chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider:  (name withheld) Primary Care Provider at Discharge: (name withheld) Admission Date: 6/22/2022 Discharge Date: 06/24/2022  PRESENTING PROBLEM: Paroxysmal atrial fibrillation   Systolic congestive heart failure, unspecified HF chronicity  COVID  COVID-19  Dyspnea   HOSPITAL COURSE:   77 y.o. male with past medical history significant for essential hypertension, sleep apnea, CKD, coronary artery disease, obesity who presented to the emergency department for increased shortness of breath.   Patient reports that approximately 4-5 days ago, he noticed that he started to have a dry cough, shortness of breath, orthopnea, and proximal nocturnal dyspnea as well as 5 lb of weight gain.  At home, he normally takes 60 mg of Lasix workup. He doubled the dose but this did not help.    In the ED the patient was hemodynamically stable and afebrile.  Initial lab work revealed creatinine 1.39, GFR 50, BNP 1829. Initial troponin 30, 2 hour repeat 33.  He did have a positive COVID test PCR test.  EKG showed new found atrial fibrillation with a rate of 70. Chest x-ray was negative for any acute findings.  He was given Lasix 100 mg IV and had adequate urine output of 700 mL.    He was admitted to Medicine in stable condition. His shortness of breath resolved. Cardiology was consulted and recommended transition back to home dose of lasix. He was started on eliquis and a limited ECHO was done. Patient was feeling quite well and discharged home in stable condition 6/24. ECHO results were pending and cardiology stated they would follow up outpatient
On 1/17/21 staff reported that client had episodes of diarrhea x2.  Client had extreme fatigue and was afebrile
aching all over including joints starting 7-8hr p/vax progressing in intensity & lasted about 6qk;also loss of appetite & dizzy for 2-3wk;no rash & no swelling;treated by PMD w/anti inflammatory meds & antihistamines;
psoriasis flare; This literature-study case was reported in a literature article and describes the occurrence of PSORIASIS (psoriasis flare) in a 52-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previous COVID-19: Yes). Concurrent medical conditions included Psoriasis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (psoriasis flare) (seriousness criterion medically significant). The patient was treated with RISANKIZUMAB for Psoriasis flare-up, at an unspecified dose and frequency; CLOBETASOL for Psoriasis flare-up, at an unspecified dose and frequency; MOMETASONE for Psoriasis flare-up, at an unspecified dose and frequency and TRIAMCINOLONE for Psoriasis flare-up, at an unspecified dose and frequency. At the time of the report, PSORIASIS (psoriasis flare) was resolving.        For mRNA-1273 (MODERNA COVID-19 Vaccine) (Unknown), the reporter considered PSORIASIS (psoriasis flare) to be related.    No concomitant medication information provided. Physical Examination : Scalp, face, trunk, arms 30% BSA (body surface area).  Company comment: This literature-study case concerns a 52-year-old female patient with relevant medical history of psoriasis, who experienced serious unexpected event of psoriasis flare, that occurred 7 days after the 1st dose of the mRNA-1273 and 7 days after the 2nd dose.  The rechallenge was positive due to reoccurrence after both doses. Patient's relevant medical history is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-447246, MOD-2022-447206, MOD-2022-447248, MOD-2022-447249, MOD-2022-447250, MOD-2022-448166 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Follow-up received by safety on 11-Jan-2022 included an Email with FTA received from team does not contain any new information.; Sender's Comments: This literature-study case concerns a 52-year-old female patient with relevant medical history of psoriasis, who experienced serious unexpected event of psoriasis flare, that occurred 7 days after the 1st dose of the mRNA-1273 and 7 days after the 2nd dose.  The rechallenge was positive due to reoccurrence after both doses. Patient's relevant medical history is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Swelling and redness at L extensor arm mild induration and tenderness with demarcotex about 14cm long and 17cm wide L deltoid not meeting-middleline on fluxor or maybe are mid deltoid area per mom started today 9/4/02. Treated with Rocephin and Augmentin.
