chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen left underarm glands; Pain down the upper arm; Fever; Chills; Dizziness; Nausea; Vaccine administered in left leg; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0207) via an unspecified route of administration in left leg (characterised as vaccine administered at inappropriate site) on 16Mar2021, at 14:00 hours, (at the age of 48-year-old) as a single dose, for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No medications were received within 2 weeks of vaccination. Since the vaccination patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 17Mar2021, the patient experienced swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea. The clinical outcome of the events swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea was not recovered at the time of this report. While it was unknown for vaccine administered at inappropriate site.   No follow-up attempts are needed. No further information is expected.
No additional AE details available. No additional AE reported.; 1 dose of ROTATEQ was administered to 1 patient/Temperature ABOVE 9°C (11.9C) for 1 hour 9 minutes and 0 seconds; This spontaneous report has been received from a licensed practical nurse referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 27-OCT-2022, the patient administered with improperly stored 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot# W02562, expiration date 12-OCT-2023, anatomical location and strength were unknown) orally for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions above 9 degree Celsius (C) (11.9 C) for 1 hour 9 minutes and 0 seconds (product storage error). There were no previous temperature excursions. No additional AE was provided (no adverse event).
At about 7:30 after taking a shower, I started shivering. I thought it was just because the house was chilly, but I couldn't stop. I did not check if I had a fever, but it felt like I did. I had body aches, nausea, and I vomited a couple of times. By about 10:30-11 I felt a lot better.
Developed Guillian Barre Syndrome. Lost mobility in legs and unable to walk, shortness of breath, heartburn, severe burning in the chest.
pain in lt hand w/in 2-3hr of vax;later devel problem w/lt eye moving slowly;BP 210/98 @ the time of visit to employee clinic;instructed to f/u w/usual physician because of past hx of HTN;
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 4th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
sore throat; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination or tested for covid-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SkinRash  shortness of breath, throat tightness  Narrative:  37 yo woman had second covid-19 Moderna shot today, lot #002A21A at 3:24 pm.  Very soon after shot, she began to feel short of breath. Lay down, developed erythematous rash near site of shot and over chest. Gave loratadine 10 mg po and famotidine 20 mg po. BP 130/80 HR 98, increased to 120 then decreased to 80s after loratadine. Rash disappeared, heart rate decreased to 60s, bp 124/70, then 130/91. Developed some skin mottling and a little bit of  throat tightness that improved. Oxygen saturation 98-99% throughout. Mottling improved, felt better. Husband picked up 17:30.   Other Relevant History:
Initial report was received from a healthcare professional on 19 July 2012. An 11-year-old male patient received dose one of a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd., sanofi pasteur Inc. lot number U4103AA (corresponding sanofi pasteur Ltd. lot number C3971); dose one of a right deltoid intramuscular injection of MENACTRA, sanofi pasteur Inc., lot number U4033AA; and dose one of right deltoid injection (route not reported) GARDASIL, Merck, lot number 1537AA on 18 July 2012. Within 24 hours of vaccination, on 19 July 2012 the patient experienced "night terrors" along with disorientation during the night, diarrhea and low grade fever of 100.6 degrees. The patient had not been evaluated by a physician. The reporter (nurse) stated she felt "this could be a form of encephalopathy caused by the ADACEL," and advised the parent to have the patient evaluated by a physician. Laboratory or diagnostic testing had not been done at this time. Corrective treatments were not reported. The patient's outcome was reported as unknown. Documents held by sender: None.
Erythema right upper arm below injection site extending to medial arm.  Warm to touch.  Pt reported itching started several hours later.  Warmth noted following day
Pain from shoulder to her hand; Pain from shoulder to her hand; Sore left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from shoulder to her hand), ARTHRALGIA (Pain from shoulder to her hand) and VACCINATION SITE PAIN (Sore left arm at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm at injection site). On 29-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain from shoulder to her hand) and ARTHRALGIA (Pain from shoulder to her hand). At the time of the report, PAIN IN EXTREMITY (Pain from shoulder to her hand), ARTHRALGIA (Pain from shoulder to her hand) and VACCINATION SITE PAIN (Sore left arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   This case was linked to US-irms-MOD21-272190 (E2B Linked Report).; Sender's Comments:  US-irms-MOD21-272190:
I had extremely bad head aces, I threw up and was extremely nauseas, I also had blurred vision. This all occurred 24 hours of receiving the vaccine. I went to the emergency room and I was given an IV, and gave me anti nausea, and I was given something else but I can't remember the name.
Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) unknown dose number, via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) (at age 82 years old) as single dose for covid-19 immunisation. There was no relevant medical history. The patient's concomitant medication was not reported. The reporter wanted to report a possible connection to an adverse event from the Pfizer COVID vaccine. The patient had the vaccine in either January or February and last week he had a heart attack. The reporter stated that he was okay. He was not completely "out of the woods" right now but he was extremely healthy and what had happened was kind of unusual. After this, the patient was given some kind of statin (unspecified). Since the heart attack, he had a lot of tests but the reporter didn't know. As for the treatment, the reporter responded that "Yes, they are having there. They are under the care of doctor now." Outcome of the event was unknown.   Information about lot/batch number has been requested.
After 2nd of 3 vaccinations of Lymerix, I became stiffer in the knees, hips and back. I had trouble walking for more than 2 or 3 blocks. This is unusual.
After about 5 minutes the patient began to have nausea and had to go throw up in the restroom. When patient was done she stated she had just eaten before getting the vaccine and felt better.
low grade fever (99.7°F); His wife had a rash on the right side of her abdomen and inner thigh/rash on the right side of hrash on inner thigh of one leger belly/rash on inner thigh of one leg; diarrhea; vomiting/Throwing up; This is spontaneous report from a contactable consumer (patient husband). This report is regarding his wife. A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: PHFEEL9263, Expiration date: Unknown), via an intramuscular route in the left arm on 28Jan2021 Thursday at 12:00 PM, as 1 ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history included cancer; however, she is cancer-free right now. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 30Jan2021 until 23:00 or midnight patient was fine, and the patient had experienced heavy 20 minutes being in the bathroom throwing up and having diarrhoea and in the morning rash on the right side of her abdomen about the size of a saucer and inner thigh and on 02Feb2021, a low grade fever (99.7 degree Fahrenheit). Her temperature never went higher than 99.7 degrees. Patient wanted to know if can expect these side effects from the second dose and could they be worse. The patient underwent lab test and procedure which included regular CBC (like whole bloodwork) on 01Feb2021, Monday. She doesn't have any test results to include. The clinical outcome of fever has subsided and outcome for the event rash on the right side of her abdomen and inner thigh of one leg was recovering, outcome for diarrhoea and throwing up was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-JUN-2014 the patient was vaccinated with a expired dose of ZOSTAVAX lot # J002869, expiration date 14-JUN-2014. Dose and route were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. Additional information has been requested.
After 7 days after vaccine my blood pressure went up to 200 oscillating  during the week .I had to increase substantially my medication dose .  I had constant and prolonged chest pain . I had to see my cardiologist and I was treated with NITRO . I never had that kind of symptoms and high blood pressure before. Due to this symptoms I canceled my second dose of vaccine .
Pt received vaccine and was in line at the register, cashier noticed he looked as if he was going to pass out and had him sit in a chair. Customer service came over to find me to let me know what I was going on, I grabbed the emergency kit, told tech to call 911(4:13) and found the pt Pt was in a chair, his eyes were dilated, he did not know where he was and he was cold and clammy. I then said we needed to move pt to the ground and elevate his feet. Pt started to become more alert and less confused. Pts blood pressure was 113/86 and pulse was 85  EMS arrived around 4:30  Pt was able to walk out of the store with them  EMS took his vitals BP 126/66, O2 99%, 94 pulse and 16 RR. Pt went home with parents and when I checked with his mother on 9/20 she said he was doing fine
p/vax pt felt sick could not finish lunch;mom came home 305Pm had a fever of 100 & very pale gave 2 APAP & laid down 45min;Md office said doubtful this r/t lyme shot;pt did not look well at all;
Chills, fever, injection site pain approximately 12 hr after injection. Continued symptoms 2 days later plus swelling 5x5 cm w/ redness and mild swelling, no itching. Resolved on day 7.
Woke up the next morning, legs would not work had to call 911. Did not go to the hospital. Legs are still weak, pain on the left side of neck has since gone.
This spontaneous case, initially received from a nurse on 07-Dec-2017, concerning a 60-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
Patient had unusual persistence of weakness. Both legs, below knees, numbness, tingling sensations. Underwent extensive tests at hospital- all neg.  9/12/08-records received for DOS 9/20-9/21/07-DC DX: Peripheral neuropathy. Presented to ED with C/O bilateral lower extremity weakness/numbness began 2 days prior. Tingling began next day.PE: decreased sensation, strength 4/4 times four. End point nystagmus L>R.  Follow-up with neurology clinic.
Injection site was hot to touch and very sore. Ran low grade fever next day (100 degrees). Upset stomach,  explosive  diarrhea.
On 06/14/2022 I tested positive for COVID-19. I had a low grade fever the only reason I tested was because my wife tested positive. I called my doctor the same day she prescribed me with PAXLOVID for 5 days.
Around 36 hours after the vaccine was administered, I began to suffer from: Hearing loss in right ear, a constant "whooshing" sound in the right ear, and symptoms of vertigo - dizzyness, nausea, vomiting etc. It has been about ten days thus far, with no noticeable improvement.
