chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 49 year old female states that she experienced "redness and swelling" which developed into painful itching and burning at site of injection (approx. 1 1/2" in diameter). At the time of report, she states that her "whole arm hurts". She has not been exposed to the influenza vaccination. She is presently recovering from bronchitis (amoxicillin was discontinued last week).  She has a positive history of migraine and is allergic to bee stings (carries an epi-pen). Follow up #1 06/19/02: During internal auditing oif all files, it was deemed necessary to amend the report by updating the Adverse Event coding ( Added Medication Error and re-ranked Adverse Events).
I am experiencing extremely high blood pressure and rapid heart rate.  I had the second dose a week ago and it is still occuring.  My normal BP is 98/56 with a pulse in the 60s.  I'm experiencing BPs of 180/102 pulse 90, 157/105 pulse 86, 154/101 pulse 87.  I'm exhausted and foggy headed.
Dry mouth, nausea, vomiting, diarrhea. Not feeling good in general several hours after vaccine was given. Patient denied drinking alcohol, eating something that didn't agree with him or anything else. His symptoms were mostly GI symptoms.
Lightheadedness; It increased the severity of the hay fever for probably 3 or 4 times; It increased the severity of the hay fever for probably 3 or 4 times; Things have starting to pop so my allergy hit me but I think this virus caused my allergy to be far more intense; Malaise; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I don't sleep well it feels like my body is electric, like there is current going on through my body, so I have tossing turning sleeping; I am slightly nauseous in the stomach; I'm so exhausted; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Had itchy throat and throat was closing so, clearly it was a reaction to the peanuts; Every cell on my body feels like it's energized and that's why I can't sleep; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199, Expiration date: Not reported), via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced very minor side effects with slight lightheadedness. After having the shot, the patient had hay fever and allergies, and obviously the things had started to pop out, so the allergy hit the patient but the patient thought that this virus caused the allergy to be far more intense. The hay fever comes along anyway, it increased the severity of the hay fever for probably 3 or 4 times. The patient literally went to four large boxes of tissues in 48 hours. So, the other thing is that the patient had extreme malaise in this reported week and the patient didn't sleep well as it feels like the body is electric, like there is current going on through the body, so the patient have tossing turning sleeping. The patient was slightly nauseous in the stomach and have been forced to try and take naps during the day just because the patient was so exhausted. The patient was definitely nauseous but not in extreme. The first 2 days of this reported week, the patient had itchy throat and throat was closing. So, clearly it was a reaction to the peanuts and never had the allergy before in the entire life and also reported that something was going on with the body. Every cell in the body feels like it's energized and that's why the patient can't sleep. The patient was wondering if they had heard any side effects which were hitting 2 weeks later. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
pt recvd vax & pt feet were warm 4-5 hrs after vax; pt was very pale, vomited, shook all over, jerking & was afeb at all subsequent checks;
extreme pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme pain at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (extreme pain at the injection site). At the time of the report, VACCINATION SITE PAIN (extreme pain at the injection site) outcome was unknown. 2nd shot      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT STATES WENT INTO VENTRICULAR TACHYCARDIA APPROXIMATELY 3 HOURS AFTER RECEIVING PFIZER COVID VACCINE IN COMBINATION WITH FLUBLOK VACCINE WHICH REQUIRED HOSPITALIZATION.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) and (batch number unknown, expiry date 22nd January 2019) for prophylaxis. On 19th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In January 2019, 18 hrs after receiving SHINGRIX, the patient experienced fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged, lymph node tenderness and lethargy. On an unknown date, the outcome of the fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged and lymph node tenderness were not recovered/not resolved and the outcome of the lethargy was unknown. It was unknown if the reporter considered the fever, fatigue, feeling bad, headache, axillary lymph nodes enlarged, lymph node tenderness and lethargy to be related to SHINGRIX. Additional details were provided as follows: The patient's wife who administered the vaccine reported this case. At 5:00 PM, the patient received SHINGRIX in the right deltoid. On Sunday, at approximately 11:00 AM, the patient started feeling bad. The patient had a fever of 102 degree F and felt lethargic. At 12:00 PM on Sunday, 19 hours after vaccination, the patient started experiencing an excruciating headache. At 6:00 PM on Sunday, 1 day and 1 hour after vaccination, the patient noted that the lymph nodes in the armpit of the arm where he received the vaccination are swollen and tender. The reporter did not consent to follow up.
