chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mother called after 4 th days , mother who is nurse said injection was given lower than muscle and thinks that pharmacist give injection lower and may be it was subcutaneous and not intra muscularand her daugher has redness and swelling around the inection site.
at 2:55pm pt. c/o dizziness and lightheadedness.  pt assisted to gurney and placed in supine position with BLE elevated. pt offered fluids vs monitored vitals t-97.7 BP: 93/68 RR-17 o2 SAT 99%RA. pt reported hx of dizziness with needlestick.  vitals- BP: 90/68 P-73 RR-19 o2 SAT 99%RA  patient verbalized relief from symptoms noted with no dizziness an light headedness as reported by pt. zero change LOC Zero SOB alert and verbally responsive.
Patient after receiving Flublok and Adacel, fainted...appeared to have a vagal reaction after around 5 minutes.  EMT's were called came and monitored patient until he had a stable blood pressure and released him under his wife's care who was with him.
I waited my 15 minutes becaues I had never had a reaction before. One my way ( about 20-25 min after) I had difficulty swallowing. I had to pull over on the side of the road to make sure I was ok.  I was able to drink water and continue talking.  My symptoms went away a little while after taking Benadryl
large rash under her breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received pf-06928316 (ABRYSVO), on 21Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "large rash under her breast". The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
COVID Infection; COVID Infection; Additional information: Report about covid vaccine: Yes Reporting type: AE Patient name: Patient name withheld Dob: DOB withheld Age group: Elderly (65+ Years) Gender: Male Race: Race withheld Ethnicity: Ethnicity withheld reporter occupation: None of the above  dose received: 3 most recent dose details: [{product=COVID 19, brand=Pfizer, brand unknown=False, lot number=FF8831, lot unknown=False, administrator route=Intramuscular, administration date=20Oct2021, dose number=3}]  previous dose details:  [{prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EN6208, prev dose lot unknown=False, prev dose administrator route=Intramuscular, prev dose administration date=19Mar2021, prev dose dose number=2}, {prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EN6200, prev dose lot unknown=False, prev dose administrator route=Intra muscular, prev dose administration date=26Feb2021, prev dose dose number=1}]  facility type vaccine: Doctor's office/urgent care  if other vaccine in fourweeks: No  adverse event: COVID Infection adverse event start date: 13May2022  ae resulted in: [None of the above] if patient recovered: Recovered  if treatment ae: Yes ae treatment: Over the counter medicine if covid prior vaccination: No if covid tested post vaccination: Yes covid test post vaccination: [{covid test type post vaccination=Nasal Swab, covid test name post vaccination=Rapid Test Binax, covid test date=16May2022, covid test result=Positive}]
My daughter received her vaccine at 2:45 on Monday 6/21.  She woke up at 1:45 am on Tuesday 6/22 with chest pains and difficulty catching her breath.  We called 911 and she continued to have those symptoms for another 20 minutes.  She no longer needed oxygen after that and her symptoms started to subside.  The hospital ran tests and concluded the symptoms were related to the vaccination since they did not discover anything wrong with her heart or lungs.  Bloodwork only showed low potassium.  Patient had a fever and still does which we are treating with Tylenol.
8/28/21 pt brought to ED with increasing SOB over past 4 days; pt states 4 dy ago she had a positive COVID test at a local pharmacy; sx have worsened since; O2 saturation 76% on RA; O2 supplementation - BiPAP; had a positive COVID test; CXR showed cardiomegaly, multifocal pneumonia, bilateral pleural effusion; given remdesivir, steroids, ABX, bronchodilators; dc'd ABX and given Baricitinib; pt had HTN and panic attacks; pt's condition worsened; desaturation into 70s% on BiPAP; continued to worsened; hospice called in and pt passed away in the hospital
Patient broke out in rash on neck/ears, elbows, and cheeks. No swelling of throat, no fever. Patient was monitored for 15 mins. The rash (redness) went away, no side effects patient stated she felt good. No shortness of breath or difficulty breathing, vitals stable. skin color back to normal.
Breakthrough case of covid on 4/8/2022. Patient hospitalized at Hospital for 3 days and transferred to Hospital for higher level of care. Patient with Left diabetic foot infection post amputation, CHF, CKD stage 4, PVD and coronary artery disease status post CABG; needs further vascular workup.
Site: Pain at Injection Site-Medium, Additional Details: patient complained of arm pain in the site of injection and it has been over a month now. Patient states he went to physician and physician state it may be nerve pain from the shot.
postherpetic neuralgia; cardiovascular event; balance problems; serious neurological problems; herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and as routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered herpes zoster, postherpetic neuralgia, cardiovascular event, balance problems, and other serious neurological problems. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, postherpetic neuralgia, cardiovascular event (cardiovascular disorder), balance problems (balance disorder), and other serious neurological problems (nervous system disorder) were considered as disabling events by the reporter.
Headache, Myalgia, Fever, Chills, fatigue Narrative:  Other Relevant History:
At time of vaccination ~5 minutes after the injection of the pfizer vaccine I developed a tightness in my throat, I was still waiting in line and I did not think much of it, therefore I did not alert the medical personnel about the reaction. Approximately @15mins after the injection I left the site and developed a sense of something wrong and did not feel "right", my chest became tight, hoarseness in my throat and speach, lightheaded, and I remember taking a sip of my coffee thinking it was more difficult to swallow than usual. May I note I was in the passenger seat and not driving the vehicle. I alerted my mother of the reaction, both sceptical because of my hx of no known allergies. We both figured as long as I can breath and I was still conscious, with no signs of cyanosis I would be fine. At around 10:45 I took my BP: which was 106/62 I typically run low. I then took two 25mg Benadryl capsules which did help the throat tightness to an extent, however the tightness in the chest, lightheaded and dizziness still persisted. I was aware of the potential for Bi-phasic anaphylaxis so we had an Epi-pen on stand by just in case. I was stable for the rest of the day. At approximately 10pm I did notice a small erythematous non-pruritic rash across my chest. The symptoms of the reaction did subside within 24hrs. I remained in stable condition and recovered with time.
