chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reason for Consultation: arthralgia after influenza vaccine. HISTORY OF PRESENT ILLNESS: Pt is a 64 year old male with gout and hypertension who received the influenza vaccine on 10/16/2017. He reported subjective fever later in the evening, then onset of generalized arthralgias involving left shoulder, wrists, knees and ankles. A few days later he noticed swelling and redness of bilateral wrists. This was also associated with mild weakness especially the first 3 days, but this has since improved. No headaches. He did not develop a rash around site of injection or other rash, hives, oral ulcers or mucosal lesions. He was given a 16 day course of prednisone and reported minimal decrease in joint pain joint swelling. No new medications have been prescribed. Those that he is currently taking, he has been taking for several years. He did travel in August, but felt well during and after he returned from his trip. He has never had these symptoms after influenza vaccines in the past. After the first course of prednisone, his symptoms improved but he still did not feel 100% so he returned for re-evaluation. Serum sickness was suspected and thus he was started on another tapering course of prednisone on 11/2/2017. Despite steroid therapy, he continues to have swelling and redness of the dorsal aspect of right hand/wrist and also swelling of the left 3rd and 4th IP joints. He has a history of gout but has not had a gouty flare in a while. He takes allopurinol 300 mg daily. He does miss a dose of his allopurinol about once a week. In the past he has had gout flares in the knees and ankles. While he was on his trip he did not take his allopurinol, but then resumed therapy after he returned in September. Last uric acid was 9.7 mg/dL. on 9/27/2017 (repeat uric acid was 5.4mg/dL on 11/10/2017). ASSESSMENT/PLAN: SERUM SICKNESS, SUBSEQ GOUT 64 year old male who developed fever, initially arthralgias and then joint swelling in wrists with onset of symptoms the evening after he received an influenza vaccine. He has had the flu vaccine yearly but has never had a reaction from the vaccine previously. No rash reported. Onset of symptoms right after injection seems atypical in this situation, but a more acute presentation is possible in those who have been exposed to the same agent previously. Thus he could certainly have serum sickness or more likely a serum sickness like reaction to the influenza vaccine. There are case reports of serum sickness after influenza vaccination described in the literature. Differential diagnosis also include severe gouty flare, inflammatory polyarthritis. He was off therapy for one month prior and then resumed therapy and this may have led to a gout flare. But unusual for a flare to persist this long and not respond to prednisone burst. Will continue to follow clinically to assess for persistent synovitis. Labs reviewed, no new neutropenia, thrombocytopenia or eosiniophilia, no rise in creatinine and UA without proteinuria. Complements can be low in serum sickness, though his were not decreased. As he remains symptomatic, will increase prednisone dose to 0.5 mg/kg/day and then re-evaluate symptoms in 4-6 weeks, sooner if needed.
arm is sore; arm is swollen; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EU283), via an unspecified route of administration on an unknown date as a single dose in the right arm for COVID-19 immunization. Medical history included lung cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unknown date. The patient experienced my arm is still sore, it is swollen on an unknown date stating it is all day, yesterday and the night. The patient treated the arm is sore and swollen with putting an ice pack on it. The clinical outcome of the pain in extremity and peripheral swelling was not recovered.
Low grade fever, up to 101 degrees F., continuing for six days so far.  Severe headache and sinus pain.
Information has been received from a registered nurse concerning a patient who on 10-MAY-2001 was vaccinated with a dose of Varivax. Subsequently, on 26-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
FELT LITTLE TIRED; DIZZINESS; VERTIGO; MILD HEADACHE; chills; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 10:30 for prophylactic vaccination. Batch number was not reported and has been requested, No concomitant medications were reported. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced vertigo. On 13-MAR-2021, the subject experienced mild headache. On 13-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced felt little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, and mild headache on 13-MAR-2021, was recovering from dizziness, and the outcome of chills and felt little tired was not reported. This report was non-serious.
Vaccine given 6-10-16, red, swollen area appeared at 9:30 pm 6-10-16. Patient used BENADRYL, TYLENOL or ibuprofen for tenderness, 6-11 -> 6012016. When she woke up 6-13-16, she had developed a larger pink area around the initial red swelling. At clinic today, 6-16-16 - red, area measured 3.27 cm and surrounding pink area measured 5cm wide x 7.5 cm long, will cont. meds as needed.
