chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: he has Covid. Clinical course: He had high blood pressure and he was prescribed with Paxlovid today and he said he has Covid. He mentioned he was vaccinated with the Pfizer and Moderna vaccines and now he has Covid. He said he would like to double check if herbal supplements (Unspecified Herbal Supplements) would have any reaction to Paxlovid. He was asking if there will be a rebound case and will rebound be a worse case for a 69 year old even with good health. He has not started taking Paxlovid and he has been prescribed and he wanted to hear from the medical information department if this would be reasonable. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
developed rash on injection site 2 weeks later/She reports it as a covid arm.; sore left arm after 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after 3 days) and VACCINATION SITE RASH (developed rash on injection site 2 weeks later/She reports it as a covid arm.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included POTASSIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), CARVEDILOL (COREG) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PAIN IN EXTREMITY (sore left arm after 3 days). On 08-Aug-2021, the patient experienced VACCINATION SITE RASH (developed rash on injection site 2 weeks later/She reports it as a covid arm.). The patient was treated with CAMPHOR, MENTHOL (ICY HOT ADVANCED RELIEF [CAMPHOR;MENTHOL]) at an unspecified dose and frequency and LIDOCAINE (SALONPAS LIDOCAINE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm after 3 days) and VACCINATION SITE RASH (developed rash on injection site 2 weeks later/She reports it as a covid arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever, headache, severe chills, extreme nerve pain.  Warm water was so painful to get into for bath. It's been 48+ hrs and still hurting at injection site, still have nerve pain more than normal.  Sleeping 20 hrs a day, no appetite, 101.7° fever this morning. Weak etc. I had some left over pain pills and had to take them for 2nd 24 hours.  Now trying without them.
COMPLAINED OH HIVES AND ITCHING OFF AND ON SINCE 4/13/21 @ 10:00PM. ON 4/15/21 AM IS WAS NOT GOING AWAY. HE MADE AN EMERGANCY SICK CALL. RED HIVES SCATTERED FROM WASTE UP INCLUDING ARMS, NECK AND FACE THAT WERE ITCHING. ON CALL PROVIDER CALLED AND ORDERS WERE RECEIVED. BENADRYL 50MG PO BID PRN X 3 DAYS FOR RASH AND ITCHING, SOLUMEDROL 125MG IM NOW. WITHIN ABOUT 1 HOUR SYMPTOMS STARTED TO SUBSIDE. HE WAS ASSESSED AT 10:15 AM ON 4/15/21 AND HE AMBULATED WITHOUT ANY DIFFICULITIES AND DENIES ANY HIVES, REDNESS OR ITCHING AND REPORTS FEELING FINE.
Right sided shoulder and neck pain. Headache. Right eye irritation with photosensitivity, persistent blurry spot in vision noted diagonally central to peripheral in vision field, and "floater" present occasionally from center to right side above the area of the blurry spot.   Massage x 2 relieved shoulder, neck pain, and headache.
WATERY DIARRHEA 10 OR MORE TIMES PER DAY. HAS BEEN PERSISTENT SINCE DAY AFTER BEING VACCINATED. SYMPTOMS STILL PRESENT AT TIME OF THIS REPORT
Pt states she had a very rapid heart rate and went to ER. Hypotension with standing and rapid heart rate were main symptoms. Did have a rash on her leg.  Spent 1 night in ER. Has Echo cardiogram scheduled.
"Covid Arm": Roundish, inflamed area on injection site. Area is hard, warm, and red. No pain or itchiness. Noticed on Monday (4/26) morning, still present 4/30 (8 days after injection).
This spontaneous report as received from registered nurse concerning to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 08-JUL-2008 the patient was vaccinated with first dose of GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. The reporter stated that the patient was in the office on an unspecified date in 2014 to receive second dose of GARDASIL. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Additional information has been requested.
