chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 03-MAR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneously (dose, strength, frequency and lot number were not provided) which was improperly stored (incorrect product storage). Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Pain at injection site; took Tylenol.  Confusion, disoriented, involuntary movement, and brain fogs.
Patient called health department on 11/1/10 to report that she had a reaction to the shots - she noted it Friday 10/29/10. It started as an itchy spot near her elbow (R), became red - swollen & warm to touch. Area was 3 inches in circumference and 6 inches below the site of injection. Area is just about resolved today. Denies pain.
1 week after 2nd vaccine, healthy female with lump in left breast,; requiring repeat mammograms, that was determined to be a swollen lymph node related to the vaccine.; Palpitations; jitters; high blood pressure; This is a spontaneous report from a contactable other health care professional (patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201) via an unspecified route of administration in left arm on 19Feb2021 9:30 AM as dose 2 single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications in two weeks included colecalciferol (VITAMIN D) Supplement. Patient was not pregnant. No other vaccine in four weeks. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) in left arm on 25Jan2021 09:00 am as dose 1 single for COVID-19 Immunization. It was reported that 1 week after 2nd vaccine healthy female with lump in left breast, requiring repeat mammograms, that was determined to be a swollen lymph node related to the vaccine. Palpitations, jitters and high blood pressure within 1 week of the 2nd vaccine all on 25Feb2021 x 8 weeks requiring a Cardiology Consult with Calcium Scoring, Echo, and Heart Monitor. All results were normal in Feb2021 and symptoms resolved within 8 weeks so cardiac symptoms were also determined to be related to the vaccine. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Adverse events treatment included 3 Mammograms, Echo, Calcium Scoring, Heart Monitor. No covid prior vaccination. No covid tested post vaccination. The outcome of all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Fever until approx 6 pm (measured orally at 100.1), mild associated chills Brain fog until 9:30 (several hours) Lack of appetite Moderate to severe fatigue all day. Took 30 minute nap at lunch time (~1230) and another 30 minute nap at 5 pm Mild arm soreness around the injection site
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 18-JUL-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-NOV-2016, the patient was treated by a physician at a hospital emergency department, for a painful and blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed famciclovir, VALTREX, prednisone and MEDROL Dose pack for management of his persistent and 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.
pt recvd vax; swelling, warmth, pain at site from shoulder to elbow 1 wk; 23mar94 f/u: also had redness & itchingl tx w/ ice packs & benadryl;
Information has been received from a medical office receptionist who saw a news report in which it was reported that a female patient who was vaccinated with Gardasil was unable to get pregnant. She had no further information and reported she only saw part of the news report. Additional information has been requested.
Called our on call MD on 8/24 reporting Uvula dropped and was having trouble talking and a lot of pain. Referred to ER. Admitted to hospital PICU. Discharged 08/26/13 on Augmentin. Cultured positive for group A strep during admission.
Nauseas approximately 3 hours after receiving vaccines. Felt tired went to sleep 3 hours after receiving vaccines. Pt woke up following morning with chills, headache, nausea & lower back pain.
Initial misuse report received from a healthcare professional on 14 February 2014. A 08-month-old patient received 0.5 ml dose of FLUZONE (no information was provided regarding the patient) on an unspecified date. No adverse event was reported. List of documents held by sender: none
Red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Red rash at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (Red rash at injection site). At the time of the report, INJECTION SITE DISCOLOURATION (Red rash at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. Treatment information was not provided.
Information has been received from a physician concerning an 8 year old female who was vaccinated with a dose of Varivax. In February 2006, the patient experienced a mild case of breakthrough chicken pox involving only 10 lesions. Unspecified medical attention was sought and the child subsequently recovered. No product quality complaint was involved. The patient's father ( WAES0604USA00481) experienced varicella after exposure to his son. Additional information has been requested.
Two weeks after receiving these vaccines, I woke up unable to move my legs. I spent a few days in the hospital where they said it was most likely a mild case of Guillain-Barre.
The evening of the day of the vaccine, I began to feel achy, more so in my neck, but generally all over. The following day, I had fever, chills, hoarseness and my throat felt 'swollen', and again had aches all over my body.
Weakness, nausea, chills, body pain Took 2nd dose vaccine at 12pm, April 3, 2021. Symptoms started around 5pm April 3, 2021
07/11/2019 SUBJECTIVE:  Pt is a 5 y/o female here with mom. Here with complains of redness and welling of leg where she got vaccines yesterday. Had Hep B and varicella vaccine on 7/10/19, is now red, warm; area of redness is ~10 cm in diameter. Denies pain/puritis at this time. On delayed vaccine schedule. Otherwise healthy child. Has had a similar reaction like this before during her last Dtap. No difficulty breathing, lip/tongue/facial swelling o vomiting. Mom reports she thinks pt may have scratched the area after vaccines and is unsure if this has contributed to the reaction.  07/12/2019 Per phone conversation, swelling had spread beyond the line drawn around by approx 1" per mom. Mom was reluctant to start ABX since child had just been on them for cellulitis. 07/15/2019- A call has been palced to parent, unable to provide update at this time.
