chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. On 5th February 2019 01:00, 16 hrs after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 4th February 2019 at 9:00 AM, the patient received a dose of SHINGRIX on an unknown arm. Next morning, the patient experienced arm was sore red and swell. The patient wanted to know, if anything that the patient could did to make the patient's arm felt better and get the swelling down.
Pt returned to clinic 7/18/02. L arm was red, swollen from mid clavicle to elbow and swelling continued 4" past elbow-lower arm. Child had seen PMD who recom. Benadryl, Advil and cold/warm compresses to site. Sl. fever noted 7/17/02.
1 3/4 inch width by 1 1/2inch length round systemic reaction. Slight redness with minimal bruising. No induration. Mother reports she noticed it a day later. Examined patient on 11/20/2013 @ 13:15 PM. No signs of distress, recommended to keep an eye on it and call us any other signs or symptoms occur. No medications given at office visit.
2 days after receiving the covid vaccine - experienced headaches; had a cyst appear on right wrist and had a swollen right arm pit.  Right armpit was also sore and throbbing.  the recipient called Occupational health on Thursday, 12/2/21 and was seen by the physician on Friday, 12/3/21.
Approximately 6 months after my booster shot (Dose 3) I contracted covid and experienced the following symptoms: Coughing, Sore Throat and a low grade fever. I called my doctor and was prescribed to take Vitamin D.  I also drank a lot of water and just do some home remedy treatments. I have fully recovered from COVID 5 days ago.
Patient was administered an expired dose of the Moderna Booster from a punctured vial over 12 hrs ago. (Vial punctured 6/23/2022 @ 10:10am)
Side effects within hours of injection that lasted approximately 48-72 hours: Left arm soreness that radiated around shoulder to left shoulder blade. Pain when lifting arm. Injection site warm to touch and swollen. Headache, fatigue, and nausea.  Started normally scheduled period on October 8. Period was the worst in my life. Very severe cramps with sweating, nausea, and diarrhea. The cramps were so bad that I contemplated going to the hospital. I took ibuprofen and the cramps became more typical after about 2 hours. The nausea and headache continued for 24 hours.
dose of YF-Vax that was incorrectly reconstituted with sterile water instead of the sodium chloride diluent provided with the product with no reporter; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. Agency number: 01222412  This case involves a 43-year-old male patient to whom dose of YELLOW FEVER VACCINE -  [YF-VAX] was administered that was incorrectly reconstituted with sterile water instead of the sodium chloride diluent provided with the product with no reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE) for Prophylactic vaccination; and RABIES VACCINE (RABIES VACCINE) for Prophylactic vaccination.  On 15-Jul-2022, the patient received   dose of yf-vax that was incorrectly reconstituted with sterile water instead of the sodium chloride diluent provided at dose 0.5 ml once (lot UJ563AA) via unknown route in right arm for Immunization with no reported (product preparation error, latency same day). A medical assistant administered the vaccine. A staff member accidently combined it.   First time product used : Yes  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     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.
About 1715,after vaccine administered (total of six), patient noted with diffuse urticaria.No respiratory but noted mild wheezing. No stridor, RR 20's, unlabored, Pulse ox 98-99%.Rx benadryl 10 mg.po and epinephrine(1:1000)0.1ml IM administered as per Dr. After total observation time of 45 min.Patient ishappy,engaging,with resolving urticaria.D/C with mom with instructions starting 2000. If urticaria resolves and not further problems, RTC 5 days as planned. If urticaria recurs in spite of plan or if he develops respiratory distress of any degree, RTC(ED) promptly.
Thick red raised rash from mid forearm to mid upper arm-rash itched and burned. Advised to continue Allegra and use hydrocortizone cream 1% to areas tid.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fj4991) at the age of 50 years 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: "Sulfa Antibiotics: Drug allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Negative, notes: Lateral Flow test; (07Jul2022) Negative, notes: Lateral Flow test; (08Jul2022) Negative, notes: Lateral Flow test; (08Jul2022) Negative, notes: Lateral Flow test; (11Jul2022) Positive, notes: Lateral Flow test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Pt with vasovagal response during observation period following injection administration. Symptom onset noted approx. 12 mins following injection.
