chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pharmacy technician pulled the wrong product (Infanrix, DTaP) from the refrigerator to restock the pediatric emergency room refrigerators with Adacel (Tdap).  Pharmacy carries Adacel for pediatric ED and pediatric inpatient.  Pharmacy carries Infanrix only for the off-site practices the hospital stock meds for.  Once discovered by nursing when requesting restock, 3 weeks had passed.  Eight patients were potentially affected.  Upon review of the charts, only one patient actually got the DTaP instead of Tdap.  The patient's parents were notified, no adverse outcome to the patient.  The physicians were writing for the drug as Tdap, DTaP and Td, the medication is not listed in the pharmacy profile or the automated dispensing machines with these designations.  We also noted that adult physicians were still writing for Tetanus-Diphtheria (TD) for adolescent and not following the updated 2005 CDC guidelines for adolescent patients 11-18 to receive Adacel (Tdap).  Additionally during chart review, we found that the documentation was not consistently in the same place or done completely (drug name, site administered, lot number, expiration date).  And the vaccine information sheets were not routinely given to the patient.  Tdap and DTaP are currently not allowed abbreviations and the policy was bypassed.  Pharmacy segregated the two products in the pharmacy refrigerator.  Pharmacy changed the designation of the products to be consistent with the labeling on the packaging.  Pharmacy requested ED physicians to write ADACEL instead of Tdap; ED evaluating a trigger on the physician order sheet with Adacel preprinted.  Pharmacy to implement bar-coding of the automated dispensing cabinet to reduce stocking errors.  Documentation of the vaccination to be consistent and placed on the consent for immunization form with triggers for the required information and directions to provide the vaccination information sheet to be universal for the hospital and related sites.  The use of Adacel for all patients (11-64) is being evaluated by the ED leadership.  Vaccines are not emergent medications and are being evaluated pharmacy review instead of the override status the vaccines are currently in.  Education to be provided to all staff regarding the updated CDC recommendations the writing of brand name of the medication in the order.  Medication order writing policy to be enforced regarding the abbreviations.
Watery diarrhea started 4 days after vaccines. Stool is hene (+) but not grossly bloody
Family reported patient had increased seizures after receiving vaccines. No documented hx of seizures prior to vaccines.
My right arm broke out in hives slightly less than 24 hours after receiving the vaccination. It started as slightly itchy spots, then progressed into hives over all of my forearm.  I also have an intermittent fever of up to 103 F over the 28 hour period following my shot and was incredibly fatigued.
Immediately after receiving vaccination my son's cheeks became flushed, he broke out into a full body rash, a lump formed under his skin at the injection site, and he began crying intensely. The dr administered 12.5 mg of BENADRYL.
pt recvd MMR vax & 24 hrs following vax pt devel nausea, aches, pain, & flu-like sx; no further details were provided;
I am nauseated; I get sick, and nobody cares for me; I feeling unwell and my ribcage on right side hurt,; my ribcage on right side hurt; I feel unwell, and like I said, when I got up this morning, my shot arm was really bad but then it went away and I got this like my rib cage; so tightening and starting to hurt, like I got infection in my chest or something; when I woke up this morning, I told you, woke up this morning my arm started hurting me, my elbow and then it went away and I started moving around; This is a spontaneous report from a contactable consumer. A 75-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN5318), via an unspecified route of administration on 03Feb2021 (Wednesday) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included prostate cancer since, 12 years ago. He has been fighting prostate cancer for 12 years, had radiation treatment in the beginning and then had hormone therapy for 9 years, on and off and is still on hormone therapy pills now; high blood pressure; radiotherapy since, 12 years ago. Concomitant medication(s) included amlodipine besilate (NORVASC) 10 mg taken for hypertension, darolutamide (NUBEQA) taken for prostate cancer, paracetamol (TYLENOL) and buspirone (BUSPIRONE). The patient's vaccination history included polio shot when he was a kid and did not get sick after that. On 05Feb2021, the patient was feeling unwell and ribcage on right side hurt; he feel unwell, and like he said, when he got up this morning, his shot arm was really bad but then it went away and he got this like my rib cage; so tightening and starting to hurt, like he got infection in my chest or something; when he woke up this morning, arm started hurting me, my elbow and then it went away and started moving around; was nauseated ; he gets sick, and nobody cares for him. The patient had to go outside move his car, but rib cage started hurting. Patient was at home and can get no treatment. On an unknown date in 2021, the patient underwent blood test which had no result. The patient had breakfast, was sick to stomach, nauseated but sick like and wanted to know if he can take Pepto-Bismol. The patient says that he stills feels the same way. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Redness, swelling, itching, feverish spot at/near site of injection received 9 days prior
Rash to both left and right thighs, red, hard raised areas at site of injection.
Chills; sometimes sweats; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HYPERHIDROSIS (sometimes sweats) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and HYPERHIDROSIS (sometimes sweats). At the time of the report, CHILLS (Chills) and HYPERHIDROSIS (sometimes sweats) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant products was not provided.