Headache, Arthralgia, Fever, Diarrhea, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:  CALLED OUT FROM 1/29/2021 AND RTD 2/3/2021 AS NOTED : Due to above symptoms lasting >48 hours post vaccination SARS-CoV-2 PCR, influenza A & B and RSV testing completed and negative. I have called patient for notification and have left a message for return call. CRNP 2/1/2021 @13:35 She was notified of the above results. Reports she had on going diarrhea and headache. Advised to seek medical care and contact us when she is able to return to work. CRNP 2/1/2021@ 13:38 She was notified of the above results. Reports she has on going diarrhea and headache. Advised to seek medical care and contact us when she is able to return to work. CRNP 2/1/2021@ 13:38
Had a reaction to Pneumovax23; Consequently, the patient was unable to walk or lift the right foot correctly; she experienced numbness and tingling in her right leg; she experienced numbness and tingling in her right leg; This spontaneous report was received from a 68-year-old female consumer, regarding to herself. The patient's pertinent medical history included a spinal tap. She had no previous drug reactions/allergies and her concomitant medications included rosuvastatin calcium (CRESTOR).  On 07-AUG-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection single shot, in the left arm (route of administration was not reported; lot number N010106, expiration date 15-NOV-2018 and upon internal validation stablished as the same) as prophylaxis (also reported as "for pneumococcal disease").  On an unknown date, the patient had a reaction to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination complication).  On approximately 21-AUG-2017 (reported as "two weeks after receiving the vaccine"; also reported as on "07-AUG-2017": inconsistent information), the patient experienced numbness and tingling in her right leg (hypoaesthesia and paraesthesia). Consequently, she was unable to walk or lift the right foot correctly (gait inability). It was reported that the patient sought medical attention and had treatment given for the adverse events, as she ordered a magnetic resonance imaging (MRI) and physical therapy. She also had several unspecified laboratories performed.  At the time of the report, the patient had not recovered from hypoaesthesia, paraesthesia and gait inability. The outcome of vaccination complication was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and hypoaesthesia, paraesthesia and gait inability was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and vaccination complication was related.
47 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea" (unspecified if ongoing). Concomitant medication(s) included: FLOMAX RELIEF. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (21Aug2022) Positive, notes: with positive at-home test 21Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical search: Patient was treated for Covid-19 with anti-viral drug Paxlovid from 10Aug2022 to 14Aug2022. Patient had no known allergies.
Bilateral pulmonary embolism. No clots detected in legs.  Treatment: removed from birth control, Eliquis (10mg) for 3 months
After I received the first shingles shot my arm was a little sore. When I got home my arm was still sore around the injection site so I applied a warm compress. A few days after, the injection site started to feel hard to touch and warm. I spoke with the pharmacist and he said when they gave me the injection they must have administered the shot a little low. He also stated the pain would go away with time. I waited for a month for the pain to go away and it did not so contacted pharmacist again and he told me that he would contact the corporate office. A week later they contacted me and told me they would report the reaction. The pain is still constant when I move my arm. It feels like a painful cramp when I move my arm. The pain shoots down my arm to my hands. If i continue to move it the pain gets worse. I have to wait for the pain to stop before I can get any relief. i spoke to my primary care doctor and he stated there was nothing he could do and I would have to speak with the pharmacist again.
Shortness of breath, wheezing within 30 minutes of giving vaccines.  ALBUTEROL treatment via nebulizer given X 1.  Chest itchiness.  BENADRYL 25 mg given.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.The patient reported that she was taking blood pressure medications.No treatment information was reported.This case was linked to MOD-2021-375273, MOD-2021-395812 (Patient Link).
Redness, pain, swelling at injection site & on entire backside of upper arm down to elbow.
shortly after administration, patient became diaphoretic and dizzy.  patient, while sitting, lowered head but did not relieve.  She sat upright, became unresponsive to verbal direction.  911 was notified and then while patient's husband and I were moving patient to a prone position on the floor, patient fainted.   Patient regained consciousness within 15-20 seconds.  Patients vitals were checked afterwards and were within normal ranges.  Paramedics arrived, checked vitals and glucose - all within normal ranges.  Patient declined transportation to hospital but remained at pharmacy for another 15 minutes as she continued to feel better and regained strength.  Contacted patient about 6pm this evening and she felt fine at that time.
