chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 11Sep2018, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th September 2018).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The pharmacist reported that the patient was at the office to receive the 2nd dose of Shingrix. The reporter asked that does the patient need to restart the whole series or complete it with 2nd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received through the manf pregnancy registry from a health professional concerning a 40 year old, black, female with a history of four previous pregnancies and 2 full term births, who on 17Feb05 was vaccinated with a 0.5ml dose of varicella virus vaccine live. It was reported that the pt is now seven weeks pregnant. The pt's last menstrual period was reported as 13Feb05. It was noted that the pt did not have any negative reaction to the vaccine. There was no local reaction at the vaccination site, no varicella symptoms post vaccination, and no herpes zoster symptoms post vaccination. Unspecified medical attention was sought. No product quality complaint was involved. No further information was provided. Follow up information from a health professional indicated that the pt had an elective termination of her pregnancy. Additional information is not expected.
7APR93 w/in 12 hrs, rash, progressed to swelling & itching; went to ER & given DPh; rash gone in 2 days;
This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 02Feb2021 08:45 at single dose for COVID-19 immunization. Medical history included stage 4 prostate cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications were not reported. The patient previously took celecoxib (CELEBREX) and experienced allergies. On 04Feb2021, the patient experienced extreme soreness on side where injection was given, also had malaise and tiredness. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results (COVID test result Pending) on 05Feb2021. No treatment was received for the adverse events. Clinical outcome of the events was recovered/resolved with sequel (reported as recovered with lasting effects).  Information on the lot/batch number has been requ
site of injection - cellulitis  Hydrocortisone cream OTC Ibuprofen 400 twice daily
Pt. noticed tingling in his L arm. Tingling got progressively worse and discussed this with his private physician by phone on 11/18/13. Pt. called health dept. with symptoms 12/20/13.
high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the seventh of eight reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown  what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patient
A bad welt on the arm; Could not eat; Was sleeping a lot; Rash all over the top of the arm; Extreme headaches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia. Concomitant products included ATENOLOL for Tachycardia.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches). At the time of the report, URTICARIA (A bad welt on the arm), EATING DISORDER (Could not eat), SOMNOLENCE (Was sleeping a lot), RASH (Rash all over the top of the arm) and HEADACHE (Extreme headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) Temperature elevated.         Treatment details was not reported by the reporter.   This case was linked to MOD-2021-314914 (Patient Link).
Patient with Bells Palsy 4 months after Zostavax vaccine.  02/12/2008 MR received for DOS 12/28-29-/2007 with D/C DX: Lower motor neuron pattern R facial weakness most likely 2' to ischemic infarct. Paroxysmal Atrial Fibrillation.  Transient Iscemic attack-amaurosis fugax.  L eye blindness since childhood infection.  Prior to admit pt noted drooling of H2O on drinking, H/A, and R facial droop with dysarthria. PE (+) for R upper motor neuron pattern facial droop, mild dysarthria, decreased vibration sensation of lower extremities, 1+ pitting edema, Ankle DTRs 0. Idiopathic Bell's Palsy was included in the differential dx however given hx of A-fib, pt was treated as such.  2/20/08 spoke with reporter who states DX is Bell's Palsy confirmed by later facial MRI. Facial weakness was not due to an infarct, and the hospital reports were incorrect per reporter. 02/22/2008 Additional records received from reporter including records from above admission. F/u appts confirm DX: Bell's Palsy. MRI of the face and brain 1/9/08 (+) for facial nerve enhancement c/w Bell's Palsy.  PE (+) severe R 7th cranial nerve palsy. Pt reports onset of headache since DX of Bell's Palsy with R sided neck and facial pain. F/U 2/5 with BP somewhat improved. Per 60 day follow up: Residual facial weakness.
Patient came in to receive 2nd booster.  I checked Vaccine card and observed that 4 months had past from last booster.  Went over Covid 19 vaccine Screening form and scanned data on lab top.   I administered the vaccine and as I was filling out new card realized patient was not over 50 and was not immuno-compromised.  Computer did not alert of medication not being recommended because due to previous Vaccines having been administered outside of Facility and they had not been reconciled into patients chart.  I informed RN on site.  And then informed patient of the error that had occurred.   Patient was advised to look for any adverse reactions and contact PCP if any adverse reactions occurred.
PATIENT'S CAREGIVER REPORTS THAT 2 HOURS AFTER RECEIVING THE TETANUS SHOT HE FELT HIS THROAT CLOSING OFF AND WENT TO THE ER WHERE HE WAS INTUBATED.
The patient fainted after the administration for 5 to 6 seconds. She wake up and fainted again for 3 to 4 seconds. We gave her orange juice because she hadn't had lunch and measured her blood pressure (72/57). We laid her down with her legs on a chair for a few minutes. We monitor her for about 45 minutes and did not faint again. Before leaving we measured her blood pressure again and was ok (112/79).