Began breaking out in a red rash on face and chest about 15 minutes after vaccines She was given 25mg of Benadryl by mouth per order of provider. Rash and redness resolved by 11:00 am.   50 minutes later
Rec. shingles vac. Jan.4, 2013 macular/vesicular eruptions approx 1/21/13 Definitive Dx: Chicken pox at hospital ER. Cellulitis down legs.
He had no side effects immediately after the shot. About 2 weeks after the shot, he had a grand mal/tonic clonic seizure. It was the first seizure he'd had in about 10 or 11 years. (He never ran fever.)
14 hours later had 103 fever with chills, joint pain, migraine x 16 hours.  The next day fever down, but has joint pain and dull headache.
Mom states that child received a flu shot at the middle school on 10/24/18. Mom states that shot was administered in the back of the arm and he developed a large hematoma. Nurse at the middle school called the child's mom on 10/24/18 and said he had a large knot on his arm and the teacher had sent him to the office. Mom took son to the Dr. and was told to put heat on it 3 times a day until Monday November 19, if not resolved she will schedule an ultrasound and may have to be surgical removed. Called 11/16/18 at 0930 to obtain information for VAERS. No answer. Patient's mom said the knot and bandaid was located more towards the back of the arm in the flabby part instead of the deltoid muscle. Patient's mom stated she was a nurse and worked at hospital. She stated she did not notice any brusing, just the knot. She took the child to Dr.'s office on 11/14/18 saw NP. Mom stated the hematoma was encapsulated. I apologized to the Mother and explained about the VAERS form and she was okay with me completing the VAERS. I also explained about the vaccine compensation program and gave her the phone number and website for more information.
On February 26 I got my second Moderna booster shot. On March 2 I got a blood test for my routine medical annual checkup. It showed my RBC and my WBC were below the minimum normal levels and my platelet count was 100, well below the 140 lower normal limit. Also, my lower lip was swollen and chapped.  On March 8 I went in for a second blood hematology panel. My  WBC was normal, my RBC was 4.31 where 4.5 is normal, and my platelet count was 123. My lower lip was still swollen and chapped. Today on March 13, my lower lip is still swollen and chapped.
Breaking out, had a rash; the pain in her arm was like something she never felt before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 02Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in arm; influenza vaccine (FLU), on 02Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (1st booster), Lot/NDC/Expiry: Not provided, caller unwilling to complete report.), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset Jun2022, outcome "unknown", described as "Breaking out, had a rash"; PAIN IN EXTREMITY (non-serious) with onset Jun2022, outcome "unknown", described as "the pain in her arm was like something she never felt before". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients were vaccinated with VAQTA (dose, lot and expiry date was unknown). The vaccine was exposed to 28 Fahrenheit for 15 days, an excursion that was found to be unsupported by in-house stability data. No adverse symptoms were reported. The nurse was unable to provide administration dates and well as lot and expiration dates for the vaccine involved. This is 2 of 3 reports by same reported. Additional information has been requested.
at 6:50 pm, 32 yo pt c/o tingling and puffy lips. Pt's speech at baseline and is able to swallow w/no difficulty.  Pt appeared in no apparent respiratory distress ( no wheezing nor stridor).  Pt noted that he did not eat anything today.  EMS was activated. O2 Sat 98%.  at 7:05pm, VS BP 130/90, HR 75, RR 18. Pt wad medically stable and released to home.
Second dose was missed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was missed) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was missed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was missed) had resolved.            The Treatment history was not reported .The concomitant medication was not reported.
deafness; Tinnitus; ear pressure; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0105) via an unspecified route of administration into the right arm on 05Apr2021 15:45 (at the age of 57-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, hypothyroidism and asthma. Patient was not pregnant. Concomitant medications included simvastatin (SIMVASTATIN), quetiapine (QUETIAPINE), magnesium (MAGNESIUM), acetylsalicylic acid (ASPIRIN (E.C.))and bepotastine besilate (POTAS). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534) into the right arm on 16Mar2021 01:00 PM (at the age of 57-years-old) for COVID-19 immunization. On 06Apr2021, patient experienced deafness, tinnitus and ear pressure. The patient did not receive treatment for the events reported. Outcome of events recovered on Apr2021.
Migraine headache, extreme sleepiness, left axillary lymph node swelling and tenderness
Rash to LUE and across abdomen. Mild dyspnea - self-limited, resolved after ~ 25 minutes. Patient refused medication or transfer to ED.
headache; body ache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th April 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, less than a week after receiving Shingles vaccine, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received 2nd shot and asked if he/she could take Aspirin or Tylenol for his/her headache and body ache and was it ok. The patient mentioned that, he/she would call his/her doctor as his/her symptoms were mild. The follow-up would not possible, as no contact details were available.
soreness around vaccination site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (soreness around vaccination site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness around vaccination site). On 27-Apr-2021, VACCINATION SITE PAIN (soreness around vaccination site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-181520 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
My wife and I were traveling, we wore our mask everywhere but did take them off to eat. On July 9, 2022 I had I scratchy throat, on July 11, 2022 I had a fever of 105F, runny nose, sore throat. I took a home COVID-19 but it came negative, I went in to an urgent care to have a PCR COVID-19 test, it came back positive. I was prescribed PAXLOVID and started it immediately. As of Saturday I feel much better even though I am still testing positive.
