chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 70 years old female patient received the first single dose of PREVNAR 13 on 15Jun2015, for immunization. Medical history included chronic kidney disease stage 3 ongoing from 2008 and acute kidney failure from 2014 but they straightened that out. The reporter mentioned also about an unspecified ACE inhibitor that gave her a cough while she was in the hospital for acute kidney failure in 2014. However, she had complications. She was in the hospital for a week and had shakes, sweats, severe fatigue, cough from ACE inhibitors, dizziness, headache, and went right into pneumonia. She got pneumonia and had severe shortness of breath, so those things plus respiratory infection. Illness at time of vaccination included pneumonia in right lower lobe which was detected with an X-ray on 04Jun2015. The patient was still very sick when she received the vaccine. Due to pneumonia they had to give her 7 antibiotics and all of the sudden she ended up with squamous cell carcinoma, actinic keratosis, and staphylococcus aureus. The reporter was unable to provide all antibiotic names, they were mostly LEVAQUIN 500 mg and cephalexin. She only got one shot of pneumococcal 13-val conj vac (dipht crm197 protein). She did not get it before she got pneumonia and they said that was why she needed it. Then, since an unspecified date in 2015, she was sick for 8 months after. Sickness resolved with sequelae in Mar2016 with lasting effects of atelectasis and a 4 mm nodule in the area where the pneumonia was.
This spontaneous report as received from an other health professional refers to a female patient of unknown date. The healthcare worker reported that the patient was vaccinated with the first dose, 0.5 ml GARDASIL on 01-AUG-2011 and received the second dose 0.5 GARDASIL on 21-AUG-2012. No adverse effect was reported. This is one of reports from the same source. Additional information has been requested.
~15 minutes after injection (while waiting in observation area)  patient witness another patient have slight nausea and mild light headedness (which quickly resolved). About 5 minutes after, the patient began feeling nauseated and light headed. I was called to check on here. She was pale and and leaning forward over trashcan. After about 2 minutes of questioning her and getting baseline vital signs, she started to slightly improve. We assisted moving her to an exam room. We had her lay near supine (as moving brought on new wave of nausea and lighteheadedness). She was closely montiroed. About 10 minutes later we began sitting her up, but after only a few symptoms began to return. Laid her back into supine. finally after anothr 30 minutes we were able to fully have her sit up and stand with no residual symptoms other than fatigue. Through out event normal VS HR, BP, O2 (other than slight tachypnea initially).  Normal physical exam (other early noted pallor and reticular rash on extremities, which all resolved). Advised patient that on next dose to ask to be given in a location where she can be laid supine and observed for at least 30 minutes after injection.
Approximately 5 minutes after vaccine administered, patient started to complain of nausea and lightheadedness. As patient was being led from the waiting area back to the exam room, patient lost consciousness. She was guided gently to the floor and did not sustain any fall-related injury. Loss of consciousness estimated to be less than 30 seconds. Patient's face covering was removed, and she was allowed to rest. Hydration and cold compresses were provided. Patient ultimately left the office ambulatory, stable, accompanied by her mother and father. Call was made to patient later that evening. She was resting comfortably without any further pre/syncopal symptoms.  Pre-vaccine BP 108/72 Post-syncopal BP 90/52
Pt completed series 3 vax; 4 months later titer was drawn and found to have an inadequate response.  Booster dose given & testing still showed inadequate response.
Headache for 1 day. lymph node swelling and injection site reacting. swelling, redness & pain from arm to underarm, Treatment: ICE, NSAID, warm packs
Patient reported to clinic that left arm injection site for PNEUMOVAX started to itch and get sore on June 15 after June 14 vaccines provided. Patient called triage when swelling was in deltoid area, proceeded to elbow area and into forearm and took 4 days to resolve the edema, itching.
Patient felt disoriented - sat down on floor floor for 10-15 minutes.  Was put into wheelchair ate apple & drank a pop felt better.  Went to private physician next day.  Blood drawn.  No other treatment needed.