FIRST NOTICED SHOULDER JOINT PAIN AND STIFFNESS ABOUT 1.5 hours after administration.  This continues to worsen over next few days to the point where even minimal pressure on my extremity caused pain, and rom was significantly decreased despite attempts with anti-inflammatories and rom exercises.  Saw occ health after 1week, started Aleve and tramadol and PT exercises,  after still worsening symptoms had an xray and MRI on 10/15 revieled small fluid collection and tendonitis.  Saw orthopedic on 10/22 recieved steroid injection.  48 hours later pain improved and rom improved.  Began PT biweekly and at home.  11/6. Noticed pain worsening again.  Today 11/10 pain is present, not debilitating but worse than yesterday and the day before.  I am still on modified duty at work and see the orthopedic again on 11/12.
The patient is 16 years old and he was given the dose for 5-11-year-olds. The patient received 0.2 ml of Pfizer COVID vaccine.
Right Eye swollen & red. Got worse- hard red bump (no discharge) . Saw GP on 3/8 who didn't know what it was..said it wasn't a sty. If it didn't improve with warm compresses I should see an eye dr. I saw an eye dr who said it was a chalazion and it co9uld be surgically removed or heal on it's own. I opted to have it heal on it's own. I had it for about 2 months. I'm reporting it now because I'm due for a booster and don't know if I should get Moderna.  In addition to the eye issue I did have a very robust response....chills, aches, pains, weakness, fatigue for about 24 hours.
Pt is a 33 y/o male who presents to the ED with c/o of left le swelling progressing over the last 4 days.  Pt has no other c/o.  Denies fever, cough, cp, abd pain, n/v/d.  Pt has had his first COVID vaccine 1/30.  Patient was noted to be tachycardic to the 120's in the ER, after 1L of normal saline still tachycardic to the 110's. Lower extremity doppler was negative for DVT, however PE protocol CTA of the chest was positive for a PE, report follows. Patient was given lovenox and flown to Medical Center for higher level of care.
Pt had a fever and rash. Mother returned to clinic with sibling and patient at a later date. Patient had recovered.
Received flu vaccine at 4 pm 10/12/2004. At 1 AM 10/13/2004 awoke suddenly with violent shaking and shuddering. Complained of severe headache and weakness also "freezing cold sensation. Taken to ER. Symptoms subsided mostly by time MD arrived. Treated with Tylenol and fluids. 0400 T102. Weakness, fatigue and aches persisted 10/13. Okay by 10/14/2004.
swelling under left arm; left arm- tender to touch; Received Booster (3rd shot) of Pfizer vaccine at work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Oct2021 09:00 (Lot number: EW0217) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heartburn", start date: 01Nov2020 (ongoing), notes: Currently taking Famotidine 2x daily; "Acid reflux", start date: 01Nov2020 (ongoing), notes: Currently taking Famotidine 2x daily. Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease, dyspepsia, start date: Jul2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Time (24 hr): 13:20, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 09Mar2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "minor soreness at the site of injection"; Bnt162b2 (Dose: 2nd, Time (24 hr): 13:20, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 30Mar2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "minor soreness at the site of injection". The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Received Booster (3rd shot) of Pfizer vaccine at work"; LYMPHADENOPATHY (non-serious) with onset 24Oct2021, outcome "recovered" (07Nov2021), described as "swelling under left arm"; TENDERNESS (non-serious) with onset 24Oct2021, outcome "recovered" (07Nov2021), described as "left arm- tender to touch". Therapeutic measures were not taken as a result of lymphadenopathy, tenderness.  Additional information: Description of Event: Experienced swelling under left arm two days after receiving Pfizer COVID-19 vaccine (booster, 3rd shot) in left arm. Optional Information: Experience no side effects from dose 1 and 2 except minor soreness at the site of injection. Relevant tests: None. Specific Relevant tests for thromboembolic events with thrombocytopenia: None. Comments/narrative: Received Booster (3rd shot) of Pfizer vaccine at work (Pfizer (name withheld)) on 22Oct2021. Two days later I noticed swelling under my left arm- tender to touch but not painful. It disappeared after two weeks. I did not experience any side effects from the first two shots except for mild soreness at site of injection.   Follow-up attempts are completed. No further information is expected.
