomfort level on a scale of 0 to10, ten feeling the worst, her discomfort was a 9/10.  At 1555 Donor stated her discomfort was 2/10.  At 1608, Donor reported discomfort level as 0/10.  Donor released alert and orientated times three, steady gait and balance, and self ambulatory.
This spontaneous report was received from a licensed practical 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 08-FEB-2016, the patient was vaccinated an the improperly stored dose of VAQTA (exact dose and route were not reported, lot # L039659, expiration date 15-MAR-2017). No adverse events were reported. Additional information has been requested.
Pt. had swelling, warmth, pain & erythema in rt. arm, at injection site. Tx'd with Motrin 800mg, swelling down to normal after 5 doses. Also, had flu shot at same time.
Patient presented to Employee Health Clinic and informed the RN that she had an allergic reaction to FLUZONE she had administered through Employee Health on 2/6/09. She presented to ER with c/o increasing SOB. Diagnosis: possible flu vaccine allergy.
Pt received KINRIX in right deltoid on 7-13-10. She developed redness and swelling at site on 7-14-10. She came into office on 7-15-10 with 6 cm x 6 cm area of erythema and tenderness at (R) deltoid, was advised to apply ice and take TYLENOL.
Starting Fri am: extreme fatigue, limb muscle weakness. Fri night: added upper belly pain, nausea. Sat am: extreme fatigue, weakness in limbs. Sat pm: added lower right side abdominal pain. Sun am: fatigue weakness in limbs, lower right side abdominal pain. Sun pm: added fever of 101.3. Mon am:  weakness, nausea. Since Fri am, thru Mon am, overall loss of appetite, fatigue, weakness in limbs.
Major hair loss. Nothing else changed in my diet or routine. I have videos from before and about a month after the vaccination showing the difference. I have always had super thick hair and have never in my life had issues with thinning hair or hair loss.
PATIENT REPORTED ITCHING OF ARM AT INJECTION SITE WITHOUT REDNESS LASTING 4 WEEKS. SKIN WAS TOUGH DURING INJECTION OF 2ND DOSE, PATIENT DID NOT REPORT ADVERSE EVENT UNTIL AFTER INJECTION.
This spontaneous report as received from a husband of patient refers to a 83 years old female patient. On 16-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX VIAL (strength, dose and lot # unknown). On an unknown date of October 2014 the patient developed a slight pink shot at the injection site. The patient did not seek medical attention. The patient was given treatment for the event. The outcome of event was unknown. Additional information has been requested.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 14 year old female patient. On an unknown date in 2012 (reported as two years ago) the patient was vaccinated with the first dose of GARDASIL (dose, route, lot#, expiration date and frequency were unknown). Later on that day the patient began to cry uncontrollably and experienced personality changes where she became worried about her animals. The patient did not finish the GARDASIL series due to these reactions. The patient did not seek for medical attention. The outcome of the events was unknown. Additional information has been requested.
temperature; This case was reported by a nurse via call center representative and described the occurrence of fever in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Two years ago, the patient had temperature of 104 degree F for 48 hours after receiving Bexsero. The reporter consented to follow up. No lot or expiration date, as this was given at another location.      Lab Comments: On unknown date, body temperature was measured.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK) lot# N014021, expiration date 4-AUG-2018 (also reported as 04-AUG-2019). The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 14-MAR-2018, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # M038863, expiration date 12-DEC-2017, for prophylaxis (anatomical location and route were not provided). No adverse effects reported.
pt recv vax 3OCT96 & has chickenpox no 24JUN98;
Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated; On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated) and DRUG INEFFECTIVE (On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced DRUG INEFFECTIVE (On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine). On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated). At the time of the report, COVID-19 (Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated) and DRUG INEFFECTIVE (On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine) outcome was unknown.            Concomitant product use was unknown by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: The follow up received does not contain any new information.; Sender's Comments: This is a case of Lack of efficacy as the patient had a positive COVID-19 test but it is unclear if the patient has any signs or symptoms of the disease. This may not be a case of LOE but since the patient refused follow-up this cannot be accurately determined. Based on current available information and the temporal association between both doses of the product and the start date of the events a causal relationship is not applicable for the event COVID-19 and possible for Drug ineffective.
Redness, swelling of arm, tenderness that developed into cellulitis and required abx treatment.
Patient reported to Pharmacy 6 days after the shot was given: She has a big round rash under her armpit that is about 4 inches by 6 inches round. The rash is red, and warm to touch. She started the rash after 5 day from receiving the shot. She is reporting mild pain. Ice did not help the rash. I informed her to go see the doctor asap.
