chrisvoncsefalvay/vaers-outcomes huggingface dataset:
quarter or half-dollar sized spot on his arm where he got the shot; looks like a brown birthmark, color so the spot wasn't red.; arm is sore when he moves it a certain way; feels discomfort in his shoulder; feels like he bumped into something and it is bruised; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (quarter or half-dollar sized spot on his arm where he got the shot), VACCINATION SITE DISCOLOURATION (looks like a brown birthmark, color so the spot wasn't red.), MYALGIA (arm is sore when he moves it a certain way), MUSCULOSKELETAL DISCOMFORT (feels discomfort in his shoulder) and CONTUSION (feels like he bumped into something and it is bruised) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION SITE RASH (quarter or half-dollar sized spot on his arm where he got the shot), VACCINATION SITE DISCOLOURATION (looks like a brown birthmark, color so the spot wasn't red.), MYALGIA (arm is sore when he moves it a certain way), MUSCULOSKELETAL DISCOMFORT (feels discomfort in his shoulder) and CONTUSION (feels like he bumped into something and it is bruised). At the time of the report, VACCINATION SITE RASH (quarter or half-dollar sized spot on his arm where he got the shot), VACCINATION SITE DISCOLOURATION (looks like a brown birthmark, color so the spot wasn't red.), MYALGIA (arm is sore when he moves it a certain way), MUSCULOSKELETAL DISCOMFORT (feels discomfort in his shoulder) and CONTUSION (feels like he bumped into something and it is bruised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD21-091826 (E2B Linked Report).; Sender's Comments:  MOD21-091826:crosslinked
AFTER 15 MINUTES OF RECEIVING THE VACCINE THE PATIENT PRESENTED WITH DIZINESS, NAUSEA, AND WEAKNESS IN THE INFERIOR EXTREMETIES.
Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't reveal any AEs. Patient received COVID vaccine on December 31
Patient felt faint around 10 minutes after vaccination, checked blood pressure went up 147/92.  Patient 25 minutes post vaccination is feeling fine and good to go home.
Stated that she gave a patient the Tenivac and should have been Adacel with no reported adverse event; staff member getting confused on the labeling between the two vaccines with no reported adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 32-year-old male patient who stated that she gave a patient the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and should have been DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered) and staff member getting confused on the labeling between the two vaccines (product label confusion).  The patient medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other concomitant vaccines reported.    On 15-Nov-2021, the patient received a 0.50 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [lot U6603AA, expiry date: 05-Mar-2022] via an intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product label confusion [Latency: on the same day].  At time of reporting, the outcome was unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
soreness or the numbness of the arm; soreness or the numbness of the arm; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (soreness or the numbness of the arm) and PAIN IN EXTREMITY (soreness or the numbness of the arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (soreness or the numbness of the arm) and PAIN IN EXTREMITY (soreness or the numbness of the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (soreness or the numbness of the arm) and PAIN IN EXTREMITY (soreness or the numbness of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took  Insulin injection for diabetes medication and medication to sleep as a Concomitant medication.  Patient took Tylenol and heat pad as a Treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received contains non-significant information. Reporter stated her mother has been dead for years and abruptly disconnected the call.
8OCT93 pt recvd flu vax on 20OCT93; pt was seen in MD office c/o rash & petechiae all over body; MD concluded p/reviewing labs pt had ITP, w/no other concurrent risk factors; thrombocytopenia x/receiving flu shot 2 wks prior;
Case number PHEH2013US012825, is an initial spontaneous report received from a pharmacist on 11 Jun 2013 with a follow-up received on 09 Jul 2013. This report refers to a 35-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with expired MENVEO (batch number: A10047 and expiry date: Dec 2012) intramuscularly on 11 Jun 2013. He had a headache that night and went to the Emergency Room (ER) just to be sure and left the ER shortly after that. Outcome was reported as complete recovery of the patient. No additional information was provided. Follow-up received from the pharmacist on 09 Jul 2013: Updated event (headache).
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K003422 with expiration date 06-MAR-2016; does, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On Oct. 27th Monday:  Nurse at medical center gave me Pneumonia shot on Right shoulder. The shot was high on the shoulder and it pricked the Bone.  Oct 29th went to Dr and complained about the shot.  My arm is paralyzed!! Dr. said take ASPIRIN and it will get better.  It has been over 2 mo.  It still not better.  3/16/09 Received PCP medical records of 10/29/08-1/6/2009. FINAL DX: right shoulder impingement syndrome; left frozen shoulder Records reveal patient received Pneumo #3 & Flu #12 vaccines on  10/25/2008 but no lot #s or sites provided.  RTC 11/12 w/frozen left shoulder since 8/08 w/decreased strength & ROM.  Tx w/PT.  RTC 1/6/09 w/right neck & shoulder pain since flu shot.  Dx w/right shoulder impingement syndrome, neck muscle spasm, insomnia.  Referred to Ortho & PT.