Neck / it felt like it was on fire / still feel the burning every once in a while; Chills; Fever; Upset stomach; red itchy neck; Itchy neck / neck was itching; Collar bone was swollen; swollen on left side which traveled up her left arm; Neck was puffy and swollen on left side which traveled up her left arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included The patient did not have breathing problems..   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2021, 2 days after receiving Shingrix, the patient experienced chills, fever and upset stomach. On 23rd July 2021, the patient experienced red neck, pruritus, bone swelling, swelling arm and neck swelling. On 24th July 2021, the patient experienced burning sensation. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On 19th July 2021, the outcome of the chills, fever and upset stomach were recovered/resolved. On an unknown date, the outcome of the red neck, pruritus, bone swelling, swelling arm and neck swelling were recovered/resolved and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, upset stomach, red neck, pruritus, bone swelling, swelling arm, neck swelling and burning sensation to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received shingrix vaccine and two days later she developed, chills, fever, and upset stomach, which had resolved on the 3rd day.  7 days later she developed a red itchy neck and her collar bone was swollen on left side which traveled up her left arm and had lasted for 10 days.  On July 22nd and 23rd her neck was itching, and by the weekend it felt like it was on fire.  She went to the ER and was discharged home with cortisone.  Patient did not have breathing problems.  Her neck was puffy and swollen on the front left side, and she can still feel the burning every once in a while. The reporter consented to follow up.
Major symptom experienced is severe swelling and pain in right armpit, i.e. lymphedema. Lymphnoid is swollen and painful for 5-7 days shot. Fatigue and overall achiness.
ED to Hosp-Admission Discharged  3/31/2021 - 4/12/2021 (12 days)  Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem                                                            Date: 4/12/2021 DOB: 1/13/1928 Admission Date: 3/31/2021 MRN: 000452141        Length of stay: 12 Days   Admission diagnosis:    POA   * (Principal) Pneumonia due to COVID-19 virus Yes  HPI: Patient is an 93 y.o. male presenting to ED on 3/31/21 with worsening shortness of breath  with fever occasional cough, and fatigue.  He just received his second dose of his covid vaccination 3//26.    Hospital Course:  Patient was admitted to receive treatment for COVID 19 infection.  On presentation he was hypoxic requiring supplemental oxygen, he was in Afib RVR. He received experimental treatment with plasma, remdesivir, and dexamethasone. He had a AKI in setting of infection that improved, and his lasix was added back. He has CKD3, would recommend re-check cr in 3 days after discharge.  He did develop acute urinary retention that required a foley to be placed. Void trail in hospital was unsuccessful, suspect relatedd to weakness/poor endurance.  Can considner ongoing voiding trails as his health improves and or outpatient urology consult.  Paroxysmal Afib in the setting of viral infection, with fluids and increasing metoprolol rates improved.  Once he recovers from Afib can consider MCOT to evaluate Afib burden, continue ASA     Covid pneumonia Acute hypoxic respiratory failure, from COVID Pneumonia Received convalescent plasma Received Dexamethasone 10 day course  Completed remdesivir 5-day course on 4/4/21  Oxygen Requirement continues at 2 L nasal cannula Inflammatory markers trended down He was vaccinated SECOND INJECTION on 3/26.    Acute kidney injury on chronic kidney disease stage IV Creatinine improved with IVF did upwardly trend again likley from acute urine retention  Cautiously watch Cr while on  Lasix, consider checking CR/BUN in 3 days Monitor creatinine, avoid nephrotoxins Discharged with foley, continue Flomax. Consider voiding trails at SNF and/or urology consult   Paroxysmal atrial fibrillation -new onset Metoprolol tartrate increased during hospitalization patient will benefit from outpatient event monitor to determine A. fib burden once he recovers from Covid, to be arranged by PCP continue aspirin
Vaccine given too high in the arm.  Being an immunizer myself for a different company  I expressed concern immediately before vaccination, but was told that that was ?where it goes? and she injected me anyway.   Experienced burning 2 minutes following vaccination.  The following day I started experiencing shooting nerve pain in my affected arm and tingling in my fingertips.  My range of motion was considerably decreased in the affected arm as well.  Symptoms worsened after returning to work and trying to use the arm all day.  I contacted facility via email on Tuesday, February 2nd, via phone Saturday, February 6th, and again via email yesterday, February 8th.   I have not received any response.  I found a provider who was able to see me and was covered by my insurance and was seen this morning at 9:20 am by the physician?s PA.  Following physical exam and observation of the small bruise indicating the injection site,  she stated she believed my immunizer hit a nerve with the needle and prescribed a rapid prednisone taper.