her leg was itching; a rash was developing on her knee; This case was reported by a nurse via call center representative and described the occurrence of itchy legs in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number T2CS3, expiry date 1st December 2021) for prophylaxis.   On 31st January 2020 11:00, the patient received the 1st dose of Shingrix. On 31st January 2020 15:00, 4 hrs after receiving Shingrix, the patient experienced itchy legs and rash. On an unknown date, the outcome of the itchy legs and rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy legs and rash to be related to Shingrix.  Additional details were provided as follows: The patient was having an adverse reaction after receiving the first dose of Shingrix. The patient experienced that her leg was itching, and a rash was developing on her knee. The reporter consented to follow up.
I felt fine the day of the vaccine. However, The  next day I was extremely tired. The next day I went to the Doctor and texted positive for covid with a rapied test. I also Had a PCR test which was neg. for covid.  Im currently being treated for a sinus infection.
INFLAMMATION OF LEG / LITTLE INFLAMMATION IN BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced inflammation of leg / little inflammation in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of leg / little inflammation in body was not reported. This report was non-serious.
Patient received FLUARIX QUAD on 10/20/163 She came back into pharmacy on 10/21/16 stating her arm is sore and she's having trouble lifting her arm.
This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 8th January 2019, 1 days after receiving SHINGRIX, the patient experienced headache, fever and injection site pain. On an unknown date, the outcome of the headache, fever and injection site pain were unknown. It was unknown if the reporter considered the headache, fever and injection site pain to be related to SHINGRIX. Additional details were received as follows: This case was reported via chat or live transcript. The age at vaccination was not reported. The day before reporting date, the patient received a dose of SHINGRIX vaccine in her pharmacy the in right arm. On the day of reporting, the patient woke up with a splitting headache and low grade fever. The patient was also reported that she had a very sore right arm at the injection site. The patient was asking, if this was a possible side effect of SHINGRIX vaccine.
This non serious case was received on 03 March 2009 from a consumer. A  49 year old female patient received a first time dose of ADACEL (lot not reported) in the right deltoid on 04 January 2009. On 05 January 2009 the patient developed a red, hard lump at the injection site 4 inches in diameter which lasted for 2 weeks. Currently she has a dime size hard lump under the skin at the injection site. She went to the doctor's office multiple times with no relief. No further information was provided. Follow-up information was provided. Follow-up information received 19 March 2009 from a consumer. The patient received ADACEL due to a cut on her left finger which required sutures at the time of vaccination. She had not received any other vaccines within four weeks of ADACEL. The patient continued to have right upper arm ache/pain everyday and had been taking over the counter pain relief. No laboratory and diagnostic testing had been performed. The patient reported the event to multiple providers including the hospital were ADACEL was administered, when seen for follow-up for a respiratory illness; when sutures were removed; when she had her blood drawn and during an orthopedic appointment for an unrelated knee injury. According to the patient, she received multiple "tetanus only" boosters in the past and "none ever caused this type of reaction". She also reported that she had a past history of Pertussis "whooping cough" approximately one and a half years prior. No further information was provided. The reporter for this is the same as for case numbers 2009-01149 and 2009-01150. List of documents held by sender: none.
Patient felt dizzy and clammy just after receiving injection. Patient was very nervous about receiving shot.  Conditioning started getting worse with chills and almost fainting. Called 911 and patient was taken to ER along with her mother for treatment. Patient was alert and and talking at all times. Followed up with later in the day and she indicated doctor treated patient and released from unspecified hospital. Mother said patient is doing fine.