Hospitalized 9/13/21; Covid + 9/13/21 fully vaccinated.  The patient has decided on symptomatic and comfort management versus continued aggressive treatment as of 9/19/21 and is currently still in hospital
3/4 arm pain along top of left arm from shoulder to finger tips. Resolved in 3 days. 3/14 itching around neck and mouth. Noted 5mm lesion on left chest, redness and itching, non-pustular. Also had several macular lesions on wrist. Lesions resolved, were never pustular. 3/17 noted 15cm redness around vaccination site, not corresponding to tape. Resolving in 48 hours.
This spontaneous report was received from a certified medical assistant via a company representative referring to an 11 year old non-pregnant female patient. The patient did not have concurrent conditions, drug reactions, allergies and medical history. On 08-MAR-2016, the patient was vaccinated with her third dose of GARDASIL 9 lot # L045711, expiration date 08-MAY-2017 (route, dose and anatomical place of vaccination were not reported). The patient did not take concomitant medications and was unspecified when the patient received the previous two doses of GARDASIL 9 series. On an unspecified date between 08 and 09-MAR-2016, the patient developed a widespread rash on an unspecified location of the body. On 10-MAR-2016, the patient sought for medical attention and was seen by a nurses practitioner who prescribed "BENADRYL" every six hours until the resolution of the rash. There was no intervention to prevent serious criteria, the event was not cancer or overdose, the patient did not die nor the experience was life-threatening, there were no significant disability or incapacity, no hospitalization and no product quality complaint was involved. At the time of the report, the outcome of rash generalized was unknown. The reporter did not provide a causality assessment. Additional information has been requested.
Female complains of sore right arm, 8 days after shot given.  Sats has limited motion of arm without having full ache in arm muscle.  No swelling or rash present or fever, taking IBUPROFEN for soreness.
Body Aches started around 5pm and through to the next morning Headache started around 5pm and through to the next morning Banging sound of my Rapid Heartbeat woke me up just after midnight;  Fitbit showed heart beat around around 107 bpm. Next day when I read my Fitbit information, I found out my heart beach had been up to 127 around midnight
father stopped by hlth dept today stating pt woke up the day p/vax w/rash on neck;states rash has gradually spread onto rest of body-c/o rash itching-states not, aware of any fever;
immediate complaint of racing heart rate and numbness in hands after vaccination, patient heart rate max was 135 but then resolved in minutes and stayed in 80s-100.  We put her in reclining chair, gave water and cookie.  She stated she had not eaten all day--she then wanted something salty and ate potato chips.  She appeared to be breathing fast and complained her mouth was dry.  after an hour she requested an ambulance.  We called one immediately.  They transported her to the ED
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Case number PHEH2014US020328 is an initial spontaneous report received from a nurse on 07 OCT 2014. This report refers to a 13 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLCELVAX 2014/2015 (batch number: not reported) intramuscularly at a dose of 0.5 ml in SEP 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Pediatrician was not concerned. No additional details available.
The day after receiving the vaccine I started my menstrual period.  I had not had a period for 7 months and thought I was in Menopause.  I continued to get a period in Feb '21, and Mar '21.  In April of '21 I got a period and that did not stop.  I visited my GYN who did an endometrial biopsy and a polyp was found.  A D&C was performed on 5/26/21.  There were no abnormal cells found in the specimen from the D&C.  I again had a period on 7/22/21.  It appears that I was not in Menopause or for some reason my periods have restarted.  I do not really think this was related to the vaccine but I know other women have been experiencing this so I wanted to report it.
Throwing up; She feels nausea; still feels woozy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 19Jan2021 at 09:11 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included ongoing nose has been running, ongoing diabetes mellitus, and sinus infection. Concomitant medication included an unspecified every day medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the shot on 19Jan2021. On the same day, when she came home, she has been throwing up for the last 30-40 minutes. It was like it came on all of a sudden. She feels nausea and still feels woozy. This was her first dose. She is scheduled to get the second dose on 10Feb2021. She wanted to know what she should do. The outcome of the events was unknown.
little tired; sore; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had shingles vaccine (Shingrix) earlier this year, the 1st shot was OK a little tired and sored. For 2nd dose tolerance refer case US2020AMR239668.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR239668:same patient, 2nd dose
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.    No adverse effects noted or voiced by patient.
The patient had a localized rash near the injection site. The patient was told to monitor the rash and report to the ED if symptoms continue or worsen.