Patient's husband states that she has broken out in hives. Her eyes are swollen. The hives has pus coming from the bumps, and they are itching. Also, she is having difficulty breathing.
Four patients received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 28th April 2022, the patient received Engerix B. On 28th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: The medical assistant reported that the patient received an expired dose of Engerix-B vaccine. The consent to follow-up was given. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used. This case was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071926:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072337:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072338:Same reporter.
at inject site pt devel erythema 70mmx70mm, arm sore, arm warm to touch & tender
Arm started getting sore on Saturday, by Saturday so sore could not lay on that side, Sunday woke up and was extremely tire, started running a low grade fever( did not have a thermometer) by Sunday night I was was running higher temp it seemed and then in the middle of the night I statrted sweating. Woke up on Monday feeling much better, still tiered than usual  . How ever no temp and injection site is not as sore,
11/8 diagnosed Paralysis of Right side of face - Bell's Palsy, dx prednisone and acyclovir 800mg. Acupuncture.
Increased ringing in both ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162B2 OMI BA.4-5, on 14Nov2022 at 13:15 as dose 4 (booster), single (Lot number: GH9697) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "Ringing in ears" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; NOVOLOG; IRBESARTAN; ZOLOFT; LAMTRACET. Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 15Nov2022, outcome "not recovered", described as "Increased ringing in both ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had no known allergies. Prior vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient had not tested COVID. The patient did not receive other vaccine in four weeks.
Pt recvd vax on 8OCT92 & 24 to 48 hrs later exp severe h/a & flu-like sx in neck & shoulders;
Initial Dose 01/21/21 - arm was sored and slight fatigue for 2 /3 days.  Then 14 days after injection on 2/4/21, developed rash on left arm.  It is hot , slightly swollen and tender to the touch.  On 2/5, rash remains and artificial left shoulder is painful.
Pt received first dose of Pfizer COVID 19 vaccine on 3/22/21 per records. He scheduled and received a first dose of Moderna COVID 19 vaccine on 4/15/21 On consent and medical screening, he states that he did not receive a prior COVID 19 vaccine, but when interviewed today after he already received the Moderna vaccine, he stated that he wanted to change to Moderna but did get the Pfizer vaccine prior. He denies any side effects or symptoms currently.
prolonged achiness in muscle, erythema 1cm X 3cm at injection site, extreme itchiness and warmth at injection site
Pt. noticed no swelling and itching in back of left arm at location of varicella inject. Symptoms first noted morning after inject - red, puffy, warm, itchy, size of palm of her hand. Advised BENADRYL topical anti-itch lotion or hydrocortisone.
Tingly all over body.; Muscle aches; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included muscular dystrophy. The patient had allergies to mangoes. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 14:00, the patient experienced tingly all over the body, muscle aches and arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of adverse events. The clinical outcome of the events was not recovered at the time of this report.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Breakthrough case admission after 2 vaccines ; Moderna 1/19/21 Lot# 037K20A;  Moderna 2/16/21 Lot# 027L20A
Patient given monovalent booster and needed bivalent booster. Patient to be called back to come in after 2 months to get bivalent booster.
fully vaccinated and diagnosed with COVID and symptomatic; fully vaccinated and diagnosed with COVID and symptomatic; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date as single dose, second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was fully vaccinated and diagnosed with COVID and symptomatic. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Large rash with raised edge, expanding, itchy, 14 weeks pregnant at time of vaccination.
Dry eyes; Wound infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4433870-00 (Agency).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Non-Tobacco User" (unspecified if ongoing); "Abstains from Alcohol" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: CEPHALEXIN AMEL; CLONAZEPAM; LITHIUM CARBONATE; METFORMIN; METHOTREXATE; PRAMIPEXOLE; VALTREX S. The following information was reported: DRY EYE (medically significant), outcome "unknown", described as "Dry eyes"; WOUND INFECTION (medically significant), outcome "not recovered".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Diffuse urticaria on abdomen, upper legs and axilla; This is a spontaneous report from a contactable physician. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Apr2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, COVID-19 and history of urticaria but no clear causes were identified. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), vitamin D (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. On an unknown date in Apr2021, the patient experienced diffuse urticaria on abdomen, upper legs and axilla. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with prednisone. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diffuse urticaria on abdomen, upper legs and axilla were recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX in the left arm. The patient developed soreness at the injection site which lasted for about day and half. The patient did not consent to follow-up. No further details were provided. This case was linked with US2019011816, reported by the same reporter.
Patient has been suffering from temporary memory loss since the vaccines were given. She is having a hard time remembering if she's done things and can't recall names of common objects. She also experienced an increase in blood pressure. BP went up to 165/105 for about 36 hours after receiving.
Stuffy nose; Runny nose; Cough; Sore throat; Swelling at injection site; Redness at injection site; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Tenderness and swelling of lymph nodes; Pain; Tenderness and swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose) and COUGH (Cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes). On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes) outcome was unknown and NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
patient who received 1st dose of shingrix more than a year ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received more than a year ago).   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: patient who received 1st dose of shingrix more than a year ago).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 23-AUG-2023 The pharmacist had a immunocompetent patient and would like to know if the series need to be restarted. No details of patient or vaccine available            The reporter consented to follow up.    Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.