chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Headache; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181), dose 1 via an unspecified route of administration on 11Jun2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, a week later, the patient experienced fever, chills, headache, shortness of breath and still having all issues. Outcome of the event was unknown.
Pt had a localized reaction to varicella, observed within 5 minutes, post vax, with redness and 1/2cm papule/hive at injection site, no itching and no other reaction observed. Diphenhydramine HCL/Benadryl (dye-free). Child was observed for 45 minutes and released. No other reactions noted, redness and hives decreased in size.
Severe chills with 102.8 fever within 12 hrs of vaccination which reverted to normal within 48 hours.  This was followed by fatigue and muscle achiness for about 5 days.  On June 18 to June 20, 2021, I then developed tinnitus which I still have with some slight sense of hearing loss now.
Woke up this morning to my hands covered in rough, dead, peeling skin.  It doesn?t hurt much, but it?s really weird. I tried exfoliating and immediately using a moisturizer but it didn?t help at all. The flaking has gotten worse as the day has gone on.
Pt admitted w/ covid pna, requiring o2. on remdesivir/dexamethasone
pt recv vax 3JAN97 & 3JAN97 pt exp breakthrough chickenpox w/less than 100 lesions;
pt recvd vax & 6 hrs following vax pt devel sleepiness & a fever of 100.5 to 101.5; pt's mom treated pt w/unspecified antipyretic; pt recovered by the morning of 10OCT93
It started with fatigue, I didn't feel anything for the first day, just tired. It was within a week that vertigo started. At first it was just a couple short episodes, within a week of the first episode it was significant. I could not sit up, stand up or walk.  I waited about 4 days to go to the doctor, they could not get me in so they suggested I go to urgent care. The urgent care gave me a prescription to help with vertigo, and zofran for nausea. It lasted for another few days. The medications did help, was not as severe as prior weeks. Follow up appointment with neurologist.
Delirious fever; temperature was high enough to where he got delirious; Headache; Muscle aches; he was just tired a little early; Swollen joints, possibly hands, knuckles, arms, shoulders; This is a spontaneous report from a contactable consumer.  A 62 years old male consumer reported that he received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8733), via an unspecified route of administration, on 26Mar2021 at 12:00 in Arm Left (at the age of 62-years-old) as single dose for covid-19 immunisation.  The first dose of bnt162b2 was received on 05Mar2021 (Lot: EN6205). Medical history included diabetes mellitus, hypertension from, gastrooesophageal reflux disease from 1977, sleep apnoea syndrome from 2000, pain from 2017, blood cholesterol increased from 2013, vitamin D deficiency from 2013, depression from 2000. Concomitant medications included glipizide for diabetes mellitus; lisinopril started about 1982 or 1983  for high blood pressure; metformin hcl for diabetes mellitus; terazosin hydrochloride from 1987 prescribed for Benign hyperplasia of prostate (BPH) but it turned out to be something else, but he still takes this medication because it helps with his urination; famotidine for acid reflux; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for narcolepsy; oxycodone for pain from 2017; VITAMIN B12  for vitamin deficiency from 2016; calcium citrate from 2019 for blood in his urine; fish oil for blood cholesterol from 2013; colecalciferol (VITAMIN D3) from 2013; ketamine hcl for depression, and CANNABIS he used it recreationally and probably medicinally too because it helps him sleep. He is not a daytime stoner, he just uses it at night to relax and go to sleep. He started about 2009, when he got a medical card. Caller reported had his vaccine shot at noon on 26Mar2021. He stated he felt fine, he was just tired a little early and went to bed at 10. He woke up at midnight with a headache and a delirious fever. He didn't test his temperature or anything but it was high enough to where he got delirious, but he doesn't know how high that was.  He took Tylenol 2500mg capsules which helped with the headache and not the fever, so 4 hours later, he took Ibuprofen  800 mg which seemed to helped with the fever. He stated the headache is gone. Caller stated delirious feverish was gone but then clarifies he doesn't know if he has recovered completely actually, it feels like he has, but these things are funny sometimes. Caller reported muscle aches started around midnight on 26Mar2021, and were gone by 27Mar2021. Further Caller reported he had swollen joints- his hands, knuckles. He adds his arms and shoulders, but he doesn't know if that was from laying on them all night for as long as he did because he slept all the next day, too. The swollen joints seems to be resolved at this point. He clarifies all the symptoms started around midnight on 26Mar2021, about 12 hours after the shot. He confirms that he did not have swollen lymph nodes.  No follow-up attempts are needed. No further information is expected.
