chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 53-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th May 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 17th May 2018, the patient experienced injection site cellulitis (serious criteria other: Serious as per reporter). The patient was treated with Cephalexin and prednisone. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) received report of this adverse event from a co-worker at her retail pharmacy, did not directly speak to the patient. The HCP reports that the physician (MD) diagnosed left arm cellulitis and documented that the SHINGRIX was administered midway in the upper left arm, not the deltoid, which led to vaccine administered at inappropriate site. Three days after vaccination the patient was diagnosed with cellulitis at the injection site on the left arm. The patient reported to the retail pharmacy that they went to the doctor, were diagnosed with cellulitis, and prescribed antibiotics (Cephalexin) and prednisone to treat. The HCP stated disagreement with this documentation and thought the cellulitis spread lower.
Right local erythema, warmth and swelling thigh; 4 hours after injection of DTAP (Daptacel) and HIB (Act HIB) into right thigh
Within 1-2 minutes of receiving the vaccine patient reported feeling nauseous and lightheaded as well as dizzy. Denies sensation of throat, lip, or tongue swelling. Denied feeling short of breath. Patient was transported via wheelchair to treatment room and placed in tendelenberg position. Reported improvement in the dizziness within several minutes. Nausea improved but did not fully resolve. Patient was able to tolerate sitting and walking without return of dizziness or shortness of breath. Vitals wnl. No signs/symptoms of anaphylaxis. Discussed with patient vasovagal reaction. Patient felt well enough to go home and was discharged with follow up precautions.
Information has been received from a registered nurse, concerning a 68 year old male with hypertension, diabetes and renal insufficiency and a history of hepatitis A who on 01, Mar 2007 was vaccinated SC with one dose of zoster vaccine live (Oka/Merck) (lot# 656606/0033U). Concomitant therapy included metformin HC1 (GLUCOPHAGE), hydrochlorothiazide (+) irbeaartan (AVALIDE), metoprolol succinate (TOPROL XL TABLETS) simvastatin (ZOCOR), aspirin and alloparinol (manufacturer unknown). Subsequently the patient experienced shingles. Several days after he received the vaccine, there were blistery rashes on his right breast and under the right arm to the back, The rashes were very painful and itchy. He was given pregabalin (LYRICA) and valacyclovir hydrochloride (VALTREX) for pain. Health care professional was not interested in VZV analysis by PCR (polymerase chain reaction). As of 12, Mar 2007 the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
***Not an adverse event*** This was  a vaccine administration error.  Patient was administered her vaccine with a contaminated syringe.  Syringe was faulty and had been used on a patient earlier in the day, thus was contaminated.  The dose was unable to be delivered from the syringe and the patient was administered their dose with a different syringe.  Patient was referred to her PCP/Urgent care/ER for treatment due to the contaminated syringe being used on her.
Swelling underneath the skin about 1/2 inch in diameter- skin became hard and swollen immediately after giving the shot, even circumference around injection site.
Pt vaccinated with DTP/OPV/HIB Titer experienced eyes deviated to rt, generalized tonic clonic movement for 30-45 seconds CT scan -; MRI -; EEG localized sporadic spike in rt temp post region & to lesser degree rt inferior temp region.  .
12/16/2020 WENT TO SLEEP AT 10PM 12/17/2020 - WOKE UP ABOUT 1:00 AM;  101 TEMP, SHAKING, CHILLS, BODY ACHES, RIGHT ARM VERY SORE, TRIED TO GO BACK TO SLEEP 12/18/2020 - FATIGUE, BODY ACHES, TEMP SUBSIDED; EVENING FELT SHAKY; 'CALLED OUT OF WORK' (NIGHTSHIFT NURSE) 12/19/2020 - ALL SYMPTOMS SUBSIDED 09/2020-10/2020 HAD FLU SHOT 'CANT REMEMBER EXACT DATE'
No additional adverse event information provided; Improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported.  On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S013715, expiry date: 01-NOV-2020) (dose, frequency and route were not reported) for prophylaxis.  The sterile diluent(DILUENT MRK INJ) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. Multiple excursions were involved with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) with unspecified temperature and time frame. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 04-JUN-2015, the patient was vaccinated with one dose of improperly stored (Oka/Merck) VARIVAX (dose, route and site of administration were not reported, lot # K008819, expiration date 19-JUN-2016. No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Initially, headache, fever to 103F for two days. Elevated heart rate, nausea, vomiting, cough congestion and subsequently severe hives and blistering all over body that still persist currently.  Hives have abated, but blisters still come and go especially on opposite arm of vaccination. Original blister has persisted throughout course never abating. It is located on right shoulder. Oval in shape, 1 x 1.5 inches.
This case was reported by a physician via call center representative and described the occurrence of general body pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 16th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported via web form email. The age at vaccination was not reported. The HCP (healthcare professional) reported the patient had body pain for 3 hours after a dose of SHINGRIX. The caller did not speak with the HCP. This case has been linked to the US2018115893, reported by the same reporter for the same patient.
