chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, once a total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
About 5 days after the vaccination, experienced very sore muscle pain in right arm that has continued to this date. Pain subsequently migrated to the shoulder area. Lower lip twitches sporadically which continues to this date. Occasional chills and tinkling of the head area that continues.
This spontaneous report has been received from a pharmacist concerning a female patient of 39 year old. The patient had no pertinent medical history or drug reactions/allergies. On approximately 21-APR-2015, (reported as "about two weeks ago"), the patient was vaccinated with (Merck) VARIVAX (lot # J008982, expiration date 19-JUL-2015), subcutaneous injection in right arm, (strength not reported), first dose, 0.5 ml. There was not concomitant medication reported. On an unknown date, in 2015, after (Merck) VARIVAX vaccination, the patient experienced injection site erythema and injection site warmth of her right arm. The patient sought medical attention, contacting the pharmacist. There was no treatment given for the injection site erythema and injection site warmth, in the patient's right arm. At the reporting time, the outcome of injection site erythema and injection site warmth was reported as not recovered. The pharmacist stated that she would inform the patient to contact her primary healthcare provider for follow up. Additional information is not expected.
Ache all over right arm hot very tired. Had to take pain medicine Rt arm hurt a lot. Felt very heavy & weighed down. Rt arm was also very hard where the shot was given.
Mom stated pt had been given APAP since recvd vax; pt started crying @2AM on 3MAR92 & temp was 102 ax; Pt given APAP; cried all night; Pt taken to MD 4MAR92 t100 R; MD told mom pt had cold; pt cont high pitched crying episodes;
Patient started to itch on Sept 3rd and notice welts. Started BENADRYL on Sept 5th and itching and welts have improved.
This spontaneous report as received from a consumer refers to a 12-month-old male patient (reported also as approximately 12-month-old). There was no information about the patient's medical history, concurrent conditions and concomitant therapies provided. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (dose, strength, route of administration, anatomical location, lot # and expiration date were not reported). A misuse adverse event was also reported. No adverse reaction was reported. Additional information has been requested.
may have a blunted immune response to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLUNTED AFFECT (may have a blunted immune response to the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic leukemia.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 BLUNTED AFFECT (may have a blunted immune response to the vaccine). At the time of the report, BLUNTED AFFECT (may have a blunted immune response to the vaccine) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.
IN THE FOLLOWING  MORNING OF MY VACCINATION I FELT VERY DIZZY & LIGHT HEADED IN THE TOILET , HAD LOOSE MOTION & PASSED OUT . HAD TEMP 101.2 F ( FELT EXACTLY  THE SAME SYMPTOMS WHEN I HAD COVID INFECTION IN APRIL 2020 ). I WAS LIGHT HEADED THROUGHOUT THE WHOLE DAY , HAD PAIN & TENDERNESS OVER  RIGHT 10TH RIB ( PROBABLY HAD A FRACTURE).  I HAD NO SYMPTOM FROM THE FOLLOWING THAT DAY TILL NOW BESIDES PAIN IN THE R RIB AREA POSTERIORLY.
Convulsions, screaming as if scared or in pain, increased heart rate, quick breathing and fever.  The symptoms lasted an hour except the fever, which lasted 2 more days.
Menstrual spotting that lasted less the 24 hours. Light pink in color and only noticeable if wiping.
Developed bilateral classic Zoster rash on neck (except that it was bilateral).  Valtrex and Keflex to treat if bacterial component.
Within minutes of receiving her vaccine in her left arm, by this RN, she complained of tingling from her shoulder down to her hand, also with slight numbness. Patient sat and was observed for 50 minutes, symptoms did not resolve or worsen. Lead pharmacist was notified. Patient left with continued tingling in left arm .
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot#L024993 with expiry date:17-OCT-2017 lot#L043214 with expiry date:30-AUG-2017, lot#L036301 with expiry date:20-DEC-2017, lot#M041212 with expiry date:21-JUN-2019, lot#M016193 with expiry date:24-APR-2018, lot#M018810 with expiry date:28-MAY-2018, lot#M032650 with expiry date:31-MAR-2019 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots of GARDASIL 9 were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# L024993, lot# L043214, lot#L036301; 37 minutes for lot# M041212; 66 minutes for lot# M016193 and 70 minutes for lot#M018810, lot#M032650. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Diarrhea, noticeably distended stomach, with severe stomach pain for about 2 days. treated with smooth muscle relaxer. Currently recovering.
8-1-08 Mom called to report that Dusty has a 3 inch sized diameter of redness on his left upper arm, where VZV vaccine was administered on 7-29-2008.  Mom also reports that there is a lump underneath the redness the size of her thumbnail.  Mom denies any distress other than the site is painful. Mom declined an office visit.
Waited 2 weeks & took ajovy shot (subq, left arm). Arm immediately developed painful rash on injection site immediately , and progressed to entire upper arm (above elbow). The itching lasted 3 days (03/09/21) and the pain and swelling lasted 9 days (03/15/21).  Not taking Ajovy for at least 4 weeks after 2nd dose.