a few days after the first shot i started having mental issues; becoming confused; paranoid; aggressive; not making any sense; have not been able to sleep; I cant eat; This is a spontaneous report received from a contactable consumer (patient himself). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: en6202) via an unspecified route of administration on the right arm on 06Mar2021 at 11.30 (at the age of 35-year-old) at a single dose and second dose on arm on 27Mar2021 (at the age of 35-year-old) at single dose for COVID-19 immunization. The patient medical history included CRPS, ADHD and PTSD. Concomitant medications were not reported. The patient was previously took haloperidol and experienced with allergy. On 07Mar2021 at 14:30 started having mental issues. Becoming confused, paranoid, aggressive, not making any sense. No one believed and send patient to a mental hospital and drugged him more and put him through terrible medical practices. He received his second dose of the vaccine and after that he had same side effect again but worse. He needed some sort of treatment asap. He also reported that no one believed him this was the vaccine. He was not able to sleep but 4 hours every 36 hours and he could not eat. These adverse events led the patient's hospitalization and Disabling/Incapacitating. Outcome of events was not recovered.
ADMINISTERED PAST THE CURRENT REFRIGIRATION BEYOND USE DATE DATE AS LISTED IN EUA
It was reported that a patient (2 of 2) received a Fluzone vaccination. Sometime after the vaccination the patient developed leg cramps. No specifics were provided. Further information is requested.
Large baseball sized red area at the injection site appeared within 10 full days after first vaccination (started out with just a small red itchy area and next morning was baseball size). It is warm to the touch and itchy.  Continues to itch and now has a raised rash... although the redness seems to be lighter in color.  I have NOT received the 2nd dose.  The second dose is currently scheduled for 2/4/2021.
Bell's palsy in right face: onset exactly 2 weeks following dose 2. Facial paralysis, hyperacusis, tongue numbness, blurred vision, no gag reflex, reduced hypoglossal activity, neck/ear/jaw pain
The patient  is a 72 y.o. male with past medical history significant for COPD, chronic hypoxia, hypertension, RA on prednisone, DDD who presented to the ED with complaints of worsening cough, SOB and fatigue.   He was started on Doxycycline by his PCP and did not improve.   He tested positive for COVID 19 and was started on steroids, lovenox, rocpehin and z-max.   Sputum Cx positive for PSA and abx changed to pip/tazo.   Patient improved quickly and was back to his baseline on day #3.   He agreed with verbal instructions to pick up anti-biotics and staroids at his pharmacy and take as directed. He agrred to be in COVID isolationthrough 11/18   11/10 Pt S+E. On room air. Tolerating diet. Ambulating well. Stable at discharge
15 year old client was unable to obtain Hep B dose 3 at PCP.  Not eligible for VFC. Gave her private, which was adult dose of Hep B vaccine.  No adverse symptoms that day or 3 days later per mother.
Pt returned to clinic 2 hrs after Flu Mist with complaints of globus sensation/chest tightness that started about 1 hr after Flu Mist.)  No other new exposures that day, no hx of egg allergy or asthma.  Faint wheeze noted on exam (had rhinitis sx thought to be related to rhinitis preceding Flu Mist) that self-resolved. She was noted to also be burping a lot- per patient this is normal for her and is being worked up for dyspepsia. She did receive Epi and Zyrtec in clinic, discharged with Zantac po. Reports sx resolved in clinic with no recurrence.
COLD; WARM; SWEATING VERY BAD; KICKED IN REALLY HEAVY; FEVER; 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: Unknown) 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 cold, warm, sweating very bad, kicked in really heavy, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kicked in really heavy, fever, cold, warm and sweating very bad, was not reported. This report was non-serious.
Sore throat started 10/16, became progressively worse and then severe for next couple days. Chills and feverish next day 10/17, then subsided. Then URI/sinus symptoms began (severe runny nose and sneezing, sinus pressure, headache, hoarseness, scratchy throat and losing voice). After OTC meds and prednisone symptoms began to improve. Towards end, developed an intermittent cough. Now I still have some runny nose and green mucus, coughing up phlegm occasionally. Voice is almost recovered.