patient came and signed in for vaccine was asked if this was first vaccine and he said yes, was asked again and he said yes. Patient brought back to room to get vaccine. Patient did not say anything when I was getting ready to get vaccine. patient given vaccine. He had no reaction during observation period.
lightheadedness, anxious/headache, observation, water/juice offered, improved, sent home
minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (minimal discomfort) in a 66-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (minimal discomfort). At the time of the report, DISCOMFORT (minimal discomfort) outcome was unknown.            No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.   This case was linked to MOD-2021-329830, MOD-2021-335336 (Patient Link).
pt had fever x 2 dasy & skin eruptions generally over body 10 days p/vax;
Painful site, developed fever 100.7, lethargy, muscle pain, joint pain, chills following day. That same night developed burning epigastric discomfort that has since turned into generalized abdominal discomfort with watery diarrhea.. Low grade fever on and off with ongoing lethargy
The day after the vaccine when I woke up and tried to stand up I felt dizzy and couldn't stand on my feet because the spinning sensation, I had been like that for 3 days and recently decided to call to the doctor and the nurse told me to take some pills for the dizziness, on Friday I spoke with a doctor, I was on scale of 10/10 and now are on 2/10.
I contracted COVID-19 on 05/19/2022 with symptoms of sore throat, cough, fatigue, and fever of 101. I received monoclonal antibodies on 05/21/2022. I was ill for 5 days before my symptoms began to resolve. I had a lingering cough that increased in severity and became more persistent. On 06/20/2022 I sought care for the cough where I was diagnosed with Bronchitis and prescribed antibiotics. The cough has still not resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 96-year-old male patient received BNT162b2 (BNT162B2), on 19Sep2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 96 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication in 2 weeks. COVID 19 Treatment: Paxlovid. Treatment start date: 05May2022 and stop date: 10May2022. Patient completed the medication. After 3 days of testing negative and was feeling fine, on 14May2022, patient's cold symptoms returned and tested positive again. Patient continued to test positive for 10 more days until finally testing negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from an executive refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were provided. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ oral (unknown strength and dose) lot # K016314 and expiry date of 05-JUN-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Instant burning lungs for 12 hours with arm soreness, next day nerve pain in left leg (chronic back and S/I issue, weak leg), then on Thursday, 48 hrs later, left underarm lymph node swelled, left neck swelled and left half facial numbness. Friday, I called Dr, they transferred me to hospital nurse who insisted I see the dr immediately. Dr did neuro exam and decided since I have blood clot history to send me to ER for a scan. At ER, dr was unsure of what to do or why I was there and sent me home. They just did a basic blood panel before I ever saw the dr. Burning lungs returned on sunday  morning and facial numbness increased.
Arm swelling around injection site - started on 8th day after injection.  Gradually getting worse.  On day 10 now and swollen/rash area several inches wide and still getting larger.
Headache; fever; body aches; chills; night sweats; loss of appetite; This is a spontaneous report from a contactable Nurse (patient). A 24-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), intramuscular on 07Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. Medical history included birth control. Concomitant medication included fluoxetine hydrochloride (PROZAC), and ethinylestradiol, norgestimate (TRI LINYAH) for birth control. The patient previously received the first dose bnt162b2 (lot number: Et1a899), intramuscular on 16Dec2020 at 11:45 in left arm for covid-19 immunization. The patient experienced headache, fever, body aches, chills, night sweats, loss of appetite; all on 07Jan2021 at 12:00. The patient did not receive treatment for the events, all events were reported as non-serious. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination, and the patient was not tested for covid post vaccination. The outcome of all the events was resolved in Jan2021.   No follow-up attempts are possible. No further information are expected.