Right arm was raised,  red, warm, and very painful. Size was about the size of a softball and became larger days later, with itching and burning sensation. MD started patient on Keflex 500mg  three times a day for 7 days, and ice has been applied as needed along with PRN Tylenol for pain. Patient had reaction occur same day as vaccine was given on 3/17/22 and area is still there as of today 3/21/22.
Left side Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Left side Swollen lymph nodes) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced LYMPHADENOPATHY (Left side Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, LYMPHADENOPATHY (Left side Swollen lymph nodes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patients treatment information included Tylenol.   This case was linked to MOD-2021-094928 (Patient Link).
COVID-19 symptoms started on 06/14/22; tested positive on 06/15/22. It started with chills on the 14th and chills were worse on the 15th and I also had a temperature. For the forehead it was 98.6 and mine hadn't gone on real high mode. I had a sore throat at that point and on 06/16/22 I called my Doctor and did a telehealth visit and he prescribed Lagebrio (Molnutiravir) 200 mg every 12 hours. I didn't think it had much effect on me because I never felt an improvement through the whole process; I noticed on 14th that I had a slight sore throat in the afternoon, on the 15th I had a slight sore throat all day as well as fever and congestion; on the 16th I tested positive and at that point is when I called the Doctor. I finished pills on the 21st and I was testing positive on the 22nd but I was feeling better by the 22nd. I called my Doctor and told them I was still testing positive and that right now once in awhile I  had sinus drainage and I've always had weak lungs from multiple instances of pneumonia when I was young and I was feeling a tickle in my chest and it seems to have gone and I'm not coughing hardly at all now. It's mostly to do with sinus drainage and I'm irrigating my sinus and taking antihistamines. I've been taking albuterol but might not be helping me because I might be aggravating the breathing and need steroids. I think I'm going to be OK and it's going to take a little longer to clear up.
3 days after vaccination experiences SOB, dizziness. Next day, continued to have SOB, dizziness (duration: on and off). Following day developed swelling on face (cheeks and up).  Pale in color, went away later at night (8pm). Relieved using Benadryl 50mg every 4 hours for a total of 3 doses. SOB and dizziness had also resolved. Mentioned to primary care 2 weeks later during a physical exam.   Similar reaction with clindamycin in the past.
Patient reported adverse reaction  (dry lesion) from Tenivac given over 4 months ago.
t105 the night of inject, grand mal sz occurred twice; pt getting Amoxicillin;
She reported receipt of a FLUMIST vaccination (MED 500549) on 9/4/2008. Approximately 2 days later (Sunday) she awoke stating she was "blind" in her left eye. She vaguely remembers some clear discharge and redness to the eye. She had no light/dark visibility, pain, itching, trauma, headaches or nasal discharge/sinus pressure. She denied any other symptoms at this time. She advised she contacted a HCP who prescribed an eye drop and was seen in his office 24 hours later (Monday) with return of vision but blurry. (Review of ophth records show pt seen in Sept 2007 for similar c/o being diagnosed with chemical keratitis with use contact lens...no blindness in 2007 or 2008). Approximately one week later (9/11/2008) she complained of cold like s/s (PND, congestion, cough, nauseated) that progressed into bronchitis. She denied any fever, headache, myalgia/arthralgia, or visual disturbance). These symptoms persisted on and off over the next 5-6 months (fall/winter with unknown duration either for symptoms or between episodes with five evaluations with PCP from 11/11/2009 to 12/4/2009 and 1/13/2010 for bronchitis/asthma exacerbation). She advised symptoms peaked during the week of 2/28/2009 with subjective fevers (101), worsening dry cough and PND. She saw her PCP (3/4/09 & 4/1/2009) being diagnosed with RAD and bronchitis. Temperature was 98.8F. She was treated with a MEDROL dose pack, ALLEGRA, albuterol and Z-PAK with resolution of symptoms. On 9/3/2009 she was evaluated for neck and sinus pain with positive oropharyngeal inflammation. She was diagnosed with chronic sinusitis treated with NASONEX and ZYRTEC. She received an intramuscular influenza 9/11/2009 (AVP 05549111a) complaining of above URI-like symptoms stating symptoms persisted intermittently thru Feb 2010 when diagnosed with asthma by a pulmonologist. She denied any swelling, rashes, hives or anaphylactic like symptoms. She eats eggs regularly with no adverse event reported.
