chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report the evening he was vaccinated noted fine slightly raised rash on upper chest and back. None at vaccination site. Rash was itchy and diminished over the next few days. on 7/26/07 fine rash on chest, left upper. None at vaccine site.
PT was administered a Moderna vaccine with expiry date 10/15/2021.  He was observed 15min after injection and no complications or adverse effects were noted. Pt. tolerated vaccine well.
Large red swollen arm 48 hours after administration of DTaP and Flu in left deltoid. Resolving on 10/22/07.
Loss breath, rash, weak dizzy-onset 2 hrs post inj. 30min later took to ER. Admit to overnight stay. Allergic reaction to hep B vaccine. No further hep B vaccine are in?ed.
Entire body muscle cramps 10 hours post shot lasting 24 hours. Headache and nausea onset 24 hours post shot lasting 48 hours. Approximately 96 hours post shot onset of early Heavy period, clot filled and lower back cramps with nickel size clots when I just experienced my usual light period 1.5 weeks prior.  I have a Muriena IUD implanted and never experienced this heavy or any clots with periods.
Dizzy & light headed   b/p 90/60 110/68 110/70   Client monitored.   Symptoms resolved, client released informed to seek medical attention with any further problems.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Mild
2JAN98 pt had elevated temp 102-103;also cough productive w/yellow sputum;elevated temp lasted for 4 days & PAPA was effective reducing temp;cough is less but cont as of this date;10JAN98 blister area n upper lip then cover body;itching;
Menveo administration of liquid portion; Menveo administration of liquid portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA955a, expiry date MAY-2025) for prophylaxis.   On 16-JUN-2023, the patient received Menveo. On 16-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo administration of liquid portion) and inappropriate dose of vaccine administered (Verbatim: Menveo administration of liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The nurse called in to report the administration of only the liquid component of Menveo to a patient.  The healthcare professional asked how to proceed with this patient. The reporter mentioned that expiration date of the dose administered was May 2025. The reporter consented to follow up. The patient received only liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Started as hard knot at injection site, which was is bony part of shoulder/supper arm. The next morning (Dec 3) I had pain at the injection site and into my armpit, with a red streak (ca. 2 fingers wide near the injection site and going toward the front of my upper arm muscle, ca. 4-5 inches long.I slept almost all day, was up about 5-6 time for 10-20 minutes each time..  Dec. 4 armpit was swollen, sore, red streak not as bright.  Used heading pad.  Upper arm painful to the touch.  Dec. 5 Armpit not as sore, swelling lessening, pain moving along front of armpit to bottom of armpit.  Dec. 6 slight tenderness injection side and front, bottom of armpit, swelling mostly down, red streak fainter, beginning to itch.  Dec. 8 Red streak faint, but still there.
Information has been received from a registered nurse concerning a 23 year old male employee with no drug reactions/allergies and a history of childhood asthma, who on 06-OCT-2009 was vaccinated intramuscularly in the right upper arm with a 0.5 ml dose of PNEUMOVAX 23 (lot # 662268/1134Y). On 05-OCT-2009 the patient was vaccinated with AFLURIA. The nurse reported that the employee returned on 08-OCT-2009 because of an adverse reaction. The patient had chills on 07-OCT-2009 ("the night before") and was taking TYLENOL. The nurse noted that his temperature was 102.6, heart rate was 130, right arm was red, his blood pressure was elevated at 148/94, his EKG was a little abnormal and there was a depression in his ST. He was given intravenously BENADRYL at Health Services, then he was sent to the emergency room because he was "starting to get blotchy". It was unspecified if the patient had had PNEUMOVAX 23 in the past. At the time of the report it was unknown if the patient recovered. No laboratory diagnostics studies were performed. The adverse experience was considered to be an other important medical event by the reporter. Additional information has been requested.
swelling knot left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling knot left) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VACCINATION SITE SWELLING (swelling knot left). At the time of the report, VACCINATION SITE SWELLING (swelling knot left) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-103072 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 2nd dose of vax 29JUN92 & exp generalized achy sensation, fever to 101-102, fifteen pound weight loss, jaundice, elevated liver enzymes; lab eval on 7JUL92 showed SGOT 96,SGPT 103, GTT 66, LDH 278; dx early lupus;
Significant edema, firmness, warm to the touch for several days --area around injection site--3x5 inches. Resolved in 7 days.
Hives, severe headache, severe stomach and chest pains, deep joint and back pain, dizzy, nauseous, loss of appetite, sensitive to light and noise, weak, and 2 weeks later couldn't walk. went to ER and they found blood clots in left leg.
temp 101 Right leg didn't want to walk Started 2115 afternoon Fever 101, meds, ice to leg
Wrong vaccine and dose given. Patient given Pfizer 0.3mL (12+) vaccine when needed Pfizer 0.2mL (5+).