T 99 degrees  12/03/2002. Redness, warmth and extreme pain in 9cm x 11cm area around injection site. On set about 2 1/2 - 3 hours after injection. States great difficulty raising arm upward. Tylenol helped her sleep that night and she thinks it's only very slightly better today. 12/04/2002 soreness much improved-redness 7cm x 6cm. temp 98
9/27/02: 74 y/o female reported, aches in legs and head and sneezing, felt lousy, low grade fever 98 degrees am increase to 99.9 pm. 9/28/05 clear mucous from nose, sneezing caused. 9/29/05 T=100 deep bronchial cough with dark green phlegm/ 9/30/05 feel much better today. No redness, no soreness at site of injection.
angina; a stomachache that lasted for 10 hours; nausea; vomited 1 time; A spontaneous report was received from a consumer  concerning an 82-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angina (angina pectoris), stomachache (abdominal pain upper), nausea and vomiting 1 time.  The patient's medical history included 3 stents in the heart and angina.  Concomitant product use was not reported.  On 03 Feb 2021, approximately 26 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) in the left arm for prophylaxis of COVID-19 infection.  The reporter stated that 26 hours after receiving the vaccine, he had a stomachache that lasted for 10 hours. The patient also experienced nausea and vomited 1 time.  Early in the week of 08 Feb 2021, the patient reported experiencing angina, which he stated he had not had for a very long time. The patient reported that no treatment medications were taken for these side effects.  The patient stated that he will follow up with his cardiologist.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, angina, was unknown.  The events, stomachache, nausea, and vomiting, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of abdominal pain, nausea and vomitting, a causal relationship cannot be excluded. The patient's medical history of 3 stents in the heart and angina confounds to the causality of Angina Pectoris.
Started out with achiness and chills.  At 2230 started feverish 99.6.  By 2245 vomiting violently for 15-20 min, sweating profusely.  Then fatigue. Still with some chills. Woke up the next say at 0600 slightly fatigued and fairly normal.  Of note, I had covid in November.
0855 Dtap-IPV and MMR administered 0900 Mom reports child is itching the neck. Child taken to pediatric clinic accompanied by the nurse to  Doctor 0902 Examined by Doctor. Benadryl 25mg given orally Was sent home around 0930 Per mother on the way home child developed facial flushing, and lip swelling and feeling of fever and taken to Hospital Discharged home on 03/24/2022 on oral prednisone for 4 days
No adverse effect reported; one patient received an improperly stored Proquad; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), injection, lot # R026722 and expiration date 17-MAR-2020 or lot # R023499 and expiration date 13-FEB-2020 (dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. The temperature was from -14°C to -10°C (-11.91 C, multiple) for 8 hours. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA003212:
Patient called 11/19/20 at 1:00pm and reported swelling above her lip and also partially on her lip. She was concerned it could be an adverse reaction from the vaccines received on 11/18/20.  Patient has a history of cold sores, but states this does not feel like a cold sore. Patient also gets lip injections. Explained to patient that this may be a cold sore or a result of her lip injections.  Also counseled patient regarding anaphylactic reactions and recommended seeking medical attention if swelling continues or patient has any difficulty breathing.  Followed up with patient 11/23/20 when back in the pharmacy and patient stated that all swelling at and above the lip was gone when she woke up on 11/20/20.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 02-JUL-2013, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-APR-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information was received on 17-JUL-2017 from a registered nurse who reported that on unspecified dates, an unspecified amount of patients (age and gender not reported) received an improperly stored dose of VARIVAX (lot# M046924, expiration 28-NOV-2018) reconstituted with properly stored sterile water diluent (lot#/expiration unknown). Temperature/time frame was 6 degrees F to 14 degrees F for 18 minutes; 15 degrees F to 46 degrees F for 72 hours. There was no previous temperature excursion. No adverse effects reported. No additional information provided. Additional information has been requested.
Severe weakness. Could barely walk and stand up for an entire day. That night when getting up to use the bathroom, I fell on the floor and could not get up. My husband helped me get back to bed. Next day I was better, but not normal, and had a severely swollen upper lip.
5 days after first dose, extremely painful, but not itchy neck rash appeared. 7 days after does entire front and sides of neck, from chin to collar bone was covered in said rash. Bright and dark red, with thick leathery complex. Painful when my neck moved or touched anything. Skin felt like it would rip if I shook head or nodded. Rash went away after 2 weeks through different cocktails of various steroids, creams and natural remedies suggested by my doctor. After my 2nd dose, the same neck rash appeared on day 5 and quickly came back, however this time was much larger and more painful. Took 2 weeks to clear up.
