chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the shots were administered he was complaining of his leg hurting. At his evening bath is when we noticed his leg. His left thigh was red, firm, warm to touch, swollen the entire size of his thigh with a bruise in the middle the size of a baseball. We called the nurse line and they said to do a cold compress and if it doubled in size or pussed to take him to the ER. No fever was present during this reaction. Since it was the weekend and the doctor office was then closed over the weekend, I awaited doctor contact until Monday morning. I was informed that this kind of reaction was "normal" - but nothing about this reaction was normal in my opinion.
Past hx of dvt/pe/factor 5 leiden gene mutation- initially diagnosed in 2008 as a complication of back surgery-occurred post op. Was treated with warfarin for 11 yrs and due to constant blood draws was switched to xarelto 1 year ago 20mg which she didn't always take with food. She was admitted on 10/20 with respiratory failure and at that time u/s of b/l le showed b/l dvts without PE thought to be provoked by her illness and hospitalization. She apparently had mx attempts at b/l femoral tlc in the ER.she was started on lovenox for the dvt's but then developed a large hematoma and she was transferred to unity for placement of an ivc filter on 10/30/20 and was eventually placed back on eliquis. She had a venous doppler 3/3/21 with no evidence of acute dvt and mild narrowing of the L common femoral vein and prox superficial femoral vein c/w residual from old prior dvt. Because Recent ultrasound report showed resolution of prior extensive bilateral DVTs and Only minimal chronic thrombus was seen it was recommended that her IVC filter be removed and Her IVC filter was removed on 4/29/2021.  At that time they noticed small caliber bilateral external and common iliac veins; she is scheduled to be seen in IR clinic next week to discuss potential venography, IVUS and angioplasty with stenting of the bilateral iliac veins. She was continued on eliquis after. Admitted to medical center with LLE acute nonocclusive superimposed upon chronic DVT in the proximal left superficial and profunda femoral veins in the upper thigh requiring lovenox 1mg/kg every 12 hours.
Was given the flu shot on his first day of feeling better after being ill for several weeks with a virus. By evening of the same day, he had to go to bed due to feeling ill with fever, aches and malaise for the next 48 hrs.
Thursday fever, diarrhea, nausea, body aches, Friday fever, headache, diarrhea, Saturday fever and diarrhea, Sunday diarrhea
Blotchy erythematous macular rash on R anterior thigh with tender injection site.
Heavy vaginal bleeding with clots, cramping in uterus and tenderness in this area prior to onset of bleeding. Vaginal bleeding lasted for 6 days.  Please note that this was not like a regular menstrual period and I was not due for my period. I also bled after my first Pfizer vaccine but it was not alarmingly heavy like it was after this second dose. After this second vaccine dose, I was fatigued during the bleeding and after. The fatigue was resolved two weeks after I received the second vaccine. One other strange side effect was that three days after I received the second vaccine my left hand was slow to respond when I needed to type on the computer. This lasted for several days.
Information has been received from a nurse concerning a female who was vaccinated on an unspecified date with Gardasil (dose and lot # not reported) at a different facility. Subsequently the patient experienced an autoimmune response. The patient was having unspecified blood work done. The patient outcome was not reported. The patient sought unspecified medical attention at the office. Additional information has been requested. No further information is available.
Pt has area of infection at injection site. Scab approximately 1 cm with redness 3 cm x 5 cm. Pt sent to Dr who started pt on sulfa. Pt asked if immunizer used alcohol swab. Pt said yes.
pt reports she became itchy and noticed red bumps on arm then went into rest room and saw it was all over her whole body she returned to her car where her husband was during trip home she developed headache and began having difficulty breathing they went to hospital where she reports she spent two days received two doses of epinephrine and three doses benydryl she reports she would have flare ups of the rash during hospitalization
pt recv vax 4JUN96 330PM;pt given APAP 2:30;home fed pt sleeping in mother-in law arms;pt not breathing right;approx 20min in arms;laid pt on bed;observed breathing;several shallow breaths, then one deep breath;could not wake pt; pale color
I had about 8 events over the past 2 months. They start in my upper arms on both sides bilaterally. Feels like weakness is coming over me. Radiates into my shoulders and into my neck. I feel like a weakness then a tightness and then it goes away. But I feel it climb up in my arms to my neck on both sides and then it subsides. Sometimes it's stronger than others. It feels like my arms are weighted down, like I want to shrug my shoulders to get the feeling to go away. So it feels like a weakness that comes over my  upper arms, shoulders, and neck. and they're super tired and tight. then they go away.  Doctor's visit today 02/09/2022.