Developed itching on neck before leaving facility. On 08-29-2017 noted diffuse non vesicular, nonpapular rash on arms and front of chest. No other area of body noted. Parent stated had also eaten shrimp, but never had shrimp allergy before. No fever, or malaise, just itching.
Patient had chills after vaccine in evening. Woke up on Friday AM with redness and pain to injection site. Patient took Benadryl with minimal relief. Patient states by Saturday AM, area was more painful and swollen.
first dose: 2019, second: did not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th November 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Subacute thyroiditis This generally healthy patient, with no history of thyroid disease, developed subacute thyroiditis (SAT) following an influenza vaccination.  He experienced no viral infection symptoms in the weeks preceding the vaccination, nor during the weeks after the vaccination when the SAT symptoms developed.  He spent approximately 3 months in phase 1 (thyrotoxic), followed by a 1 month transition to hypo-thyroid, followed by a 1 year gradual transition to normal thyroid function.  The patient sought medical care for his thyrotoxic symptoms several times before they were correctly diagnosed almost 3 months post vaccination. In the several days following the vaccination, mild soreness at the upper left arm injection site spread up over the shoulder and into the left side of the neck, where it gradually worsened over the next 2 weeks.  12 days post vaccination, the patient visited his Primary Care Physician (PCP) for this pain, which was most prominent in the left neck, but also present on the left side of the head and the anterior and posterior neck.  The patient also noted some throat discomfort with swallowing.  Examination revealed possible thyroid swelling, but no indications of respiratory infection.  Over the next 2.5 months, his neck pain persisted, with increasing anterior neck pain, sometimes radiating to the jaw and ears.  Discomfort with swallowing increased, and headaches were no longer confined to the left side of the head.  The patient also felt progressively unwell, with difficulty sleeping, body aches, and increasingly frequent chills.  (Though he did not measure his temperature.)  87 days post vaccination, the patient again sought care from his PCP.  He had started measuring his temperature in recent days and found it varying from 96 to 102 degrees F.  At this point, his thyroid was more clearly painful when palpated, so additional lab tests were ordered on 2020 March 2.  High sed rate (93 mm/hr), high Free T4 (2.10 ng/dL), and very low Thyroid Stimulating Hormone (TSH, < 0.005 uIU/mL) indicated subacute thyroiditis (SAT) in the thyrotoxic phase, and the patient was referred to endocrinologist.  Additional tests over the next 3 weeks confirmed the SAT diagnosis.  These included Thyroid Stimulating Immunoglobulin (< 1.0), Free T3 (7.40 pg/mL), a thyroid ultrasound (enlarged with increased vascularity), and thyroid radioactive iodine uptake (0.9% at 6 hours, and 0.8% at 24 hours).  At 124 days post-vaccination (2020 April 8), the patient's thyrotoxic symptoms had largely resolved, consistent with the hypo-thyroid c ondition indicated by lab tests:  TSH = 19.600 uIU/mL, Free T4 = 0.67 ng/dL, and Free T3 = 2.50 pg/mL.  Periodic TSH and Free T4 tests over the next year showed gradual recovery to normal thyroid function on 2021/03/22 (TSH = 3.75 uIU/mL, Free T4 = 0.91 ng/dL).
felt strange; body aches; nausea; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt strange), MYALGIA (body aches), NAUSEA (nausea) and HEADACHE (severe headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced FEELING ABNORMAL (felt strange), MYALGIA (body aches), NAUSEA (nausea) and HEADACHE (severe headache). On 12-Aug-2021, FEELING ABNORMAL (felt strange), MYALGIA (body aches), NAUSEA (nausea) and HEADACHE (severe headache) had resolved.            Concomitant medication included unspecified heartburn pills.  Treatment information was not reported.
Diagnosed with Bell's Palsy, second week of July.  Given Anti-virals, and Steroid (prednisone) for one week.  Full recovery after 3.5 weeks
On 8/13/01, the vaccinee received her 2nd injection of Hep-B vaccine. In mid 9/01, approx. 1 month post vax, the vaccinee experienced difficulty breathing and was unable to "catch her breath" when playing soccer and exercising. She had wheezing on 2 occasions. The most recent information received on 2/25/02, indicated the events resolved "around the end of December or the beginning of January".
SkinRash, Rash, Reported itchiness and skin rash radiating to the rest of her body. Narrative:
I hadn't been feeling great over the weekend, on Sunday night I was very lethargic. On Monday I woke up with a headache congestion, and tired. I called my doctor and had a telehealth visit. I did qualify for the Paxlovid, my husband pick it up and I started it immediately. By day three I developed diarrhea, my body ached but I was able to work from home. I do feel better now, I am getting my energy back and starting to be able to walk now, I do still have a lingering scratchy throat.
Patient reports continued pain at L shoulder joint after receiving first Moderna vaccine. This was reported when coming to receive his second dose from writer today. pain started resolving 1-2 days ago in the L shoulder and pt believes it is slowly getting better.
