chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. tried to leave ~ 15 min after pt.?s vaccination and stated that she was light headed (she had not eaten or drank water that day).  We proceeded to provide water and power-aid to her.  Shortly after this she developed altered mental status and did not respond to verbal or physical stimulus  while sitting up against her husband and helping to support her own neck/head.  Pt did respond to sternal rub by opening her eyes and said, ?that hurt?.  Shortly after pt. opened her eyes she closed them again and began having bilateral upper extremity tonic-clonic like movements.  During this time, pt. had some seemingly purposeful movements such as trying to reach for her husband.  The event lasted ~10-15 seconds after which she stopped the movements and was laid down on the couch.  Due to seizure like activity local EMS was called and responded.  EMS took over patient?s care where there was normal BGT and blood pressure obtained both laying and standing.  Patient was able to be discharged home with husband per EMS.
I began having a metallic taste in my mouth; This is a spontaneous case from a contactable consumer. This 74-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3248) via an unspecified route of administration from 21Jan2021 at 02:15 pm to 21Jan2021 at 02:15 pm at single dose (dose number; 1) on left arm, second dose from 11Feb2021 at 02:15 pm to 11Feb2021 at 02:15 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported as hospital. Patient was 74 years old and not pregnant at the time of vaccination. Patient's medical history included high blood pressure, macular degeneration (dates unspecified), known allergies; no. Patient's concomitant medications included lisinopril, fish oil, ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS 2 vitamin) (dates, dosage regimen and indication unspecified).If other vaccine in four weeks; no. Patient reported that on 22Jan2021 at 07: 00 am 'I began having a metallic taste in my mouth after my first dose of the Covid vaccine. The taste has continued for 3weeks.''. Treatment for adverse event was reported as no. If covid was present prior vaccination was reported as unknown. If Covid was tested post vaccination was reported as no. The outcome of events was not recovered.
Starting date above, two days after flu vaccine, I have been chronically affected by rhinorrhea, fatigue, sore throat and cough.  These are unusual symptoms for myself and if coincidental, unusually prolonged.  I have never had the flu vaccine in the past and never suffered from the flu since age 20.  I did have a rxn to thiomerosol in an eye drop preparation over 30 years ago. Please let me know what you suspect as an explanation?  I'm very doubtful this is coincidence.
Walked on 10.25.23 as normally does in home, to vehicle, in/out of pharmacy for 3 vaccines.  The next morning, unable to walk and hasn't walked since.  Very Weak, decreased appetite.
My tongue, way at the back behind my teeth, hurt like I had bitten it very hard with my teeth. It was too far back for this to have happened however. This started about 12 hours after having the shot, and lasted for about 40 hours.
Rcvd Varivax on 5/29/09.  Reports she  developed generalized papulovesicular rash on 6/17/09 @ 1600.  On 6/19/09 States 10 "bumps on face, 2 on neck, 1 on each wrist, and on shoulder". Denies fever, redness or drainage from lesions.  States most are "bumps", some are drying, and a couple are like "pimples".  States some tiredness over the past week.   On 6/22/09 dry, scabbed lesions: 1 Left foot 4-5 web space, 1 post. neck, 4 rt flank, 1 ant. neck, 1 rt upper thigh, 1 rt lower leg.  One 3mm vessicle left side under bra. 6/24/09 One vessicle noted rt post knee, she states noticed on 6/22/09.  All other lesions dry and crusted.  6/25/09 All lesions dry
This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported from on Dec 27, 2007. Male patient, 22 years of age, was vaccinated with FLUMIST on Dec 27, 2007. "pt had no previous history of influenza vaccine. He stated that he never received flu shot before ever." Immediate oral swelling, sneezing, unlabored respiration, alert and oriented x 3. Seen in ER and was discharged with prednisone, CLARITIN and BENADRYL." None. None. Patient recovered."