Oxygen: currently on room air on admission, monitor oxygenation and titrate as needed to maintain between 90-96% - Labs: Labs notable for :  ? CRP 76.3 ? Procal 0.32 ? WBC 8.5 ? Platelet 107 - Imaging: CT chest on admission showed hazy ground glass opacities of the left lingua and left lung base. no additional imaging needed at this time - Breathing treatments: no inhalers needed; avoid nebulizers in favor of MDIs  - IV fluids: not indicated at this time - Antibiotics: not indicated  - COVID-Focused Medications: Remdesivir x 5 days or until hospital discharge, started on 1/16/22. Monitor oxygenation and start dexamethasone if hypoxia develops. - DVT Prophylaxis: at high risk of thrombotic complications due to COVID-19 (DDimer = N/A ).         - PROPHYLACTIC dosing: lovenox 40mg daily       - consider anticoag on discharge for 30 days & until return to normal mobility
Arm with 7x8 cm circumferential erythema with minimal swelling, minimal tenderness child without fever.
Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.
Dry heaves; Very tired; Not able to eat in am; Left large black eye; Chills; Blood vessel in right eye bursted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot/Batch number: EN6206, Doses: 0.3 mL, Route of administration: Intramuscular, Anatomical location: Upper arm muscle, Dose no: 1), administration date: 07Mar2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Blood vessel in right eye bursted"; RETCHING (non-serious) with onset 29Mar2021, outcome "recovering", described as "Dry heaves"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "Very tired"; FEEDING DISORDER (non-serious) with onset 2021, outcome "recovering", described as "Not able to eat in am"; EYE CONTUSION (non-serious) with onset 2021, outcome "recovering", described as "Left large black eye"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "Chills".  Clinical course: The reporter stated that several weeks before eye/ face cleaned up started feeling better by 02Apr2021 except for blood eye. Had booster shot administered in upper arm muscle but did not put date down, had mild symptoms, but was prepared. Prior vaccination: None. No specific relevant test for thromboembolic with thrombocytopenia. No relevant tests.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Rash/Hives all over body. Been going on for two weeks now. I have been treated with prednisone pills, steroid shot, and doxycycline nothing has helped.
General feeling of malaise.  Lasted approximately 12 hours. I experienced the same type of reaction when I got the second dose in March 2021 and that time the symptoms lasted about 24 to 36 hours.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Oka/Merck) VARIVAX. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12 months year old patient of unknown gender. On 17-JUL-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L003775). This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Her arm became itchy; Her upper arm became warm between her shoulder and half of her arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Her upper arm became warm between her shoulder and half of her arm) and PRURITUS (Her arm became itchy) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included WARFARIN, CLONIDINE, CALCITRIOL, FUROSEMIDE, SIMVASTATIN, VALSARTAN and INSULIN GLARGINE (TOUJEO) for an unknown indication.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING HOT (Her upper arm became warm between her shoulder and half of her arm). On 29-Mar-2021, the patient experienced PRURITUS (Her arm became itchy). At the time of the report, FEELING HOT (Her upper arm became warm between her shoulder and half of her arm) had resolved and PRURITUS (Her arm became itchy) outcome was unknown.            Patient stated that she applied cold compress on her arm. No treatment medication were provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Patient demographics updated, concomitant medications added, events updated. On 15-Jun-2021: Event details added.
Swelling in axillary lymph nodes on right side. Swelling size is about 1/2 an apple. Radiating pain into elbow and dull pain throughout arm and shoulder. Treatment Advil TID. Pain has decreased, swelling size has not.
Malaise began at 12:00am on 4/6/2021 Fever began at 1:00 pm on 4/7/2021 and dissipated around 3:00 am on 4/8/2021 Raised, red, very tender lump appeared about two inches below injection site around 12:00pm on 4/8/2021
Swollen tongue - 6-12-2018. Loss of taste - 6-13-2018 to present. Metallic taste - 6-13-2018 to present. White skin patches (vitiligo) on hands 6-13-2018 to present. Headache 6-12-2018 to 6-15-2018. Fever (103 degree) 6-12 and 6-13-2018.
Redness, swelling and heat at injection site 3 days after injection, 4?x 3?
pt recv vax in 1993 & in 1996, exp lymphadenopathy;pt will be worked up for an infectious cause;sx cont;
This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # L07757, expiry date 08-APR-2018 (strength, dose, route and site of administration were not reported). No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), Age at vaccination 67 years old, on 05Feb2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Feb2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Sep2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 16Apr2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing), notes: Other medical history: Sleep apnea. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient not had Known allergies. Patient did not take other medication in 2weeks. Patient took Paxlovid Anti viral Treatment from 05Jul2022 to 10Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 shots 2 weeks apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shinlges so decided to get vaccinated. The patient received 2 shots of shingles vaccine 2 weeks apart, which led to shortening of vaccination schedule . The patient was told that the arm was probably be sore for a couple of days. The patient reported no soreness or any kind of after effects. Also stated that get a flu shot every year.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR168290:same reporter
Rash and itching in various body parts. Last night midnight  left ear. Today2/19 right upper arm and right shin;  by 11 pm  rash and more intense itching on upper left arm, and rash plus welts on upper right arm and left hip , and rash on upper left arm. Itching pretty intense. During the day  on 2/17 I notice slight itching on upper right arm but not too intense. Site of injection on 2/08 was left arm.
