chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blisters around the eye; Some medication gets on skin; Occupational exposure while preparing product for administration; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than an hour after receiving Shingrix, the patient experienced blister, exposure via skin contact and occupational exposure while preparing product for administration. On an unknown date, the outcome of the blister, exposure via skin contact and occupational exposure while preparing product for administration were unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that while pulling stickers off the vial of Shingrix, some of the medication gets on skin, which led to exposure via skin contact and occupational exposure while preparing product for administration and also had Blisters around the eye the blisters started to appear around the time of preparing Shingrix. The reporter consented to follow up.
nausea, light headed, headache, sore arm, body aches, chills, fever
A rash occurred on my left arm and chest, about days after my injection.  It is June 5, 2019 and it seems to be getting be getting a little better, for instance, from where it started in the middle of my chest (where I had a little bit of Shingles about 3 months after first  Shingrex shot)  but its continuing  to spread around towards my back, now.  Same on the arm, its starting to spread upwards towards my shoulder but not as bad as chest. Just been bathing it in alcohol in mornings, sometimes with Peroxide and using Gold Bond or Benadryl creams to sooth the itching. Hot showers as well but it dosent help the healing.
Initial report received from a healthcare professional on 12 April 2013. A 27-year-old female patient, had received an intramuscular first dose of ADACEL vaccine (batch number: C4366AA, expiry date: 06/27/2015, site of administration was not reported) on 10 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history, health during pregnancy, specific risk factors and concomitant medications were not reported. The patient's last menstrual period date was 16 August 2012 and estimated delivery date was 23 May 2013. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none. Follow-up information received from health care professional on 05 July 2013. The date of birth of the patient was updated. The date of vaccination of ADACEL was updated as 30 April 2013 previously reported as 10 April 2013 and the vaccine was given in left deltoid. The patient had no family history of congenital abnormality and not received any treatments for infertility. The patient had one previous live birth and a congenital abnormality was not reported, no pre-term births, no elective abortions, no fetal deaths (20 weeks gestation) and no complication for delivery. The patient had received Prenatal vitamins during pregnancy on unspecified dates. The patient had gestational diabetes on an unspecified date, during pregnancy which was controlled by diet. The pregnancy outcome details were as follows: The patient gave birth to a female single baby weighing 23.75 (unit not reported) without any congenital abnormality, APGAR score after 1 min was 8 and after 5 min was 9. Mode of delivery was vaginal. List of documents held by the reported: None.
Hives as of first dose that went away and then came back. Now hives upon second dose, in increasing amounts. Hives so far have occurred on both arms, both legs, right for and ankle, and neck.
FEELS HORRIBLE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced feels horrible, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and feels horrible was not reported. This report was non-serious.
Patient received her first Moderna vaccine on 1/22/2021.  She received her second Moderna vaccine on 2/5/2021, 14 days later.  Manufacturer recommends 28 days between doses.
Nausea, near syncope and arm soreness approx. 3 hours after receiving injection; 2 days past injection date pt reports not as bad but still very painful.
Pt developed pain at injection site approx. 36 hours after administration - hardened area without redness.  Also had muscle spasms at site of injection.  The next night she developed itching on her chest and trunk area, woke the morning after that with red rash on trunk and hives around her neck.  Her throat was itchy, chest was tight, lips were swollen.  Came to ER.  Took a Clarinex, symptoms improved minimally but then got worse again.  Later took a Zyrtec, went to bed.  Woke feeling better.
Patient's arm became hot and red around the area where the injection was given. Over the course of two days redness spread until almost the entire posterior area of her left upper arm was affected. Additionally, patient developed a quarter-sized bruise in the immediate area where the injection was given. Patient was advised to use cold compressed to decrease inflammation, Benadryl for itching and to return to the clinic if symptoms worsen or fail to clear within 48 hours.