Softball size swelling and redness at site of shot, developed fever of 105 in a half hour leading into a 20 min convulsion
on 5/12 developed body aches and sore throat, on 5/15 loss of smell, confirmed to have covid-19 on 5/15 Narrative:
Patient received COVID-19 vaccination Moderna booster (previously received 3 Pfizer doses), Boostrix vaccination, and Shingrix vaccination at the same visit. Patient called approximately 6 hours after administration of vaccinations reporting dizziness and not feeling well. Patient called about 1.5 hours after initial call reporting right side jaw/facial numbness, pressure in head, and trouble urinating.
I went for a routine cardiologist 6 month visit. They took an EKG and when the DR saw the EKG he said heart rate was too slow and skipped some beats. And he said I should get a 24hr halter after I stop taking the medication. I was told to go to the ER because my heart rate was still too slow. I was in ER 37 bpm and so they admitted me for 24 hr observation - I had no symptoms but was checked on when the alarm went off for my heart rate being too slow. The next day I was discharged because it was benign with no symptoms. Couple of days later I received DR call that they made a Cardiac electrophysiologist appointment.  At the appointment the DR said after reviewing all results old and new he said I needed a pace maker asap. 5 days later I had pace maker implant surgery. since the surgery I recuperated fine. My heart beat is at a good rate now. Because I had a history of slow heart rate. I used to have slight cough, dizziness getting out of bed/chair, some fatigue but now are gone after heart pacer surgery.
Persistent chest pain lasting 24 hours day after dose, concern for myocarditis. Resolved with nsaids after one day.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 36-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date, before 2006, the subject received unspecified dose of Hepatitis B vaccine (unknown). In 2006, 3 years after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy. A physician reported to a medical assistant that he had a new patient who received an unknown hepatitis B vaccine at another facility several years ago. In 2006, a titer was drawn and the results were negative. This office gave the subject an ENGERIX B booster on 10 April 2009.
SM with multiple medical diagnoses: 1) patellofemoral syndrome (PFS), 2) postconcussive syndrome, 3) esophageal reflux/spasm, 4) asthma.  Review of >700 pages of medical documentation from 1991-2008 indicated onset of PFS antedated receipt of AVA #1; onset of other diagnoses non-temporally related to AVA receipt, no evidence of disease exacerbation associated with receipt of subsequent AVA doses, or other vaccines given on same dates.
Chills, headache, nausea at 2:00am, temp 101.3 at 4:30am with headache, body ache, nausea, fatigue. Temp 101.4 at 10:30am with headache, body ache, nausea, fatigue. Temp 101.7 at 4:30pm with headache, nausea, body ache, fatigue.
Localized swelling and redness at the injection site 6cmx5cm which started one week following the injection.
Vomiting, Diarrhea, Passed out, Had to crawl to the couch, Could not stand or get up. Fuzzy memories.
Pfizer was given to the client beyond date of vaccine handling and storing. CDC and Pfizer manufactory made aware, instruction was given to revaccinated. Supervisor made aware. I spoke to client and parents informed them of the vaccine and the need of revaccinated, clients agreed appointment is scheduled for clients and will follow up with care.
only DTaP-IPV component of Pentacel was inadvertently administered to a patient/No AE; Initial information was received on 10-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a patient of an unknown age who received only DTaP-IPV component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number not reported and expiration date unknown), via an unknown route at an unknown administration site.  Medical history, past medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  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 Directive and Module VI of the 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.  Information on the batch number was requested.
17 year old that was given Pentacel with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00296932) was received from a nurse and transmitted to Sanofi 01-Oct-2020.  This case involved a 17 year old male patient who was vaccinated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot not reported expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was reported that a patient, age 17 years, had never had vaccines and the doctor thought it would be okay to give the patient DTap along with PENTACEL AND IPOL. The reporter stated that she was not sure if the patient should have received ADACEL.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, patient had not experienced any adverse 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 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.  There will be no information available on batch number for this case.
Patient wife called and spoke to an LPN that was in the clinic-she reported to me that the wife told her husband was having a reaction to the ZOSTAVAX injection he received yesterday.She said he felt his throat was closing up.Icalled her right away-she told me her husband used an EPI-PEN that he had from 2008 and also took several BENADRYL tablets.He told her he still had the same feeling but it did not get worse.I advised her to take her husband to the nearest ER or to her PMD for eva.Iwill forward this not to the provider.
Patient got a Tdap on 2/12/14 and says it started itching on 2/14/14. It is still itchy today. Her doctor told her to use a hot pack on site.
Large bruise on left arm where shot was given.  Patient has put ice on it.   Still bruised 6 days out.
1 y/o given DTaP (IM) and ProQuad (SQ) in upper (r) arm on 5/1/07. Presents 2 d late with 9 x9 cm area of warm tender redness at vaccination site
PT REPORTS LOCALIZED RASH THAT RESOLVED IN A DAY FOLLOWING FIRST DOSE OF THE VACCINE.
Pt vaccinated with Engerix-B developed, within 4-5 days, arthralgia in ankle & wrist.