chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 82 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sept-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Open, weeping leg ulcers one month after getting the booster vaccine. Use of antibiotics for infections. Wound dressings applied along with wearing  compression stockings. Wounds are ongoing.
Was notified by ER that he was flown there via helicopter today after being unresponsive at home where first responders started CPR. Was responsive when arrived at ER but was having spells of apnea. Patient was intubated and admitted to critical care.
Pt was given an immunization of ZOSTAVAX, at 4:30 pm on 2/2/15. Pt reported feeling dizziness/nausea, patient put head down and took deep breaths, dizziness/nausea subsides after approx 15 min. Pt given some water and orange juice (pt. request).
Red, hard, raised, hot, painful swelling at injection site. Circumference size of a golf ball. Raised swelling of about 1/4 inch depth. Started evening of vaccine and only slightly better (as fear as color and heat) 48 hours later. Stiffness and pain in arm. 48 hours after vaccine, diarrhea onset.
Rash at injection site; 2 days after: sore throat; Eye pain in one eye that lasted for a half hour; 3 bloody nose events; This is a spontaneous report from a contactable consumer (patient and patients mother). A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0180), dose 2 via intramuscular, administered in Left upper arm on 03Jun2021 15:00 (age at vaccination 13-year-old) as dose 2, single for covid-19 immunisation. The patient had no other medical history and no concomitant medications. The patient had no known allergies. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0183), dose 1 via intramuscular, administered in Biceps/ Upper arm Left on 13May2021 17:30 (age at vaccination 13-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Jun2021 17:45 the patient experienced eye pain in one eye that lasted for a half hour, 3 bloody nose events within 4 hrs after vaccine, on 05Jun2021 (2 days after) the patient had sore throat. On 06Jun2021 the patient experienced Rash at injection site (covid arm). 3 bloody nose events within 4 hrs after vaccine required visit to consultation with primary care doctor. The patient did not receive any treatment for the events. Seriousness of the event was reported as non-serious. No relevant tests were done. The outcome of the events eye pain in one eye that lasted for a half hour, 3 bloody nose events, Rash at injection site was recovered on unspecified date in 2021 and sore throat was recovering.  Follow-up attempts are completed. No further information is expected.
Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 43-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th March 2020).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist not administering vaccines at this time due to COVID-19. The reporter asked how long can a patient wait for second dose. The reporter did not consent to follow up.
Within office visit felt like he was going to pass out when came to stand, drank some water and continued to feel light headed before leaving office, Chilled during that night did not feel well tired and fatigued, He felt like he was going to pass out in the shower that night. Called the dr that night and todl them something was wrong. Arms ached for a week could feel injection site as tender.  A headache that came and went over 2 week and had low grade fever 99-100 until Sept fever increased to 103.4 with urgent care visit. skin conditions occured of Kelartosis Pilaris at in jection sites. and eczema  on anterior neck with molluscum contaglosum diagnosis and removal of lesions.
21JAN98 pt reported rxn to pneumonia vax;rt arm got very sore, not able to raise arm, inc TEMp, chills, last noc-lasted about 4-5hr;pt fine this morning;
Patient wants her 2nd dose, states she had her 1st dose in 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 11st May 2018 the patient received 1st dose of Shingrix. batch no9V, expiry date 25th April 2019).   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 Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The registered pharmacist stated that a patient wanted her second dose of Shingrix and received her first dose in 2018.  The reporter gave consent to follow up. Additional supportive Information: Till the time of reporting, the patient did not want to receive 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Case number PHEH2013US026416 is an initial spontaneous report received from a pharmacist on 20 DEC 2013. This report refers to a 56-year-old male patient. His medical history and concomitant medications were not reported. On 20 DEC 2013, he was vaccinated with FLUVIRIN 2013/2014 (batch number: 13375) intramuscularly in the right arm. On the same date, fifteen minutes after vaccination, he developed blurriness in his right eye. The final outcome was reported as condition unchanged. The seriousness and causality of the event were not assessed.