9:24 am -Client felt a little lighthead, no SOB or difficulty breathing no dizziness not complaint of feeling that throat was closing, no N/V, no clamminess or diaphroesis observed P-68 P 20 9:27 am- no longer feeling lightheaded, no flushing, she reports no history of allergies or allergic reaction that require an epipen. She advised "it may be anxiety"p-68R-22 9:32 am-complained of they feeling had return she felt tingling in her neck and arm and feeling lightheaded lasting briefly less than 1 min P-80 R-22, no dizziness, no difficulty breathing, no feeling that her throat was closing, no N/V, or clamminess observed 9:54am EMT on site, responded no epipen needed, EMT took over. Client left POD at 9:54 no rescue
a side effect that lasted a few minutes in her mouth an hour later from her first dose of the COVID-19 vaccine on 29Dec2020.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a side effect that lasted a few minutes in her mouth, an hour later from her first dose of the COVID-19 vaccine on 29Dec2020. The outcome of the event was recovered on unspecified date.  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 respiratory therapist concerning a 58 year old female with drug reaction/allergy to flu vaccination, who on 23-July-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 658763/0990U). It was unknown if this was the patient's first vaccination with PNEUMOVAX 23 vaccine. There was no concomitant medication. The respiratory therapist reported that within 24 hours of the vaccination, approximately 24-Jul-2008 the patient developed an injection site reaction. The patient developed a fever of 102 degrees F, injection site pain with significant injection site swelling and redness. The patient was seen in the office and was treated with Prednisone (unspecified). The therapist reported that on an unspecified date, the patient's injection site reaction, fever of 102 degrees F, injection site pain, significant swelling and redness had resolved. Additional information has been requested.
Information has been received from a consumer concerning a 15 year old female patient who started therapy in August 2009 with the first dose of GARDASIL. The caller reported that her granddaughter received all three doses of GARDASIL and was fine after the first and second dose. She received the third dose two weeks ago (January 2009) (lot # not reported) and "yesterday" (approximately 08-Feb-2009) woke up with a headache, stomach ache and threw up. No diagnostic tests or laboratory work was performed. The outcome was not reported. A product quality complaint was not involved. No further information was provided.
pt recvd vax 13NOV c/o rt arm sore p/inj that day mom noted redness 14NOV;pt taken to ER dx cellulitis & ATB prescribed; t98.4; P1-4, RR24 in ER
hurt after she received; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 05Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden bleeding disorder" (unspecified if ongoing), notes: not on blood thinners or statins. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EW0150), administration date: 01Apr2021, when the patient was 61-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, single, Lot: EW0172), administration date: 23Apr2021, when the patient was 61-year-old, for COVID-19 immunisation, reaction(s): "hurt after she received".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "hurt after she received".  Additional information: It was reported that the vaccine was given in left shoulder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218053 Same patient/vaccine/event, different dose;US-PFIZER INC-202300218534 Same patient/vaccine/event, different dose;
Mom reported to -us on 6-30-09 that 24 hours after receiving vaccines pt had a fever of 104 for 48 hours.
This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 15-year-old patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced neuropathy. On an unknown date, the outcome of the neuropathy was unknown. It was unknown if the reporter considered the neuropathy to be related to FLUARIX TETRA. Additional details were provided as follows: The age at vaccination was not reported. The physician refused to provide further details.
Complaint of runny nose/congestion, loss of taste and smell, malaise and diarrhea.
Sinus congestion, sore throat, severe cough, exhaustion, bronchitis, chest congestion for 2 weeks
Pt recvd 3 Engerix-B doses given on 14JAN91, 14FEB91 & 6JUL91; following these, titer=9; Pt was given a 4th dose of vax 16AUG91;
she was administered the first dose of Shingrix back in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she was administered the first dose of Shingrix back in 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter called on behalf of herself to inform that she had not received the 2nd dose of Shingrix yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
patient received flucelvax and pneumovax administered in the Left deltoid) around 1-2 pm and started to develop swelling, redness and pain in the left arm  extending from underarm to the elbow. The swelling got bigger and redder overnight but started to resolve gradually the next day and following day. She walked into the pharmacy on 12/2/21 and expressed concern about the swelling which is still red and swollen but mildly. She was advised to consult with an MD due to symptoms looking similar to cellulitis. patient consulted with her PCP who diagnosed her with cellulitis and prescribed her Cephalexin and advised to use Ibuprofen and heat pads to resolve the swelling.
Information has been received from a healthcare work referring to a 51 year old female patient. No relevant medical history or concurrent conditions were reported. On 17-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
MOTHER STATES THAT PATIENT WAS COMPLAINING OF PAIN IN ARM EVENING OF VACCINATION. GAVE HIM MOTRIN AND ICE PACK. THE NEXT DAY SITE WAS RED/PURPLE IN COLOR AND WARM TO TOUCH. SHE CONSULTED FAMILY DOCTOR WHO RECOMMENDED THAT HE TAKE BENADRYL AND STATED TO MOTHER THAT CHILD HAD AN ALLERGIC REACTION. MOTHER STATED THAT BY SATURDAY CHILD WAS MUCH IMPROVED. NEVER HAD FEVER OR PROBLEMS BREATHING, JUST SITE REACTION ONLY.
