chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving her vaccine, client stated she feels light headed.  Vital Signs obtained:  B/P 175/90, HR 80, O2 Sat 100%.  Client advised that she needs to go to the ER with EMS.  Client declined.  Client states she feels better.  Client discharged home by EMT.
Patient had episode of pallor, hypotonia and hyporesponsiveness approximately 2 hours after receiving his 2 month immunizations (DTap, Hib, PCV, IPV, Rota and Hep B).  The episode lasted approximately 1 hour then resolved spontaneously.  He had several shorter episodes of similar symptoms over the next 3 to 4 hours.  His parents called 911 shortly after the onset of the initial episode and he was transported by ambulance to the ER.  He was evaluated with a head CT and a sepsis workup and was started on Rocephin.  The CBC and CSF were not concerning for infection and the blood, urine and CSF cultures were eventually reported as negative.  He was hospitalized for 3 days and also had a normal EEG while in house.  He had no recurrance of symptoms during that time.  6/02/2008 MR received for DOS 4/18-21/2008 with D/C DX:  Apparent Life Threatening Event. Hypotonic-hyporesponsive episode after vaccination. Infant presented after several episodes of pallor, decreased responsiveness, and decreased muscle tone. In ambulance had episode of bradycardia into the 80s.  Only responsive to sternal rub. PE WNL. Pt improved and had no further episodes.
5ml syringes that had been provided  were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/23/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable in my left armpit since Friday 3/12/21 noon, but I only realized it was swollen when I went to take a shower around 8:00 pm. I'm feeling it  swollen, burning and mild pain.
Within 24 hours post-vax, the patient developed a local area of redness and swelling at the injection site. Further information was requested.
Swelling was hot to touch; Bruise at injection site; Itching near the injection site; Arm at the injection site was really swollen up(finger's length amount of swelling); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Swelling was hot to touch), VACCINATION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Arm at the injection site was really swollen up(finger's length amount of swelling)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Swelling was hot to touch), VACCINATION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Arm at the injection site was really swollen up(finger's length amount of swelling)). At the time of the report, VACCINATION SITE WARMTH (Swelling was hot to touch) outcome was unknown, VACCINATION SITE BRUISING (Bruise at injection site) and VACCINATION SITE PRURITUS (Itching near the injection site) had not resolved and VACCINATION SITE SWELLING (Arm at the injection site was really swollen up(finger's length amount of swelling)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had itching like a mosquito bite.  No concomitant medications were reported.  No treatment information was provided.
did not receive the second shot; two days after taking the shot, the patient's boobs grew a lot; vaginal bleeding from  the uterus/started bleeding and that was not a good thing; vaginal yeast infections were still there ( re-occurring every 3-4 weeks); This spontaneous case was reported by a consumer and describes the occurrence of BREAST ENLARGEMENT (two days after taking the shot, the patient's boobs grew a lot), VAGINAL HAEMORRHAGE (vaginal bleeding from  the uterus/started bleeding and that was not a good thing), VULVOVAGINAL MYCOTIC INFECTION (vaginal yeast infections were still there ( re-occurring every 3-4 weeks)) and PRODUCT DOSE OMISSION ISSUE (did not receive the second shot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding from  the uterus/started bleeding and that was not a good thing) and VULVOVAGINAL MYCOTIC INFECTION (vaginal yeast infections were still there ( re-occurring every 3-4 weeks)). On 13-Feb-2021, the patient experienced BREAST ENLARGEMENT (two days after taking the shot, the patient's boobs grew a lot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive the second shot). At the time of the report, BREAST ENLARGEMENT (two days after taking the shot, the patient's boobs grew a lot) and VAGINAL HAEMORRHAGE (vaginal bleeding from  the uterus/started bleeding and that was not a good thing) outcome was unknown, VULVOVAGINAL MYCOTIC INFECTION (vaginal yeast infections were still there ( re-occurring every 3-4 weeks)) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not receive the second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Weight: weight gain of 5 pounds (High) weight gain of 5 pounds. On an unknown date, Weight: weight loss (Low) After 5 or 6 months, the weight when away like woof..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided. The patient went through tests and the physician found out that there was no cancer. These  reactions never happened to the patient before. The patient thinks that the patient got too much of the shot. The patient wants to know if the vaccine could cause any hormonal imbalances and whether the 3rd dose (dosage amount) is given the same to a man weighing 210 lbs and the same for a 1000 lb woman.