Sharp pain in upper arm, attributed to flu shot, but has not gone away, and has become chronic, keeping me up at night, etc. Reported to Doctor, and now following up here. Never had this problem before.
I had mild symptoms I had running nose and had a fever of 102.0. When my fever was that high, I wanted to test myself because that was not normal. Then my test was positive it was a home test and I tested myself two time.
This spontaneous report was received from a other  source (office manager) refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot #: M005972, expiry (exp): 02-FEB-2018, lot#: L024256 exp: 01-JUL-2017, lot# L034369 exp: 08-SEP-2017, lot# L037561 exp: 29-SEP-2017, lot#: L046884 exp: 23-NOV-2017 and lot#: L049533 exp: 08-DEC-2017. The temperature excursions were reported as -8.4 C for 11 hours, -9.7C for 16 hours and -11 C to 13.9 C for 59 hours. No previous excursion reported. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Systemic: Other- SOB, light headed, numb hands. Pulse ox was normal. Patient has a history of anxiety.
Patient reports intense pain in her right leg morning after vaccinations. Husband came into pharmacy to ask if it could be vaccinations. Suggested patient should see provider. Husband stated she had previously refused, but he would pass along suggestion to his wife. Still reporting pain as of 11/2/19.
- 11/11/09: patient received Pneumovax vaccine - 11/12/09: patient presents with complaint of left arm severe pain, no redness.  Pain radiates down arm with some hand paresthesia, m swelling and pruritis. Lab shows elevated WBC, pt developed low-grade fever. Diagnosed with cellulitis and started on Keflex.
Initial report received from a healthcare professional on 21 March 2013. A 36-year-old pregnant female patient had received intramuscular first dose of ADACEL (Lot number: U4586AA, site of vaccination was not reported) on 20 March 2013. The patient's last menstrual period was on 01 August 2012 The patient's estimated date of delivery was reported as 8 May 2013. As per reporter, the patient had no experienced any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were reported as "not applicable". Documents held by sender: none.
Headache, NauseaVomiting, LEFT DELTOID PAIN, UNABLE TO LIFT ARM Narrative:
This spontaneous report as received from a register nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB, (strength, dosage, route, and lot# were not reported). None symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220766, 2018SA220774, 2018SA220775 and 2018SA218532 (same reporter). This case involves a four years old patient (four years 26 days old, gender not reported) who received a dose of PENTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on 30-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. 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 sender: none.
Information has been received from a nurse practitioner concerning a 12 year old female patient with juvenile diabetes "not well under control" who on 30-AUG-2009 was vaccinated intramuscularly with her 0.5 ml second dose of GARDASIL. Concomitant therapy included FLUMIST received on 16-SEP-2009. According to the reporter, on 26-SEP-2009 the patient experienced acute anxiety, started feeling dizzy, scared, nervous, extremely tired, had bad dreams and also experienced auditory hallucinations and dry mouth. The nurse thought she had symptoms of a psychotic breakdown. The nurse also stated that the patient was first taken to the pharmacist who informed the patient's guardian that it was caused by GARDASIL. It was also reported that the patient started her first menstrual cycle on 16-SEP-2009. Therapy with GARDASIL was discontinued. No diagnostic tests were performed. The patient sought medical attention by an office visit. Additional information has been requested.
Intense upper stomach / upper back pain began on 3/28/21. Went to ER. Was held for emergency gallbladder removal surgery. Doctor said bad inflammation seen inside the abdomen area during surgery. Gall stone removed size of golf ball and gallbladder removed as well.
The day after the vaccines I started developing pain on the side of my torso. This then developed and turned out to be shingles.
At 8pm the evening of the vaccination, patient felt tired and achy.  The next morning she felt flushed.  Later on in the evening, the patient noticed that she had a swollen lymph node in her one of her armpits.
expired pentacel was administered with no reported adverse event; Initial information received on 12-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Caregiver).  This case involves a 32 days old female patient for whom  expired Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired dose of 0.5 ml dose 1 of suspect Diphtheria/Tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection with unknown strength, batch number & expiry date via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: same day).  Information on the batch number was requested.  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.