1 day after: mild chills, sore arm,  headache (night) 2  days after: mild chills, achy eyes, dry sandpapery eyes, skin sensitivity, headache (night) 15, 16 days after: dry sandpapery eyes (all day), injection site shooting pain -come/ go  Ibuprofen taken
Nausea & vomiting, blood in stool. Open reduction of ileocolic intuss with incidental appendectomy.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II, 0.5 ml (route, lot # and expiration date were not provided). Concomitant medication was not provided. On an unknown date, the patient had negative titers for measles and the physician believed the patient was a non-responder. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. The physician also mentioned that she had seen unspecified patients that were administered an unspecified flu vaccine on unspecified dates and the unspecified patients contracted the flu virus. The physician believed this was vaccine failure of the most recent unspecified flu vaccine. This is one of several reports received from the same source. Additional information is not expected. The physician did not authorize to be contacted.
Had initial first vaccine on 1/18/21, no problem to report !! However on 1/29/21 my left arm where vaccine was administered, I had profound itching occured around 12 noon. I pulled my arm outof my garment to reveal a well defined rash on my arm. The rash ran from the the top of my arm to the elbow. Over the next 4 days, I tried tylenol, warm compresses, only to have the rash to become more pronounced and navigate to the elbow with more definition and  involve the elbow with arthralgia With the slighest tough to the elbow, I would flinch. On Monday, Feb 1, 2021, I took photos  and called my PCP who then sent me to to the ER. At the ER I was diagnosed with cellulitis and put on a course of prednisone, cephalexn and diphenhydramine. As of right now, they are concerned about phebitis
Muscles aches - shoulders, neck, arms, headache; TYLENOL 2 days with relief - slept well; next day soreness at injection site - more intense achiness lasting 48 hours has had yearly flu shots forever - 1st time she has ever ached like this.
PCR results Tested Positive for COVID-19 on 10/2.; PCR results Tested Positive for COVID-19 on 10/2.; This is a spontaneous report from a contactable consumer, the patient. This 43-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EL3247, Expiry date: 31May2021) in the left arm on 22Feb2021 (at the age of 42-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EL3247, Expiry date: 31May2021) in the left arm on 15Mar2021 (at the age of 42-years-old); both via intramuscular route as single doses for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient tested positive for COVID-19. Date of start of reaction/event was reported as 28Sep2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received. Lab data included COVID-19 test PCR nasal swab on 29Sep2021 with positive result and COVID-19 test PCR on 02Oct2021 with positive result. The outcome of the event was recovered with lasting effects. Since the vaccination, the patient has been tested for COVID-19.   Investigation results were received from the Product Quality complaints Group for compound BNT162B2 COVID-19 vaccine suspension for intramuscular 2ML multiple dose vial x1, Lot-# (CR): EL3247. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of  complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up (29Oct2021): Follow-up attempts are completed. No further information is expected.
Injection site with 2x2 inch pink raised rash itchy, NT,  without C/C or axillary lymphadenopathy.
This spontaneous report as received from a Healthcare Worker regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored oral, ROTATEQ lot # K015816, expiration date- 29-MAY-2016, lot # K017576, expiration date- 12-JUN-2016. There was no information about concomitant medication. No adverse event was reported. No Product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
24 hours later I started with tingling and numbness in my feet and hands and 48 hours later it got worse, I started having numbness in my buttocks and perineal area. I went to Urgent care they assumed it was a reaction to vaccine, they gave me decadron 10 mg and Benadryl 50 and I went my physician on Tuesday she put me on prednisone 60 mg 2 days tapers to 40 mg 4 days then 20 mg 3 days 10 mg 3 days. I'm reporting back yo my doctor. I'm having some improvements, I still am have paresthesia and neuropathy. I believe the person giving me the vaccine hit a nerve I had excruciating pain.
Pt admitted on 6/2 with diverticulosis, and on 6/9 developed a dry cough with low grade fevers and was found to be COVID positive.
UrticariaPruritus, INJECTION SITE PAIN/SWELLING Narrative:
This is a spontaneous report from a non-contactable consumer reporting on behalf of her son. A male patient of an unspecified age and race/ethnicity received 4 single doses of PREVNAR 13 on unspecified dates, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was checked on an unspecified date by an immunologist and tested for antibody titers, which showed he was only protected against 3 of the 13 serotypes. Furthermore he was keeping getting ear infections since an unspecified date. The doctor recommended to get a fifth dose of the vaccine to improve the titers. Patient's mom wanted to know if this was recommended or not. No follow-up attempts possible. No further information expected.