Course redness in the feet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Course redness in the feet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced ERYTHEMA (Course redness in the feet). At the time of the report, ERYTHEMA (Course redness in the feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
rash all over her upper body(shoulders, chest, neck and arms); Hives; itchy and the itching is unbearable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy and the itching is unbearable), RASH (rash all over her upper body(shoulders, chest, neck and arms)) and URTICARIA (Hives) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (itchy and the itching is unbearable). On 18-Mar-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced RASH (rash all over her upper body(shoulders, chest, neck and arms)). The patient was treated with CORTISONE (topical) ongoing since an unknown date for Rash and Itch, at a dose of UNK dosage form; PEPPERMINT OIL [MENTHA X PIPERITA OIL] (topical) ongoing since an unknown date for Rash and Itch, at a dose of UNK dosage form and HYDROCORTISONE ACETATE, NEOMYCIN SULFATE (HYDROCORTISONE N) at an unspecified dose and frequency. On 23-Feb-2021, PRURITUS (itchy and the itching is unbearable) had resolved. On 19-Mar-2021, URTICARIA (Hives) had resolved. At the time of the report, RASH (rash all over her upper body(shoulders, chest, neck and arms)) had resolved.            No concomitant medications were provided. The patient provided pictures of a rash which has spread over her upper body, on her shoulders, chest, neck and arms. At the time of the report, products used as treatment for the events had not provided relief of her symptoms.   This case was linked to MOD-2021-027896 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Initial additional information received on 23 Mar 2021 contains non-significant information. On 21-May-2021: Initial additional information received on 21 May 2021 contains information regarding second dose events pics and had no previous history like this. On 31-May-2021: Initial additional information received on 31 May 2021 contains  non-significant information. On 24-Jul-2021: Significant Follow-up received event and event outcome was updated
17JAN96 115PM when mom went to change diaper found pt rt leg hot, swollen & red;also screamed a while;mom took pt to MD who gave DPH;
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dead; couldn't walk; Decompensated; WBC count plummeted; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date patient received 1st dose of Shingrix). Concurrent medical conditions included chronic lymphocytic leukemia (had low grade chronic lymphocytic leukemia for 12 to 15 years).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Dead) (serious criteria death and GSK medically significant), unable to walk (Verbatim: couldn't walk), general physical health deterioration (Verbatim: Decompensated) and white blood cell count decreased (Verbatim: WBC count plummeted). The outcome of the unable to walk, general physical health deterioration and white blood cell count decreased were not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death, unable to walk, general physical health deterioration and white blood cell count decreased to be related to Shingrix.     It was unknown if the company considered the unknown cause of death, unable to walk, general physical health deterioration and white blood cell count decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUL-2023 The patient was around 90 years old.  The patient was not being treated for chronic lymphocytic leukemia.  It was watch and wait at that point for his chronic lymphocytic leukemia.  The patient wanted to get Shingrix. His doctor (reporter) said no, doctor did not thought patient should get it but the patient wanted it as he was afraid that getting shingles would kill him. The patient insisted and took both doses within the scheduled period. Immediately patient white blood cell counts plummeted, he could not walk, patient decompensated and was dead within a week.  The reporter estimated that this happened 2 to 4 years ago from reporting date. The reporter consented to follow up.; Reported Cause(s) of Death: Unknown cause of death
Pt advised received first Covid Vaccine on Friday (Moderna) and began having shortness of breath, dry non-productive cough, BLE edema 3 days ago. He does admit to increased salt intake over the past week as well.    He presented to ER in April with CHF/COPD exacerbation with TTE showing EF 30 to 35%, moderate MR with posterior jet impingement on wall, mild TR, bicuspid aortic valve, mild pulmonary hypertension.  He underwent IV diuresis and steroids.  He initially thought the level of shortness of breath he was experiencing was caused by his first Moderna COVID-19 vaccine because it became acutely worse after receiving the vaccine.  He saw his outpatient cardiologist who ordered stress test which showed severe lateral wall and inferior wall ischemia, infarction in circumflex territory, EF 38%.  He was then referred for left heart catheterization with diagonal 1 90%, LAD 75%, circumflex 100%, RCA 60%, PDA 75 to 80%, PLB 100%, DFR of the LAD 0.80 then 0.66 which is significant, EF 30 to 35%, mild MR.  Since his hospitalization, he admits to shortness of breath while working in his yard but states that his shortness of breath improved.  He underwent PFTs which showed FEV1/FVC 77, FEV1 3.11, FVC is 4.03, DLCO 49.5.  Other past medical history of diabetes (A1c 9.2), hypertension, spinal stenosis.  He is a former cigarette smoker with 35-pack-year history.  Family history of father with heart disease.
starting 01:51 pt was dizzy/nauseous and  back on bench at 45 degree angle then put in Trendelenburg and vitals were taken/epi given. pt was transported to ER at 01:54.
Ten minutes after receiving Pfizer Covid vaccine shot in right shoulder, experienced partial numbing of the hands which persisted all day. Next day no numbing of left hand, but right hand still partially numb.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL0142), in right arm, on 27Jan2021 as dose 2, single (Lot number: EL9265), in right arm and on 14Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient experienced recurrent COVID symptoms and positive test after Paxlovid. Anti viral products included COVID 19 Treatment (brand: Pfizer) from 22Jun2022 to 27Jun2022. Patient had no known allergies.
Got the flu shot friday am in my left upper arm. By sunday pm my left hand was very red and itchy and my fingers were swollen. Monday am, I woke up with hives in the area of my right rib cage.  I've never experienced hives before. The swelling, itching and hives went away after taking benadryl for two days. I've gotten the season flu shot for many years and have never had a reaction before. None.
