chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had syncope; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Patient had syncope) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Patient had syncope) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Patient had syncope) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had syncope that was momentary and came back, and vitals were ok. It was reported that EMS (emergency medical service) was called and everything was fine, and they transferred the patient.   No treatment medication was reported.  Company comment: This is a spontaneous case reported by a pharmacist regarding a patient of an unknown age and gender, with no reported medical history, who experienced unexpected and medically significant event of syncope after receiving mRNA-1273 vaccine (dose number unknown). Vaccination date and onset date of the event were not provided, latency cannot be assessed. Patient experienced syncope and came back to his senses and vitals were ok. It was reported that EMS (emergency medical service) was called and everything was fine, and they transferred the patient. It is unknown if patient was transferred to hospital or if any diagnostic tests/intervention/treatment was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-714400 (  Linked Report).; Sender's Comments:  MOD-2023-714400:Pfizer vaccine case
After receiving Flu vaccine injection on 10/14/10 notice periodic numbness to left arm/hand. Numb maybe brief up to 10 min/few times/hour.
Starting 12 hours after injection fatigue, overall body aches and headache. Starting 12 hours after injection red hot painful welt over the arm. Increased to 3inches by 4 inches after 48 hours. At 48 hours began to itch.
High fever for two days so far, reached was 102.7 on Tuesday 4/20 and 103.1 on Wednesday 4/21. Extreme fatigue, chills, unable to lift right arm above waist level due to extreme soreness. Heat rash over most of my body, probably from the fever.
"Pain, swelling, and redness at the site of the pneumonia shot and going down arm. He received pneumovax 1/11/05 ,developed the above has been going down but still there,he denies fever and chills. Hx pneumovax in the past with no side effects,denies itching at the site."  Previous is copied from physician note. Arm appeared swollen about half way from elbow to wrist, with erythema.
Conception following the advised three months waiting period for MMR vaccination resulted in miscarriage between wks 6-8.
I developed fever 102 comes down to 101, severe headache and today I began having dyskinesia for lack of better words, this has persisted for more than 3 hours.  Don?t know what to do or who to call. Message in to new doctor but haven?t seen him yet.
pt recv vax 22OCT96 720AM & exp itching & lt upper arm began 23OCT96 6PM-7PM;became red, warm to touch & induration was noticed on 24OCT96;itching cont on 25OCT96 erythema is 9.5cm diameter;felt flushed 24OCT96;
The next day I felt achy and tired as to be expected. But 48 hours after I started to have an intense splitting headache that ibuprofen would not touch and it has not gone away. It gets worse when I bend over at all
Patient came to get her booster and was given a regular COVID dose. What she needed was the booster dosage not a regular dosage but the new booster dosage.
This case was reported by a physician and described the occurrence of hepatitis B antigen positive in a 78-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline). Concurrent medical conditions included congestive heart failure, diabetes, hemodialysis and renal failure. Concurrent medications included DIGOXIN, Metoprolol, CARDIZEM, COUMADIN and LASIX. On 08 May 2008 and 9 April 2008 the subject received 2nd dose and 1st dose of Engerix B at 2 ml (40 mcg). Sometime in April 2008, the subject developed elevated alanine aminotransferase and elevated aspartate aminotransferase. On 08 May 2008, the subject alanine aminotransferase level was 891 and his aspartate aminotransferase level was 33. On 12 May 2008, 4 days after the 2nd vaccination with Engerix B, and an unspecified time after vaccination with Engerix B, the subject was tested and found to be hepatitis B antigen positive. The subject suffered a systemic reaction. Repeated tests showed that the subjects alanine aminotransferase and elevated aspartate aminotransferase levels were dropping (improving) with aspartate aminotransferase at 11 and alanine aminotransferase at 81. At the time of reporting the outcome of the positive hepatitis B antigen was unspecified. The physician considered the events were probably related to vaccination with ENGERIX B.