Three hours after the shot I felt pins and needles on my right side of the face, six hours later I experience extremely high blood pressure 200/100, a couple days after I started having gastrointestinal problemsIndigestion acid reflex felt like a lump in my throat.
LIGHTHEADED, DIZZY,NEAR SYNCOPAL EPISODE. PATIENT LAID DOWN  AND ELEVATED LEGS. PATIENT STATED IT FELT BETTER
Patient received a full dose (0.5ml) when she should have received a half dose (0.25ml) booster. Patient was informed. No adverse effects reported by patient.
Tinnitus - 24/7 since onset, sound of varying degrees of volume Symptoms also include pain in teeth and jaw, headaches
sick; Initial information received on 21-Feb-2022 regarding an unsolicited valid  social media non-serious case received from a consumer/non-hcp.  This case involves a 67 years old male who experienced sick while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect vaccine influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunisation. Information on batch number was requested.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of vaccine influenza vaccine. Patient got one 5 years ago, never been so sick. No more.  Action taken: not applicable.  Outcome: Unknown
Vaccine dose =3, brand=Pfizer / BioNTech/ vaccine dose =4, vaccine brand =Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 4 (booster), single (Batch/Lot number: unknown) and on 29Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine dose =3, brand=Pfizer / BioNTech/ vaccine dose =4, vaccine brand =Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid administered from 23Oct2023.
Patient had a delayed skin reaction/rash , diagnosed with Shingles. Treated with Valacyclovir
Pt had a 6cm x 5cm raised, red area over L deltoid where DTaP was given.
19 DAYS AFTER MY VACCINE WAS ADMINISTERED I HAD MY FIRST SYMPTOM. SYMPTOMS CONTINUED SEVERAL WEEKS UNTIL DIAGNOSIS MADE BY MULTIPLE PHYSICIANS AS *RHEUMATOID ARTHRITIS DISEASE*  NO FAMILY HISTORY. NO PERSONAL HISTORY. NO CO -MORBIDITIES. NO ILL HEALTH ISSUES.
An hour after vaccine I felt lightheadedness, some fogginess, a slow wave of weakness flowed from my face down to the neck, shoulders, arms, torso, thighs, knees, legs, feet.  Although my entire body experienced weakness, I tried & was able to stand and walk cautiously, ate a little bit of chicken, had tea but I had to sit. The weakness remained for about an hour. After which my strength was returning slowly. It took 30min more for the strength in my legs & feet to  fully return.
Patient was given the 2 Influenza Vaccine's at our local pharmacy. They were both administered into her Left Deltoid on 8/24/20 and 9/28/20. We have been unable reach the patient at this time. 10-6-20-pt contacted by pharmacy; no side effects.
Patient received immunizations of HPV. Pt tolerated vaccine. Ambulated self to chair against wall. Approximately 5 minutes after receiving vaccine pt was noted to have uncontrolled body movements.  Pt eyes closed. Nurse supported pt body while she appeared to be losing consciousness. Pt responded to name while being directed to keep eyes open. Pt became diaphoretic, and clammy. Respirations were even. Pt did not lose control of bladder or bowel. Pt continued to have uncontrolled body movements for approximately 3 additional minutes. Pt then continued to appear to lose consciousness, but remained alert to name and ability to follow commands. Pt had emesis x1 of clear liquid.
Severe burning sensation in lower right leg lasting 2.5 hours. Subsided after 2.5 hours Internal tremors/vibrations in lower right leg (shin area) into upper right leg (hamstrings/quad area)still apparent today.
Patient said her arm immediately started getting red, itchy and swelling from shoulder down to elbow. going to doctor today to have it looked at
Initial misuse report received from a health care professional on 01 October 2013. The 63 year old patient had received FLUZONE HD. No adverse event was reported. List of documents held by sender: none
Vasovagal syncope after three minutes of receiving first vaccine dose. Paleness, nausea, sweating, dizziness, and vision blackout. Treated by lying down, applying ice packs, and hydrating with water. Symptoms subsided within five minutes.