This consumer report (initial receipt 05-Mar-2014) was received via a pharmaceutical company and concerns a male patient who was aged between 60 and 69 years. Medical history included acid reflux, allergy to animals, citrus, dairy, iodine, peanuts, walnuts and shellfish; osteoporosis (diagnosed in Oct-2010). Concomitant medications included metformin hydrochloride, vitamin D, multivitamins and esomeprazole. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not provided) and pneumococcal virus vaccine (manufacturer and batch number not provided). On an unspecified date, within months of vaccination with the influenza vaccine and pneumonia vaccine, the patient developed serum sickness and lung congestion. On the 15-Nov-2013, the patient commenced fluticasone propionate/salmeterol xinafoate inhaler 500/50mcg to be taken one puff twice daily for the lung congestion which was secondary to the serum sickness. The patient was concerned to take the steroid inhaler therefore reduced the dose on the 24-Nov-2013 to 250/50mcg, one puff before bedtime when he felt a build-up of phlegm on his chest and would start to cough. The fluticasone propionate/salmeterol xinafoate inhaler allowed him to sleep, as he was not sleeping well, and was pleased with the medication. On approximately 23-Dec-2013, the patient received a blood test which showed his blood sugar numbers increased to 5.8 during treatment with fluticasone propionate/salmeterol xinafoate inhaler. Late Dec-2013, the patient was diagnosed with diabetes but his doctor said he was right on the edge of having diabetes. Outcome was reported as not recovered for serum sickness, lung congestion, mucus in chest, cough, diabetes, increased blood sugar. The patient had recovered from the poor quality sleep.
Information has been received from a nurse concerning an 18 year old female who in approximately September 2007, also reported as one year ago, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 04-SEP-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). No adverse reactions were reported. Additional information has been requested.
Patient was administered an undiluted children's Pfizer bivalent dose instead of the Pfizer adult dose-Bivalent. Dose administered was 85mcg instead of 30mcg. Patient was followed up the next day and just exhibited symptoms of fatigue.
Redness, heat around injection site (Pneumovax) left arm. Tx: Benadryl, cool compress.
fever, H/A, blurred vision all Sx self resolved after "a couple of days" per Pt
Post vax the patient developed a 3cm x 3cm warm tender erythema lesion at the injection site on the left thigh.
Received shots on 4/13/06: right thigh: V2V, Dtap. Left thigh: MMR, IPV. Developed erythema on right thigh since arm of 4/13/06 gradually enlarged. Seen at clinic in the afternoon around 5pm 4/14/06. Possible vaccine reaction vs soft tissue infection. Started Keflex and Bactroban or 4/14/06.
Booster; fully vaccinated plus boosted and have contracted COVID-19; fully vaccinated plus boosted and have contracted COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated plus boosted and have contracted COVID-19".  Additional information: Reporter was requesting a clinical trial for his son and girlfriend and asked "Are there active trials for people who are fully vaccinated plus boosted and have contracted COVID-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Pt reports stiffness in (R) arm approximately 2 days after inj. this by day 5 progressed to excruciating, throbbing pain. No redness or swelling of site was noticed. No fever. Took OTC meds without relief. Seen MD 1-11-11 & received KENALOG & DECADRON inj. Also given tramadol & Prednisone dose pack.
I have arthritis; This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arthritis. On an unknown date, the outcome of the arthritis was unknown.   It was unknown if the reporter considered the arthritis to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient had arthritis but was not clear if it occurred after getting 1st shot of Shingrix or if it was patient's current condition. No further information was provided. The consented to follow up was unknown. The case been linked with the case US2021AMR066208, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066208:Same reporter.
A few days after the second injection I noticed a pulsing tinnitus in my right ear that lasted a few hours in the evening. It only occurred that one time. 6 days ago I woke up with severe tinnitus in my left ear. After a few hours, the ringing was better but has not gone away, 6 days later.  The severity varies throughout the day. I also have experienced some pain near the bottom of my left jaw area but it only lasts for a few seconds when it does occur.
After getting J&J Janssen vaccine at 8pm, patient felt dizzy and was unresponsive for about 10 seconds or so. After that she regained consciousness. Her friend and I helped her to lay down and I put her feet on the chair. Patient stated that she did not eat all day, so I have her 2 glucose tablets. About 30 minutes later patient was feeling normal again.
