chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DID NOT TAKE THIRD DOSE ON TIME; This spontaneous case (PVX2019-977) was received from a pharmacist on 23-Apr-2019. It describes an adult female consumer who "did not take third dose on time", while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif on 18-Apr-2019 and 20-Apr-2019, respectively. Then, she left Vivotif unrefrigerated and threw out the remaining two doses. Thus she missed the third dose which was due on 22-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "did not take third dose on time" was unknown.  Company's Comment: The causality of the event "did not take third dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take third dose on time" was considered as not applicable.
Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale and stayed that way 5-10 min. Mom stated baby was sleepy for 3D and did not eat well. This incident was not documented in chart and nurse had no recollection of being notified no phone calls were received following. Mom refused vaccines at todays visit.
Diarrhea and loss of appetite began eight hours after polio immunization and continued for 36 hours after immunization.  Patient vomited 48 hours after immunization.
Tiredness and Fatigue; Headache; This is a spontaneous report received from a contactable reporterThe reporter is the patient.  A female patient 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: FATIGUE (non-serious), outcome "unknown", described as "Tiredness and Fatigue"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache".  Additional information: The patient was not related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had short of breath for couple of days. on one occasion i wake up as I was feeling that I couldn't  breath in my sleep. was horrible experience
On day 8 after first dose, I noticed a red, slightly raised and blanched, circular, mildly itchy rash that grew outward from vaccine site over about 7 more days before it began to fade.
pt recvd 2 doses of Engerix-B & p/1st dose had tender arm, p/2nd dose @ inject site had 1 cm hot erythema, induration & tender spot;
Upper left arm soreness around site of injection was distinct and noticeable after I woke up on 3/21;  Soreness lasted all day but was gone upon waking on 3/22
Pt awoke @ approx 930PM on 1APR92 w/high pitched cry which lasted approx 1 1/2 hrs continuous; t97.8 ax; pt lt upper leg was very edematous, red, & hot to touch; mom gave APAP; mom called MD- pt slept restlessly but was back to nl 3rd day
9/28/06 temperature 105 left thigh erythematous edematous MOTRIN every 6-8 hours, BENADRYL every 6 hours, ice comfort given measured region of reaction to flu next day at office or sooner concerns/questions. 9/29/06 afebrile improvement less edema less erythema.
I started with body aches and chills on December 11th, 2-3 months after my vaccine. My heart rhythm was off beat, it felt like it was skipping beats. I felt dizzy and nausea and then it went away after a few hours. It came back on Tuesday and lasted a few hours, stronger this time. I felt fatigued for the entire week. I did not have shortness of breath though.
eight days after 1st injection, my left arm swelled and a large itchy red rash appeared.  Also noticed under left arm swelling of lymph node-which was not there before the injection.
Did not feel well; Achy; Frequent bowel movements; Unable to keep food down; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), PAIN (Achy), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), VOMITING (Unable to keep food down) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 03-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Did not feel well), PAIN (Achy), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), VOMITING (Unable to keep food down) and PYREXIA (Fever). At the time of the report, MALAISE (Did not feel well) and FREQUENT BOWEL MOVEMENTS (Frequent bowel movements) outcome was unknown and PAIN (Achy), VOMITING (Unable to keep food down) and PYREXIA (Fever) had resolved.            It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No concomitant product reported by reporter.  The reporter's causality for the events of Did not feel well and Frequent bowel movements with Adalimumab Solution for Injection was not provided and for events of Achy, Fever and Unable to keep food down was no reasonable possibility.  No treatment medication reported by reporter.
Site reaction. Arm was hard and swollen and red for about 2 weeks. Said it hurt to lay on that arm.
Information has been received from a license practical nurse concerning an 66-year-old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P).  On approximately 27-SEP-2005 the patient experienced swelling, tenderness, and redness at the injection site.  The patient was treated warm compress and antihistamines.  The symptoms resolved.  The outcome was reported as recovered.  No further information was available.  There was no product quality complaint.  Additional information has been requested.
Every time I get a shot I get sick within a week; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient with unknown demography who got sick within a week (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick within a week (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patients received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Information has been received from a consumer concerning a 15 month old male who on 3/4/98 was vaccinated with MMR II. On 3/9/98, the pt developed diarrhea. The pt was treated with Diflucan. The dx was chronic mucous candidiasis. The pt also "stopped talking for months" after receiving MMR II. The pt's mother reports no prior history before this episode. The pt was treated with Zantac that started on 11/00, Zyrtec that started on 12/00 and Diflucan. Treatment with these therapies continue. Upon internal review, the pt's experiences were considered to be an "Other Medical Event". The pt subsequently, experienced product misuse following vaccination with varicella virus vaccine live (MSD WAES01011264). The consumer reported another child who had an experience following vaccination with MMR II (WAES01011080). Additional information has been requested.