She complained of coughing and shortness of breath.  She thought it was due to mask she was wearing but it continued.  She went home.   She continued to cough so she brought a pulse ox.  Her oxygen sat was 93%.  She started having chest tightness.  She called our office on Sun night 8/22 and then called on Monday 8/23.  Due to symptoms it was suggested she seek medical attention.  She went to hospital and they told her they coughing was due to a reaction.  They referred to cardiologist.  She was told by cardiologist it was related to vaccine reaction.
Arm got red, swollen, itch, warm to touch from shoulder down to elbow.  Symptoms have improved but still has big red blotch Patient took tylenol for symptoms
Information has been received from a physician concerning a 76 year old female with a history of breast cancer who on 06-FEB-2008 was vaccinated with a single dose of Zostavax (Oka/Merck).  In February 2008, after vaccination the patient had an outbreak of chickenpox.  It was reported that the patient never had chickenpox in the past.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. Follow-up information has been received from the physician concerning a white retired female who was vaccinated in the left deltoid with an intramuscular second dose of zoster vaccine live(Oka/Merck) (lot# 659326/1924U).  There was no illness at the time of vaccination.  On 06-Feb-2008 the patient developed skin lesions diffusely consistent with chicken pox which required an emergency room/doctor's visit.  There were no diagnostic or laboratory tests performed.  Follow-up information received indicated that on 18-Feb-2008 the patient recovered from the chickenpox.  Additional information is not expected.
dizziness and imbalance, ongoing for more than 5 weeks, severity ranges from moderate to mild, no treatment available
first dose on Feb 8th 2019 and she never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th February 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 case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  The reporter was looking for information about timing on Shingrix schedule. No data available about lot number and expiration date at the time of reporting. The reporter consented to follow up.
Fever lasting 4 days between 100.4 and 101.0 on third day a rash started on the forehead and then spread down the neck and onto her abdomen and back. Rash lasted 5 days.
Pain of right side of belly button; soreness. Hernia surgery in 2022. Inflammation of elilim. 2022 August soreness began to spread up to rib cage. Since December 2022 began to spread to left side of belly button.
pt recv vax; approx 3-5 days later, pt's arm became very red, swollen & warm covering large area around site;lasted 1 wk;
Pt received three Vaccines. Hep B, HPV, and Tdap. These were given at approx. 3:30PM. She became lighted and diaphoretic. Placed on exam table, Bp was taken at 3:33 102/68, pulse 96. Continued to monitor. Unable to tolerate sitting position. Layed her back down Bp@ 3:50PM was 94/78, Pulse 98. ER called @ 4:00PM. Arrived in ER @4:00PM. Per Patient request Mother notified.
A non-serious spontaneous report of 52 year old got a dose of H1N1 LAIV was received from a consumer/non health professional concerning a 52-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-Dec-2009, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
General unwell feeling; fever of 102 F; Body chills; Headache; Tired; 1 mL for dose 1 and dose 2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 21-May-2021, the patient experienced MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache), FATIGUE (Tired) and ACCIDENTAL OVERDOSE (1 mL for dose 1 and dose 2). On 21-May-2021, ACCIDENTAL OVERDOSE (1 mL for dose 1 and dose 2) had resolved. On 22-May-2021, MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Body temperature: 102 (High) 102 F.         No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-403390 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up information included no new information
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hemochromatosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that treatment of COVID 19 with Paxlovid start date was 03Apr2023 and stop date was 08Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 18AUG95 & devel chicken pox on 7MAR97;
Pt recv vax on 5/6/98; post vax pt exp fever (105F)
High fever of 102.7 F for 6 hours, hard chills for 6 hours, Body aches, headache. No treatment
Began to have buzzing and ringing in right ear.  Few days later saw Dr. who said it was probably a viral infection in ear.  Wants to rule out relation to flu shot. Saw ENT, MRI done.  Now wears hearing aid.  Was given PO Steroids with no improvement.
Arthritis flare while on Humira: fatigue, swollen red knees. Improved with decreased activity, but not yet resolved almost two months later.
Patient said that his arm was normal sore on Saturday but then got better on Sunday. On Monday he says he started having severe, debilitating left arm pain that made him unable to move his arm. This has persisted until today (Thursday).
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 07-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Client has hx of passing out after shots. Hep A was given. She became pale. Give her smelling salts. Put a call wash rag on neck. Mother kept "you're OK patient you're OK". She then hunched forward. We leaned her back. Eyes rolling in the back of her head. Snored once. Put wet wash rag on head, face, neck and she woke right up.
Red, raised, warm pear-shaped area 3x5" noted 1/4/2021 @ 8:00 PM.I had used Benadryl 25mg night before for sneezing d/t putting Christmas stuff into attic. On Jan 4th, I used a cold compress and used Benadryl 50mg.  I notified my Dr's office and pharmacy.