Patient reported experiencing adverse reaction 9 hours after receiving vaccine. The reaction included a splitting headache, fever (not measured), chills, weakness, and full body aches. After calling her daughter she took Tylenol at 3 am and began to feel better at 6 am. She felt better by morning and did not go to a healthcare facility for assistance but reports that she "felt like she was going to die."
PATIENT STATES SHE IS HAVING MUSCLE SPASMS, SLEEP DISTURBANCES AND TINGLING SENSATIONS IN HER FINGERS.  THESE SIDE EFFECTS COME AND GOES THROUGH OUT THE DAY.
4:50 20 minutes with GARDASIL injection #1, pt c/o Left leg hurting, stating "I know I received shot in my left arm, but my leg hurts like I had the shot in my leg." Pt also c/o dizziness. BP 110/60, P76, R20. Pt had not eaten or drank anything all day. H/o hypoglycemia. Provided juice and crackers Pt felt better. Dizziness gone. At 15:15 pt discharged per Dr - leg was still painful.
pt's wife reports that with 1st dose pt experienced left arm soreness and pain which went away the next day. With 2nd dose, pt experienced muscle ache and whole body was painful to the touch, had very low grade fever for ~1/2 hour which all dissipated within a day or two. Then ~2 weeks post-vac of 2nd dose 1-2 rash-like spot appeared on the left arm, then 1 week later afterwards 3/30/2021 the rash spread through the pt's entire body and they are itchy describing it as "like a measle" looking rashes.
Chest Pain started 9/8/21 typically noticed when lying down, felt like pressure/tightness and like heart was beating stronger, some pain radiating into left shoulder.   Went to the doctor on 9/20/21 to be seen for this.  The initial symptoms have mostly subsided but am experiencing some sharper pains in chest that come and go occasionally that started on 9/26/21.
Pt recv vax on 6/24/98; on 7/7/98 pt exp indurated, erythema at vax site
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # M020100, expiration date 07-MAR-2019; dose and route were unknown). The vaccines were exposed to temperature excursion of 1 degree centigrade for 12 hours and 1 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. No adverse effect were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
they had a temperature excursion 3/31/2023/ Date of administration: 7/7/2023; The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally administered after the new short dated expiration date; The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally administered after the new short dated expiration date; This spontaneous report was received from an office manager and refers to a patient of no reported age or gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliters, lot #W035470, expiration date: 06-MAY-2024, administered as prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) following a temperature excursion of 6 degree Fahrenheit (F) up to 14 F 4 hours 0 minutes; 14 F up to 46 F 4 hours 0 minutes; 47 F to 77 F (50 F) 3 hours 57 minutes (TOTAL: 11 hours 57 minutes)  (Improper storage of product in use). The vaccine was short-dated, and a new expiration date of 30-JUN-2023 was given, it was mentioned that the vaccine was labeled but still accidentally administered after the new short-dated expiration date (Expired product administered, Product expiration date issue).  This is one of several cases from the same reporter.
Sore and achy with muscle weakness, lower respiratory congestion, cough, temperature over 100 degrees Fahrenheit, nausea,  loss of appetite,  indigestion, diarrhea, headache, delirious, brain fog, bedridden. Treated at home with bed rest, ice packs, increased fluids, Ventolin inhaler, and OTC meds including Tylenol, Mucinex, and antacids. Discussed situation with medical professionals.
pt recv vax 6JUN90 & 13MAR98 lab eval revealed elevated liver enzymes;13MAR98 lab tests were performed: alk phos 244;SGOT 36;SGPT 71;Bilirubin 0.6;GGT 289, triglycerides 279, cholesterol 288 & leukocyte esterase positive;
Received PNEUMOVAX 7/19/10. Came back to clinic 7/21/10 L upper arm swollen red, warm - diagnosed cellulitis - Prescribed ROCEPHIN 1 gm on 7/21. Also KEFLEX PO for 10 days.