INCREDIBLY SEVERE, WORSE-THAN-NORMAL MIGRAINE, SEVERE CHILLS, 104 DEGREE FEVER FOR APPROX. FIVE DAYS
tinnitus and hearing loss. hearing loss. Treatment was high dose oral steroids for 2 weeks. Ringing in ears still persist today.
This spontaneous report was received from a 60 year old female patient regarding herself. The patient's concurrent condition included fibromyalgia and unspecified sensitive's and/or slight reactions to medication in general. On 13-DEC-2014, the patient was vaccinated with ZOSTAVAX in her right arm, (dose, route, lot number and expiration date were not reported. The patient's concomitant therapies included Vit D3 (unspecified); Vitamin B (unspecified) and Fish Oil. On the same date 15 to 30 minutes after vaccination with ZOSTAVAX, the patient "felt sick and needed to sit down" (malaise), and she experienced paraesthesia and paraesthesia oral described as "felt tingling on feet and lips" for 10 to 15 minutes. At the time of the report, the outcome of the "felt sick and needed to sit down" and "felt tingling on feet and lips" was reported as recovered on 13-DEC-2014, in addition the patient stated that she was able to walk around to resolved the feeling of sickness and tingling. No treatment was given for the events above described. The patient did not seek medical attention. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
I GOT HIVES AND HAD TERRIBLE ITCHING THAT LASTED 24 HOURS.   NORMALLY I WOULD NOT MENTION THIS.   BUT IM 70 YEARS OLD AND NEVER GOT HIVES OR ITCHING FROM HIVES SINCE IM BORN.   I HAVE NEVER BEEN ALERGIC TO ANYTHING IN MY LIFE TO MY KNOWLEDGE.  NEVER HAD A REACTION TO ANYTHING.    I WAS FINE 24 HOURS LATER.  MY WIFE GAVE ME BENEDRYL AND IT WORKED.  I WOULD NOT HAVE REPORTED IT HAD IT NOT BEEN SOMETHING BRAND NEW FOR A 70 YEAR OLD MAN.  QUITE UNUSUAL.  RED BUMPS AND BLOTCHES ALL OVER MY BODY.  NEVER HAPPENED BEFORE.
Woke up on  4/22 with red, itchy blisters on back of right hand , neck, face and left side of trunk. On 4/23, itchy bumps had spread to legs. Made appointment to see primary care doctor
red "zits" on arms and abdomen; itchy red pustules on back; red pustules on back; red pustules on back; pain at injection site for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2022, the patient received the 1st dose of Shingrix .5 ml. On 5th August 2022, 4 days after receiving Shingrix, the patient experienced pruritus, pustular rash and erythema. On an unknown date, the patient experienced injection site pain and pimples. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pruritus, pustular rash and erythema were not recovered/not resolved and the outcome of the pimples was unknown.   It was unknown if the reporter considered the injection site pain, pruritus, pustular rash, erythema and pimples to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR133730   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: The patient who also was a Registered Pharmacist (RPH) who had reported that he received his 1st dose of Shingrix in left arm. He reported that he had pain at injection site for 2 days. He also reported that on 5th August 2022, he had noticed some itchy red pustules on back. He then had noticed that he had red zits on the back of both arms and some on abdomen. He went to Primary Care Physician (PCP) then to 2 dermatologist, one who did a biopsy and gave him Valacyclovir x 7 days. He stated that this was still unresolved. The reporter was referred to a Healthcare Professional (HCP). The reporter consent to follow-up via mail. Additional supportive information: The time taken to onset for the event - pruritus, pustular rash and erythema was captured as 4 days. This case was linked with US2022132695 and US2022AMR133730 for same patient.; Sender's Comments:  US-GSK-US2022AMR133730:Same patient
Allergic reaction. Hives and itching around neck and chest and other spots on arm and leg. still remain 5 days later
Severe chest pain which caused me to grasp my chest and fall to the ground. I got into my knees and stayed down for approximately a minute, suspecting a heart attack. The pain resided and I was able to stand and continue my day. I have had repeated heart pains and fluttering sensations in my chest. Those continued for several months after the 2nd vaccine, but have since stopped as far as I can tell.
