chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient felt "very hot at 10:05 became flushed,  skin was reddened  all over. waited 10-15 minutes improved went home and developed red blotches all over. took benadryl po at 1100 am at home and symptoms  resolved.  tc to client today 12/21/2020. he is fine at this point.
chest congestion Narrative:  Pt reported chest congestion a few days after his covid dose #2.
lt arm very red & swollen; c/o achiness; tx APAP & topical applications of DPH;
patient received first janssen vaccine. Right after administration, passed out on the floor and started to shake a bit.  Pharmacist ran to get some water for pt while patient's friend was trying to wake patient up. Patient regained recovery in a couple of seconds to a minute. He was made to sit and we gave him ice to put on the head. We also called 911 and the ambulance came and checked the pt. He reported that his vitals were okay and the Emt told him he was okay. Pharmacist counseled patient to follow up with  primary doctor and to also have head checked out since he fell on the floor, However Patient declined and stated he was okay.
Injection site arm pain, headache, grabbing low back pain first on 2/11, resolved on 2/13. Then repeated on 2/16 with injection site arm pain followed by back pain & headache. Arm pain gone on 2/18, but back pain and headache persisting.
Patient received only the liquid component; Patient received only the liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd June 2022, the patient received Menveo. On 2nd June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: Nurse reported that a patient received only the liquid component of Menveo. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
4/14/03, 7 day take check revealed major take and one satellite lesion below primary vaccination and three other pinpoint lesions-mild generalize vvaccinia. The three other pinpoint lesions are located on one superior to Rt antecubital and two are in vicinity of L antecubital. Pt reports itching above R eyelid and below R eyebrow. Has developed small pustule inferior to medial R eyebrow. No conjunctivitis, d/c, visual change, eye pains.
titer test shows the patient has titers for measles and rubella but not for mumps; got very ill; This spontaneous report was received from the patient's mother referring to a male patient of unknown age. Information on concomitant medication, pertinent medical history and drug reaction/allergies was not provided.      On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not reported)for prophylaxis. On an unknown date the patient got very ill after having measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). On an unknown date, an unknown titer test was performed and results showed the patient had titers for measles and rubella but not for mumps.  The outcome of the events was unknown. The causality assessment was not provided.
This nurse administered a Bivalent Pfizer vaccine that was 13 days past the use by date.
After shingle vaccine, 2 days later I felt painful rash underneath my both foot...painful blister..can't walk. I am unable to visit a doctor. I have no health insurance.
Information has been received from a certified medical assistant concerning a female patient (age not reported) who on an unspecified date was vaccinated with a dose of Pneumovax 23. Subsequently the patient developed cellulitis. The patient sought unspecified medical attention. It was unknown if the patient recovered. This is one of two reports from the same source. Additional information has been requested.
This medically-confirmed spontaneous report (initial receipt 11-Oct-2013) involves a female patient. On an unreported date, the patient received an influenza virus vaccine (batch and manufacturer not reported). On the same day the patient received GARDASIL. 24 hours after receiving the vaccines, the patient experienced elevated temperature, fever, flank pain and eyelid swelling (eyelids bilaterally swollen). The fever resolved within 72 hours, however the eyelid swelling was still present when patient was last reviewed, but there was no redness/itching. Laboratory work showed mono-like syndrome (EBV+), no proteinuria, renal function normal, elevated LFTs (liver function tests) and other lymphocytes. Outcome was not reported.
Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm.  Gradual development of SOB and cough. Temp of 101.4 at 10 pm.  pulse ox 92% at 10 pm.  Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113.  EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive.  Found to have no pulse, stopped breathing. CPR initiated at about 0140.  King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.
Sore arm, achy, initially. High fevers began every night approximately 3 weeks after the vaccine, accompanied by bad headaches. Provider would not see me as they suspected COVID. I had to test negative before they would see me.  White blood count was off the charts, so they suspected infection. Results pointed to Lupus. Adult onset of autoimmune disease. I was sent to a rheumatologist who ruled out Lupus. I was given Methotrexate and Hydroxychloroquine and I have just stopped taking Methotrexate.
PATIENT GIVEN COVID VACCINE 2 WEEKS PRIOR TO TURNING 65. PATIENT MADE AWARE, NO SIDE EFFECTS EXPERIENCED.
We were both sick the whole winter.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  This case was referred to patient's husband. The age at vaccination was not reported. The patient received flu shot and experienced sick (whole winter). This case had been linked to the case US2020AMR202139 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202139:Same reporter
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; burning eyes; dry mouth; Pink eye; This is a spontaneous report from a contactable consumer (Patient sister).  A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number was not reported) dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient after she got the second dose of the vaccine, she was tired she could not get out of bed, had fever, chills, headache and aches. She was long hauler who had COVID. Periodically she had a pink eye, burning eyes, joint pain or dry mouth. Her symptoms were on and off. Sometimes she feels very sick and other times she was okay. After receiving the vaccine, she felt like she had COVID like around three. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected. Information on lot/ batch number has been requested.