No additional AE reported; HBP reporting a patient was inadvertently administered a dose of MMR II after the labeled expiration date.; This spontaneous report has been received from a office manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 02-AUG-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (recombinant human albumin (rHA) 0.5 milliliters (ml) as prophylaxis (lot number: T013727, which was determined to be valid, with an expiration date on 21-APR-2022) (scheme, route and anatomical location of administration was not reported) (Expired product administered). Caller confirmed the vaccine had no temperature excursions. No additional adverse event was reported.
pt recvd vax & w/in 24 hrs, pt devel redness, induration, swelling, & warmth @ the site of inj;
received her 1st COVID vaccine shot 22Dec2020, however she got diagnosed with COVID; received her 1st COVID vaccine shot 22Dec2020, however she got diagnosed with COVID / pneumonia; rash; This is a spontaneous report from a contactable consumer (patient).  This 77-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. After the first dose, the patient got diagnosed with COVID. She does not want to waste a second dose if it will not be useful. Everyone on her department has had COVID, and have been told to wait 3 months before getting their second dose. Caller had a 'rash' after her 1st dose of the COVID vaccine. The patient is now recuperating from the pneumonia. Outcome of pneumonia was recovering while outcome of the other events was unknown. Information on the Lot/Batch Number has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 18-JUL-2017 the patient was vaccinated with an improperly stored dose of M-M-R II (lot number M010426 expiration date: 01-MAR-2018, lot number: M032157 expiration date: 01-JUL-2018, lot number: M039913 expiration date: 26-SEP-2018) for prophylaxis (digital data logger). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects reported.; Sender's Comments:  US-009507513-1708USA002800:
Rash and swelling at site of injection. Rash and itchy primarily on face and a bit of rash on other area of body.
pt recv dtap on 5/10/1999 symptoms  presented with swelling, redness & itching
I felt no major discomfort immediately after my first Covid-19 Vaccine injection. I did notice some soreness in left arm about a month after first shot but decided to get the second shot in same arm anyway. I had little arm pain and no other side effects following this second shot.  After about another month I began noticing increasing pain upon certain movements like reaching behind my back while dressing.  This pain increased quite slowly and I finally saw the doctor in mid July. He recommended a Physical Therapy evaluation. The PT diagnosed left shoulder impingement syndrome which he thought was likely related to the vaccine injection in January.  This would have been a reaction to the injection itself, not a reaction to the vaccine. I have completed a course of 12 PT sessions with some pain relief and some increased range of motion.  I still have quite a bit of pain upon certain movements and often am unable to sleep through the night due to pain in my left arm.  I will begin a second course of PT next week.
Called hospital call center.  Pt reports left side of cheek  feels some slight swelling. At this time, pt denies taking any medications for said swelling, nor having done any interventions at the moment other than calling.Pt in no apparent distress, A/O x4,Pt was advised to go to nearest ED, informed if worsening symptoms to call 911. Pt will drive self to hospital. Pt verbalized understanding.
Boy got wrong dose of Fluzone pediatric vaccine instead of Fluzone 6-35 month lot # UT3478CA he got Fluzone 3yr.> Lot # UT3251AA. The package for 3 yrs.and older was found on top of the 6-35 month old vaccine and given by mistake.
I'm feeling really exhausted all of the sudden; experience a fever up to 101.9; he experienced soreness in his arm; This is a spontaneous report received from a contactable consumer (parent). An 18-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8737) via unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 21Mar2021 for COVID-19 immunization. On 11Apr2021, the patient experienced soreness in his arm (last night) and at 20:30 the patient felt really exhausted all of the sudden and experienced a fever up to 101.9. The patient wanted to know whether fevers go that high after getting the vaccine. The outcome of the events was unknown.  Additional information has been requested.