When child woke up Sunday AM mother states his lt arm was red, warm to touch and sl swollen.  When she called to report incident on Monday AM, she states area has grown to approx 5 inches in diameter. Area is warm to touch red and hard. She had just been contacted by school nurse with concerns about the area and was encouraged to call and report it to the HD.  Advised client to contact MD to assess it and requested that mother call back to HD with outcome of MD visit.
Significant gas; mostly flatulence; some burping; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown) via an unspecified route of administration in arm right on 15Feb2021 11:00 (Age at vaccination: 52-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing , gluten sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included eszopiclone (LUNESTA) taken for an unspecified indication, start and stop date were not reported; alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported; lorazepam (LORAZEPAM) taken for an unspecified indication, start and stop date were not reported. On 15Feb2021 05:00 PM, patient experienced significant gas, mostly flatulence, some burping. Facility type vaccine was other. Other vaccine in four weeks was none. No treatment received for Adverse event. COVID was present prior vaccination. No COVID tested post vaccination. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Fever of 100.5 degrees on 2/25/22 from 12:45 pm until 6:00 pm. Swollen and painful lymph nodes under left armpit from about 7:00 pm on 2/25/2022 until 5:00 pm on 2/28/2022. Redness on left arm at injection site and feverish at site from about 3:00 am on 2/26/2022 until 11:00 pm on 2/27/2022. Treated with Tylenol, Advil, and ice packs until symptoms were relieved on morning of 2/28/2022.
had Covid 19 disease; had Covid 19 disease; he has had no symptoms of diabetes since having Covid-19; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's cousin). A 62-years-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history included diabetes. The patient's concomitant medications were not reported. It was reported that on an unspecified date, the patient had Covid 19 disease, had diabetes and on insulin, he has had no symptoms of diabetes since having Covid-19. At the time of this report the outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101211823 same reporter/vaccine, similar AE, different patient
I developed a redness around the injection site. The Employee Health nurse took a look at it this morning and upon analysis noticed a bump formed.
Soreness at injection site, fatigue, headache day for about a week long. Friday 10/22 I went to the ER because I was having difficulty breathing and felt some stomach tightness/ pain close to my left chest area. I recovered the next day. Saturday 10/30 I experienced covid like symptoms such as coughing, sneezing, runny and stuffy nose along with headache and body aches. Majority of those symptoms lasted until Thursday 11/4. On 11/ 4 I went to the doctor and took a covid-19 test and flu test. Both came out negative, however my WBC count was still high so the doctor took some blood work to further investigate. Today , I feel better but still experiencing sore throat cough and nasal drainage which cause me to have to blow my nose sometimes. I?d like to add that because of my allergies blowing my nose often isn?t uncommon. However, the sore throat and coughing is.
As I am driving home from the vaccine, I got the shot on my left arm so numbness there seemed normal.  I also got numbness in my left jaw and left thigh which seemed strange.  I thought later maybe this was a mini stroke.  It went on for at least 30 minutes.
Recd flu shot on 9/28/13. 9/30/13 noticed slight rash which spread over next few days and was diagnosed as shingles on 10/3.
Information has been received from a physician and a healthcare worker concerning a patient who was vaccinated subcutaneously with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient developed "swelling and heated skin in the area of the injection." It was reported that the patient sought unspecified medical attention and was not hospitalized. At the time of the report is was unknown if the patient recovered. Additional information has been requested.
pt recv vax; w/in 2 hr of vax,began feeling weak & dizzy & devel elev blood pressure & a HA;c/o tingling in extremities; to MD who said rxn to vax;tx w/ rest for 48 hr & recovered;reporter felt that there was a problem w/ that lot;
A spontaneous report had been received from pharmacist concerning a child, patient of unknown gender. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. The patient had received FLUMIST. The FLUMIST expired on 24-Feb-2016. Child received the vaccine on 07-Mar-2016. The outcome of use of expired product was unknown. The reporter assessed the use of expired product to be non serious.