Truncal rash, papular, of various sizes, typical appearance for varicella, sparing the face and extremities, 10 lesions, no other signs or symptoms.
I woke up in the night from a slow heart rate and tingling in my left hand (same side the shot was given). After a short while my heart went back to feeling normal, but my hand has not been the same since.  It has been 23 days since my first shot. The feeling in my left hand is much less then before, as is that arms strength. This really stood out to me when I was touching a hot pan and it took a few seconds for my body to react. I then tested the reaction of my right hand, which reacted immediately.  I also had the normal reactions of headache, and muscle aches for two days after the shot.
developed a complex seizure.  Was also febrile at the time.  Admitted to hospital and started on anti seizure medications with follow up with Neurology outpatient
on Saturday feb 13 2021 pt received covid 19 vaccine and next day morning at 8 am she woke up with Bells palsy
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On 27-Oct-2021 at 4:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.45 years.  Concomitant products were not provided.  On 29-Sep-2021, the vaccines were moved to fridge and on 27-Oct-2021, 02 vials were moved to clinic. Proposed beyond use date for these two vials was 29-Oct-2021.  On 05-Oct-2021, the vaccines were moved to fridge and on 27-Oct-2021, 04 vials were moved to clinic. Proposed beyond use date for these four vials was 04-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 29 Fahrenheit and on the same day, at 10:00 A.M., the temperature recorded was 32 Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
patient describes she was terribly ill and sick for 5 days. started about 30  minutes after injection. flu like symptoms. not able to eat.
I had a breakthrough case, I tested positive for COVID 6 months after my booster vaccine.
Breathing difficulties, wheezing, coughing, tightness of chest for 3 hours after immunization, until medical help was sought.   Redness, heat and swelling at injection sight for 96 hours after immunization.
Dizzy and light headed for approximately 45 minutes.  Lowered to ground and feet elevated.  Water, juice and cookies given.  Blood pressure taken.  Escorted to elevator when feeling better.
Headache, Myalgia, Arthralgia, Fever, Malaise lasted 24 hours Narrative:
Yesterday is when it really started to increase and has gotten worse since starting; has "intense" pain on all the joints; intense pain that started in the left side of his jaw, in the joint; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 10Feb2021 13:30 as single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus had for 5-6 years , ongoing hypertension had for about 8 years. There were no concomitant medications. Reporter stated that he had covid vaccine on 10Feb Wednesday and afterward he has had joint pain which he explains was intense pain that started in the left side of his jaw, in the joint. He also has intense pain in his left thigh, in the joint socket. He stated that he also got a headache, but it was gone away. Patient wants to know if this was a side effect. Patient stated that he got the shot on 10Feb2021 and the joint pain was noticed that day, it was real faint that evening. Yesterday is when it really started to increase and has gotten worse since starting. Patient stated that his wife got the shot too when he did and had some joint pain but is has gone now. Reporter stated that on the back of the card it says After: 03Mar2021. This might be when he gets the next shot. The outcome of the event has "intense" pain on all the joints and intense pain that started in the left side of his jaw, in the joint was not recovered. The outcome of the event headache was recovered. The outcome of the event yesterday is when it really started to increase and has gotten worse since starting was unknown.  Follow up (12Feb2021): This is a follow up spontaneous report from a contactable Consumer. No new significant information was added.
Patient received Johnson & Johnson on 6/29 (lot # 205A21A).  He presented to the ED on 6/30 with complaint of dizziness.   Patient said he felt that the room was spinning every time he sat up or stood up.  Patient denied any history of vertigo in the past.
12/26/21 presents to ED for "PEG tube issue". PMHx of "CHF, COPD, HTN, CAD, VDRF, stroke, metabolic encephalopathy, left IJ DVT on Eliquis"
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: She has a history of vasovagal reaction to needles and blood draws. Provided her with water and crackers and observed for about 30 minutes.
pt recv vax 5NOV97 & hurt when needle was given;could not raise arm up or move in any direction;
I hurt all over my body. I could not sleep last night like I drank 10 cups of coffee. Hot and cold hot and cold. Severe headache and cramping. Unable to pay attention and irritable.
MOMENTARY LOC PER VACCINATOR CHILD FLUTTERED EYES THEN OPENED THEM AGAIN LASTED FEW SECONDS ONLY THEN FULLY AWAKE....
Abscess on right thigh. Received Flu shot on 10/20/17 and as per mom there was redness and swelling at the site, she called and was told to apply Mupirocin, it improved and there was no pus discharge, but it started draining again yesterday when she called and was started on oral antibiotic.
Day of shot no swelling no redness positive soreness increased in arm call Pt's mo, went to MD, ordered SOLUMEDROL dose pack continued to have pain referred to Orthopedic MD - Xray's taken - instructed exercise and Physical therapy. X-ray negative the orthopedic MD said it was Bursitis from exam and hx.