Experienced left arm soreness and swelling; Experienced left arm soreness and swelling/Left deltoid arm it is really sore; Lymph node swelling; Soreness at injection site/Left deltoid arm it is really sore; swelling in the arm where she got vaccinated; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program . A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left deltoid arm on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient experienced left arm soreness and swelling, left deltoid arm it was really sore, lymph node swelling, swelling in the arm where she got vaccinated, soreness at injection site, all on apr2021 with outcome of unknown. Clinical course: The patient received the first dose of the Pfizer COVID vaccine in her eft deltoid arm and experienced left arm soreness and swelling more so yesterday than the first day and she also had some swelling under her left armpit. That is her non-dominant arm and it was really sore. The patient had read a lot of side effects too and they also told her at the testing site at the hospital and they noticed like yesterday, it was under her arm, like in her arm pit she felt swelling. Soreness at injection site and armpit was swollen wanted to know if this was a normal side effect and how long it would last. She was reading the factsheet and it stated could have swollen lymph nodes.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 03-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 02-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    Concomitant medication was not provided.  Reported that on 03-Jun-2023 patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of Blue cap vial (25 mcg), when blue cap was indicated. Patient was given with appropriate vaccine or scheduled as per CDC. No adverse effect was noted.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:
arm swollen-elbow to shoulder first notice 6APR95 PM 530 feels tight warm, red white(ish) purple area where shot was given (size larger than fifty cents piece);
Nursing was called to the lobby. Patient had been seen by a provider for a well-child visit and received three vaccines. Mother reports that while waiting for the elevator after the visit patient was nauseous. Patient and mother went to the restroom instead of getting on the elevator. Nurses found patient kneeling in front of a toilet. She appeared pale and shaky. Nursing took her back to a patient exam room by wheelchair and observed her, checked her vitals which were all within normal limits, gave her juice and graham crackers. Patient had not eaten breakfast this morning and was anxious for her vaccines today.   Provider and team manager evaluated the patient. Patient's vitals remained within normal limits and she was dismissed home with mother.
I went on a cruise from May 7-15, 2022. During the cruise even though there were sign to mask up, no one including myself wore a mask.  I later learned from a social media page of other cruise passengers that 14 cabins were in quarantine during the cruise, but the Captain did not inform any us about this.  I feel if he had, many people including myself would have worn mask and I and my friends might not of gotten Covid.  Starting on the last morning of the cruise I woke up with a headache and sore throat, by noon I was coughing and congested in my lungs and nose. By bedtime I was very tired.  On Tuesday, I did a video conference with a doctor at my clinic and was prescribed Paxlovid after he saw my positive test result that I did on Monday, May 16, 2022.  I only took one dose because it had a very bad metallic taste for several hours and made me gag.  I am now in my 5th day and feeling less tired, my lungs have clear out and I have less of a cough.  I expect to be back to normal in the next few days. Very glad I received the original vaccine on January 28, 2021 and all three booster on 2/19/21, 8/21/21 and 4/14/22.
45 year old employee received the incorrect influenza type, she received Fluad, the high dose flu vaccine for people 65 and above.
profoundly challenging; debilitating; 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. The following information was reported: AGGRESSION (non-serious), outcome "not recovered", described as "profoundly challenging"; FATIGUE (non-serious), outcome "not recovered", described as "debilitating".  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101599532 Different patients, Same reporter, vaccine, event.
Shingles- rash to abdomen began tuesday evening- went to urgent care wednesday morning and started 7 day course of antiviral (3 times a day). Postponed second shot- currently awaiting scheduler to return call to set up second vaccine
I awoke around 1 am  and I was freezing, and I had muscle ache and joint pain all over my body. Went into closet and found heaviest blanket I had and put over me. Was same when I woke in morining and took my temp, it was 101.2. I called pharmacy that gave me shot and they said to take aleve and I did. Fell asleep and was ok when I woke up about 2-3 hours later.
FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA057309 (CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error, latency: Unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Night of vaccine profuse sweating with no fever Next morning severe confusion trying to go to work through mailboxes were deer slamming on breaks thinking they would run out in front.  Tiredness, EXCESSIVE CRYING FOR NO REASON
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chills, Felt like having an out of body experience like in a fog. Narrative:
I already had some cervical pain before the vaccine. But maybe a day or 2 after the vaccine, I had left sided pain, left back pain, left shoulder all down my left arm into middle left finger-down the nerve line, like a pinch nerve, very aggravating. I am still experiencing the symptoms but its not as intense. I've been experiencing extreme nerve pain.
Extreme fatigue, muscle pain. Started about 12 hours after vaccine and lasted a full 24 hours
Patient's left arm is very hot to the touch, red and swollen with induration measuring 11 cm laterally across and 7 cm distally down her arm.