Pt devel a sterile abscess @ the inject site p/recvd DT (ped); surgery was required to treat this rxn;
Pain at the location of the injection site, headache formed roughly 8 hours later. Roughly 14 hrs post dose, body aches began. Advil was taken, symptoms improved after a couple of hrs later chills began to set in, Advil was used again. On day 2 post dose a tender red rash appeared at the injection site. All other symptoms resolved except for a mild headache
In September, 1999 the pt received her first dose of Lymerix, subsequently , she experienced arm pain which "is getting worse".  In November, 1999, the pt received her second dose of Lymerix, subsequently, she experienced arm pain again and is "getting worse".  The pain started at the vaccination site and has progressed to both of her arms.  The most recent information received on 12/7/99, reports the condition of the pt as getting worse.
itching to face, neck, head while off Xeljanz; This is a spontaneous report from a contactable other health care professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 46-year-old), as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ) taken for an unspecified indication from 18Mar2021. The patient experienced itching to face, neck, head while off xeljanz on an unspecified date. The patient took off Xeljanz per MD request 1 day prior and 1 week after receiving COVID vaccination. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu-like symptoms; feeling a bit tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series complete; , Dose 1, Single), for COVID-19 Immunization; Comirnaty (Dose 2, Single), for COVID-19 Immunization; Comirnaty (Dose 3 (Booster), Single), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "feeling a bit tired".  Additional information: Description of Event: After approx. 10 hours from a covid vaccine booster shot experienced flu-like symptoms. 24h after still feeling a bit tired.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
powder reconstituted with non approved diluent/ Received diluent only; powder reconstituted with non approved diluent/Received diluent only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The reporter reported that, they had 3 extra Shingrix  powder vials.  The medical information asked reporter if they knew what happened with the missing diluents and if they believed patients received diluent only.  The reporter seemed upset about this question and said did not  even go there, did not know what happened but there was no error. The reporter said that, they did not know what happened with the vials and asked medical information if the powder could be reconstituted with a non approved diluent. The reporter did not consent to follow-up. This is 1 of 3 linked cases reported by same reporter, different patients. Additional Supportive Information: The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid based upon verbatim that they believed patients received diluent only.; Sender's Comments:  US-GSK-US2022AMR152101:Same reporter US-GSK-US2022151415:Same reporter
The patient came to the pharmacy with her parent (Dad) He mentioned she was at the appropriate age to take the vaccine. The vaccine was administered, the pharmacy got a call notifying us that the vaccine was administered 8 months early before the patient's 12th birthday. The patient has not reported any issues with the vaccine, and she is doing good. No adverse reaction has been identified or communicated by the patient or her dad.
Rash (erythema multiforme) started on chest and spread to entire body. Rash got progressively worse over 4 days then started to taper down. Rash is extremely itchy and Benadryl and hydrocortisone cream were used.
In the spring of 2000, the pt experienced finger joint, wrist, and elbow pain. His concentration began to decrease and his grades fell.
Pt vaccinated with TD/PPD c/o of lump, erythema, pain, chills/fever at injection site.
Case number PHEH2014US003784 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 17-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 03 JAN 2014. No adverse event occurred to the patient showing following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Fever began 1.5 weeks after vaccines, low grade- on and off for about 2 weeks, also cutting teeth at the same time. 10/30/2002 at 10:30 am, when awakened, mom noted rash. Round, red, several of spots are fluid filled, located on upper chest, upper back and upper arms and left calf and ankle. Slight cough up a little phlegm- clear to white.