Large hard red itchy area appeared 7 days after injection, same arm. Lasted 2-3 days
This spontaneous report was received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-OCT-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" with lot number J009689 with expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 5544. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
10-12-Thursday-12th-headache, achy, nauseous. 10-16-Sunday night-fever-101 and muscle weakness. 10/18-To MD- no treatment except increase Iron. Missed work 10-12-17 through 10-19-17.
patient received a dose of Tenivac after it had experience extended transit time on 20 Jul 2019/ No symptoms reported; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) via phone.  This case is linked to case 2019SA203084 (same reporter).  This case involves a 16 years old male patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Batch number: U6265AA and expiry date: 19-Apr-2021) via intramuscular route in the left arm on 20-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included patient received MCV 4 and Meningococcal B vaccine.   It was a case of actual medication error due to Incorrect product storage.  No symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by the sender: none.
Patient reported feeling tingling in the left arm. Raised red lumps about the size of a quarter where observed on both arms.  Some bruising at the injection site. Patient reported they started the day after the injection and were getting better several days later.  I advised the patient to take oral allergy medication and see her doctor the next day if symptoms did not improve.
Mother brought child in with report of swelling and redness to area. Some redness and swelling observed.
Patient was initially injected with 0.1mL air bolus from empty sterile syringe to left deltoid. NP administering vaccination immediately noticed error and withdrew needle. Full dose of Moderna vaccine, 0.5mL subsequently administered to left deltoid by NP. Patient was immediately made aware of error and verbalized understanding. No further reaction occurred during injection of dose, 15 min observation period, or at hour 5 during post vaccine check in by myself.
On 7/18/23, pt received 2nd dose of Men B (Bexsero), 3 hrs later, pt began having myalgia, arthralgia, headache and nausea.  On 7/20/23, pt developed fever T102.5F for 2-2.5 days.  On 7/21/23, pt developed nausea and diarrhea that lasted until 7/24/23.
This was my second dose of shingrix vaccine. Mild numbness in two smallest digits on my left hand started a few days after I got the 2nd dose of the vaccine. This was the same arm that the vaccine was administered. The numbness started to go away after about 17 days and the fingers seems to be going back to normal now at about 19 days. Not a serious event but I wanted to report it for the record.  Note, I did have expected flulike symptoms the day after the 2nd vaccine dose but nothing serious. Almost no symptoms after the first dose.
Her symptoms started on a Tuesday or Wednesday. She had diahhrea for a couple days, no fever. For four days she would get up, go to the bathroom and go back to bed. She was picking at her dinner so we gave her Ensure. There might have been aches, she was showing that it was hurting. A couple days ago she was a lot better, eating and staying up more. She has been showing relaxed improvement. For about 3 to 4 days all she did was sleep. We never did test her for COVID-19.
body aches; felt woozy; Headaches/headache is worse; diarrhea; vomiting; chills; body aches; Headaches; nauseated; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), the second episode of PAIN (body aches), the first episode of PAIN (body aches), DIZZINESS (felt woozy) and AXILLARY PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoma in 2008, Lymphoma in 2012 and Stem cell transplant (Patient had stem cell transplant of her own cells.) on 29-Nov-2012.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced AXILLARY PAIN (sore arm). On 29-Jan-2021, the patient experienced NAUSEA (nauseated). On 30-Jan-2021, the patient experienced the first episode of PAIN (body aches), CHILLS (chills) and HEADACHE (Headaches). On 30-Jan-2021 at 2:30 AM, the patient experienced DIARRHOEA (diarrhea) and VOMITING (vomiting). On 31-Jan-2021, the patient experienced the second episode of PAIN (body aches), DIZZINESS (felt woozy) and HEADACHE (Headaches/headache is worse). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency; KAOLIN, NEOMYCIN SULFATE, PECTIN (KAOPECTATE [KAOLIN;NEOMYCIN SULFATE;PECTIN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Jan-2021 at 6:30 AM, DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved. At the time of the report, last episode of PAIN (body aches), AXILLARY PAIN (sore arm), NAUSEA (nauseated), CHILLS (chills), HEADACHE (Headaches/headache is worse) and HEADACHE (Headaches) was resolving and DIZZINESS (felt woozy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-027499 (Patient Link).