Pt recv vax on 4/15/98; on 4/22/98 pt exp hives every other day on legs and some on body; tx=Ranitidine
Bad migraine; Feels hot; This is a spontaneous report from a Pfizer sponsored program via a contactable reporter (patient) reported for herself. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 27Apr2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 06Apr2021 at a single dose for COVID-19 immunisation. No events were reported for the first dose. On 27Apr2021, the caller experienced bad migraine and felt hot after getting the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Well I started getting swelling in my feet and legs and I went to urgent care and they gave me some Lasix pills and said it was fluid but it kept happening so I saw my PCD. My DR wanted me to see a vein DR, I did and then he diagnosed me with venous insufficiency. I do not recall the dates it was so long ago I'm sorry. The vein DR gave me a prescription for compression stockings and that has helped the swelling. There is still some swelling but it has helped, there is bearable pain as well.
Information has been received from a registered nurse concerning a 6 month old male who was vaccinated with the first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) at six months of age and the second dose at 7 months of age. It was unk if medical attention was sought and the pt did not have any symptoms. Additional information has been requested.
Headache, Fever, Diarrhea, Body Aches, Sweats Narrative:
pt recv vax 29DEC98 & on 2JAN99 pt devel diarrhea described as up to 8 mucus stools daily;pt was seen by MD on 9JAN99;the diarrhea persisted as of 11JAN99;
Events occurred 12 hrs p/pt rec'd 1st vax & resolved, w/out tx, w/in 48 hrs; Experienced onset of flu-like sx, upset stomach, diarrhea About 8hrs post vax (given 21AUG90); Recovered w/in 24 to 48 hrs, w/out tx; Vaccinee opted not to cont.
I have developed a large itchy rash on my arm just below the site of the injection.  It began about 30 hours after the injection and is still there after 24 hours. I did not get this after my previous three shots.
Rash, Knot in arm, soreness, fever,  NUMBNESS IN ARMS/HANDS AND LEGS, TINGLING/BURNING IN ARCHES OF FEET
Patient was given Moderna for second dose in the primary series instead of the Pfizer as requested by the parent
10/14/08-2mo set given (pediarix{DTaP/IPV/HepB}, Rotateq,PCV,Hib)
Has aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (COMIRNATY), on 20Oct2022 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: Covid-19 vaccine (Primary immunization series completed, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Has aches". Additional Information: The patient reported that she had aches, is walking around fine, is just achy. The patient wanted to know if Tylenol could be taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reaction to 09/06/17 shots seen 09/07/17/17 and called pediatrician immediately. Red, swollen, inflamed and splotchy area around the injection site was noticed about 16 to 18 hours after the vaccination and was about the size of a large grapefruit. The reaction grew larger and faster than the reaction that was produced with the 03/08/17 and 06/14/17 vaccinations. The pediatrician said to give benadryl, motrin and warm baths to work the leg out. The reaction started to subside about 1 to 2 weeks after the vaccine was  given and there was still a knot or nodule in my son's thigh after 1 month.  The pediatrician again did not have us come into the office to evaluate the reaction.
Rapid heart rates of about 200 for 3 times this past week, two times lasting about 20 minutes, yesterday lasting three hours. My husband has experienced fatigue, low fever, weakness starting 5 days after second shot, also.
Pfizer-BioNTech COVID-19 Vaccine EUA  Patient experienced tingling tongue, odd taste on her tongue and neck swelling.  Actions taken:  Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient  monitored, EMS called and care transferred. Patient was alert and oriented.
Received Nasal Spray H1N1 vaccine during the day clinic.  In the evening, had shortness of breath which resolved.  For the next few days felt sluggush and run down.  A couple weeks later had a sinus infection and has had recurring shortness of breath episodes since 10-24-09 til today (12-17-09).
Employee called to report that she developed a red elevated, dry, itchy, rash on her trunk and axillar area. States rash area tender to touch. Has no known allergies - received seasonal Flu vaccine in 2008 for the first time - has not received seasonal influenza vaccine this yr. No reaction after.
Suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in an unspecified number of adult patients 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The physician reported that he heard that of several patient developing shingles after receiving a Shingrix dose. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
pt stated the next day after getting the 2nd dose of the covid vax, she had chills, slight fever, body aches and slightly nauseated.  On 2/12/2021 she felt better, no fever, but noticed she had developed a slight rash around the injection site.  On 2/14/2021 she noticed some red streaks moving down her left breast that disappeared fairly quickly.  She had an apt w/ her Dermatologist on 2/15/2021 and the pt had a slight rash on her left arm.  On 2/16/2021 she noticed she had a 'covid arm' rash that covered 3/4 of her left upper arm.  On 2/18/2021 the rash was still noticeable and was itching so she took a Benadryl and then again on the 2/19/2021.  She saw her Dermatologist again on 2/24/2021, her rash is less red and seems to be disappearing.
Doctor 2/27/03 describes reaction "normal to DTaP booster" L upper arm soft 6.0 x 8.0mm pink warm area around puncture-mildly tender.
Vaccine was improperly reconstituted which resulted in patient receiving a more concentrated dose than normal. Patient was already out of clinic when the issue was noticed. The provider attempted to call and left a voicemail to notify the parent and let them know dose does not need to be repeated but to look out for any increase of reaction to the vaccine.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Vomiting-Mild