Information has been received from a health care professional concerning a 7 year old female who on 08/14/1996 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine. There was no illness at the time of vaccination. It was reported that the adverse event startedon 02/15/2001; however, conflicting information from the pt's father reported that the first indication of chicken pox in his daughter was the appearance of approximately 20 red spots scattered about the back and legs on 02/17/2001. These crusted over in 1-2 days and spots then appeared on her face on 02/19/2001, again crusting in 1-2 days. It was reported that on 02/2/2001 the pt was examined by the  physician and then released to return to school. Subsequently, the pt recovered. Additional info has been requested.
Anaphylaxis approximately 3 minutes after administering PNEUMOVAX 23, 0.5 mL IM in left deltoid. Pt became dizzy and stated could not breathe. Had lower right back pain and started to have labored breathing and went pale. Blood pressure dropped patient stooped forward. Administered 0.3 mg EPIPEN within 5 mins - 911 called.
My hands and feet break out in hives that itch extremely bad. In the morning  and again at night has been happening sense first shot. Has not subsided. Will it go away?
Left arm got tender/Tenderness and redness in arm; Left arm got tender/Tenderness and redness in arm; Tenderness and redness in arm; mouth felt a bit funny and started to swell; mouth felt a bit funny and started to swell; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female consumer A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: Unknown) via an unspecified route of administration in left arm on an unspecified date as a single dose for covid-19 immunization. Medical history included allergic reaction to eating shellfish and Allergic to Sulfa. The patient's concomitant medications were not reported. The patient experienced left arm got tender/tenderness and redness in arm, nose got red, tenderness and redness in arm, mouth felt a bit funny and started to swell, mouth felt a bit funny and started to swell. The reporter has said that She just had the first shot on Tuesday at around 11. She was fine and just had tenderness in arm. She had nothing else except today around noon, she noticed her nose was red and around the area of the nose and it just felt like there could be swelling, but it is not. The arm is not swollen, it is just red. The outcome of the event was unknown
This female subject was enrolled in the prophylactic double blind study. On 19 October 2004, 16 November 2004 and 18 April 2005, the subject received the 1st, 2nd and 3rd dose of Human papillomavirus type 16 and 18 vaccine (HPV, IM deltoid) or hepatitis A vaccine (Havrix , 720 EU, IM deltoid). This subject received Havrix (lot DVHA819B9). The child's mother, who is the study subject, was exposed to the vaccine before conception (see case ID B0473510A for more details). The subject's concomitant medications during pregnancy included Penicillin G and Narcan. On 15 October 2007, after 40 weeks of pregnancy, the subject gave birth to a healthy male infant by normal vaginal delivery. The infant had an Apgar score of 8-9, a weight of 3.854 Kg and a height of 52 cm. On 15 October 2007, two years after the 3rd dose of Havrix, the newborn was diagnosed with a ventricular septal defect. The event was a congenital anomaly. The event was unresolved at the time of reporting. The investigator reported the ventricular septal defect as possibly related to Havrix. Maternal side family history: Marfan's syndrome in 7/9 maternal aunts and uncles of mom. Grandmother of baby has lupus, Sjogren's. Mother complained of heart palpitations during pregnancy cardio work up negative. Patient phoned multiple times from September 2007 to early December 2007 to inquire about pregnancy and birth. Mother returned call 15 December 2007, giving birth details and saying baby was "fine", no problems at birth. Patient in window for follow-up but wished to wait until after new year. Patient (mother) called multiple times in January to schedule appointment. Returned call 01 February 2008 and relayed that baby had been taken in for testing (date unspecicifed) at which time a diagnosis of ventricular septal defect was made. The baby's MD is planning to just observe defect by now, to see if it will close spontaneously (as these defects often do). More details will be forthcoming after Wednesday 06 February 2008 when mother signs a waiver of release of medical information for the baby. "Probably unrelated to the investigational product, but cannot be ruled out" was the  doctor's statement over the phone. Regarding relationship to investigational product, the doctor will be able to give further narrative remarks once she returns Wednesday 04 February 2008 and reviews patient recovered.