Information has been received from a consumer concerning his 11 year old daughter with no past medical history who in September 1998, may have been vaccinated with varicella virus vaccine live (Oka/Merck). On 21-OCT-2007, she developed shingles. On 24-OCT-2007, therapy was initiated with acyclovir. A product quality complaint was not reported. Follow up information by the patient's physician reported that she could not confirm which vaccine was administered since it was administered by a prior physician. The physician confirmed that on 21-OCT-2007, the patient developed vesicle/papule lesions over to dermatomes on the lower thoracic area on the back. A specimen sent for varicella virus identification was reported as "inadequate". The physician reported that at the time of this report the patient was recovering. Additional information has been requested.
Fever or Chills  Cough  Shortness of Breath  Fatigue  Muscle or body aches  Headache  Sore throat  Nausea or vomiting
I had a measle like rash on my torso several hrs after receiving the shot. The next day the rash continued down my thighs and still was on my belly. Then the third day, the hives reappeared on my legs but less pronounced
An initial report was received in the USA, from a parent. It was reported that an 18 month old male presented with difficulty breathing and generalized hives an unspecified time after receiving a fourth dose of DTaP vaccine, lot number W307CA (which is not a recognized lot number), date of vaccination, site and route not reported. He also received a fourth dose of IPOL and PREVNAR, date, lot numbers, sites, and routes not reported. He was transported to the emergency room and reportedly, recovered. Treatment and duration not reported. Additional information was received on 7/12/05 from a return call from a physician contact provided by the patient's mother. He stated that he is not the treating physician or the vaccine provider. He does not want any follow up letter sent to him, therefore, he did not provide his address. The mother had called asking advice and reported the event. This has been reported to VAERS. He did report that the vaccine was TRIPEDIA with lot numbers U1307CA and the lot number for the IPOL was X0799-2. He will notify the mother to call us to provide us with any additional information needed for follow up. Additional information was received on 7/12/05 from a telephone call received from the patient's mother. She stated that her son received TRIPEDIA, IPOL, and PREVNAR on 1/3/05 and had an immediate allergic reaction. In the doctor's office he received epinephrine, Benadryl, and nebulizer treatments. He was transported by ambulance to the ER where he was treated with IV steroids and admitted overnight. He has fully recovered. He was tested by an allergist and tested positive for DTaP and Prevnar but not IPOL. He had no reaction to previous immunizations received. The mother had contacted the manufacturer to obtain information on the other ingredients in the vaccines so her son could be tested on the other components of the vaccines. The mother also provided the name of the allergist and the primary pediatrician so that additional follow up can be requested. She also provided the patient's date of birth as 7/2/03.
Case number PHEH2014US001602 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 13 Jan 2014. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Approximately 2 hours after the vaccination, started experiencing vision changes. She attempted to google similar symptoms but had a hard time reading computer screen. Thinks it may be kaleidoscope vision. Describes it as a blob in the middle of her field of vision that is changing.
6 Days post immunization pt saw spots appearing on trunk and legs- they then became red and painful where she went to her dr and he diagnosed her with shingles
Pt had episode of forcefull vomiting,decreased PO and diarhea lasting aruond one week following first admin of Rotateq on 1/25/07. When Rotateq was given again on 3/19/07 pt also had vomiting and diarhea but this time it only lasted 3 days. Both times smtx started w/i 24 hrs of vaccine.
Pt. stated, "I felt short of breath 3 minutes after getting vaccinated."  Vital signs done: BP 132/84, O2Sat 96%,  HR 78, R 16, glucose 134.  Pt. also stated, "I have asthma but I forgot my inhaler at home."  "I live near here, I will use it when I get home." At 12:20pm pt. stated, "I feel better and I don't think I need to go to the hospital."   "As soon as I get home, I will use my inhaler."  At 12:25pm pt. went home with family member.
Patient received three doses; Patient received three doses; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 34YF7, expiry date 23rd January 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 2393S, expiry date 20th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th March 2019, batch number EH9Z7, expiry date 08th March 2021).   On 20th January 2022, the patient received the 2nd dose of Shingrix. On 4th April 2022, the patient received Shingrix. On 20th January 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th April 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: Immunization coordinator reported that, the patient received three doses of Shingrix. The patient received 1st dose of Shingrix on 26th March 2019 and 2nd dose on 20th January 2022. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received three doses of Shingrix, which led to extra dose administered. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071360:Same Reporter US-GLAXOSMITHKLINE-US2022071347:Same reporter
Patient received a Janssen vaccine, dose 1, and about 5 minutes after leaving the pharmacy passed out in the store. She did not hit her head, she was caught by another customer. 911 was called and when she was assessed, most vitals were normal (blood pressure, glucose, pulse ox) but her heart rate was fluctuating up and down ranging from about 180 to 65. She refused to go on the ambulance, but her host father stated he was taking her to the Hospital for evaluation.