I'm think I'm having side effects from the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'm think I'm having side effects from the shot) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I'm think I'm having side effects from the shot). At the time of the report, VACCINATION COMPLICATION (I'm think I'm having side effects from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.
Pneumococcal Polysaccharide (Pneumovax) Given 02/19/08 L deltoid. Seen 02/26/08 with large red lesion at site. Seen In ER and diag: cellulitis and prescribed clindamycin.
Headache, Fever, NauseaVomiting, PAIN, HOT AT INJECTION SITE, CHILLS Narrative:
Acute Pancreatitis, diarrhea, nausea, vomiting, chills, headache, fever, chest pain, heartburn, fatigue, bowel incontinence. Started within 2 days of vaccine. Still currently under treatment.
She did not have any bad reactions to the previous COVID-19 vaccines other than soreness; 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.  An 82-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetanus toxoid, reaction(s): "Allergies", notes: she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "she did not have any bad reactions to the previous COVID-19 vaccines other than soreness"; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "she did not have any bad reactions to the previous COVID-19 vaccines other than soreness". The following information was reported: PAIN (non-serious), outcome "unknown", described as "She did not have any bad reactions to the previous COVID-19 vaccines other than soreness".  Additional information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to 12 years - 15/15 mcg per dos. 82-year-old female patient wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and how often elderly female patients experienced side effects. Caller mentioned that her doctor recommended her to get it. Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. Caller also wanted to confirm if the vaccine is still being studied and under emergency use. Caller wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and if it contained any tetanus toxoid or diphtheria toxoid. Pfizer's 4th vaccine shot, the COVID-19 vaccine, the latest vaccine for the Omicron. She wants to know what are the adverse effects. She's 82-year-old and is leery of taking this vaccine. She reacted before to Tetanus toxoid. There's other vaccines she cannot take because they contain the diphtheria toxoid. No other product names provided. She worked as a medical secretary. She has a hard time hearing. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300087801 same patient/event, different vaccine dose;
Large, red welt like rash all over child's body the next morning. Gave BENADRYL as directed by doctor and they went down and next morning child woke up with rash all over again and large welts in all different areas. Large red, bump at injection site.
Mistakenly administered the yesterday's vial to 1 patient for their 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Mistakenly administered the yesterday's vial to 1 patient for their 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Mistakenly administered the yesterday's vial to 1 patient for their 2nd dose). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Mistakenly administered the yesterday's vial to 1 patient for their 2nd dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
pt received J&J vaccine. Registrar talking to pt 3 min then pt stated "I feel warm dizzy like I'm going to pass out".  Pt became pale, diaphoretic, warm dizzy  - vaccinator put ice pack to back of neck and gave water to hydrate while sipping water pt drooled water out of mouth. pt was shaking and sliding down in chair, ammonia salts were used .  Medical evaluator called  - pt had vasovagal near syncopal episode.   Staff moved her to cot  no facial or tongue swelling noted. no LOC increased breathing VS 160/80, HR 88, resp 22 non labored.  Medical evaluator NP at side Ice pack to neck, arm pits between legs to cool down. Pt stated very anxious about getting vaccine. family present. Pt stated  this happened  in 2010 when she received an injection for TMJ. Provided reassurance to calm pt down.  EMS called -  FD responded  transferred care to EMS transported pt to hospital at approx  12:30 pm.  4/11/21 called husband to check on condition no answer no call back as yet
Case number PHEH2011US06145 is an initial spontaneous report received from a nurse on 06 Oct 2011. This case refers to a 58-year-old female patient. She was vaccinated with FLUVIRIN vaccine (batch number: 1102001) at a dose of 0.5ml intramuscularly on 30 Sep 2011. On 03 Oct 2011, she began to experience fatigue and difficulty in breathing. Subsequently, she was hospitalized. Final event outcome was not reported.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "NSCLC of lower lobe" (unspecified if ongoing), notes: NSCLC of lower lobe; "osteopenia" (unspecified if ongoing); "hypothyroidism post-operative" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM oral; PANTOPRAZOLE SODIUM oral. Past drug history included: Demerol, reaction(s): "demerol: Drug Allergy"; Tylenol, reaction(s): "tylenol: Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible
6 days later had acute gout episode Right 1st metatarsal bone. Relieved with Indomethicin. No previous episode of gout or family history.
