chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jan 21 , headaches, scratchy  throat, bodyaches, weakness  Jan 22- current - weakness, balance issue, tachycardia,dizziness, shortness of breath
The pt experienced hives, vomiting, face redness, left leg swollen and red. Symptoms appeared 15 minutes post vax. No treatment given.
Patient showed local inflammation at site of Anthrax vaccine associated redness, swelling, induration, tenderness extending concentrically around site from just below shoulder to elbow postercally. Dx: local reaction vs cellulitis.
Axillary lymphadenopathy on same side as the injection. Recommended warm compresses. Follow up in 2 days.
Patient felt "flush" sensation immediately after vaccination. Flush lasted "30 seconds" and went away. Five minutes later, patient reported "fast heart rate for 30 seconds" and went away. He stated the fast heart rate was likely from being more aware of his body. He was monitored for 15 minutes and reported feeling well. No other symptoms.
1 of 3 pt's who experienced an inject site rxn which included swelling 2' in diameter, induration 1-2 in diameter, redness & hot to touch; Tx included heat @ inject site & advil or APAP for pain; Pt is currently asymptomatic;
Facial shingles dk: 9/18/08 by Dr. Varicella vaccine 5/23/06
Initial unsolicited report received from a non-healthcare professional on 21 December 2015. This case involves a 69-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI513AA, expiration date: 12 June 2016, dose, dose number, route were not reported) site of administration was reported as "left" on 18 December 2015. The patient's medical history was none reported. Concomitant medicaltion was not reported. On 19 December 2015 (the next morning), one day following the vaccination, the patient experienced redness of 3x2 inches and swelling noted to injection site. The patient denies warmth, stated it was tender to the touch and slightly itchy. Laboratory investigation and correctieve treatment were not reported. The outcome of the event was reported as unknown. List of the document held by sender: none.
2 hrs p/vax given pt devel fever 104.2 ? of sz activity also; No fussiness; Mom notifies clinic @ 6mo PE, did contact private MD @ time;
Information has been received from a registered nurse concerning a 10 year old female who on approximately 06-AUG-2008 was by vaccinated with the first dose of GARDASIL. Concomitant therapy included "other vaccines" (therapy unspecified). On approximately 06-AUG-2008, the patient fainted and her blood pressure drop after vaccination with GARDASIL and other vaccines gave at the same time. The patient sought medical attention. On an unspecified date the patient recovered. This is one of two reports from the same source. Additional information has been requested. The doctor going to call and ambulance for one the girls (unspecified).
Patient tested positive for Covid-19 3 days after receiving first dose of Pfizer-BioNTech vaccine. She is pregnant. Her husband tested positive for Covid-19 about 2 weeks prior to her.
Patient received Janssen COVID-19 vaccine on 3/11/2021 and was subsequently admitted and diagnosed with COVID-19 at our hospital on 11/23/2021
After second vaccination, I experienced severe body aches, including a debilitating  headache; 101 temperature with resulting hallucinations;  diarrhea and extreme shivers.  In short, this was so bad, I think I would rather have the Covid instead.
My nose is very stuff; Upper respiratory problems; Tinnitus/Tinnitus is very aggravating; General malaise worst after the 2nd dose; Mendnebular nose; Runny nose; I am very scared; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose) and NASAL DISCOMFORT (Mendnebular nose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised, Blood pressure management and Diabetes. Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure management, INSULIN DEGLUDEC (TRESIBA) for Diabetes, ADALIMUMAB (HUMIRA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LORAZEPAM (ATIVAN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared) had resolved.            Concomitant medication were reported. Treatment medication were reported. The patient had upper respiratory problems. The patient was immunocompromised and was very scared. The patient nose was very stuff, Tinnitus was very aggravated. Went away finally and came back immediately after 3rd dose.   This case was linked to MOD-2021-324159 (Patient Link).
Site of injection very red, hot & tender to touch; raised, itchy hives around patient's midsection (abdomen and middle back).
Patient was administered vaccine that was stored in freezer for 19 days prior to moving into the refrigerator.