Microhematuria; Burning; This case was reported by a physician via call center representative and described the occurrence of microscopic hematuria in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix. On 28th June 2019, 2 days after receiving Shingrix, the patient experienced microscopic hematuria and burning sensation. On an unknown date, the outcome of the microscopic hematuria and burning sensation were unknown.   It was unknown if the reporter considered the microscopic hematuria and burning sensation to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient received the 1st dose of the Shingrix vaccine 2 days ago and on the date of reporting presented to his office with microhematuria and burning. The reporter said, could not obtain any additional information as the caller disconnected the phone line
45 mins after vaccination, symptoms occurred in right foot/ankle: mild to moderate burning and tingling sensation. It has been intermitent since 1 vaccination. Appears to be improving as the days go on. But has not gone away.
ADMINISTRATION OF EXPIRED JNJ VACCINE; This spontaneous report received from a pharmacist concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21a, expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced administration of expired JNJ vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired JNJ vaccine was not reported. This report was non-serious. This report was associated with product quality complaint : 90000181676
I received vaccine on 10/16/19 & by 10/24/19 not feeling well flu like symptoms, chills my hips were hurting the were aching & heavy & tight. Then the weekend went on a trip for weekend with mom & sisters alot of far walking. Pain started to radiate to legs, groin & knees took me a bit to get up & get moving. By Sat 10/26/19 not feeling well exhausted pain all thru legs could not sleep or relax, kept taking naproxen & flexeril & rub cream. Hot tub & heating pad. Went back to room & crawled in bed sevre pain legs. Hard to relax & enjoy my rest. Then we drove home Sunday 10/27/19. Hard to drive 8 hours, raining out & getting cooler out. Its now Thurs 10/31 & still have tightness & pain & stiff legs. Using furniture to brace myself to walk. Detoxing & flushing system with the oregano tumerica, I called CDC 10/31 they gave me to Vares & this form. Starting my new job Nov 3 & Im miserable I need to sleep & relax. I was instructed to fill out this form & return to clinic that gave me the Tdap & have them report it. The Director insisted on me being seen by their Dr. I was seen by Dr. He prescribed me a muscle relaxer & prednisone. I explained to him this pain in my legs was from my waist thighs knees & to my feet. Its tight & heavy & stiff & difficult to lift up my legs & walk I tried to stretch & do exercise to help stimulate my circulation to get this out of my system. Im using detox natural tumeric tea & lots of purified water. Today 11/2/19 - Some improvement as now the intense pain in stuck in both knees & down to feet. But still hard to lift my legs like doing steps getting up from toilet & getting in & out of car. I did not sleep at all 11/2/19 Dragging all day today. Did rest on couch, took hot bath & my meds.
Pt was 7 wks pregnant when received vaccine.  Pt had bleeding 2 days following.  After this, bleeding started again at 8 weeks gestation and continued for 2 weeks.  ultrasounds showed sub chorionic bleeding on 4/26 which increased in size and severity on ultrasound done in the ER on 5/15.  Patient had increased pain and cramping and delivered at 17 weeks at home, on 5/21.  The cause of pregnancy loss is felt to be due to placental bleeding/abruption.   EDC for this pregnancy was 10/28/21.   The patient has had 2 prior uncomplicated term pregnancies.
Patient recieved expired ActHIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00628862) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 3 years old male patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ263AAA and expiry date: 02-Jun-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 03-Jun-2021.  The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for immunization.  The reporter asked Is the protocol to revaccinate or is there a grace period in the expiration date since it was expired by only 1 day, what is a live vaccine and Is ActHib a live vaccine.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.   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.
left arm warm, red.  Patient has some malaise symptoms.  currently has symptoms, but not severe
Pt developed erythema and induration of 4-5 cm in anterior right thigh.