chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated the pt. with pfizer bivalent at 3:07 in left deltoid he commented how I had good hands he didn't feel it. Then vaccinated with MMR in Left subq at 3:08 he started to get hot. His wife asked for alcohol wipes to put under his nose and on his forehead. I put an alcohol wipe on the back of his neck to help cool him off. The patient started to close his eyes and his arms and legs tightened up. So I asked for help, and he came right in and got an ice pack, a bag for nausea and started taking vitals at 3:10. The 1st set of vitals were B/P 99/60 P80 O2 100% at 3:13 the patient stated he was feeling better. Next set of vitals were B/P 108/69 P78 O2 100% at 3:17. Pt. wife stated he was fine to continue to finish the vaccines. He said it was my decision so I finished vaccinating the pt. and he was observed for 15 minutes and went home.
Arm soreness from day of injection through the next day. A little bump at injections site noted at night when band-aid was removed. Next morning, felt fatigue that progressed through the day, chills, but no fever and minor headache. As fatigue subsided towards evening, headache became increasingly worse, nausea and vomited 3 times. By the next morning, all symptoms were gone. On the 7th day, 1/12/21 at night, noted a little bump around injection site bigger than the first day. It was a little itchy. Next day, by lunch time, itchiness was worse and 3 itchy bumps noted below injection site. Swelling and slight warmth felt and worsened towards evening. Heaviness and some numbness also felt around biceps area.
Patient called Sunday, 9/24/2023 and reports this morning (Sunday, 9/24/2023) he developed intermittent chest discomfort on the right side that comes and goes.
Hand reaction beginning 8 days after booster shot. Began with hand itchiness and pain Friday evening of December 17, continued Saturday, December 18 with wheal hives in back, shoulder, arms area, with swelling and pain on arms. Unable to make a fist and pain in torso. By Sunday, December 19, more hives in naval and crotch area appeared, with more pain in entire torso and difficulty moving / getting up and out of bed, continued swelling in arms and wheals appearance all over body, and palpitations. Had to go to ER department for treatment with Benadryl, Dexamethasone and Pepcid. Discharged and took prednisone prescribed dosage on Monday, December 20, and by early morning of Tuesday, December 21st, continued with the swelling, pain, muscle aches, shaking, palpitations and heat emanating from body, and tight throat with extreme difficulty swallowing. Then returned to ER for another treatment, and was given muscle relaxant and discharged. By afternoon of the same day, Tuesday, December 21st, extreme swelling all over body appeared, and reached anaphylaxis, and had to call emergency.  Was administered dexamethasone, epinephrine and benadryl by paramedics and taken to Hospital ER. Was then admitted for 2 nights of observation and received high doses of dexamethasone steroid and benadryl to treat edema caused by anaphylaxis. Experiencing dizziness,  headaches, sweaty hands and feet,  muscle aches, with heat emanating from body, with itchiness. Chest tightness with breathing difficulty. Discharged with a taper of dexamethasone prescription, benadryl as needed, and zyrtec daily. Still experiencing all symptoms on and off in variating degrees, but more extreme at night.
TInnitus in left ear. Occured after first injection. Subsided. Returned after second injection and has been constant ever since. It is a low roar.
Patient got his 2nd shot around 1:15pm. About 10 minutes later patient started feeling like his joints are on fire with some stiffness. Came to report around 1:50pm. Checked injection site area, no signs of allergic reaction, anywhere. Gave him 50mg of Benadryl at 1:56pm. Patient also stated that the next day after his first dose, he felt the same way and it took 3 days to feel better. He also said heat makes his joints feel better, cold makes it much worse. At 2:28pm, patient said he felt better but still feels "tight". At3:30pm came back saying he felt worse. Had him take 800mg Ibuprofen. At 3:58pm patient told me in addition to the ibuprofen, he also took 1000mg acetaminophen around 3:35pm, and that he isn't feeling any better. 4:22pm, patient still not feeling any better.