Chills, fever, body aches, elevated high heart rate  (not normal), nausea,
This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received HAVRIX. On an unknown date, the patient received HAVRIX at an unknown dose. On an unknown date, unknown after receiving HAVRIX, the patient experienced fainting and dizziness. On an unknown date, the outcome of the fainting and dizziness were unknown. It was unknown if the reporter considered the fainting and dizziness to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient fainted following administration with HAVRIX from last week. The health care professional refused to provide further information, but ok with information being sent via postal mail. This case has been linked with case US2017176451 as reported by same reporter for same events.
received the second dose of the vaccine yesterday and a lot of it leaked out; The facility realized this and administered a third dose; Syringe Connection Issue; A spontaneous report was received from a healthcare provider, HCP concerning an unknown age female patient who was administered Moderna Covid-19 Vaccine, the patient was administered second dose of mRNA-1273 Vaccine, but a lot of it leaked out. The facility realized this and administered a third dose.  On an unknown date, the patient received first dose of two doses of the Moderna mRNA-1273 vaccine, for prophylaxis of COVID-19 infectious, batch number unknown, date first dose administered unknown. Route unknown. The nurse called on behalf of her friend which in this case was the patient. The patient received the second dose of the vaccine yesterday and a lot of it leaked out. The facility realized this and administered a third dose. The nurse would not disclose the patient's information and shared that she would inform her friend the patient to reported the adverse event.   The patient medical history was not provided, no concomitant medications were reported.  On 04 Feb 2021, the patient was administered the second dose of mRNA-1273 no batch number unknown for prophylaxis of COVID-19 infectious.  Action Taken was to administer a third dose.  The event was considered resolved after the third dose was administered.; Reporter's Comments: This report refers to a case of underdose, extra dose administered and device connection issue for mRNA-1273 (lot# not provided) with no associated AEs.  Causality of these events is not applicable.
5 min after rec GARDASIL, HAVRIX & VARIVAX inj - pt became pale, lightheaded - nausea ringing in ears - pt laid on exam table recovered.
approx 830PM mom states pt started having sz; mom states pt had 3 sz, a/going to ER;
ACTHIB at a low of negative 5.1C out of range for 12 minutes and a  low of 1.3C out of range for 10 minutes with no reported adverse event; Act HIB was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and acthib at a low of negative 5.1c out of range for 12 minutes and a  low of 1.3c out of range for 10 minutes with no reported adverse event and act hib was administrated post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received a  dose of 0. 5ml of  suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot UJ665AA, expiration date: 11-Mar-2023,via intramuscular route in the left thigh as immunization.  On an unknown date the acthib at a low of negative 5.1c out of range for 12 minutes and a  low of 1.3c out of range for 10 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  On 30-AUG-2022 the act hib was administrated post excursion with no reported adverse event (poor quality product administered) same day following the administration of HIB (PRP/T) VACCINE. This situation was reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard. No further information provided by the reporter.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (ACTHIB at a low of negative 5.1C out of range for 12 minutes and a  low of 1.3C out of range for 10 minutes with no reported adverse event, Act HIB was administrated post excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a registered nurse referring to a patient of unknown age and gender Information about medical history and concurrent condition was not reported. On 31-DEC-2014 the patient was vaccinated with improperly stored PNEUMOVAX23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 69 year old female smoker with hypothyroidism, hypertension, osteoporosis and hypercholesterolaemia, and as of 29-NOV-2007 no known allergies, who on 02-OCT-2007 at 10:16 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot# 656233/0200U). Concomitant suspect therapy included FOSAMAX. Concomitant therapy included calcium, hydrochlorothiazide, lisinopril, lovastatin, LEVOXYL, and nifedipine. On 02-OCT-2007, the patient developed swelling, redness, and induration of the left arm. On 05-OCT-2007, the patient was seen by the physician. It was reported that the patient presented with pale red and yellow discoloration, edema, and mild induration of the left arm, there were no signs of infection and the injection site was clean. The patient's blood pressure was 120/80, pulse 68, temperature 96.6F. The patient was diagnosed with an allergic reaction to pneumococcal 23v polysaccharide vaccine and advised to take NSAIDs as needed. The patient was instructed to observe the symptoms, and report promptly if there was any worsening or unexpected persistence. The patient was also advised on signs and symptoms that would need immediate attention in the emergency room. The patient recovered on 07-OCT-2007. No further information is available.