high pitched crying, irritability, fever 103 poss higher;emesis & dec fluid intake;swelling & acute tenderness of inj site;nearly complete resolution by 2MAY96;
Raised red bumps (size of quarter) on back of forearms.  Only one or two bumps, very itchy.  Started on left arm, moved to right arm.  Small round raised bumps on lower, inside of left forearm (about 3-4.)  Then gastoinstestinal symptoms with diarrhea (second bout more severe.)  Subtle red coloration on trunk that when stroked with finders turned white.  Trunk itching, genitals itching.  Hot burning hands, feeling of unease.  The symptoms have lasted for days.  Injected on 2/5 still having symptoms on 2/23.  Taking Benadryl.
pt had a rash the same day, some itching, came into pharmacy 6/25 and has a large bruise on the inside of the left arm. not near inject site.
Two days after receiving the first Covid shot I awoke with complete numbness on the entire left side of my body. I received the shot in the left arm. As well, I was extremely dizzy and off balance. To this day, six weeks later my equilibrium remains off balance.
Localized L. Arm swelling and skin reddening (1" circumference around injection site), Warm-to-touch, Moderate Pain at injection site.
Pt recvd vax 27NOV91 @ 830 & @ 2400 27NOV did not feel well; felt nauseous; 28NOV aching all over, felt as if getting flu, very "fatigued", felt like had a temp, back itchy & red, light rash across chest;
Patient was admitted at Hospital from 2/11/2021 to 2/17/2021 after a fall with presyncope.  Patient sustained head trauma with scalp laceration and staple were placed.  Patient has longstanding history of atrial fibrillation and has been taking Eliquis.  He was initially seen in the office complaining of fatigue blaming it on the Eliquis that was started.  Patient had a Covid vaccination on 2/8/2011.  Patient denies any respiratory symptoms.  No cough no chills no fever.  Complain of exertional shortness of breath.  He was seen in the emergency room at and tested positive for COVID-19.
Patient received two doses of Abrysvo, one in each arm in error. Patient requested to still receive the Fluad vaccine after error occurred.
Information has been received from a consumer concerning a 28 year old daughter who 13 years ago (1993) was vaccinated with a dose of VARIVAX (Oka/Merck).  In 2008 a VARICELLA titer showed that her daughter did not have immunity to VARICELLA.  Patient was vaccinated with VARIVAX (Oka/Merck) 13 years before becoming pregnant.  As of 18-DEC-2008 the outcome of the patient was unknown.  Additional information has been requested.
Child in for immunizations.  Had 2 series of vaccines at health unit.  Computer not checked and immunization I not updated - 4th Pediarix given.  Child had been given vaccine 4-5-07.  Reported to doctor.
I have had a continuous ringing in my right ear since Sept 4th.    It could be described as tinnitus but I never had this before in my life and it came on shortly after the second vax.   I recently saw a report about others with this side effect so I am reporting it.    I was not sick and had nothing that would set this off other than the second vax.
foggy brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "foggy brain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
it made her extremely weak; sweated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 11:00 (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: HYPERHIDROSIS (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "sweated"; ASTHENIA (non-serious) with onset 07Apr2021, outcome "unknown", described as "it made her extremely weak".  Additional information: In the afternoon (06Apr2021), patient sweated which lasted through the night.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore injection site Chills Headache Fatigue Low Grade Fever 99.9F
AFTER I administered the SECOND Pfizer IMZ today, 8-7-21, I told the patient not to laminate his vaccine card in case we have to get booster shots. He then informed me that he received the J&J Covid shot in April. He said his dr told him to get the other COVID IMZs for more coverage. I informed him that the CDC is not recommending other shots at this time. He also stated the pharmacist who gave him his first Pfizer shot on 7-17-21 said to get the Pfizer IMZ. I spoke to the patient later, about 12:45 on 8-7-21 and he is doing fine after receiving the second Pfizer IMZ I administered today. I am filling out this form for the 2 Pfizer IMZs both from the same Pharmacy; on on 7-17-21 and the other on 8-7-21 since the patient already received the J&J IMZ in April 2021.
Case PHEH2016US024377 is an initial spontaneous report received from healthcare professional on 20 Sep 2016. This case refers to unknown demographics patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported, expiry date: not reported) at a dose of 0.5 ml single dose intramuscular on 20 Sep 2016. No adverse event was reported following this medication error.