Patient was accidentally administered the Moderna Covid-19 vaccine which only has an emergency authorization for age 18 and older. No adverse signs or symptoms reported in the first 15 minutes following vaccination.
hypotonic hyporesponsive episode; seizure like activity w/in 24 hrs of vax w/DTP;
dosing outside of 2-6 month window/ late for 2nd dose; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 3-Aug-2022. Reporter's Comments:  Healthcare professional inquired about dosing outside of 2 to 6 months window for the patient who was late for 2nd Shingrix dose. The consent to follow up was granted. No additional information available. Unknown if follow up was permissible. Additional Supportive Information: At the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Red, raised area around injection site about a fist sized area. Painful & tender around injection site.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 30-year-old male patient received BNT162B2 9 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm left, administration date 22Jun2021 (Lot number: ew0181) as dose 2, single (at the age of 30 years old) and intramuscular, administered in arm left, administration date 01Jun2021 (Lot number: ew0185) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 20Nov2021, outcome "not recovered" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Nov2021) negative, notes: Nasal Swab; (20Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
warm erythematous macule 4x6cm lt deltoid; 12 hrs p/inject of TD; local itching also DPH given;
Vaccine is placed in refrigerator on 26-Oct-2021, expired product date on 13-Oct-2021, administration date on 29-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 26-Oct-2021, expired product date on 13-Oct-2021, administration date on 29-Oct-2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 26-Oct-2021, expired product date on 13-Oct-2021, administration date on 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 26-Oct-2021, expired product date on 13-Oct-2021, administration date on 29-Oct-2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. There was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. Date place in refrigerator was 26-Oct-2021. Patient did not experience temperature excursion and any adverse event. No treatment medication information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
Pte started with pain, redness and swelling of the arm where the shot was given. No fever. 24 hrs after vacc was given.
Fever, headache, body aches, weakness, fatigue, dry cough, nausea, pain at injection site
On May 21st I had an excessively swollen lymph node under my jaw.  It did not reduce and by the 24th I went to the Urgent Care facility near me.  A mono spot was done and it was negative. The Dr. gave me an antibiotic shot and put me on antibiotics (10 days).  He advised if it was not better within 24-48 hours to go to the ER.  The swelling improved but did not resolve and on the 27th I returned to the urgent care for follow up.  They sent me to the ER.  The ER performed a CT Scan which showed that my lymph node was necrotic and that other lymph nodes were enlarged and they referred me an ENT. Dr. ordered another 10 days of antibiotics and a biopsy which was performed on June 7th.  The results came back negative for cancer. I was referred to my dentist to ensure there were no abscesses.  The Dentist confirmed that whatever caused the issue with the lymph nodes was not dental related. I am following up with a primary care physician  and have an appointment July 9th.  Please note that I had no other symptoms other than the issues with the lymph nodes. I am new to the area and had to get a new primary care physician and will pursue follow up after the initial appointment tomorrow.
Approximately 5 hours after receiving the vaccine, I became achy.  For the 5 hours thereafter, I had a 103.6 degree fever and severe chills.
Dizziness, myalgias, syncope (apart from time of vaccine), subjective high fever, paresthesias.
Five days after immunization, she developed a warm, itchy, red patch just inferior to the injection site on her left arm measuring approximately 10 cm x 15 cm.  We initially thought it was cellulitis due to the delay in presentation, but it spontaneously resolved less than 24 hours later without antibiotics.
Patient pulled her arm away, while administering the product, this caused them to administer an incomplete dose to the patient with no reported adverse event; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case from other healthcare professional and non-healthcare professional via Media information (under the reference 00820789).  This case involves a female patient of who pulled her arm away, when received the vaccine, this caused them to administer an incomplete dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (once, oral solution, total, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  This case was a special situation due to vaccine underdose (latency: same day).  It was reported "Medical assistant states that they were vaccinating a patient with ADACEL, states while they were administering the product, the patient pulled her arm away, this caused them to administer an incomplete dose to the patient. Medical assistant states they do not know how much ADACEL the patient actually received, asks if they should re-vaccinate the patient and how long they should wait if re-vaccination is required."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  There will be no information on batch number for this case.
I have a fever and chills and felt weak all over.  In addition, the arm there received the shot swelled up and had hives.  For several days, it was very warm and tender to the touch.  I treated it with Ibuprofin and ice.  After a few days my fever and chills went away but my arm is still tender to the touch in certain places.
Pt received annual Flu Shot and pneumovax at approx noon on 11/7. felt until dinner time when he began developing shaking chills, temperatures to 102-103 degrees F, severe headache, and his left deltoid became swollen red hot where injections were given. Symptoms lasted 48 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral Paxlovid start date was reported as 26Jun2022 and treatment stop date was 29Jun2022, administrator route was reported as oral for Treatment of COVID-19. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously receive a COVID-19 Vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine. Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the tiem of this report, the patient has recovered from the event (date unknown). the nurse reported that there were total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of Gardasil out of 130 total doses administered by the office. Additional information has been requested.