chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered a dose of ACTHIB reconstituted with sterile water instead of provided 0.4% Sodium chloride with no reported adverse event; Initial information received on 06-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride with no reported adverse event , while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH.  On 27-May-2022, the patient received a  dose of 0.5 ml of  suspect HIB (PRP/T) VACCINE , (lot:  UJ740AA ; expiry date:  11-Feb-2023)  via intramuscular route in the left vastus lateralis for immunization.  It was reported that on 27-May-2022,  the patient was administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride with no reported adverse event (product preparation error), (latency: same day.  Action taken :  not applicable.  Outcome: unknown  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.; Sender's Comments:  01132906: US-SA-2022SA213022:
While hospitalized he continued to have PAP needs for respiratory difficulties, and an increasing oxygen requirement with fluid overload. He had an acute decompensation which resulted in discovery of and diagnosis of pulmonary emboli causing right heart strain. His AKI gradually progressed to HD need unfortunately, felt due to ATN with vancomycin and hypotension. He did HD 2 days but progressively became weak and had increasing pressor requirements making it hard to tolerate. Ultimately with his wife and son he decided to pursue home hospice for his remaining days, and to discontinue HD.
Patient came to pharmacy 8-12-14 to ask about ab OTC product for itching. He didn't think it was a shingles outbreak but after showing the Rph the rash I thought it certainly looks.
This spontaneous report as received from a licensed practical nurse and healthcare worker (reported also as: Health Department Employee) refers to an unspecified patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date unspecified patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot#, expiration date not reported) that was improperly stored on 27-APR-2014. No product quality complaint (PQC) was reported. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Reports generalized itching all over body 5minutes after receiving vaccine. Provided with Benadryl 25mg.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored unspecified dose of GARDASIL 9 (route of administration and frequency were not reported) lot # N023952 (expiration date: 12-JUL-2020) for prophylaxis. No adverse effects were reported. Temperature and time frame: 0-1 Celsius degrees for 59 minutes and below 35 Fahrenheit degrees for 9 hours and 4 minutes. There were no previous temperature excursions. It was found because of a digital data logger.
Fever 102-103 degrees the night of vaccine through 4/12/15, + dizziness, headache and shaking through 4 days.
Low grade fever, widespread vesicles. Dx: varicella post vaccination. Tx: Zovirax, Bactroban 2%.
Sinus infection; Vaginal discomfort/thought it was a yeast infection; Both sides of my neck started to swell/looked like I had swallowed a hot dog side ways; Fever/ fever that would not go away; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Both sides of my neck started to swell/looked like I had swallowed a hot dog side ways), VULVOVAGINAL DISCOMFORT (Vaginal discomfort/thought it was a yeast infection), SINUSITIS (Sinus infection), PYREXIA (Fever/ fever that would not go away) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SWELLING (Both sides of my neck started to swell/looked like I had swallowed a hot dog side ways), PYREXIA (Fever/ fever that would not go away), CHILLS (Chills) and HEADACHE (Headache). On 20-Apr-2021, the patient experienced VULVOVAGINAL DISCOMFORT (Vaginal discomfort/thought it was a yeast infection). On 27-Apr-2021, the patient experienced SINUSITIS (Sinus infection). On 25-Apr-2021, VULVOVAGINAL DISCOMFORT (Vaginal discomfort/thought it was a yeast infection) outcome was unknown. At the time of the report, SWELLING (Both sides of my neck started to swell/looked like I had swallowed a hot dog side ways), SINUSITIS (Sinus infection), PYREXIA (Fever/ fever that would not go away), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported   This case was linked to MOD21-086553, US-MODERNATX, INC.-MOD-2021-103751 (E2B Linked Report).; Sender's Comments:  MOD21-086553: US-MODERNATX, INC.-MOD-2021-103751:Cluster case
Left upper extremity deep vein thrombosis. Left arm swelling started 5/3/21.  Swelling and pain worsened. LUEDVT of the axillary vein confirmed by ultrasound at ER on 5/8/21.  Xarelto 15 mg PO BID initiated.
Fever (100.4) and chills starting approximately 12 hrs after administration. Temp was back to baseline by noon the following day.  Some lymph node swelling to right armpit noted the day following administration. Subsided 2 days later
RED RAISED RASH ABOUT 1.5 IN IN DIAMETER.  ITCHY.  DOES NOT LOOK LIKE SHINGLES.
Got immunizations in AM. Pt with runny nose x 1-2 days. No fever. Leaving for overseas on 8/5/07. 7/31/07 Out of apartment. In evening noted to have purple rash/dots on right calf. Eval at Urgent Care 7/27/07. Given Rocephin with f/u next day. No repeat labs below. Just runny nose. No fever.
Dizziness, Arthralgia & Palpitations The problems began with frequent PVCs which were recorded with the patient's loop recorder (has for paroxysmal atrial fibrillation and has occasional PVCs) but these worsened then on 2/14/2021 developed 20 second run of slow VT at the rate of 160 bpm. Palpitations subsided and then February 18 began having arthralgias of bilateral hips and knees. This eased and then on February 20 had sudden severe pains in the right knee which continued to progress until both bursae were bulging and patient could bare walk with toe touch only the right due to the pain. This persisted until March 8 when the patient developed fever of 101 with chills. Went to ER on March 9 where noted to have increased WBCs with Neutrophil shift. Knee improved after IV Tylenol and Rocephin - still tightened quadricep tendon with occasional pain.