THE PT FAINTED AT A RESTURANT 30-1HOUR AFTER RECEIVING SHOT AND FEELS CHILLS ALL OVER BODY . NOT FEELING WELL
mom stated pt was crying then stated went limp & was asleep;advised mom to take child to pvt MD or nearest MD or clinic;
pt recv vax & had clenched fists, both arms contracted, curled body forward, rhythmic arm & head tremors;color pale, bladder control lost;BP 90/60, appear faint;hyperventilate;vasovagal vs sz activity;
Immediately post vax, the pt held breath, became very pale. An ammonia stick was placed under nose - baby acted like he fainted. Respirations shallow, slowly became more alert but took 10-15 minutes. Baby went to PMD.
This is a  76 Years  old  Female, accompanied by an adult female family member, complaining of skin rash for the past 3 hours.  Patient reports that she just had her fourth Pfizer COVID-vaccine shot then shortly after she started to experience a red rash to her chest and neck that is itchy in nature.  She denies any sore throat, difficulty breathing, or tongue swelling.  No chest neck back abdominal pain vomiting or diarrhea.  No edema.  She reports that she had 3 COVID vaccinations prior to this 1 without any reaction.  She attempted to treat her symptoms with Excedrin, but it did not help with symptom relief.  Has over-the-counter Benadryl at home.
pt recvd vax JAN95 & w/in days following vax pt exp diffuse polyarthritis in shoulders,elbows,wrists;seen by MD;sx cont;
This is a spontaneous report from a contactable nurse. A 6-month-old male patient received PREVNAR 13, via intramuscular in the Vastus Lateralis Left, first dose (Lot number: X13847, expiration date: 01Jul2020) on 23Oct2018 at 1:23 p.m. and second dose (Lot number: X34315, expiration date: 30Sep2020) on 02Nov2018, both for immunisation. The patient's medical history and family medical history relevant to AEs were reported as none. Concomitant products included PENTACEL vaccine and Rotavirus vaccine in error on 23Oct2018 plus the flu vaccine as part of the patient's 6 month wellness visit. She declined to provide any additional information for these products including Lot, Expiry, NDC, and manufacture explaining it has already been reported to those companies. The nurse reported that pneumococcal 13-val conj vac (dipht crm197 protein) was given too soon to a patient. One week after the first administration, another was given. The first one was received on 23Oct2018, the second was given on 02Nov2018. It was marked in the patient's chart that the visit was 6 month well check and that was not accurate. The nurse explained later in the call that the patient returned to the office yesterday, on 08Nov2018, with fever, vomiting, and constipation. She was not sure if there is a correlation. The only treatment was prune juice. The nurse did not think there has been any harm to the patient as a result of the events. The outcome of the event "given too soon" was recovered on 02Nov2018, the outcome of the other events was not recovered. The event "given too soon" was assessed as serious (medically significant) and unrelated to pneumococcal 13-val conj vac (dipht crm197 protein) by the reporter.
pt began having abdominal and back pain the next day after vaccination, pt presented to emergency room the day after , pt had inflamed gallbladder where they removed it during surgery
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016417468) on 13-Sep-2016. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergy to tetanus toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 062e21a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Non-Significant follow up appended-Email ID updated
She woke up in the middle of night and had a high fever of a 103.9axilary, tachycardia, and was vomiting with chills She was taken to the emergency department and received ibuprofen and tylenol and IV fluids, we were released after 6 hours.
After the expected reaction of fever, chills and aches subsided. I developed a rash at injection site that spread to my right arm and right side of my back
Difficulty swallowing pills, swelling of throat Fast heart beat bad rash all over body weakness/falls x 3 blood pooled in L eye.
On Monday, 01/08/01, at 9 PM, the patient had a rash on her body. On Tuesday, 01/09/01, the patient experienced itching, hives and throat swelling. The doctor administered Cortizone treatment lasting 7 days. The patient stated by Thursday, 01/11/01, she had no signs of hives, itching, rash or throat swelling
There was not an unusual reaction other than temp around 101 and body ache. However, she was not 18 at the time of administration. Due to temp Patient consulted MD for note for a excuse from work leave
Mother called clinic approx 3hrs after administration stating child c/o myalgia, dizziness legs aching-instructed mother to take child to ER was unable to reach mother
Pfizer-BioNTech COVID-19 Vaccine EUA I developed severe body aches and fatigue about 36 hours after dose #1. Body aches lasted about 36 hours. Fatigue lasted about 48 hours. Symptoms managed with rest, increased fluids, ibuprofen 800mg as needed.
This spontaneous report was received from Licensed practical nurse refers to multiple patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored RECOMBIVAX HB (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was getting her first dose.  More than half the vaccine leaked out of the syringe.  Patient dose was readministered per protocol.  No adverse reactions
Shot about 11:30, Physical Therapy at 2:00 Substantial weakness in legs and core with difficulty getting out of car.   Difficulty standing and walking, fell but caught by PT.  Performed PT exercises ok.  This report produced about 6:09.