Received her first dose of Pfizer on 1/05/21. Patient reported after receiving first dose patient experienced mild throat swelling a couple hours after receiving COVID vaccine. Patient did not go to urgent care, ED or receive care from her PCP. Patient stated that she did not take any medication. Patient stated symptoms subsided after a couple of hours. Patient came back for second dose Pfizer on 1/26/21. Patient stated she experienced the same symptoms a couple of hours after receiving second dose. Patient stated she experienced mild throat swelling when she got home. Patient stated that this time she did take Claritin and symptoms subsided after two hours. The patient notified RN about her two past doses. RN  submitted a medical consult via text message to leads, requesting to proceed with the COVID vaccine booster Pfizer. Approval to proceed with COVID vaccine Pfizer was obtained from medical consult team with 30 minute observation, Lead via text message. Patient received COVID vaccine booster LOT#FF8839 on 10/25/21. RN educated patient on adverse effects of COVID vaccine and signs and symptoms of an allergic reaction to the COVID vaccine and when to seek EMS or go to urgent care, ED or PCP. Patient verbalized understanding. The patient did not report any symptoms during the observation period. The patient left vaccination site at 1711 unassisted and with a steady gait.
patient said shot caused immediate pain, radiating down arm.  hasn't gotten better. got medical atttention to noted to get a MRI
sleeping more than used to/11-12 hours of sleep; lot more fatigue than usual; night sweats; muscle soreness at injection site; muscle fatigue in various spots of the body; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included myalgia, urinary tract infection. The patient's concomitant medications were not reported. The patient experienced muscle soreness at injection site on 06Mar2021, muscle fatigue in various spots of the body on 06Mar2021, sleeping more than used to/11-12 hours of sleep on an unspecified date, lot more fatigue than usual on an unspecified date, night sweats on an unspecified date. The events outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COLD SORE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced cold sore. Treatment medications included: valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold sore was not reported. This report was non-serious.
Information has been received from a licensed practical nurse (LPN) concerning a 62 year old female who on the morning of 11/12/2004 was vaccinated with a dose pneumococcal 23v polysaccharide vaccine (it was unknown if the patient had received pneumococcal 23v polysaccharide vaccine in the past).  The LPN reported that on 11/12/2004, a few hours after being vaccinated, the patient developed a half dollar sized raised are on her right arm.  Unspecified medical attention was sought and the patient was treated with ice.  at the time of this report, the outcome was unknown.
His son had a weepy nose (runny nose)/A lot of sniffing; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 07Jun2021 (at the age of 13-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2, via an unspecified route on unspecified date as 1st dose, single dose for covid-19 immunisation. On 07Jun2021, the patient experienced a weepy nose (runny nose)/a lot of sniffing. Caller advised that her 13 year old soon to 14 year son got his second dose today and he is okay but he has a runny nose and a lot of sniffing and she wanted to know if it would be alright to give him Benadryl. The clinical outcome of the his son had a weepy nose (runny nose)/a lot of sniffing was unknown.  Information about batch/lot number has been requested.
Left mild to profound sudden sensorineural hearing loss 3 weeks after COVID vaccine. Associated tinnitus.
PATIENT REPORTED A FEELING LIGHTHEADEDNESS AND DIZZINESS AFTER RECEIVING HER FIRST VACCINE. PATIENT WAS FIRST MADE TO LIE ON THE FLOOR AND THE FEET ELEVATED FOR ADEQUATE BLOOD RETURN TO THE UPPER EXTREMETIES AND BRAIN. PATIENT RESUMED CONSCIOUSNESS AND WAS TO PUT ON A STRETCHER AND MOVED TO OBSERVATION UNIT. AT THE OBSERVATION UNIT,  PATIENT VITAL SIGNS WERE CHECKED ROUTINELY AND RECORDED. HE WAS ENCOURAGED TO CALM AND RELAX TO RELIEVE ANY ANXIETIES THAT COULD BE THE CASE. HE WAS DISCHAREGED HOME BY SELF AT 12:00PM IN STABLE CONDITION.
CHILLS FEVER PROFUSE SWEATING BODY ACHES EXTREME JOINT PAIN
HUGE APPETITE; HUNGRY 80 PERCENT OF THE TIME/WAKE UP AT NIGHT STARVING; BACK ACHE; WAKE UP AT NIGHT; GENERALLY UNWELL; HEADACHE; TIRED; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 patient experienced huge appetite, hungry 80 percent of the time/wake up at night starving, back ache, wake up at night, generally unwell, headache, tired, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, back ache, headache, tired, generally unwell, huge appetite, hungry 80 percent of the time/wake up at night starving and wake up at night was not reported. This report was non-serious.