Elevated heart rate.  My normal resting heart rate is mid 60s.  After the 2nd shot, my resting heart rate is consistently at 80 or higher.; This is a spontaneous report from a contactable consumer or other non hcp.  A 49-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 2 intramuscular, administered in Arm Right on 13May2021 12:00 (Lot Number: EW0179) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 49 years). The patient medical history was not reported. There were no concomitant medications. The patient received historic vaccine bnt162b2 (BNT162B2, solution for injection, Lot number: EW0172), dose1 Left arm via Intramuscular route on 22 Apr 2021 at12:00 PM and experienced Flu symptoms.The patient did not take any vaccine in four weeks nor other medications in two weeks. There were no known allergies. The patient experienced elevated heart rate in Jun 2021.Patients normal resting heart rate is mid-60s, after the 2nd shot, his resting heart rate is consistently at 80 or higher. The patient was not tested covid post vaccination. He had covid prior vaccination. There was no treatment received for event. The patient underwent lab tests and procedures which included electrocardiogram: appears normal, heart rate:mid 60's, sars-cov-2 test:positive on 10Nov2020 , sars-cov-2 test: negative.on 20Nov2020, sars-cov-2 test: negative on 23Nov2020, sars-cov-2 test: negative on 03Dec2020. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Had shot at 7:30pm on 9/24/21, felt fine, no problems. Woke up on 9/25 still felt fine until approximately 11:15am when I started having tingling in the back of my neck and head while driving my son to baseball. Within 15 minutes the tingling had become so strong that I felt like I was going to faint and at the same time my lower stomach started to cramp, like I felt I had to release a bowel movement. I dropped my son at baseball and returned home immediately. The tingling was now going from lower neck up the back of my head to the left side of my cheek, I continued to have severe abdominal cramping but no bowel movement would come out and I developed heart palpitations. I tried to lay down in my bed and concentrate on my breathing to relax but my heart was racing so fast I was ready to faint. My 11 year old daughter called 911 because no one was home to drive time to the ER. The paramedics came, loaded me into the ambulance and checked my temp. They said I had a fever of approximately 101. While in the ambulance my body went back and forth between having severe chills to heart palpitations and a feeling of fainting. I was brought into the ER and left in the hallway as the hospital was filled with patients. After approximately an hour my symptoms had lessened enough where I was discharged. The ER doctor told me I had an adverse reaction to the vaccine. Over the next week the tingling and numbness remained in my neck and left side of my head and cheek. I found it difficult to sleep at night due to this. My spoke with my PCP about the reaction. She said she could not recommend me getting the second shot.
Dizziness, NauseaVomiting, lymph node swelling under arm, face swelling and eyes burning Narrative:
Non serious Adverse event of unexpected benefit: TED improvement  My mother's exophthalmos/ Thyroid eye disease (TED)  improved by approximately 50 percent post Pfizer 2nd dose of vaccine.  Consequentially, she stated her vision is better and less "double" at times.   Prior to the vaccine she greatly needed treatment with Tepezza . She is scheduled to see her ophthalmologist soon to see if the treatment with Tepezza is still needed.     My mother and father think the improvement is related to the vaccine use.   As a nurse, I think it is possible as she has not changed any medications or received any type of treatment.   The reduction was very great and very soon after the 2nd dose of the vaccine.
Within 30 minutes of vaccines, sneezing, stuffy and running nose, 3 hives on neck and face. .
pt recv vax & devel of 104 & pain in the lower rt side;pt mom reported that the dx was a touch of pneumonia which attributed to vax;pt recovered from the abd pain & pneumonia;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. No known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound COVID with new symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Sep2022 to 20Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports had 2nd vaccine yesterday, later in the afternoon developed soreness at injection site (but no redness or swelling), headache.. both of which he had with his first dose as well...  As night progressed, headache became more severe. With nausea, body aches.  No fever, chills, vomiting.  Pt has not been taking tylenol, ibuprofen, etc. but will now.  Provider recommended continue monitoring and if persistent over 48hrs then be evaluated.