Pt had no adverse reactions. We called and spoke with the patient on 7/6/2023, he stated he felt fine.
patient who received the VARIVAX in 1993 (he was 8 years old at the time) and has negative varicella titer; This spontaneous report has been received from a nurse and refers to a 35-year-old male patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 1993, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route and anatomical site of administration were not provided).  On 26-SEP-2022, Varicella titer test was negative (varicella virus test negative). The reporter wanted to know if the patient would receive one dose o 2 doses of the varicella virus vaccine live (oka/merck) (VARIVAX).  At the time of reporting, the outcome of the event was not provided.  The causal relationship between the event and the suspect product was not provided.
Neuropathy began in my toes 12 hours after 2nd dose and has progressed steadily since. My feet, legs, and hands are now included to the extent that I'm having to file for disability because I cannot function.
RED WARM AREA TO RIGHT ARM WHERE MENACTRA WAS GIVEN(03/04/2009). PATIENT WAS SEEN BY DR. AND MOM WAS INSTRUCTED TO WATCH AREA FOR ANY CHANGE AND APPLY COOL COMPRESS, GIVE IBUPROFEN. RECHECK IF NOT BETTER.
felt warm; Feeling  "not great /feeling like she would pass out; felt extremely weak; dizzy/ had to lay down on the floor/m feeling like she would pass out/everything was "whirling"; clammy; "extremely hot"; had to lay down on the floor /30 to 45 minutes of laying on the floor; everything was "whirling"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt warm), FEELING ABNORMAL (Feeling  "not great /feeling like she would pass out ), ASTHENIA (felt extremely weak), DIZZINESS (dizzy/ had to lay down on the floor/m feeling like she would pass out/everything was "whirling") and COLD SWEAT (clammy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease, Latex allergy, Drug allergy (Allergy to codeine), Bee sting, Drug allergy (Allergy to codeine derivatives), Drug allergy (Allergy to Morphine) and Acetaminophen (Allergy to Tylenol). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING HOT (felt warm), FEELING ABNORMAL (Feeling  "not great /feeling like she would pass out ), ASTHENIA (felt extremely weak), DIZZINESS (dizzy/ had to lay down on the floor/m feeling like she would pass out/everything was "whirling"), COLD SWEAT (clammy), FEELING HOT ("extremely hot") and SOMNOLENCE (had to lay down on the floor /30 to 45 minutes of laying on the floor). 12-Mar-2021, the patient experienced VERTIGO (everything was "whirling"). At the time of the report, FEELING HOT (felt warm), FEELING ABNORMAL (Feeling  "not great /feeling like she would pass out ), ASTHENIA (felt extremely weak), DIZZINESS (dizzy/ had to lay down on the floor/m feeling like she would pass out/everything was "whirling"), COLD SWEAT (clammy), FEELING HOT ("extremely hot"), SOMNOLENCE (had to lay down on the floor /30 to 45 minutes of laying on the floor) and VERTIGO (everything was "whirling") was resolving.            It was reported that patient is healthy, and  iron levels are good, and kidney and liver functions are good.   No treatment medication was taken by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021:
In the emergency room workup, patient was found to have metabolic  acidosis also COVID-19 positive on August 5, 2021.  The patient admitted for  acute respiratory failure due to COVID-19 pneumonia requiring mechanical  ventilation.  CT of the chest showing ground-glass opacities demonstrated  likely due to pulmonary edema.  Patient was started on IV vancomycin and  Zosyn.  Also found to have diabetic crisis DKA.  Patient was started on DKA  protocol, insulin drip, also started on Decadron and remdesivir, concern for  sepsis due to COVID-19 pneumonia.  Lactic acid was elevated with possible  superimposed gram-negative rods and pneumonia.  During hospital stay, D-dimer  significantly elevated.  Lower extremity ultrasound showing a nonocclusive DVT  in the right femoral vein and left femoral vein.  Patient started on full  anticoagulation, Lovenox per ICU, acute respiratory failure, likely due to  metabolic acidosis from DKA.  Patient was extubated on August 7, 2021. Patient started on sliding scale.  Per chart review, shortness of  breath likely due to metabolic acidosis from DKA, Decadron and remdesivir were  stopped.  Hospital stay complicated with hypernatremia and hypokalemia.   Patient was started on D5W and sodium corrected.  Magnesium was normal limits  but patient was refusing to take potassium tablets.  Wide-spectrum antibiotics  were de-escalated.  *** urine and blood.  Patient did test positive for MRSA  on nares and received vancomycin.  Patient was started on long-acting insulin  b.i.d.  For his lower extremity DVT, plan is to discharge him on Xarelto.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 31-JAN-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/13/2021. PATIENT FULLY VACCINATED ON 03/18/2021.
Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patient received doses of ROTATEQ (lot#, dose, not reported, orally) stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
My COVID-19 symptoms started on 02/01/2023 at 02:00AM. I had low grade fever. The next morning on 02/02/2023 I did a COVID-19 home test which was positive. I called my doctor on the same day and he prescribe me PAXLOVID for 5 days. After 6 days I tested negative. The first time I had COVID-19 infection I had permanent lung damage. Then I contacted COVID-19 infection again after my 4th dose.