Herpes Zoster; has a hiatus hernia and mentioned that her condition is becoming severe; has a hiatus hernia and mentioned that her condition is becoming severe; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization. Medical history included ongoing hiatal hernia on her stomach from an unknown date. The patient's concomitant medications were not reported.  The patient has a hiatus hernia and mentioned that her condition is becoming severe on Feb2021, after receiving her first shot. She may undergo a surgery to remove the hiatal hernia on her stomach but at the moment she is not sure. It was also reported that the patient developed a Herpes Zoster infection on 23Feb2021. The patient stated that she got infected with herpes on her legs from her sister and asked if there are recommendations/information for this scenario. The outcome of the event has a hiatus hernia and mentioned that her condition is becoming severe was not recovered while the outcome of the event  Herpes Zoster as unknown.   Information on the lot/batch number has been requested.
Swelling at injection site bigger than quarter size. Feels warm at injection site. Feels hard at injection site. No rash / no trouble breathing.
Information has been received from a registered nurse and physician concerning a 52 year old female registered nurse with hypertension and sulfonamide allergy who upon administration of ROTATEQ (lot# 660291/1829U) to an infant (WAES# 0804USA04929) on 18-APR-2008, the infant coughed some of the dose into the nurse's right eye. The nurse immediately used an eye wast eye with cold water. On 19-APR-2008 through 20-APR-2008 the nurse experienced a fever and tiredness. On that same day the patient experienced malaise since the incident occurred. On 22-APR-2008 the patient experienced ocular symptoms including erythema, pain, burning, had "heavy unusual" feeling in the eye and sclera with a "hemorrhage spot." The patient was seen by the physician for medical attention. Lab diagnostic studies performed included a fluorescein test which was negative. The patient's symptoms of malaise and ocular events persisted. There was no product quality complaint. Additional information has been requested. Follow-up information from a licensed practical nurse indicated that the 52 year old female registered nurse who on 18-APR-2009 at 10:45 upon administration of vaccine (WAES0804USA04929) the infant coughed and split vaccine into her right eye. She also experienced burning and heaviness in the right eye on 21-APR-2008 (also reported as 22-APR-2008. On 22-APR-2008 the eye was painful and burning with red aclera. The patient had an office visit on 23-April-2008 with an ophthamologist, no treatment was recommended. The patient was recovered on 25-APR-2008. Additional information has been requested.
3mins post vaccination, pt experienced a syncopal event. Vitals: 19:40 96/57, 71, 22, SpO2 100 -- > 19:45 94/52, 71, 100% -- > 19:50 97/65, 75, 100% Pt stable and released from the vaccination site @20:00.
A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 28-year-old male. The patient's medical history and concomitant medications was not reported. On 28-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Constant throat clearing  and dryness, fatigue headache from day 2  forward. Shingles breakout began day 9 after shot on eyebrow and spread to forhead by day 12 then spread to eyelid and scalp day 13. Began Valocyclovir on day 13.
Per Dr - MA called me, c/o reaction after vaccine, has some tiny hives on face- itchy , no distress. Benadryl given, 7 ml, reassessed , better , hives fading , not itchy. So2 100 %.
Nausea, vomiting (began ~10 hrs after immunization), duration 48 hrs; Rash/hives (began ~28 hrs after immunization), duration 4 hrs (gave Benedryl); Fever 103 degrees (began ~10 hrs after immunization), duration 48-72 hrs.
After patient received vaccination, patient was given information about the vaccine. Patient did mention that the vaccination hurt. Patient then left the pharmacy and later on, fainted outside of the facility in the parking lot where she scraped her head. Paramedics came and offered assistance and recommended she go to the hospital, but she refused and instead had a neighbor pick her up. She also mentioned that she is prone to fainting.
Sudden, intense chills lasting approximately 3 hours, along with sudden diarrhea, leg cramps. Followed by tiredness. 100% recovery within 12 hours of onset.  No physician seen. Patient is public health practitioner with experience working in healthcare facilities.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1 vaccine, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, and reporter causality assessments were not applicable and the event was considered to be resolved.
On or around late June 2021, I started to feel an elevated heart rate, which I have never had issues with in the past. The elevated heart rate felt like my heart was pounding out of my chest. I felt dizzy during the episodes and would have to sit down to get my heart back to normal rhythm. When I caught the Omni variant January 2022, I found blood particles in the sputum I would cough out. It seems whenever I get a cold now, I have these black specs of blood in my sputum.