Awoke with searing pain in center of sternum. Minimal pain at rest cannot sneeze, breathe deeply, mop, vacuum without increased pain. Ibuprofen relieves 80% of pain. The pain is persisting 7 days post vaccine with minimal improvement.
Headache, Myalgia, Arthralgia, Diarrhea, Localized pain, numbness/tingling in legs, chills, fatigue, base of lungs feel like they're on fire Narrative:
Vaccine administered was outside of approved storage and handling Instructions. Pfizer manufacturer recommended revaccination because it does not have data to support vaccine stability.
bloody nose at least a couple times daily for a month, still have a bloody nose infrequently but had not had a history of a bloody nose prior to the vaccination; heart palpitations or heavy pumping of the heart especially when laying down; random sense of anxiety; diagnosed by a cardiologist as picking up an extra heart beat intermittently; sometimes fogginess or forgetfulness.
Patient has not yet received the second dose and has passed the recommended period; A Spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and has not yet received the second dose (inappropriate schedule of vaccine administered) and has passed the recommended period.  The patient's medical history was not provided. Concomitant medications reported was insulin for Diabetes type 1.5.   On 16 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date (reported as 42 days after the first dose), the patient had not yet received the second dose and has passed the recommended period.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event patient experienced has not yet received the second dose and has passed the recommended period was not reported.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration (delayed (missed) second dose administration for mRNA-1273), with no associated AEs
Information has been received from a RN concerning a 29 year old female who on 08/01/96 & 10/01/96 was vaccinated with the first and second doses of VARIVAX. In April 1997, a negative titer was drawn. The pt is currently doing well. Unspecified medical attention was sought. There was no product quality complaint.  The reporter also indicated that one other pt had a negative titer (WAES # 0402USA01574).  Additional information has been requested.
Symptom onset 8/19/22. Treatment includes potential Paxlovid and assessment during hospital stay.
Arm pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included covid-19 (recovered from Covid-19 (Corona) infection). Previously administered products included Pfizer Covid-19 vaccine (three total shots of the Pfizer Covid-19 vaccine (dates not provided)).   On an unknown date, the patient received Flu vaccine (unknown arm). On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced pain in arm (Verbatim: Arm pain). The outcome of the pain in arm was resolved (duration 1 day).   The reporter considered the pain in arm to be related to Flu vaccine.     The company considered the pain in arm to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023063076   Additional Information: GSK Receipt Date: 28-APR-2023 The patient self-reported this case. The patient reported that he experienced arm pain of the injected arm but he did not report it because the pain was gone in a day. It was similar to the pain level that he has felt after receiving [unspecified] flu shot. The reporter did consent to follow up. For tolerance to the Shingrix dose refer case US2023063076.; Sender's Comments:  US-GSK-US2023063076:Same reporter
listed in order of occurence: coughing vomiting pale cold to touch/shaking high fever (102.5) went to hospital emergency room at 7:00pm...admitted around 12:00am
Pt had redness, swelling, low grade 99.5 degree temperature and vomiting x 1, nausea. Swelling, redness to (R) upper deltoid area. Foster mother stated also her son had been ill with nausea and vomiting 2-3 days prior. Pt given steroid and antibiotic on 1-6-2012 advised client and was given by foster mother Ibuprofen on 1-5-2012.
3" raised, hot, itchy circle at injection site. Started 5 days after injection.
6 x 8 cm erythematous induraiton on left arm at shot site. Mild swelling. Full range of motion of extremity.
Pt. received Rabies vaccine on 1/15/2020 for pre-exposure.  She received one previous dose 10/04/2017 after which she had a near syncopal episode.  She decided at that time not to continue with the remaining 2 doses of the series.  In 2017, pt. was also receiving immunotherapy for allergy desensitization which she discontinued as well due to multiple near syncopal/ syncopal episodes.  She is currently studying veterinary medicine and decided she wanted to finish the pre-exposure series due to the risk she is exposed to.  Pt. sent the following message to our clinic  today: "From: Sent: 01/16/2020 11:28 AM To: TRAVEL NURSE **** Subject: Rabies vaccine reaction? Hi, I received the rabies vaccine yesterday afternoon (3:40pm) and felt fine all day afterwards. However, this morning about (6am) 5 minutes after getting out of bed I passed out 3-4 times and it took about 30 minutes after the last episode for me to be able to get up and move around without feeling faint. Most of today I have felt dizzy and I have periods where I begin to feel light headed again. I felt that I should let someone know about this possible reaction to the vaccine and I am debating about not finishing the series.  I am not really sure what to make of what happened this morning and would like to speak with someone today if possible. I will be available by phone after 3pm today.  Thanks,  "
Received vaccine at work around 10:30am on 1/19/21. Around 01:00am on 1/20/21 I woke up with my arm feeling as if it were on fire. My entire shoulder locked up and my ROM has been limited since receiving the vaccine. It continues to get worse as of 2/1/21.
Pain (soreness) inside left armpit since 4-5-21.  Pain (soreness) at injection site 3-30-21 to 4-2-21, 4-7-21.  No treatment yet.