About 3 and a half hours later. I kept having trouble swallowing my saliva. I would have to try several times each time to swallow. It felt as if my throat was swelling up.
12/7/22  My husband had tested positive for COVID 3 days previously and I tested and I was negative.  I woke up that morning feeling fine.  I started slowing down later in the afternoon. By the evening, I had slowed down a lot. I tested positive with a home COVID test.  I had a low grade temperature. 12/8/22 I was in bed not moving much. My temperature got up to 99.6. My head was filled up, I had a dull headache from the pressure, very sleepy and sometimes my nose was completely stuffed, blocked. I had a dry cough, kind of a tickle.  Then my nose would run constantly.  I felt very out of it and unable to think very well. I also had sneezing.   I began taking Paxlovid on 12/8/22.  On 12/10/22 my symptoms had slowed down, but I did not have any energy.  12/12/22 through 12/17/22 I was feeling better, still had some weariness. On 12/18/22, the symptoms started to return. I had a low grade fever again, full head, stuffy and runny nose, headache and sleepiness.  On 12/19/22 I had temperature up to 100, scratchy throat, achy head and very tired. On 12/20/22 my fever was down, other symptoms were better, but I still felt very tired. 12/21/22, I had a phlegmy cough. I started taking Benzonatate and Tussin. Continued to have very low energy and did another test on 12/23/22 and it was positive for COVID. 12/26/22 and 12/27/22 , I tested negative. I am still sneezing, head stopped up a little and am limited with my activities.  I still have not recovered.
12/16- received vaccine at 6:44pm,  12-17- 0400am woke up with nausea/ vomiting and fever, had to call off work 12/18- continued to have nausea/ vomiting and fever until 10 am at which time symptoms and fever resolved
hives; severe rash; Initial information was received on 10-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Agency Inquiry Number: 00513226).  This case involves an adult female patient who experienced hives (urticaria), severe rash (rash), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  In October 2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route at left arm for prophylactic vaccination.  On an unknown date, the patient developed hives (urticaria), severe rash (rash) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from the reported events.  There will be no information on batch number for this case.
Information has been received from a pharmacist on 11-JUN-2010 concerning a 63 year old female with no pertinent medical history and no drug reaction/allergy who on 09-JUN-2010 was vaccinated subcutaneously with a "standard dose" of ZOSTAVAX (Merck) (LOT# 665516/1271Y, expire March 2011). There was no concomitant medication. After receiving the vaccine, (approximately 09-JUN-2010) the patient experienced some redness at the injection site. There was no lab diagnostic study performed. Unspecified medical attention was sought. At this time of reporting, the patient was recovering. Additional information has been requested.
Patient came in for five vaccines (Hepatitis B, Tdap, Hepatitis A, Influenza, and Meningococcal) on January 10, 2008 at 3:15 p.m. Patient was asked if he had allergies to medications, foods or previous vaccines. He denied having any allergies, except to tomatoes at one time. Patient was alert oriented to place, time and name. Patient was reminded that if he were to feel light headed to notify administrator so that the vaccines could be stopped. He acknowledged. Patient was sitting in a chair at the time of administration of vaccines. Tdap, Hepatitis A and Meningococcal were administered via intramuscular injections on the right deltoid. Patient was asked if he felt okay, and he stated "yes". Hepatitis B and the Influenza Vaccine were then placed on the left deltoid via intramuscular injection. After the completion of the vaccines patient complained of feeling light headed. He then placed his head in between his legs for about 3 minutes; he proceeded to sit up again. But, he felt dizzy and began sweating profusely. Patient stated that he had not eaten all day long. He was offered a hard candy and chewed on it for a while. Again, he placed his head in between his leg. He was asked to spit out his candy so as to prepare to lay him flat on the floor. With no relief in dizziness and sweating patient was assisted down to the floor. His legs were elevated above the level of his heart. Emergency medical services were notified. After remaining on the floor of the clinic for a couple of minutes, patient stated he felt better. His vital signs were 120/72 mm/Hg. blood pressure and 72/minute pulse. Again his pulse was checked minutes later and it was 80/minute. E.M.S. arrived at the scene and rendered first aid. Patient refused medical transport and stated he felt much better. He stated that he takes Lexapro (unknown dosage) and another bi-polar medication. Patient remained at the clinic for about 30 minutes before requesting to step outside to smoke a cigarette. Patient did not have any wheezing or difficulty breathing. Patient was alert oriented to time, place and person and was very cooperative. Patient did state that he did have a similar reaction when he was given multiple vaccines and had blood drawn several years prior.