6 hours after my J&J vaccine I experienced a burning sensation for about 10 seconds. I also experienced tingling sensation to my scalp, face, hands, arms and legs. I also experienced an immediate muscular type pain.  I also had one episode of palpitations with pause on the vaccine of the three week window and that is what prompted to go see a doctor. I had EKG, holster monitor which my tests were normal.
pt recv vax 3MAY96 & 12MAY96 pt devel a very fuzzy, blanching, erythematous typical measles like rash on torso & back, lethargy, fever 104.5 & fussiness;pt tx w/APAP & Ibuprofen & fluids;13MAY96 pt recovered;
Information has been received from a certified medical assistant for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL (dose, route and lot # not reported) rather than the flu vaccine. The patient became pregnant with LMP of 06-MAY-2013 and EDD of 10-FEB-2014. Initial exposure to GARDASIL was at 36 weeks. The pregnancy outcome was outcome pending. It was reported that the fetus was a low birth weight prior to the receipt of GARDASIL. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 12-year-old male patient who received BEXSERO (batch number 169701, expiry date 31st January 2019). On 13th September 2017, the patient received the 1st dose of BEXSERO (intramuscular). In September 2017, less than a week after receiving BEXSERO and an unknown time after starting KEFLEX, the patient experienced cellulitis (serious criteria disability, GSK medically significant and other: as per reporter) and fever (serious criteria disability and other: as per reporter). The patient was treated with KEFLEX. On an unknown date, the outcome of the cellulitis and fever were recovered/resolved. The reporter considered the cellulitis and fever to be almost certainly related to BEXSERO. Additional details were reported as follows: The patient received 1st dose of BEXSERO on unknown deltoid and experienced a fever of 100 degree F and cellulitis. The cellulitis was in the arm that received the BEXSERO injection. It was unknown if he received any other vaccines in his other arm. On 15th September 2017, the patient returned to the office with these symptoms. The patient's parents were instructed to call the office if the symptoms did not resolve. The office had not heard back and assumed the symptoms had resolved. The reporter believed that was disabling and jeopardized the patient because he had to seek medical treatment and was prescribed KEFLEX. The patient visited emergency room. This case was 1 of the 3 cases, reporter by the same reporter.
Shingles; rash on right side of face, above right eye brow spreading to the back of the ear to the bottom of the jaw line; Itching; Sensitivity; This is a spontaneous report from a non-contactable healthcare professional. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) on 09Apr2021 (at the age of 37-years-old) as a dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On Apr2021, 1.5 days after the vaccination, the patient experienced rash on right side of face, above right eye brow spreading to the back of the ear to the bottom of the jaw line, some sensitivity and itching, shingles. Provider (Cancer Center) thought it might be shingles, another (Express Care) told patient to take BENADRYl and PEPCID. Therapeutic measures included cetirizine hydrochloride (ZYRTEC) as a result of events. The patient planned to use this if reaction occurred again. The clinical outcome of the events rash on right side of face, above right eye brow spreading to the back of the ear to the bottom of the jaw line, some sensitivity and itching, shingles was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Itching on extremities, severe redness with bumps. Patient was issued a script by phone 10/21/15 for steroid cream.
On April 12, 2010 patient c/o itchiness at site of injection. On April 13 site was red, 2 inches in diameter, raised & itched. Later in afternoon states redness was from shoulder to elbow was seen at primary's office treated for cellulitis. Treated by Dr. with prednisone and KEFLEX.
Pt recvd 1st dose of Engerix-B on 11JUL91; 8 hrs p/inject pt exp burning ears & face; No tx given;
One week and 1 day after the vaccination  my arm started to itch at the injection side.  I thought I might have gotten a bug bite.  When I awoke the next morning (Jan. 14) it was still itching and I had a large area which is reddened and bumpy.  It does not hurt.  I went to our local Health Department and had a nurse take a look and she and another nurse had not seen this reaction before but indicated I should report it to you.  It  is approximately 3 inches long and 2 inches wide.  They also advised me to take Benadryl and Ibuprofen.
pt recv vax & devel a localized rxn (not described);this is 1 of 3 patients at this site who exp the above rxn;no other details known as of the date of this report
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 11-FEB-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) 0.5 ml, subcutaneously (lot # not reported as K005429, expiry date: 15-APR-2016). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
rapid heartbeat once a while and it has happened four times; Feverish; Headache; Chills; nausea; Taste buds were off; Enlarged lymph node below the chin; Sleeps a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (Taste buds were off), LYMPHADENOPATHY (Enlarged lymph node below the chin), SOMNOLENCE (Sleeps a lot), TACHYCARDIA (rapid heartbeat once a while and it has happened four times) and PYREXIA (Feverish) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced AGEUSIA (Taste buds were off), LYMPHADENOPATHY (Enlarged lymph node below the chin), SOMNOLENCE (Sleeps a lot), PYREXIA (Feverish), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (nausea). On an unknown date, the patient experienced TACHYCARDIA (rapid heartbeat once a while and it has happened four times). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. At the time of the report, AGEUSIA (Taste buds were off), LYMPHADENOPATHY (Enlarged lymph node below the chin), SOMNOLENCE (Sleeps a lot), PYREXIA (Feverish), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (nausea) had not resolved and TACHYCARDIA (rapid heartbeat once a while and it has happened four times) outcome was unknown.            No relevant concomitant medications were reported.  Additional treatment medication included pain reliever.   This case was linked to MOD-2021-218773 (Patient Link).