Within 12 hrs. Pre- term contraction 1am  and 6am Chills  at 33 weeks and cervical soften and did not have any dilation, observed at labor and delivery in the hospital observation with hydration - IV fluids and monitored contractions for 10 hrs. Contractions was spaced out and  their was not dilatation and the verified that she was not in pre-term labor so she was discharge. Followed up with doctor later contractions continued and received  Beta Methasone 2 dose 34 weeks , to mature the baby lungs. Continued to monitor for 1 to 2 weeks continued contractions with no dilations.
Day of vaccine: body aches, nausea chills, low-grade fever, heartburn, feeling of heart racing, ear ache Subsequent days intermittently (going on one week since vaccine): heartburn (daily), fatigue, nausea
1 of 3 pts exp an inject site react; pt exp a react 2 inches below needle site resembling a rubber band around the arm; arm was red & swollen; pt recovered; No treatment given; No culture taken;
Janssen shot on Mar 12, 2021. On Mar 25,2021 at 10 AM, I woke up with a headache, sore joints, nausea. Also blurry vision and inability to read words on a page. Sensing something wrong, my sister drove me to emergency room at Hospital where I was admitted. I was later told I suffered a stroke. I was in the hospital for 5 days, receiving various tests. (Hospital has all info on record).  I am awaiting surgery to remove blockage from carotid artery. Doctor has all my information and should be reporting the event also to VAERS.
Received MENACTRA 7/24/09. Felt bad the next A.M, with headache. -Progressing to HA - with fever 103.0 degrees F orally. Went to ER on 7/26/09 with HA fever and rash - was treated with TYLENOL, BENADRYL and 1% hydrocortisone cream.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
child was pale , weak, lethargic, unresponsive for 1 minute. it happened same symptoms again for 1 minute on 7/12/22. 911 was called , child was seen in ER.
potentially not getting second dose before day 35; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (potentially not getting second dose before day 35) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (potentially not getting second dose before day 35). At the time of the report, PRODUCT DOSE OMISSION ISSUE (potentially not getting second dose before day 35) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Roughly a month after getting her vaccine, she began having skin irritation that began to occur, sores broke out over her entire body  and then would crust over, patient went to her PCP and got another opinion. After biopsy she was diagnosed with spongiotic dermatitis. She has not had any period of relief since the outbreak started. Has been taken off of the hydrochlorothiazide medication, currently seein dermatology specialist who is completing further tests on her.
Received IM injection H1N1 L deltoid area, c/o pain upper deltoid and axillary area on movement. Painful movement L arm started the next day after vaccine. Healthcare worker referred to neurology clinic and orthopedic clinic. Healthcare worker reported to on 11/23/09 with c/o pain. Neurology clinic r/o nerve damage and orthopedic clinic evaluation pending.
redness had a little bit of a fever in it; arm a little bit of a knot on it; arm was red and splotchy; arm started to swell up a little bit; arm was starting to itch; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE WARMTH (redness had a little bit of a fever in it), INJECTION SITE MASS (arm a little bit of a knot on it), INJECTION SITE ERYTHEMA (arm was red and splotchy), INJECTION SITE SWELLING (arm started to swell up a little bit) and INJECTION SITE PRURITUS (arm was starting to itch) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE WARMTH (redness had a little bit of a fever in it), INJECTION SITE MASS (arm a little bit of a knot on it), INJECTION SITE ERYTHEMA (arm was red and splotchy), INJECTION SITE SWELLING (arm started to swell up a little bit) and INJECTION SITE PRURITUS (arm was starting to itch). On 22-Jan-2021, INJECTION SITE WARMTH (redness had a little bit of a fever in it), INJECTION SITE MASS (arm a little bit of a knot on it), INJECTION SITE ERYTHEMA (arm was red and splotchy) and INJECTION SITE SWELLING (arm started to swell up a little bit) had resolved. At the time of the report, INJECTION SITE PRURITUS (arm was starting to itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up received on 16 April 2021, NNI