Extreme fatigue, sinus issues and congestion, headache, joint pain, body aches, pain at the injections site
Patient received vaccine and went to sit in the waiting room and then proceeded to apparently faint. It was not witnessed by the pharmacy staff. He was given water, gatorade, a wet rag, and a vomit bag. His blood pressure was taken 3 times and he declined emergency services. He felt better by 8pm and left on his own with his girlfriend driving.
Patient developed a cellulitis reaction in the arm within 48 hours of receiving the vaccination. Patient received medical treatment - received prescription for cephalexin 500 mg TID x 10 days.
Local reaction - redness, swelling, warm to touch x 2 days ago per Dr common local reaction pt. should not receive vaccine again.
Patient came in 2 days after vaccination with a raised rash at site of injection approx. 2 inches in diameter. Patient described mild discomfort. Recommended oral BENADRYL and topical hydrocortisone.
Rash, red cheeks, puffy eyelids, red patch on right knee.  Tender thenar eminences.
My sinuses bled for 5 days. I kept blowing out small clots of red coagulated blood every morning for 5 days. Then it stopped.
Pt received FLUVIRIN in right arm around 4:45 to 4:50PM. RPH asked him if he was interested in PNEUMOVAX and pt said yes. RPH prepared script for PNEUMOVAX, Gave VIS to pt and pt got up and signed for PNEUMOVAX at register then sat back down. RPH drew up PNEUMOVAX and then administered in pt's left arm. While administering pt tightened up arm and RPH asked him if it was hurting and pt stated, "you can tell" RPH finished up. Pt got up and started to leave. While exiting Technician noticed him looking dizzy. RPH and Tech sat pt down. Pt was breathing fine, but looked a little pale. Meanwhile, a customer went down hall and got a doctor. RPH took BP on left and right arm. Both readings were around 116/64. Patient started to complain of throbbing lower right back pain. Technician called 911. MD arrived and figured pt was reacting to needle but was confused about lower throbbing back pain and thought pt should follow thru with ambulance. Ambulance checked out pt and asked him some questions. Pt refused to go to ER because he was feeling fine now. Ambulance checked out BP and it was approximately 136/70-80. Pt signed waiver not to go to ER. Pt left pharmacy because he said he was feeling better. RPH gave pt OJ and pt said he was confident enough to drive home. Pt regained color in face and showed no signs of confusion, dizziness or shortness of breath.
Extreme fatigue, my daughter passed completely out and her lips turned blue within a couple seconds. Took her to the doctor, they said she tested positive for the flu.
redness; soreness; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case was received from patient's cousin via interactive digital media. The reporter wants to know that how long should the redness and soreness last after the first shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Day after shot, I had itching, two red dots, and 2 small knots at contact site. This was there for 3 days, then went away. Two nights ago on March 22nd, I noticed itching again. The next morning on the 23rd, there were red dots and knots again. The knots have continued to get worse to where they are now one golf ball sized knot. The skin is still very inflamed and slightly itchy.
Normally I always have regular menstrual cycles (26-28 days). For the first time in my life, I had my period only after 20 days, which started one week after the vaccine.
My daughter complain of burning sensation throughout her chest and stomach. She also complain of tingling in her arm and fingers. She received the shot on her left arm and she complain of pain and numbness in that arm. She also states that she has sharp pain in her feet and tingling sensation running down to her legs. She complain of headaches and pain in her jawline.She continue to have the pain daily. After seeing multiple doctors she was prescribed Gabapentin. We have a neurologist appointment on 11/13/19. Several test were conducted and spent 3 nights in the hospital and many other ER visits since the injection. She is currently in pain and continue to describe the pain as burning sensation, jabbing/Throbbing and tingling pain.
nausea; fever; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 07Mar2021 17:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, low testosterone, and thyroid. Patient had no known allergies and was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. Patient had no other vaccine in four weeks. On 08Mar2021, the patient experienced nausea, fever, chills and diarrhea. No treatment was received for the events. Outcome of the events was not recovered. Patient had not been tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shot felt hot. Very dizzy about 90 minutes after shot.  Bronchial irritation around 12 hours later.  Asthma begins next morning.  Throat, ears, nose, eyes begin to itch same day, about 24 hours after shot.  Treated with Claritin & albuterol inhaler.  Visited Dr. on staff at Hospital.