Feeling sick; No energy; Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) 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 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, MALAISE (Feeling sick), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown.            Treatment medication was not provided.  Concomitant medication was not provided.  Patient experienced events on an unknown date in Dec 2021..   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow up received contains no new information.
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-MAY-2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a hospital pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.  Additional information has been requested.
Hospitalized 9.8.21;  COVID-19 positive (9.8.21);  fully vaccinated  Admitted for Tumor Lysis Syndrome Brief history and medical decision making:  62F with myeloma admitted for worsening renal function and altered mental status in the context of COVID-19.   Would be unusual to note tumor lysis syndrome with myeloma - and most likely her hyperuricemia is related to acute renal injury.  Appreciate Infectious Disease guided monoclonal antibody treatment.  Nephrology assisting.  No additional chemotherapy while inpatient.  SUBJECTIVE:   This is a 62 y.o. patient with a past medical history significant for recurrent Falls, Right/left hip replacement, DM type II, Morbid obesity, CKD IV and Multiple Myeloma who presented to ED with symptoms of altered mental status and fever. In the ED, patient was found to be also Covid 19 positive, her CXR revealed Left basilar airspace opacity, atelectasis versus pneumonia with a low magnesium. Patient was treated with IVF and antibiotics and her magnesium was replaced. Upon arrival to, patient was found to have an elevated uric acid 10.1. Patient denies SOB, chest pain, palpitation, nausea/vomiting, abdominal pain, dysuria, hematuria and melena. This patient also reports recurrent falls at home despite the use of a walker and last fall was on 9/7/21 which resulted in bruising to the left hip and an open wound to the right foot, she denies hitting her head, headaches and trouble with vision. Note from 9.17.21 (still admitted) ASSESSMENT / PLAN: Covid 19 Pneumonia - Febrile at home- no fever here, no SOB - CXR with Left basilar airspace opacity, atelectasis versus pneumonia - Covid 19 positive on 9/8-S/P Regeneron 9/9 - Lactic acid neg, CRP 79.1 - Blood cx NGTD - ID following - s/p cefepime/azithro in ED- stopped per ID - s/p dex but stopped as no hypoxia - Tessalon pearls, Mucinex - stable on room air  TLS-resolved             - Nephrology following              - monitor labs              - IVF held              - continue allopurinol  AMS- resolved - possibly secondary to renal function, TLS, or infection - UA neg - Neuro checks - Fall precautions
1. Facial numbness on the right side  2. At the site of the injection (mid upper of the left shoulder): muscle pain, at night time is throbbing and cannot sleep on that side  -pain comes and goes but mostly present  -she has done nothing and taken no medication to relieve it at this time  -there are no visible marking s or rashes at the site of the injection
A healthy teenager had received a dose of Menactra. Three days post immunization, the pt developed lower leg weakness and was then admitted to the hospital. The demographics of the pt were not reported. The date of administration, route, site and lot number of the Menactra was not reported. The reporter indication that the hospital physicians did not think this was a case of Guillain Barre syndrome. At the time of this report, the recovery status of of the pt was unk. Follow up information has been requested from the reporter. Follow-up: I just called the doctor. He said that this 15-year-old boy definitely did not have GBS. The pt had an old fracture in the lumbosacral region of the vertebral column. Exam was normal.
Severe redness swelling in right arm by bed time 12/07/2004 Seen at walk in Keflex given.12/08/2004 Seen at ER given Benadryl (IM), Tetracycline 12/09/2004 Swelling and redness pain from wrist to above shoulder/ 12/13/2004 all redness swelling  has subsided only tenderness at inj./ site now.
When she received the flu shot it seemed like a normal flu shot. It hurt a couple of days as it usually does. As the days went by, her arm began to hurt more. She had limited arm movement, she had trouble bringing her arm above her head or move it to the back. As of 10/23/09 it was feeling a bit better but not back to normal.
Received shot 10-2-15 at 1:30pm at pharmacy, 10-4-15 Sunday morning at 5:00am I woke up because my tongue felt funny, I looked at it in the mirror and saw it was swollen and my lips also, I waited till noon then I started to lose my voice so I went to the hosp. When I got to the emergency room I could hardly talk, there the doctor put me on an IV, the hosp report I have enclosed with this info. 10-6-15 I called my Dr and told them what happened, they said if the swallowing had gone down I should be ok, it had so I skipped one day of prednisone 10-7-15, then on 10-8-15 my lips swelled up again so I called Dr up and they had me come in 10-9-15, I had started the last of my prednisone 10-8-15 and by the evening the swallowing had gone down again, on 10-9-15 Dr gave me another script for prednisone and checked me out and said it was a reaction to the flu shot. Sunday 10-4-15 I also developed hives over my entire body, on my back, stomach, armpits, arches, buttocks, legs, top of my feet, rib cage, arms. When I was at the hospital my wrist started to swell up. On 10-3-15, I started coughing, this was around 6:00pm.