This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received the 1st dose of Flu seasonal TIV .5 ml on 21st October 2014 14:00. Concomitant products included Prenatal Vitamin. The subject's estimated date of delivery was 1st May 2015. On an unknown date, an unknown time after receiving Flu seasonal TIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received: Patient in week 12 of pregnancy received FLUARIX vaccination. Patient's due date is in May 2015. No chronic diseases, no maternal or paternal genetic issues.
fatigue; This is a spontaneous report from a contactable consumer (patient). A 5-decade-old (late 40s/early 50s) male patient received BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot number: unknown, Expiration date: Unknown), via an unspecified route on an unknown date at 2nd dose, single dose for covid-19 immunization. The medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 for covid-19 immunization and experienced a sore arm for 24 hours afterwards. On an unknown date, patient experienced fatigue for 24 hours afterwards. It is unknown if patient received any treatment for the event. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
She is breastfeeding; She is breastfeeding; could not sleep last night; felt chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Mar2021 17:30 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing); "COVID-19", start date: Mar2020 (unspecified if ongoing); "Pregnancy", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 22Mar2021 17:30, outcome "unknown" and all described as "She is breastfeeding"; INSOMNIA (non-serious) with onset 22Mar2021, outcome "unknown", described as "could not sleep last night"; CHILLS (non-serious) with onset 22Mar2021, outcome "recovering", described as "felt chills". Therapeutic measures were not taken as a result of insomnia. Therapeutic measures were taken as a result of chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021330252 ;US-PFIZER INC-2021330252 Baby case
Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG and CXR were normal in ED and she was given albuterol, decadron, famotodine, and epinephrine and resolved.
Past lot that had been expired was administered to patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired was administered to patient).    Patient age was reported as 38 years and 06 months.  Concomitant product use was not provided.  Reportedly, the number of patients at facility that received this Moderna vaccine with batch number O70H21A had an expiration date of 07-Apr-2022 between 08-Apr-2022 and 15-Dec-2022. Additionally, In the second list, reporter discovered a past lot that had also been expired and administered to patients with batch number as 065F21A.  Treatment information was not provided.  NDCID number was reported as 80777027398.
Headache & Myalgia Narrative:  Developed headache and severe muscle pain, could not sleep, lasted 36 hours, resolved spontaneously
This spontaneous report as received from a physician refers to multiple patients of unknown age. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB, lot # K002747, expiry date: 09-DEC-2016 (dose and route not provided). Digital data logger had recorded the vaccine temperature excursion of 28.4 F for 602 hours. The physician discussed temperature stability. No adverse effects were reported. Additional information has been requested.
Pt was given Zostavax to LUE on 08/06/2009 and presented to office 6 days later on 08/12/2009 w/ possible shingles lesions to RUE.  Pt presented after ~2 hrs of noticing pruritic lesions -  scattered erythematous maculopapular lesions, nontender, no drainage.  Pt denied any flu-like sxs, no f/c/s, no paresthesias to site prior to erruptions of lesion.  Pt had Herpes Zoster 20+ years ago to same location on RUE (following Right Lumpectomy w/ axillary node dissection, radiation & chemotherapy in 1996).  Pt was given prescription for Valtrex 1000mg 1 tab tid x7 days.
Information has been received from a nurse concerning a 64 year old female with no allergies or drug reactions who on 03-DEC-2007 was vaccinated (site and route not reported) with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot#658200/0804U). On the same day the patient was concomitantly vaccinated (site and route not reported) with a influenza virus vaccine (unspecified). On 05-DEC-2007, the nurse reported that the patient developed redness and pain at injection site and fever 48 hours post vaccination. The patient sought medical attention and was prescribed antibiotic by the physician. No further information available. Additional information has been requested.
i  cant upload my data information in the application my job is requesting my information and i have to travel as well . i keep saying my information cant not be found . can some one help me
severe crying for 2 hrs following vax admin; arm became quite warm & swollen; inject site still warm & swollen 4 days p/inject w/pt favoring & holding the arm;
Sore arm for two days tolerated: regressed 99 percent   headache affecting sleep pattern. Interrupted nausea .