24 hours after injection- area was hot, increased pain, and reddened to size of orange,  Site continued to get worse, at 48 hours area of redness had more than doubled in size, very itchy, hot, painful.  Pt states area of redness approx. 2-3 inches below vaccination site.  Today, 1/18/22 pt reports still reddened, but getting darker in color like a bruise, very itchy, and hot.  Pt reports icing area several times per day, Benadryl cream to area.  Pt states she notified her provider this am via portal
High blood pressure, high resting heart rate over 120 bpm, fever, chills, excessive sweating, joint and body pain, swollen lymph nodes .
Increase in heart beat without physical activity followed by chest paid, not continually but on and off.
Fever; Chills; This is a spontaneous report from a contactable consumer (the patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration on 03Feb2021 07:00 (at the age of 68-years-old) as a single dose for COVID-19 immunization. There was no medical history and no concomitant medications. On 04Feb2021, the patient had two side effects, fever and chills. The patient got his shot about 7 am (03Feb2021), and about 1 or 2 O'clock the next morning (04Feb2021), he woke up with fever and chills. He did not receive any treatment. He will get the second shot. The clinical outcome of fever and chills was recovered on an unspecified date.
Your vaccine messed me up; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Your vaccine messed me up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Your vaccine messed me up). At the time of the report, FEELING ABNORMAL (Your vaccine messed me up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Inappropriate schedule of vaccine; Rash; Felt ill; Red injection site; Swollen injection site; Sore injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2018, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling unwell, injection site erythema, injection site swelling and injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rash and injection site erythema were recovered/resolved and the outcome of the feeling unwell, injection site swelling, injection site pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash, feeling unwell, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 65 or 66 years. The patient experienced red, swollen, sore injection site, a rash, and felt ill for three days.  It was reported that the red, swollen injection site lasted longer than 3 days. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Myalgia, Fever, chills, sore throat, and pain at injection site Narrative:
07:35 Flu shot given, 7:40am  starting feeling weak, dizzy and pressure in throat and puffy lips. Went to the ED immediately  and was put on IV of  Benadryl, decatron  and pepcide .  Observered for 2 hours then given  PO dose of decadron  when discharged and instructed to take the dose of decadron 48 hours after she left and benadryl  q6hours and pepcide q24 hours
PT CAME IN TO REPORT INJECTION SITE RXN - DID OBSERVE LOCALIZED REDNESS, NO WARMTH OR SWELLING, NO PAIN OR TENDERNESS REPORTED BY PT.
PATIENT REPORTS ARM IS SWOLLEN  AND ITCHING. INJECTION SITE IS SWOLLEN. REDNESS AROUND THE INJECTION SITE EXTENDING DOWN TO THE ELBOW.  PATIENT HAS APPOINTMENT WITH PRIMARY CARE TO FOLLOW UP AND RECEIVE TREATMENT IF NECESSARY.
This spontaneous report was received from a physician, via company representatives and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified date, the vaccine experienced a temperature excursion of 32 F for 48 hours (lowest recorded temperature). The vaccine status was reported and "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)".  This is one of several reports received from the same reporter. Additional information has been requested.
From history and physical on 1/9/22: "Patient is a 63 y.o. male with PMH of COPD, AFIB on anticoagulation, HTN, HLD, Hep C and homless who presents to the ED for evaluation of chest pain and high heart rate. The chest pain is intermittent, having increased shortness of breath with these episodes as well as shortness of breath, wheezing and cough worsening x 2 days. He reports compliance with his medications including his Xarelto and inhalers. He has had the single dose Janssen COVID-19 vaccine 4/7/21 followed by a Pfizer booster dose 12/20/21 after being hospitalized from12/6-12/16/21 at BHL for COPD exacerbation requiring ICU/intubation. Denies fever, chills, lower extremity swelling, orthopnea, syncope. He has been eating and drinking ok, tells me he was on a puree diet while in the hospital but has advanced back to regular food without any coughing or choking episodes.   Review of EMR for that admission on 12/6/21: intubated in the ED, empiric abx w/ rocephin/doxy, diuresis, steroids and bronchodilators. Extubated 12/10/21 and tx to tele floor 12/13/21, transitioned to PO prednisone at that time. Was d/c'd w/ 5 days or PO doxy/prednisone, Spiriva, Pulmicort, expectorant w/ plans to f/u w/ pulmonary associates; also given flu/pna vaccines; d/c'd back to the Center.   ED w/u today w/ findings of patient testing positive for COVID-19; leukocytosis w/ WBC 16.32; proBNP 2327.0, troponin negative x 2 and d-dimer elevated at 2.53; chest xray w/ nonspecific findings pulmonary venous hypertension and bilateral ISLD at or near baseline.    COVID-19 - oxygen saturations 91-93% on room air, not on baseline oxygen"