Initially I had a sore arm at injection site, which I didn?t have with previous Covid shots. Within a few days my arm became more sore, internally. It didn?t hurt as much to touch as it did to move my arm or to lie on my arm, there was a slight bruise near the injection site and the injection site was lower than typical for shots. I assumed it would just go away. My arm continued to feel worse over the following two weeks. It was sore along the upper arm and into my shoulder area. It hurt to lift  items, movement to the side and upward, painful  to take my shirt off/on and to sleep at night. I took ibuprofen for the pain. It?s been four weeks and I still have soreness and pain internally and in my shoulder. The movement in my arm is somewhat limited and there is still some weakness. My arm has limited flexibility to move back and is still sore when lifting and moving in certain directions. Hurts to lift above my head when sleeping.
Gets her period on the 1° or 2° of the month, but this time she just got her period today, which is very ununsal; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Gets her period on the 1° or 2° of the month, but this time she just got her period today, which is very ununsal) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M209) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MENSTRUATION IRREGULAR (Gets her period on the 1° or 2° of the month, but this time she just got her period today, which is very ununsal). At the time of the report, MENSTRUATION IRREGULAR (Gets her period on the 1° or 2° of the month, but this time she just got her period today, which is very ununsal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Hard lump approx 1 inch Red oval skin blotch approx 2.5 inch by 1.5 inch Severe itching Around injection site Began taking OTC Allegra at day 7 Total duration 9 days
PATIENT REPORTED TO THE PHARMACY ABOUT 20 MINUTES AFTER THE VACCINE WITH COMPLAINTS OF ITCHING AND SWELLING. THE PATIENT WAS RECOMMENDED AND RECEIVED ONE DOSE OF 25 MG DIPHENHYDRAMINE AND WAS MONITORED FOR 15 MINUTES. PATIENT DENIED COLD PACK. PATIENT WAS COUNSELED ON S/S OF ANAPHYLAXIS AND WAS INSTRUCTED TO CALL 911 IF THE SYMPTOMS SHOWED UP. PATIENT WAS RELEASED AFTER 15 MINUTES OF MONITORING.
TESTICLES SWELLED UP; ERECTILE DYSFUNCTION/PENIS WOULDN'T GET HARD; This spontaneous report received from a patient concerned a 44 year. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total, administered on beginning of AUG-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, approximately 7 days later the vaccination, the patient experienced testicular swelling and went to the emergency room and was admitted to the hospital (dates unspecified). The patient also consulted with urologist, but could not provide further information. The patient was hospitalized for 7 days (date of discharge was not reported). The testicles were swollen for approximately 3 weeks. On an unspecified date, the patient also experienced erectile dysfunction. The patient experienced that his penis was not getting hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from testicles swelled up, and had not recovered from erectile dysfunction/penis wouldn't get hard. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210931764-COVID-19 VACCINE AD26.COV2.S- erectile dysfunction/penis wouldn't get hard, testicles swelled up. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
(Lt) upper arm with erythema 12x11 cm. (+) edema; Tx: Ibuprofen q 6-8 hours x 48 hours; warm compresses PRN.
mom states that approx 3hr p/vax child woke from nap & was sitting in which chair when noticed was very pale & shaking;states felt cold to touch;mom wrapped pt in a blanket & rocked pt & color improved;
At time of 2 mo shots, IPV, prevnar given in one thigh (R)-marked limb swelling, lasting a few hours with complete resolution.
1 hour after booster started seeing black spots in right eye only.  Next morning spider like images and black dots.  Off and on.  Next day small white dots.  Seeing eye doctor today
Experienced swelling of eyelids (both L/R), intense itching  primarily in eyes, some itching on hands and feet, sneezing, runny nose Took 1 25mg Benadryl tablet within 5 minutes of start of symptoms, had to take another 25mg Benadryl tablet approximately 30 minutes later because eyes were continuing to swell and itch Also experienced onset of severe headache about 45 minutes after shot Went to bed and slept for 3 hours after taking the second Benadryl.  Felt better after waking, still had slight swelling in eyelids. Experienced minor itching  at 10:30 pm, took 2 more Benadryl tablets at 11 pm. Minor eyelid swelling next morning, minimal itching.
3MAY98 started w/low grade fever & pox;seen 4MAY confirmed chickenpox by MD;had approx 75 pox-lots of itching;no known exposure;all pox scabbed over by 9MAY98;
Pt received less than recommended dose due to the patient pulling away from RN before receiving all vaccine. RN unable to determine how much vaccine patient received as the liquid was on patients leg with nothing left in the syringe. After seeing the amount of liquid on patient's leg, RN assessed it is likely that the patient received less than half of the vaccine
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a 39 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
Vaccines MMRV, Hep A, HIB due at 1 year of age were given to the patient 5 days before age 1 as custodial grandparent said he had to have them before going to day care. Informed her of this via phone call.
fully vaccinated and boosted on 23/16/21.  Asymptomatic COVID infection breakthrough with inpatient hospital stay.