1-2 mins after vaccine she became dizzy, slumped over, unfocused, pale, color returned after 3 mins. BP normal.
Patient called health system call center to report a red bump, pimple like rash accompanied by red streaked below injection site. Patient denies any worsening pain nor swelling on injection site. Patient states they will follow-up with outside PCP.
Pt develop diffuse maculopapular rash in patches on her bilateral legs, swelling around her eyes with crusted lids and lips and a "orange" discoloration around the lips. She also developed infection of the right ear
Not sure when the reaction began for the patient. Put in today's date. Patient states arm began to swell and rash began to spread down arm. She went to doctor 2/5/16 who told her the site was infected. I told patient we would fill out adverse event report for the reaction.
Headache Nausea/vomiting Shortness of breath Chills Joint pain
A serious report of asthma has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included obesity. The subject had no family history of asthma and no history of previous wheezing episodes. No concomitant medications were reported. On 30-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event. On 28-Oct-2009, the subject began to wheeze and had symptoms of urinary tract infection with fever; he was seen at emergency room. On 29-Oct-2009, the subject was admitted to the hospital for asthma. on 30-Oct-2009, he was discharged from the hospital "in good condition". Discharge medications included beclomethasone and albuterol, which he used for four days. On 05-Nov-2009, at follow-up examination, the subject was doing well. He did not have cough or fever, was playful and had good appetite. Although reactive airway disease was coded in the hospital, the follow-up exam states reluctance to define the event as asthma since it was a first episode. The outcome of the event was resolved on 30-Oct-2009. The investigator assessed the causality for the event of asthma to FLUMIST as none. The severity of the event was mild. The alternative etiology was upper respiratory infection. The sponsor assessed the causality for the event of asthma as not related to FLUMIST.
It felt like she was hit with a foam baseball bat in the lower back; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Mar2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Feb2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the patient reported that it felt like hit with a foam baseball bat in the lower back. Therapeutic measures were not taken as a result of this event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date, the patient underwent nasal swab (SARS-CoV-2 test) and the test result was negative. The clinical outcome of the event lower back pain was recovered on an unknown date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical histories and drug reactions/allergies were not reported. On unkonwn dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, strength and router were not reported). These unspecified doses of PEDVAXHIB might have been administered using the following lot#: J016188 with expiration date 02-OCT-2016; J015435 with expiration date 13-OCT-016; K002747 with expiration date 09-DEC-2016; K008879 with expiration date 30-MAR-2017; K016964 with expiration date 16-JUL-2017; K025006 with expiration date 22-JUL-2017; L002867 with expiration date 11-NOV-2017; L009649 with expiration date 19-NOV-2017. No adverse effects were reported. This is one of several cases from the same reproter. Additional information has been requested.
I had gone in for my annual mammogram and they found something that looked abnormal. I had a needle biopsy that confirmed I had Ductal carcinoma in situ in the left breast. I had a partial mastectomy. I am currently going through chemotherapy and radiation.
t103.6 R 645PM, knot to lt leg; APAP given, cold bath; no lethargy or sx reported by mom;
Painful site of injection, all over muscle soreness and fatigue. Chills and fever in PM. Bed rest required on 2nd day.
Headache chills, fatigue, injection site pain/arm pain, swelling at injection site
At 5:00 AM,  18 hours after the initial injection, immediate onset of brutal exhuastion, chills, fever,  aches in every joint, muscle aches, and tendonitis behind the left knee, intense all over headache plus unpredictable stabbing headaches.  Took plain aspirin and a Delta 8 and slept under an electric blanket turned up to high. (the room was not cold, but the chills/fever were that bad).  Around 12 hours later, awake with most lingering headache and body ache and the tendonitis persisted behind the left knee.  12 hours later, vomited once, and the rest of the symptoms faded, leaving only the exhaustion.  At this point 03/05 at 9 PM all symptoms gone but the exhaustion.
For this dose, reported lightheadedness and redness along chest and back. No hives.  First dose, same reaction but had hives for 3 days.  No shortness of breath reported.  Self treated with Benadryl.  Referred to an allergist from primary MD.
Patient present in the clinic today to receive 12 yr. vaccines of Tdap and MCV4. Paperwork filled out and completed by mother and patient and mother explained the procedure. Patient noted to be calm and relaxed and showed no signs of being afraid of shots. First Tdap was administered IM into the left deltoid, approximately one min later MCV4 was administered into right deltoid IM. Nurse turned her back to get band aid to apply to site when patient began to go limp and shake with eyes rolled in the back of his head. Nurse grabbed patient's head and guided him to the floor. Patient seemed to have what looked like a seizure for approx. 30 sec before being able to speak. instructed to call 911. Patient reported "I need to throw up". Nurse helped patient to a sitting position and given a waste basket where he spit up. Patient rested his head against the wall where it seemed he was going out again. Nurse grabbed defibrillator from hall, and Benadryl and epi pen in case any was needed. Patient skin became cold and clammy, skin color pale. Patient kept saying "I do not want to die". Mother began praying for child until EMS arrived. No defibrillator or emergency medications was used. EMS present and performed vital signs and EKG. Patient was taken to local ER approx. 2 miles away via mother's private car, per mother's request
patient describes having discomfort during injection, whereas she did not have the same discomfort for her first shot. She describes having pain in that arm since the injection, which has resulted in her not being able to fully lift her arm. She has sought medical treatment and advice regarding the pain and limited movement
chills / shivering; fever; headache; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2020, the patient received the 1st dose of Shingrix. On 9th March 2020, 1 days after receiving Shingrix, the patient experienced chills, fever, headache and upset stomach. On an unknown date, the outcome of the chills, fever, headache and upset stomach were unknown.   It was unknown if the reporter considered the chills, fever, headache and upset stomach to be related to Shingrix.  Additional case details were reported as follows: The patient after vaccination had chills, fever, headache and upset stomach. The patient  wanted to know how long the events may last. The Prescribing Information was reviewed and offered. The patient also referred to his physician. The patient consented to follow up.