PT was found on floor in dining room expired by wife on 6/20/21 at approximately 7:30.  Body was hard and cold.  Called EMS immediately , EMS provided treatment.  Declared dead.  Body taken to coroner for autopsy.
expired vaccine to 5 patients; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 22nd May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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-JUN-2022 Reporter's Comment: The pharmacist reported a clinic inadvertently administered expired Shingrix vaccine to a patient. Health care professional (HCP) had no information at time of chat for lot or patient details but said she could get it and might follow up via email or telephone. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient inadvertently received expired Shingrix vaccine, which led to expired vaccine used. This is 1 of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100398:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100400:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100403:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100404:Same case/same reporter
pt recvd vax;pt MS signs & sxs worsened p/ vax; 1 wk later exp mild inability to ambulate; sxs peaked around 19jun95 & have slowly improved;series of vax discontinued
Flu like symptoms with fever, myalgia, fatigue and elevated heart rate, that continues to be present even now. Gradually developed severe symptoms of POTS. Severely decreased cardiac endurance and exercise tolerance. Shortness of breath after short walk or climbing a set of stairs with rapid heart rate response.
Injection site swollen to elbow, redness, warm to the touch and hardened tissue under skin.
hands got yellow; strong color and even the fingers are yellow now; feeling down; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of YELLOW SKIN (hands got yellow), YELLOW SKIN (strong color and even the fingers are yellow now), VACCINATION COMPLICATION (feeling down) and VACCINATION SITE PAIN (vaccination site pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4046b21A) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), MULTI VITAMIN & MINERAL and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced YELLOW SKIN (hands got yellow), YELLOW SKIN (strong color and even the fingers are yellow now), VACCINATION COMPLICATION (feeling down) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, YELLOW SKIN (hands got yellow), YELLOW SKIN (strong color and even the fingers are yellow now), VACCINATION COMPLICATION (feeling down) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Pt states  her throat and eyes feel itchy, Pt taken to traige 1.  126/81 HR 108,  02 97% RA. 3:30 pt developed blanching rash on chest and left side of neck going under chin.  Pt refused Benadryl stating it makes her tired and she has an hour drive home.  She received in ER when allergy to unknown antibiotic and went to sleep.    pt accepted Zyrtec  15:55:  pt states she feels better.  Agrees to go to ED if worsens.  understands to not take 2nd dose of Pfizer until discussed with PCP.
1130- complained of itchy throat and dry mouth. Stated that this was what she had reaction in the past. Benadryl given, continued to monitor. No progression of symptoms
Chills, fever (100.5), headache, muscle and joint aches - resolved in  48 hours  Pain at injection site - resolved in 72 hours
blood pressure became elevated about 1 1/2 weeks after the first shot.  Tightness in my chest occurred - heart side.  Squeezing in my chest occurred - heart side.  Soreness across my chest occurred.  Pain slightly under my left arm pit.
Very rapid heart rate.  Normal resting rate is 70 bpm.  The morning after Moderna booster my resting rate was as high as 122 bpm.  My blood pressure was not affected.  Two days after the vaccine, my pulse rate returned to normal and has remained normal.
15JUN97 pox appeared 13JUN97 fever up to 100.3, tired, h/a, backache-cough & cold x 1wk;exposed 14 days ago via cousins;confirmed by MD 16JUN97;by 19JUN97 approx 70pox by 23JUN97 all but one are crusted over now;
Redness, swelling, warmth of entire arm: shoulder to elbow local reaction is cellulitis -> SEPTRA DS bid x 10d -> resolved.
Following shots-pt became tachypneic. At office RR-60's with tachycardia 150's-170's. Peds cardiology saw-sinus tachycardia. NL Echo CXR-mild vascular congestion CBC 16.7 with 2% bands.