Vaccines were diluted and drawn up into 10 syringes on 12/10/2021. They were not wasted at the end of the day.  Monday patient was in office and one from this batch was grabbed and given to patient on 12/13 @ 3:34 pm.  They stored in the refrigerator.  Contact mother and she is not having any issues or side effects. According to manufacturer they expire 12 hours once drawn up from vial into syringe.  Contacted CDC and they recommend patient gets re-vaccinated immediately and no wait is necessary.
c/o fussy & constipated since vax 4MAR99 afeb-seen 9MAR99;exam-nl;
3 days myaglia of injected leg. Erythema of injection site, 7.5 x 10 cm. Fever 102 degrees F. Pain & tenderness at site. Difficulty to bear weight on affected leg.
3/31/2022 at 1356 Employee called the Nurse Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Pfizer Vaccine Date - 3/30/2022 Booster Dose - Yes Location - Left Deltoid Date of Symptom Onset ? 3/31/2022 (~0900) Symptoms ? Low Grade Fever (TMax 100.9F), Left-Side of Body with Numbness/Tingling, Body Aches, Pain with Movement to Body, Headache Last Day of Work and Shift ? Schedule: 3 Shifts per Week (7p-7a) / Missed Work: Thursday, 3/31/22 Home Remedies ? Tylenol 1000 mg x1 at 0900, Rest Any Improvement ? No Improvement
Chronic severe headache continuing to present; stiff neck causing inability to turn head; red rash on left side of head and in left ear canal with extreme pain and tenderness; swollen lymph nodes left side; extreme weakness continuing to present; light headedness continuing to present; shortness of breath; feeling of anxiety and nervousness; fever immediately following injection and lasting for 4 days
Patient hospitalized from 7/17- 7/21/21 due to breakthrough infection. Patient fully vaccinated with Pfizer: received dose #1 on 12/21 /20 and dose #2 on 1/11/21. The following is copied from the discharge summary:  Hospital Course: a 56 y.o. male with PMHx of HTN who is being admitted for evaluation of COVID.  Patient reports that his first started having symptoms about a week ago after returning from vacation. He is vaccinated with pfizer, 2nd dose completed back in 1/2021.   COVID 19 infection/ Acute Hypoxemic Respiratory failure - Continue Dexamethasone 6 mg Po daily to complete 5 more days - Completed Remdesivir 5 days - Supplemental oxygen for target saturaion >90% - CRP 6.7, ESR 30, Ferritin 817, D-dimer 494, procalcitonin 0.18 - Telemetry, no arythmias - PRN albuterol as needed - Ambulation oxygenation test done, originally qualified for oxygen but today repeat doing ok at room air.  - Cm consulted for home oxygen, awaiting delivery for discharge   Elevated Cr - resolved - Cr 0.89    HTN: stable - Continue home lisinopril   HLD - Atorvastatin    Vitals and labs personally reviewed.   Dispo: Discharge Home today with above.
Pt. states that after receiving the 2nd dose of Moderna 05/05/2021, started experiencing symptoms 12/26/2021 of suffering a TIA Stroke. (Previous Stroke 04/22/2020) Medical Center admitted from 12/26/2021 (Heart valve "Branch Pocket" with Arrhythmia) discharged 02/22/2022. Pt. still experiencing symptoms.
nausea vomiting x4 diarrhea x1 abdominal pain  Treated with oral rehydration & Zofran symptoms started 3 hours after ingestion. Symptoms gradually improved over the next day
Patient arm was swollen around the injection site, it was all red, puffy and itchy. It resolved after 12 days using Triamcinolone and cold compression. Patient came today claiming she's still weak from the injection and asked to file a report for her.
Went to bed around 830pm woke up around 10 with a migraine, chills, body aches, felt like someone was sitting on my chest, upper arm where shot was administered was super sore.  Dealt with that all night and barely slept.  Next morning still had a migraine and body aches worse than when I had Covid the prior month.  Took an 800mg Ibuprofen and dealt with the pain all day.  Went to bed and tossed an turned but got more sleep than the night before.  Tuesday wasn't too bad arm was still sore and still had a migraine.  Wednesday my left elbow ached all day through Thursday.  Felt like my arm was in a vice.