Arm pain. Patient did not return for 2 1/2 months. Now has frozen shoulder. Cannot say patient has plexopathy. Referred to in-network doctor for further evaluation.
Edema of lymph nodes in left armpit and left breast with pain and tenderness in breast lasting 4 days. Took Motrin 600 mg twice for discomfort twice on 03/22/2021.  Discomfort abated gradually over time. As of today, 03/24/2021 pain remains occasional with overall tenderness in Left breast continuing.
Not sure whether to describe as "adverse", his urinary urgency subsided (enlarged prostate) from partially filled bladder and was replaced by a typical bladder "awareness"; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9262, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 12Feb2021 at 10:15 (at the age of 77-years-old) as dose 2, single for COVID-19 immunisation. Medical history included urinary urgency and enlarged prostate both from an unknown date. The patient has no known allergies in vaccine based on list of chemicals posted by Pfizer and CDC. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient has unspecified concomitant medications received within two weeks for blood pressure and prostate. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient experienced not sure whether to describe as "adverse", his urinary urgency subsided (enlarged prostate) from partially filled bladder and was replaced by a typical bladder "awareness" on 12Feb2021. The event started a few hours after the vaccine and remained for 3 days. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are possible. No further information expected.
Since completing the original 2 dose vaccine, I started to experience a significant loss of taste.  I never have tested positive for the virus either in Rapid, PCR or home tests, nor did I ever experience any symptoms of COVID.  I have tested regularly since the tests began because my father resides in a nursing home along with having a new grandchild.  At least once a week and as a few months ago I test twice a week.  AFter my third dose of the Moderna vaccine, the loss of taste has become even more evident.  My senseof smell has not been affected only my sense of taste.  Salt helps but it has been severely compromised
Hemorrhaging in the hospital; Suspected to be pregnant has a miscarriage; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting.; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; This is a spontaneous report from a Pfizer Sponsored Program  A contactable consumer reported for a female patient   A female patient of age 3 decade received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) Via an unspecified route of administration on an unspecified date as a dose number unknown, single for (at the age of 3 decade) COVID-19 immunization. Patient medical history and concomitant medication were not provided. After administration of the vaccine, on an unspecified date she was hemorrhaging in the hospital and suspected to be pregnant, has a miscarriage. Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After brushing my teeth the left side of my mouth (same side as vaccine) started pulsating and I was drooling. I called the nurse through my insurance company and she said this is a normal reaction for the PREVNAR vaccine. I was awake for 90 minutes until I got sleepy and slept the rest of the night. I did not have the pulsating again in the past 3 days. I have had numbness in my mouth on the left side.  However, Dr. and another primary care doctor said this is not a normal reaction. I saw a different doctor this morning and she could not find my response to this drug wherever she was looking.
Information has been received from a college health registered nurse concerning a female who was vaccinated with either a second or third dose of Gardasil (lot #659962/1740U).  Subsequently the patient developed pain at the injection site.  It was reported that it was the worst shot she ever had.  The patient sought medical attention in the office.  At the time of the report, the patient's outcome was unknown.  The register nurse is requesting a lot check.  Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 3/14/2008; 7/8/2008; 1/7/2009. Initial and follow-up information has been received from a registered nurse concerning an approximately 20 year old female who was vaccinated IM with either a second or third dose of GARDASIL (lot #659962/1740U). Subsequently the patient developed excrutiating pain at the injection site. It was reported that it was the worst shot she ever had. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number 659962/1740U was satisfactory. The lot # 659962/1740U met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check was performed. All in-process quality checks for the lot number 659962/1740U in question were satisfactory. In addition an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot number 6599/1740U met the requirements of the Center for Drug Evaluation and Research and was released. This is one of several reports received from the same source. Additional information is not expected.
I got very sick after my second vaccine. I also had a mild case Covid 19, threw up for 24 hours, I had a terrible headache.  I work in field of immunology, because I had covid the reaction, I don't think the dosage is right for a covid patient. I think a person should have antibiotics to begin with and I think the second dose threw my system out of control.   I do have headaches to this day frequently and I also have shingles.   After I had Covid and was done for like two months afterwards I had repeated cold sores , would go away and come back, like three to four times.  I would like to know if other people had problems like I have.