Patient received the 1st dose of Pfizer (LOT# FJ6369) at 1204 in the right deltoid. At 1210, patient reported tightness in throat to RN 1. RN 1, RN 2, and RN 3 responded to patient. RN 3 notified Lead RN. RN 2 assessed patient: blood pressure 129/94 mmHg, pulse rate 91 beats/minute, and SpO2 97%. Patient denied itchiness, rashes, difficulty breathing, or difficulty swallowing. Lead RN offered patient intramuscular diphenhydramine. Patient agreed to take intramuscular diphenhydramine. At 1215, Lead RN administered intramuscular diphenhydramine in left deltoid. At 1220, RN 2 reassessed patient: blood pressure 125/86 mmHg, pulse rate 78 beats/minute, SpO2 96%. Patient stated she was "dizzy". Patient denied itchiness, rashes, difficulty breathing, or difficulty swallowing. RN 2, RN 3, and Lead RN assisted patient to anti-gravity chair. At 1226, Lead RN reassessed patient: blood pressure 145/92 mmHg, pulse rate 68 beats/minute, and SpO2 99%. Patient reported feeling nervous and decreased tightness in throat. Patient denied itchiness, rashes, difficulty breathing, or difficulty swallowing. Lead RN offered EMS. Patient declined EMS. At 1231, Lead RN reassessed patient: blood pressure 149/96 mmHg, pulse rate 67 beats/minute, and SpO2 99%. Patient reported decreased tightness in throat. Patient denied itchiness, rashes, difficulty breathing, or difficulty swallowing. At 1240, Lead RN reassessed patient: blood pressure 148/98 mmHg, pulse rate 63 beats/minute, and SpO2 98%. Patient stated she felt "okay". Lead RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on V-safe. Patient stated she was "okay" to drive herself home. At 1248, Lead RN assisted patient to stand. Patient immediately stated she wanted to "sit down" and felt "drowsy". Lead RN educated patient on side effects of diphenhydramine. Lead RN assisted patient into anti-gravity chair. At 1300, Lead RN reassessed patient. Patient denied feeling drowsy and throat tightness. Patient stated she felt "good" and felt "okay" to drive home. At 1301, patient left facility with unlabored respirations and steady gait.
pt recvd vax;presented to ofc at 3pm w/ inc t of 103, cyanosis, and shallow resp;
pt recv vax 12MAR98 & began 13MAR98 w/swollen, red, tender 3" diameter arm @ site of inj;
About 2-4 mins after injection my left hand and fingers were tingly which lasted a few minutes.  I also had tachycardia and dizziness which lasted about 1 minute.
Case number PHEH2014US012573 is an initial spontaneous report received from a nurse on 11 Jun 2014. This report refers to a 12 years old male child. He was given only MenA component of MENVEO (batch number: M13013 and expiry date: Sep 2014) reconstituted with sterile water instead of MenCYW-135 on 10 Jun 2014. No adverse event was reported following this administration error.
Around 3 became fatigued with headache; by 7 still fatigued with muscle aches; chills with normal temp at 9; temp up to 101.5 over night and gradually returned to normal by 7am next day.
Moderate soreness at injection site 10/20/2005, lasted 24 hours, nodule formation at injection site 10/20/2005, lasted 24 hours, itching at injection site 10/20/2005, lasted 12 hours numbness right deltoid to wrist 10/20/2005, lasted 24 hours.
Started with chills for about 1 hour then fever (about 100.4) and tired.   It was now in the middle of night when chills ended then I was very restless.  It lasted about 24 hours then I felt fine - no fever.
On 09/05/2003 received MMR/Varicella/HIB/Prevnar, called office 09/08/2003 to report on 09/06/2003, child awakened with hives on face,cheeks, skin, underarm across forehead began Benadryl stat prescribed every 6 hours for 3 days.
Pt recv vax on 3/31/99; on 4/2/99 pt exp erythema area of left arm; tx=Benadryl
pt c/o cold, weakness, sinus headache & nausea off & on for 2 months; MD state this condition was part of pts chronic bronchitis;
received the first dose of Shingrix on 10/10/2020/ not yet received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th October 2020 from batch number 5cb4k with expiry date 23rd August 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided as follows: The pharmacist was called to report the late second dose of shingrix. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. Health care provider declined to be contacted for follow-up. The reporter did not consented to follow-up.
I a flare carpal tunnel syndrome. Surgery on 04/27/2021 for carpal tunnel tendon release in both hands.
Patient was given MMR 05/09/14 and given varicella on 05/22/14. Per AAP, if live vaccines are given separately it is recommended they be given 4 weeks apart for best efficacy. The vaccines were given 13 days apart.