Received Hep B and MMR 04/08/2003. During night of 04/08-04/09 began S+S of fever of 102 degrees (responded to Advil), occ dizziness. 04/14 continued to feel "achey" all over and "very bad headache" that has been nagging since Friday. PCP prescribed Percacett. 04/21 c/o Headache triggered by light/glare.
Information has been received from a registered nurse concerning a 69 year old male patient with history of "immunosuppression of unspecified etiology" who on 28-OCT-2009 was vaccinated intramuscularly with his first 0.5 ml dose of PNEUMOVAX 23 (Lot # 664554/1243Y). It was reported that one day after receiving the PNEUMOVAX 23, on 29-OCT-2009, the patient experienced an injection site reaction, he was seen at the office exhibiting redness, swelling and severe pain at the injection site and down the arm. No treatment was prescribed. The patient recovered within one week, on approximately 05-NOV-2009. No diagnostic tests were performed. This report is related with WAES # 1003USA00981, WAES # 1003USA00982, WAES # 1003USA00983 and WAES # 1003USA00984, same source, same adverse experience. Additional information has been requested.
sneezing; mild cold; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported), dose 1, via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. After receiving first dose of vaccine, the patient experienced sneezing, mild cold on an unspecified date. Therapeutic measures were taken as a result of sneezing, mild cold with tylenol. The outcome of events was unknown at the time of this report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Entire thigh swelled with erythema, fevers to 102.5 x 2 days.
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 10:00 as dose 1, single (Lot number: EP7534), in left arm, on 12Apr2021 at 10:00 as dose 2, single (Lot number: EW0158), in left arm, on 15Dec2021 at 10:00 as dose 3 (booster), single (Lot number: PD0809), in left arm and on 25May2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 28Jun2023 to 03Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300246180 same patient, different drug/ event;
MN 26OCT91 pt fussy & started inconsolable screaming; continued thru Sat & Sun; MD admitted pt to hosp 27OCT91 dx hyperirritability post DTP vax, broke out in rash from head to toe;
Rash on left arm,  dehydration, chills, fever, headache, nausea, body aches, exhaustion.  This occurred both with the first and second shots.  (I also had COVID in October 2020).
Red flat rash began and has spotted her whole body. Rash is not uniform, some are wider in diameter. No itching, parts have dried up.
Very mild rash at the injection site and approx. 1 inch around the injection site.
Pt developed redness, swelling extending above injection & streaking down to elbow. Seen in ED tx with Clindamycin 300 mg QID.
The symptom started in 2001 with standard seasonal flu shots. When exposed to flu strains at any time after the injection I would get a muscle spasm in the neck, randomly one side or the other, never both sides. The spasm is a painful stiffness and muscle spasm of the type that can be caused by sleeping with the wrong pillow. But these spasms are not helped or treated by use of heat, cold, massage or muscle relaxers. They started out lasting 8 hours to 24 hours but now they are one to ten days. They stop with immediate activation of flu symptoms such as sensitive skin, feverish feeling, diarrhea or elevated body temperature. I used to get one neck spasm per year most of my life with sleeping position but it started becoming a predictable symptom that I was exposed to the flu. In layman's terms the flu 'hibernates' in my neck muscles for a varied length of time and generally the longer I had the stiff neck the less severe the flu symptoms would be when the spasm suddenly stopped and attenuated flu symptoms appeared. I believe the vaccinations are helping me to avoid severe flu symptoms as I never lost time from work or became bed ridden by seasonal flue since starting annual vaccine doses. My last two episodes this year was severe neck spasm 8 months ago that left me totally incapacitated for a day. Moving my body at all caused horrible neck pain like neck muscles were tearing apart. I was having treatments for a dental abscess at the same time and neck spasms in the dentist chair hindered treatment but two days later mild flu symptoms suddenly appeared as neck pain vanished. Then last week had a stiff neck again for 3 days then suddenly hit with serious diarrhea for 12 hours before all discomfort starting to subside.
Sedation, Myalgia, Arthralgia, NauseaVomiting, Tachycardia, Insomnia, sore arm, chills Narrative:  Other Relevant History:
Skin break-out in 3 different locations and at site of vaccination (left arm). Doctor visit. Mometasone Furoate Cream USP 0.1%.