Fever up to 103, still febrile 36 hours later (now at 100) tachycardia up to 130 bpm now at 90-100 bpm, severe systemic joint pain especially in hands and fingers, muscle pain, headache, weakness, chills
23APR91 fever, fretfulness, unconsolable, temp 104.4R;
Rash and intercostal right scratching of about 2 inches that has remained almost unchanged in the same area that I had shingles 2 years ago, I received the two doses of shingles vaccination.
SHORTLY AFTER RECEIVING VACCINES,  PATIENT BEGAN FEELING RINGING IN EARS,  DIZZINESS, AND PASSED OUT FOR A COUPLE OF SECONDS.   SHE WAS MONITORED AND GIVEN WATER WHILE  WAITING FOR EMS. EMS ARRIVED ON SCENE AND WALKED HER TO AMBULANCE. DAD CAME BACK TO PHARMACY ( APPROXIMATELY  1:35PM) AND STATED THAT SHE WAS  FEELING BETTER AND DID NOT NEED AMBULANCE TO TAKE PATIENT TO HOSPITAL. HE SAID IF SHE WORSENED, HE WOULD GET HER TO ER.
booster dose < 5 months after second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose < 5 months after second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21AB) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose < 5 months after second dose). On 24-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose < 5 months after second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was reported.  The nurse stated the patient was not immunocompromised.   This case was linked to MOD-2022-460376 (Patient Link).
Subsequently to vax, this 4-year-old experienced Haemophilus influenza type B infection. No further information  is available.
I didn't even feel like I got a shot; Maybe something was wrong with it; 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 (BNT162B2) (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. Vaccination history included: Flu shot (verbatim: I get a flu shot (Unspecified medication) I always have arm or muscle pain for a couple of days.), reaction(s): "arm or muscle pain". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't even feel like I got a shot; Maybe something was wrong with it".  Additional information: Consumer stated, "Patient had a concern that patient received the Pfizer vaccine and not had any side effect or even any arm pain at all, patient didn't even feel like got a shot whenever patient get a flu shot (Unspecified medication) patient always have arm or muscle pain for a couple of days. Patient just didn't had anything at all. Patient just wondering if patient should be concerned that maybe something was wrong with it (COVID 19 vaccine)."  No follow-up attempts are possible; information about lot/batch number cannot be obtained
My menstrual cycle following the vaccine (March) was late and I experienced much more severe painful symptoms along with it. I track my period regularly and start between day 28 and 30 every month. My period did not start until day 36 and cramping was severe. All of these symptoms were abnormal and I had no other unique changes to my diet, stress, environment, etc. within the month. The next menstrual cycle (April) was back on track with a 28 day cycle.
Administered four vaccines during immunization clinic visit. Within five minutes of injection, client became very pale, c/o of dizziness and lightheadedness, H/A and buzzing in ears.  Client did not lose consciousness or fall.  Client eased to floor, feet elevated, cool pack to back of neck and client given sucker.  CLient alert during entire process.  After 10-15 minutes client's status improved although she still had H/A and buzzing in ears, client changed to sitting position and then standing position over next 5 - 10 minutes and left office under the mother's care.  Client's gait steady and she ambulated without assistance.  Mother advised to have child eat once home and lay down.  Mother called approximately one hour after leaving office to report, client dizzy intermittently, had severe H/A and buzzing in ears.  Advised mom to notify MD of s/s.
This spontaneous report as received from a registered nurse refers to a 24 year old female patient without any pertinent medical history or drug reactions/allergies. On 17-JUL-2013 the patient was vaccinated with the first dose of 0.5 ml GARDASIL (Lot# not reported) intramuscularly. On 23-SEP-2013 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot # J002641, expired date: 10-DEC-2015) intramuscular. There were no concomitant medications. It was reported that the patient was seen in the office on 25-SEP-2013 and reported upper body aches and fatigue. No treatment given at this time. There was no lab diagnostics studies performed. The outcome of the events was not recovered. Additional information has been requested.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 10Apr2021 as dose 2, single (Lot number: Er8729), in left arm and on 11Nov2021 at 14:30 as dose 3 (booster), single (Lot number: Ff2593) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Have a susceptibility to chest infections if i get a cold" (unspecified if ongoing), notes: Used a rescue inhaler albuterol and alvesco when these episodes happen.; "Have a susceptibility to chest infections if i get a cold" (unspecified if ongoing), notes: Used a rescue inhaler albuterol and alvesco when these episodes happen. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) positive; (29May2022) negative; (08Jun2022) positive.  Clinical course: The patient did not take any other medication in 2 weeks. The patient had no allergies. Reported, 24 may tested positive, and took Pablo in. 29th negative and played sport. 06June chest started to tighten and didnt feel well. 08June tested positive again. Tight chest, headache, unable to lie down, very tired. Patient had Paxlovid from 25May2022 to 31May2022 for Treatment of COVID-19. Patient had treatment for adverse event (Antibiotics and over the counter relief).  No follow up attempts are possible. No further information is expected.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.