Reddish Injection Site after booster shot; Swollen Injection Site after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Reddish Injection Site after booster shot) and VACCINATION SITE SWELLING (Swollen Injection Site after booster shot) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 030L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Reddish Injection Site after booster shot) and VACCINATION SITE SWELLING (Swollen Injection Site after booster shot). At the time of the report, VACCINATION SITE ERYTHEMA (Reddish Injection Site after booster shot) and VACCINATION SITE SWELLING (Swollen Injection Site after booster shot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
When I first got my shot I had a wave of heat go through me and then my throat and moth went dry. I waited my 15 minutes and get fine. 40 minutes after my shot I developed swollen face, lip, tongue and throat numbness and get like I couldn?t breathe. Then I went to ED. They gave me Benadryl and steroid and eventually sent home. Today 04/10/21 I woke up. Took my Benadryl and prednisone and about and hour after that my face has been extremely red, numb, and burning. It?s been 9 hours and I?m still having these symptoms. Called ED they said to stop the prednisone and only take Benadryl but my face is still really hot, red and burning.
First Dose: felt tired a lot; First Dose: didn't feel right and didn't feel well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (002591). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER6207) at the age of 48 years for covid-19 immunisation. The patient's family history included: "Crohn's Disease with Hereditary Alpha Tryptasemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "recovering", described as "First Dose: didn't feel right and didn't feel well"; FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "First Dose: felt tired a lot".  Additional information: The report related was to a study or programme. HCP Type was reported as Gastric disease doctor. Reporter stated after his First Dose of the Pfizer Covid 19 Vaccine he felt tired a lot and he cried to his mom and partner at the time that he didn't feel right and he didn't feel good. The patient had no additional Vaccines administered on Same Date of the Pfizer Suspect. Reporter stated right after getting the vaccine on Thurs or Friday, that weekend he felt really bad then he was fine, not as bad, and then he knew something was wrong because he was really tired. Reporter stated it was mid-day when he got them both and the side effects started at night and were there when he woke up the next morning, tired. Reporter stated his appetite changed almost immediately. The patient had no prior Vaccinations within 4 weeks.The patient had no AE(s) following prior vaccinations. Reporter stated his sister had some of the symptoms and she was starting to see a doctor for it. No relevant tests were performed. Reporter was unsure of exact dates.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200804232 Same pt/drug, diff event sep in time;
Tachycardia started after 12 minutes, observed for 45 minutes. Symptom resolved over this period of time
she did not pay much attention; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (she did not pay much attention) and FATIGUE (Really tired) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002331) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (she did not pay much attention) and FATIGUE (Really tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DISTURBANCE IN ATTENTION (she did not pay much attention) and FATIGUE (Really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2022-443324, MOD-2022-443290 (Patient Link).
My son was sore for the remainder of the day after receiving his 2 shots on 6/12/09. He refused to allow me to look, and thinking he was only sore (and maybe a bit of broken pride) didn't fight to look. The following morning while dressing him, I noticed that he had developed hives on the arm around the shot and down to his elbow. While my reported time will be that morning, I suspect it was the evening before, if only I had gotten to see it.
Received the vaccine at 10:52am, and was observed for 15 minutes in the clinic.  After leaving the clinic, she noted slight shortness of breath on her way to her car a few blocks away.  While in the car on the way home around 11:57am, she developed severe headache, nausea, chest pain, chest tightness and shortness of breath.  Chest tightness is "terrible."  History of asthma but has no recent exacerbation in last 3 years.  Referred to urgent care at Cancer Center, which has emergency room capabilities.
Information has been received from a medical assistant professional referring to a currently approximately 18 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 19-FEB-2013, the patient was vaccinated with the first unspecified dose of GARDASIL (route, lot# and expiration date unknown), at age 12 years, for prophylaxis. On 08-APR-2019, the patient was in the office to receive the second dose in the HPV vaccination series, GARDASIL 9 (route, lot# and expiration date unknown)(interchange of vaccine products and inappropriate schedule of product administration). No adverse effects were reported.
coughing with white crystals; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "coughing with white crystals".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200028309 Same reporter/ drug, different patients/ events;US-PFIZER INC-202200998496 Same reporter/ drug, different patients/ events;
Menstrual cramping for three days, followed by spotting, then bleeding.  Postmenopausal for six years, since age 51.