Pt called into clinic on 8/12/10 (2 days after injection) c/o pain at the shoulder and axilla area on same side of injection. States has red streak on her arm and tender to touch appt made - Pt seen by provider (noted redness (R) upper arm near axilla) documented streaking per pt on 8/11/10 but none observed - Treated for cellulitis with cephalexin.
sicker than any other time; flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Social Media and transmitted to Sanofi on 29-Oct-2020.  This case is linked to cases 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306295, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300, 2020SA306301, 2020SA306302, 2020SA306303, 2020SA306304, 2020SA306305 and 2020SA306306.  This case involves unknown age and gender patient who was sicker than any other time (Illness) and got flu (influenza), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sicker than any other time (Illness) and got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE and it was reported that would not take more shots.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Events outcome was unknown, at the time of reporting.  There will be no information regarding batch number for the case.
A patient received only the liquid portion of Pentacel without reconstituting, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Regulatory Authority (Reference number- 00448757) and transmitted to Sanofi on 27-Jan-2021.  This case involves a seven-month-old male patient who received only the liquid portion of pentacel without reconstituting the Hib powder portion (product preparation issue), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) and NA (sodium).  On 27-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6890AA and expiry date: 08-Mar-2022) via an unknown route in right thigh for prophylactic vaccination.  This was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, 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 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.
Spreading redness beyond the injection site that is raised, hard to touch, and warm to touch, along with red streaks going out from area of redness.
itchy in her legs,itchy in her shin,itchy in her arm between the breasts and elbows; tired; dizzied; headache; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm), PRURITUS (itchy in her legs,itchy in her shin,itchy in her arm between the breasts and elbows), DIZZINESS (dizzied), HEADACHE (headache) and FATIGUE (tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and FOLIC ACID for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (little sore arm). On 10-Apr-2021, the patient experienced DIZZINESS (dizzied) and HEADACHE (headache). On 11-Apr-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced PRURITUS (itchy in her legs,itchy in her shin,itchy in her arm between the breasts and elbows). At the time of the report, PAIN IN EXTREMITY (little sore arm), PRURITUS (itchy in her legs,itchy in her shin,itchy in her arm between the breasts and elbows), DIZZINESS (dizzied), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.            Treatment information included for cancer treatment
Patient required hospitalization due to breakthrough infection. Patient received Pfizer vaccine (2nd dose in series) on 03/28/2021. Patient was hospitalized from 08/31/21 - 09/24/21.  Below is copied from patients discharge (death) summary:   Patient is a 73 y.o. female with PMH of RA/PMR and hypothyroidism who was initially admitted to the hospital on 8/31 for stroke like symptoms (left sided weakness, right facial droop and aphasia) for which she recieved TNK and had neuro ICU admission. MRI and stroke workup was unrevealing how patient remained enephalopathic with development of hypoxic respiratory failure requiring intubation from 9/5-9/14. Following extubation, patient was downgraded to hospitalist serevice for further management on 9/16. On 9/24, patient was admitted to MICU following cardiac arrest with asystole noted on telemetry. Patient recieved 6 rounds of CPR, epix3, bicarbx2, and calcium. She was intubated at that time and ROSC was achieved with post-resuscitation BP 100/50. Epi gtt was started and patient was admitted to MICU service. Immediately upon arrival to patient coded again at 4:21 AM with PEA arrest. She recieved Epix5, bicarbx3 with ROSC at 4:36. Upon achieving ROSC, patient again became pulseless with PEA arrest at which time an additional 3 rounds of CPR were performed however patient did not achieve ROSC and began to have copious blood return from ETT. Given patients anemia and active bleed, TNK was not administered as risks overweighed benefits. No further rounds of CPR performed. No  Subsequent spontaneous movements were present. There was no response to verbal or tactile stimuli. Pupils were dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses or peripheral pulses were palpable. No heart sounds were auscultated over entire precordium. Patient pronounced dead at 5:16 AM.  Family was notified and condolensces were offered.
Patient complaining of swelling, pain, area is hard, can't sleep due to pain in arm
pt. had mild generalized itching and requested a benedryl  Benedryl given.  No other complaints.
pt recv vax & exp mild vesicular rash w/six lesions that MD felt was a mild case of chickenpox;felt the second dose would not create a problem;
Patient stated that her shortness of breath started after she received the booster Pfizer vaccine on 11/12/2021. She denies having issues with the first 2 vaccines. She only had symptoms of a headache with the first 2 vaccine shots. Post booster on 11/12/2021, she has been experiencing shortness of breath,  chest pain, chest heaviness, headache, cough, headaches, and intermittent diaphoresis. She describes her chest pain as "someone is sitting on top of my chest."
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion.Total of 173 doses/vials were given from LOT  070H21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
lost hearing in right ear. Serious dazzy. Urgent care in Hospital and also visited  Institute. Now use Prednisone, 3 once per day