body aches; 2"x1" (size) rash at site of injection/ Rash was red; The rash was red in color with no blisters; Rash at site of injection / Rash was warm to the touch; Arm was sore; Slight soreness at the site of injection; no apetite; bad headache; feel tired; This case was reported by a consumer and described the occurrence of tiredness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received 6 months ago, refer case US2020AMR108487).   On 22nd June 2020, the patient received the 2nd dose of Shingrix. On 22nd June 2020, less than a day after receiving Shingrix, the patient experienced headache. On 23rd June 2020, the patient experienced tiredness, appetite lost, general body pain, injection site rash, injection site erythema, injection site warmth, pain in arm and injection site pain. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the appetite lost, headache, general body pain, injection site rash, injection site erythema, injection site warmth, pain in arm and injection site pain were unknown.   It was unknown if the reporter considered the tiredness, appetite lost, headache, general body pain, injection site rash, injection site erythema, injection site warmth, pain in arm and injection site pain to be related to Shingrix.  Additional details were reported as follows: On 23rd June 2020 the patient felt tired and with no appetite, arm was sore and had a bad headache last night. The following day there was a 2 inch multiplied by 1 inch (size) rash at site of injection. The rash was red in color with no blisters, and warm to the touch. The patient had body aches. The tiredness resolved after day 2 but the rash is still present along with some slight soreness at the site of injection.  Consented to follow up. This case has been linked with case US2020AMR108487, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR108487:
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On 01-OCT-2020, the patient was vaccinated with  an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S025608, expiration date 18-AUG-2021, for prophylaxis  (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported) that was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was stored in a temperature of -14°C to-10°C (-12.50C) for 1 minute and -14°C to-10°C (-14C) for 1 minute (multiple excursions) as recorded by a data logger. There was no previous temperature excursion reported.
pt recv vax & devel a fever of 104-105, sz & inconsolable crying;child was taken to ER & hosp;pt recovered;vaccinating MD dx this event as an allerg rxn to tetanus toxoid;however, the reporting allergist does not consider event allerg rxn;
Severe pain at injection site went to ER with severe pain, swelling at injection site and fever.
Pain in face; Ophthalmic herpes zoster; Eye inflammation; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1. On 02-Feb-2021, the patient experienced EYE INFLAMMATION (Eye inflammation). In February 2021, the patient experienced HERPES ZOSTER (Shingles). In April 2021, the patient experienced OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster) (seriousness criterion medically significant). On an unknown date, the patient experienced FACIAL PAIN (Pain in face). At the time of the report, OPHTHALMIC HERPES ZOSTER (Ophthalmic herpes zoster), EYE INFLAMMATION (Eye inflammation), FACIAL PAIN (Pain in face) and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included prednisone.  Very limited information regarding the events has been provided at this time. Additional information regarding date of vaccination and Humira infusion, and correct onset date for the events are required for further evaluation.; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information regarding date of vaccination and Humira infusion, and correct onset date for the events are required for further evaluation.
Patient reported having nausea and abdominal discomfort Patient provided with water and symptoms improved Patient refused medical transport and signed AMA form
spiked fever Am p/vax;recv APAP q 3hr;temp didn't go down;all the next door 7 was 104.6 @ 5PM in ER;fever cont on & off for the next 24hr;pinkish rash noted on legs 4 days p/vax;
Red, inflamed raised rash on torso that began very small and gradually spread. Itchy and a little painful.
upper lateral arm area : confluence of vesicles about size of a quarter surrounded by erythema. No weeping lesions
Pt began with headache and fever 101 degrees F. Went to ER, Had swollen lymph nodes in his neck. Pt has history of asthma. Treated with po predisone and inhalers for respiratory systems; Condition improved 24 - 48 hours.
has a really bad headache; feels like she's going to throw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2), administration date 10Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 10Nov2021, outcome "not recovered", described as "has a really bad headache"; VOMITING (non-serious) with onset 10Nov2021, outcome "not recovered", described as "feels like she's going to throw up". Additional information: The reporter was calling on behalf of her mother (Withheld). The patient received the Pfizer covid vaccine today and she now had a really bad headache and feels like she's going to throw up. Reporter asked is this normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.