Had the shot 2018, broke out 5 weeks ago/ suspected vaccination failure; Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. In 2018, the patient received the shingles shot and broke out with shingles 5 weeks before the date of reporting and still have them. The patient stated that shingles was the most horrible thing the patient ever had. The patient stated believe him/her that they did not want to get them. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
8cm x 5 1/2cm erythema 11 days p/vax & induration;
Four days after, I woke up and had a strong ringing in my ear, especially the left. It went away after a few days, but I still periodically hear it. I went to my Audiologist.
Metal flavor and swelling tongue,  trouble breathing, hives, itching, fast heartbeat, mental confusion,  tingling, swelling lymph nodes,  body ache, headache.
Fever on same day of second dose of the Moderna COVID-19 vaccine (5/7/2021). For a week (5/7/2021 - 5/14/2021) I had an accelerated heart rate, high blood pressure and rashes along the left arm and leg. These symptoms I have never experienced since I do not have any medical conditions and have never had an allergic reaction to any food, drink or medication.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified patients of unknown age and gender. From 24-JUL-2017 to 16-AUG-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # N001348, expiration date on 31-OCT-2019 and lot # N000238, expiration date on 25-OCT-2019. No adverse event was reported. The doses of PEDVAXHIB were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C during a time frame of 1 hour 39 minutes which was detected by the data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007499.
Telephone call from client regarding pain at left deltoid where Hep B #2 was given.  On a scale from 1 to 10, pain is a steady 5.  Noted radiation towards the elbow.
My arm began to start itching and still gets itchy every once and a while where i got my shot and I have a clear dot on my arm where the person put the needle in my arm.
Red hard area 13 mm W X 7.5 mm high, warm to touch, resolving from larger area reported by mom in AM.
pt developed a shingles/herpetic like rash over elbow on same side where vaccine was given about a month after vaccine was given (painful) resolved on its own but now has recurred (about 6 months later)
Breakthrough case admission after 4 vaccines pfizer 1/21/21 Lot# EL3249;  Pfizer 2/11/21 Lot# EM9810;  Pfizer 10/25/21 Lot# FF8841;  Pfizer 5/18/22 Lot# FM0173
On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired. BUD was 15-Jan-2022.; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired. BUD was 15-Jan-2022.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 2:09 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Jan-2022 at 2:09 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired. BUD was 15-Jan-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired. BUD was 15-Jan-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 16-Dec-2021, moderna vaccine was pulled from freezer. Beyond use date was reported as 15-Jan-2022, which was printed in red and taped to the top of boxes. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired. Total 5 doses had been given at that point. On 27-Jan-2022, remaining ADA county sites were checked. All other clinics found to have same error of not noticing the beyond use date. The date was then added to daily covid usage and wastage report. On 31-Jan-2022, moderna responded as revaccination was not required but VAERS needed to be completed,  No treatment medication were provided.
Salvage vaccine was given greater than 6 hours after reconstituted. The patient was contacted and will follow up with her doctor. Patient experienced sore arm and shoulder. She also experienced swelling of her hands
Pt recvd vax 11MAR92 & devel fever 99.6 for 6 days & devel extreme erythema w/quarter size nodule, still present until 27MAR93; pt recovered;
This spontaneous report was received from an office manager regarding a patient of unknown age and gender. Information on medical history, current conditions and concomitant therapies was not reported. On 16-AUG-2018, 10-MAY-2018 and 03-JUL-2018 the patient was vaccinated with 1st, 2nd and 3rd dose VARIVAX for prophylaxis (strength, anatomical location, route, lot# and expiry date not reported) (inappropriate schedule of drug administration). It was also reported that the patient did not had any adverse event. No product complaint involved.
Immediately after receiving the below listed vaccines, client c/o pruritis, with reddened patches on upper right arm.  These areas were not raised.  Took patients blood pressure (120/80)and readied epinephrine.  Client continued to c/o of itching and some tightening in the throat.  Continued to breathe normally with pulse rate of 78.  Client remained seated for approximately 45 minutes before she stated  she felt fine.  Blood pressure/pulse remained WNL.  Client said she would return home and relax.  She stated she had some pills to take for allergic rxn and planned to take one when she got home. Noted above on clients immunization record and advised client to return to her family doctor for further vaccinations. Client stopped by on 3/30/06 to report hospitalization.  Said that vaccines were not at fault but medication she took after vaccinations was to blame.  Unsure what name/translation of medication is - client is from a foreign country and could not remember medication at this time. 4/20/06 Received D/C summary from hospital which revealed patient experienced allergic reaction to Percocet w/left arm & facial dysesthesias.  Cx to Neuro & ENT both exams were WNL but ENT felt reaction could be to Hep B vax. /ss
This spontaneous report as received from a certified medical assistant via a company representative, refers to unspecified number of less than 10 patients. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with GARDASIL which was improperly stored (lot # J003727, expiration date 07-NOV-2015) (doses, administrations sites and routes unspecified). This is one of several reports from the same reporter. Additional information has been requested.