Bruising and petichia. Admitted into hospital 2 days later for ITP and life threateningly low blood platelet level.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 24-JUL-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 " 10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -3.0 Celsius Degrees for 1172 hours, 8.88 Celsius Degrees for 24 hours, -1.11 Celsius Degrees for 80 hours, 9.44 Celsius Degrees for 168 hours, 8.33 Celsius Degrees for 416 hours and 15 Celsius Degrees for 56 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an 18 year old female patient with no medical history who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (LOT# 659653/1448U) 0.5 ml intramuscular into the left arm. There was no concomitant medication. After receiving the injection the patient fainted and fell face first onto the the floor and was unresponsive for three minutes. Subsequently 911 notified and transported the patient to the hospital. The patient underwent a CT scan of the skull (no result was provided) and received 7 stitches to the upper lip. No other laboratory tests were performed. There were no other symptoms or treatment reported. Then the patient was released from the emergency room. At the time of this report, the patient's father reported that the patient was at home and feeling better. This is one of several reports from the same source. Additional information has been requested.
Fever and chills the first night. Then, a large (half dollar coin sized) hard bump formed under the skin. It was red and warm to the touch for two weeks.   We had to treat with doctor prescribed antibiotics and cream.
Information has been received from a nurse practitioner concerning a 23 year old female patient who on 24-SEP-2008 was vaccinated with the first dose of GARDASIL 0.5ml. There was no concomitant medication. On 25-Sep-2008, the patient experienced pain in the arm, also in her shoulder and axillary area. She was seen in the office, date not provided, with a hard lump and swelling at the site. No treatment required. The patient not had any labs test done. There was no product quality complaint. Additional information is expected.
Case number PHEH2016US023342, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 70 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 12 Jan 2016. On 12 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
TD given lt deltoid; no fever, chills, malaise or systemic sx but local redness, warmth & tenderness & well demarcated area of erythema extended inferiorly to past elbow w/advancement still wk later; treated w/meds; CBC showed 910 EOS;
Diarrhea began 2pm on day of i hection. 1 episode.  Then beginning 4:00a.m. Saturday morning the 30th. And I'm still having episodes today, February 1st.
Gradually worsening chest pain with exertion.  Found to be having an NSTEMI.  Transferred to Medical Center for treatment.
9-7-06 tiny red raised rash appeared 1st stomach armpits, back and legs by 7-8. At 4 p.m.- rash generalized entire body, temp range 99-102 degree F.  to Dr. On 9-7-06 vaccine induced varicella diagnosed - RX- benadryl and Aveeno bath
Patient is fully vaccinated and boosted. COVID test positive at ED visit. 97-year-old male presents to the ED secondary to COVID exposure and generalized weakness.  Patient also endorses some difficulty urinating.  Symptoms have been going on for the last day.  No fever or chills.  No chest pain shortness of breath or cough.  No abdominal pain nausea vomiting or diarrhea.  BP 164/58  | Pulse 89  | Temp 97.7 °F (36.5 °C) (Oral)  | Resp (!) 40  | Ht 172.7 cm (5' 8")  | Wt 63.5 kg (140 lb)  | SpO2 95%  | BMI 21.29 kg/m² He was given a 500 cc normal saline bolus. EKG nonischemic.Chest x-ray with mild cardiomegaly.  UA unremarkable.  BMP within acceptable limits.  Troponin 0.02.  Patient is breathing comfortably on room air, oxygen saturation 94%. Discharged