extreme chills; hot flashes intermittently; has not yet gotten her second vaccine; minor flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, chills, hot flashes and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, chills and hot flashes were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills and hot flashes to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced minor flu like symptoms for about 3 days. The following 4-10 days post vaccine, she had extreme chills and hot flashes intermittently. All of her symptoms had resolved. The patient was unsure if she made a visit to the hospital during the time she was experiencing the chills and hot flashes.  Till the time of reporting the patient did not receive 2nd dose of Shingrix because was wary of the side effects, which led to incomplete course of vaccination. Spoke per content and referred to HCP(health care professional). The reporter consented to follow-up.
pt recvd vax & head tilted back, eyes rolled to back of head, assisted to lay on floor; pt rigid, arms & legs tremored; duration approx 1 min; instructed to lay back down; laid down for 5 mins w/cold pack to head due to h/a;
"approx 12-14 hours post 2nd injection developed severe body aches/pain, fever, and chills.  About 24 hours post injection developed left axilla pain and swelling (same side as injection)
mom reports t104, red eyes, watery eyes, congestion, & rash all over x 3 days, starting 7 days post vax had roseola immed prior to vax;
CP received with sl NTG. Required admit r/o MI. NI cardiolyte study. All one hr post vaccine. Back to nl by next am. Discharge summary states chest pain. msv
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old patient (gender not reported), who was inadvertently vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6310NA and expiry date: 30-Jul-2019) via intramuscular route in the left thigh on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given. It was a case of actual medication error due to overdose because the patient was inadvertently vaccinated with 0.5mL dose instead of the 0.25mL. No AE symptoms reported since injection. 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 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. Documents held by sender: none.
Per grandmother the patient presented pain to touch, red and warm to touch in the right arm after the KINRIX vaccine was administered.
Temp pre vaccine (97.5) within minutes of receiving vaccine injection student became hot feeling, sweaty, and pale - helped her to the floor and put her head towards her lap felt slight nausea. Last ate 6 hours prior to vaccine dose. Gave OJ. BP 96/60 HR 80 RR 20 at 11:50 after resting moved via w/c to cot and felt better. BP 94/60 11:58 at 1215 92/60-72-20 feels fine ate a bagel & went home with her mother. Mother was advised to notify the student's PCP.
This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0162) via an unspecified route of administration in the left arm on 27Apr2021 at 15:45 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19. The patient previously received sulfur (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced allergy. The concomitant medication was taken by the patient (unspecified) within two weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 15:45 the patient experienced nausea, tiredness, headache, muscle pain, joint pain, fever and feeling unwell. The clinical outcome of the events nausea, tiredness, headache, muscle pain, joint pain, fever and feeling unwell was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Was admitted to hospital.  A 17-year-old, male, who has been in good health. Apparently, the patient had a physical a week ago and 4 days ago had his meningococcal vaccine. He seemed to do fine that day, but 24 hours later he began to talk in a bizarre fashion and to act inappropriately. Apparently, he was evaluated and found to have left maxillary sinusitis and was treated with amoxicillin. The patient took 2 doses, but became worse. No rash was noted, but the mother did notice him to "blink his eyes a lot." The patient denies photophobia. There was no significant fever. No seizure activity has been noted. The patient presented to hospital last night and a lumbar puncture was done, which was totally normal. He has had an MRI of the head today which shows left maxillary sinusitis, but no other abnormality. At this point, he is complaining of some headache. He still talks in a bizarre fashion and inappropriately at times. This is some blinking eye movements, but the patient denies photophobia. He has been afebrile so far, and vital signs have been stable.
This spontaneous report as received from a medical assistant refers to a 68 year old male patient with history of an unspecified reaction to unspecified "statins". On 18-MAR-2014 the patient was vaccinated with PNEUMOVAX23 lot # J009689, expiration date: 29-JAN-2014; dose 0.5 ml, intramuscular. No concomitant medications were reported. The patient called the medical assistant's facility on 31-MAR-2014 and stated that he experienced dizziness and vomiting on an unspecified date after 18-MAR-2014. Patient sought medical attention at un unspecified emergency room on an unspecified date. It was unspecified by medical assistant whether patient was hospitalized. The outcome of events is unknown. The relatedness between PNEUMOVAX23 and events was not reported. Additional information has been requested.
Headache, Myalgia, NauseaVomiting, chills , fatigue Narrative:  Other Relevant History:
BLOOD OOZING OUT OF INSULIN PUMP; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced blood oozing out of insulin pump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood oozing out of insulin pump was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious