chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presents to Birth Center Triage for "scheduled repeat LT C-section". PMHx of "cesarean section, gestational diabetes mellitus"
Instant bleeding, hematoma, pink around injection site, and lump.   The next day there is purple bruising that has expanded and the injection site is warm to the touch.  It is mildly painful in that region as well as to move my left shoulder. There is also a lump in that area.
arm is hurting, like there is a bruise; arm is hurting, like there is a bruise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2022 as dose 3 (booster), single (Lot number: FJ4991) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, LOT- EW0187), administration date: 23May2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, LOT- EW0180), administration date: 06Jun2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), CONTUSION (non-serious) all with onset 20Mar2022, outcome "not recovered" and all described as "arm is hurting, like there is a bruise".  Additional information: No other products reported. No investigations reported. Reporter stated he was listening to the radio right now and stated he was getting a reaction to the Pfizer Covid shot. Stated he got had shot on 17Mar2022 and his arm was still like it was bruised, clarified there was no bruise but it felt like a bruise, started about 3 days after the shot, stated it was his left arm. Stated that it was his third dose.   No follow-up attempts are possible. No further information is expected.
SHORT OF BREATHING  SWOLLEN LIP  RASH ON HAND SORE THROAT
Starting the evening of the 5th day after receiving the vaccine I noticed a sore, irritated throat. By the 7th day it was a more severe sore throat, runny nose, violent sneezes and the beginning of a deep painful cough. No fevers have been noted to date, with the highest oral temperature of 98.6F on the 7th day. I called the employee hotline, had a virtual visit with a Dr and took the drive up COVID test around 11:00 am on 12/23/20. I am in self quarantine currently awaiting results of the COVID test.
Mild injection site pain following initial dose 12/22/21. Severe myalgia approximately 12 hrs post 2nd dose vaccine (1/19/21) that lasted for approximately 12-16 hrs.. Body aches in legs/back mostly, chills, low grade temperature (99.2). Mile headache and fatigue lasting until the following day. Returned to baseline approximately 30 hrs post vaccination.
14 hours after injection woke up with swollen upper lip and extreme systemc itching. Took 50 mg Benadryl. 12/26/2020 at 0900 continued itching took claritin 10mg and 25 mg Benadryl lip still swollen.12/26/2020 @2000 took 25mg benadryl for itching lip no longer swollen. 12/27/2020 itching has now become burning sensation systemically took 25 mg benadryl and 10mg Claritin. Upper lip swollen 12/27/2020 @ 2000 took 25 mg benadryl for continue burning and itching Lip no longer swollen. 12/28/2020 @ 0600 took 10 mg claritin till itching no burning. 12/28/2020 at 2100 took benadryl 25 mg for continued itching. 12/29/2020 0600 took claritin 10 mg for itching.
Two days after receiving varicella and TDAP developed "red, raised, itchy bumps about 10 cent size on back & arms. Red lump, itchy size of walnut to vaccine site". Denied SOB - Lump to arm dev. 1 day after immun.
Itching and swollen size of softball. Applied ice pack and took Benadryl. Continued from onset to swell and itch. Someone mentioned that if you're allergic to metal that would happen and I am allergic to certain metals. Swelling in lymph nodes under arm.
severe muscle pain throughout the body -especially in the neck and lower back; fatigue. headaches, chills, vomiting (twice) and diarrhea (once)   Lasted the entire day (2/15/21.   By the next morning, (2/16/21) I was feeling fine.
Patient c/o fatigue and cough on 1.4.2021 and was encouraged to be tested for COVID. We were notified that the patient was hospitalized on 1.7.2021 with COVID symptoms and positive test results. She is currently on a ventilator and dialysis.
I have no idea if it's vaccine related. I woke up in the night with numbness in my lower right arm and a throbbing ache that slowly moved up my arm (along with tingling below it) and to my shoulder by about 9 am. The pain was so bad in my arm that I thought I was going to throw up. I also had pain and tightness in my chest and difficulty breathing. Leading up to this (and also after) I had been having a lot of pressure in my head, behind my eyes, head and body/muscle aches.
Lower back pain progressively worsening. After 3 days of flu shot, I have severe lower back pain and right leg pain. I am unable to stand straight and having pain when walking.
Patient was administered HPV and Tdap vaccines IM. Patient got off of exam table and walked over to a chair in the room. I began to inform pt and mother of precaution to wait after HPV vaccine to watch for reaction when mother looked over and asked pt if she was ok? Pt was noticed to be pale and sweating profusely. I went over to her and held her and asked mother to open door and ask for help. MA got Dr. to come in for further assistance. Pt was laid down and vitaled 11:08 am BP 83/52 Pulse 67 O2 98 Fb 86.
Next day, patient spent all day in bed because she felt feverish and weak. Took ADVIL and felt better; did not call doctor. On 5/16, noticed vaccination area red, warm, and swollen. Checked-in with pharmacist and told to take BENADRYL. Today, patient feels better and site of vaccination still is red, warm but not itchy.
No adverse event 2nd Vaccine was administered 2 week early.  patient did not bring in the vaccine card from the 1st vaccine dose and the date of the 1st dose was not verified before administration
fully vaxed as of 5/20. ADmitted to hospital for other reasons but found to have COVID when tested on 8/08/2021. Did have symptoms as early as chills and myalgias on 8/04/2021.
Sore arm at injection site, fever of 102°, chills, aches and headache
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female patient with no pertinent medical history who on unspecified dates were vaccinated with two doses of GARDASIL (lot# not reported) at another office but does not recall when. There was no concomitant medication. Her Last Menstrual Period was 17-SEP-2009. Her expected date of delivery was 24-JUN-2010 (also reported as 23-FEB-2010). On 16-NOV-2009, the patient was seen in the office for pregnancy. The result of ultrasound was pregnancy. She was being referred to "a high risk physician" because she received GARDASIL during pregnancy. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from a medical assistant informing that the patient had a "normal healthy delivery" on 23-FEB-2010 (22 weeks from LMP). The medical assistant reported that their office had no information on the health of the baby. Upon internal review, a "normal healthy delivery" on 23-FEB-2010 (22 weeks from LMP) was determined to be an other important medical event. The baby's experience has been captured in WAES 0911USA02681B1. Additional information is not expected.
pt recv vax MAR94 & devel tiredness, joint pain, black & blue marks & rashes;initially attributed to sports activities;pt was found to have a low platelet count in summer of 1994 & hosp & dx w/lupus erythematosus;pt did not grow x 4yr
ERYTHEMA, EDEMA, WARMTH IN THE LEFT THIGH OF ABOUT 25 TO 30 CM.
Develop a rash on Right arm 8 days after, 7-8 inch in length x 3 inch wide.  Area red, swollen and hot to touch.  No pain. Notified PCP on line 3 days after. Recommended Zyrtec am and Benadryl pm (protocol). Also, observe for infection. Seen by Urgent care 4th day.  Rx'd Triamcinolone and Clindamycin (held off on antibiotics per my preference).  6 days on-rash remains the same.
Got shot at church at 11:00 AM, had adverse effects immediately after sitting down. Started off being disoriented and light headed which led to me losing consciousness. Would go in and out of consciousness until sternum checked multiple times. Got picked up by the ambulance and taken to the hospital as blood pressure was low and was fevering per first responder. Had an ekg with tachycardia, once delivered to the hospital. Still in and out of consciousness. Stayed there roughly 6-7 hours and received fluids and magnesium before being discharged,
Pt was given 2 varicella immunization on the same day. Also given PROQUAD at 1 yr.
Client reports with in minuets of being in the observation room her tongue started to tingle. Approached staff in hall and client and nurse went in to an exam room. Nurse started taking vitals and called Nurse Director and was instructed to administer 25ml IM of Diphenhydramine to right arm. Nurse cont. with taking vitals signs until client reported to feeling better.
Red (R) deltoid, warm, local reaction vs. cellulitis AUGMENTIN 400mg x 7 days.
Lower back pain; Anxiety because of the error in his wife's vaccine; Headache; Hurts at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (Lower back pain), ANXIETY (Anxiety because of the error in his wife's vaccine), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurts at the injection site) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced BACK PAIN (Lower back pain), ANXIETY (Anxiety because of the error in his wife's vaccine), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurts at the injection site). At the time of the report, BACK PAIN (Lower back pain), ANXIETY (Anxiety because of the error in his wife's vaccine), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurts at the injection site) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.
Information has been received from a physician assistant concerning a patient who was vaccinated with ROTATEQ vaccine (dose and route not reported). On 10-JUL-2008 the patient received first dose of ROTATEQ vaccine. On 18-NOV-2008 the patient was in the office to receive the second dose. No adverse effect reported. Additional information has been requested
Information has been received from a Merck pregnancy registry from a nurse concerning herself. She reported that on 21-APR-2007 she was vaccinated IM with the first dose of Gardasil (Lot#0641B). On 29-MAY-2007 she received the second dose of Gardasil (Lot# not provided). On 01-JUN-2007 she learned she was four weeks pregnant and experienced viral vaccine exposure during pregnancy. On 28-JUN-2007 the patient experienced a miscarriage and was hospitalized. Unspecified medical attention was sought. Subsequently, the patient recovered from the miscarriage. Upon internal medical review the spontaneous abortion was considered an other medical event. Additional information has been requested.
Patient completed Moderna COVID-19 vaccination series on 2/16/21. Patient presented to reporting hospital with symptoms of general fatigue, decreased oral intake, shortness of breath, cough and found to be in acute hypoxic respiratory failure with a positive COVID-19 test recently. Patient reported that friend was also COVID positive and brought this friend to COVID testing without a mask on. Admission testing was positive for COVID.
rt deltoid area became swollen, red, hot, about 10/24/99 p/vax;area also became raised about size (approx 5cm in diameter);has not sought medical f/u;
Hives beginning on scalp and spreading throughout body to limbs over the course of 12 hours.  Treated with Benadryl and hydrocortisone cream effective until Benadryl wears off and then hives begin again.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patients' medical history, concurrent condition nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB, (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provide any further details at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
Localized reaction on left arm with cellulitis and low-grade fever and pruritus around site.
pain swelling redness heat treated with cortisone, tylenol with codeine, ibuprofen, ketoralac, prednisone, keflex
30SEP96 pt recv vax 27SEP96 & came to office w/ c/o pain in lat arm;6"x6" area of erythema;warm to touch;area of redness, sl raised;
h/a, swollen reddish lump; put ice pack on for several hrs; took a few ASA;
5mins post vaccination pt reported dizziness. Vitals: 184/94, 59, 20, 97% -- > 166/90, 57, 20, 97% Educated pt to record BP and to take it to her PCP. Pt stable and released from the vaccination site.
Pneumonia due to severe acute respiratory syndrome coronavirus 2-He completed all of Covid related therapy in the form of remdesivir, dexamethasone and baricitinib -He was also requiring insulin coverage because of his hyperglycemia after his Covid and IV steroids -Will be discharged on cough syrup Accu-Cheks at home ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored MMR II (dose, route, lot # and expiration dates unspecified) and GARDASIL (dose, route, lot # and expiration dates unspecified). Concomitant medications were not reported. No adverse effects reported. No additional information to report. Additional information has been requested.
Patient recieved a thier 2nd dose of Pfizer and Jynneos at the same time.  Shortly after, they tested Positive for COVID and recieved Paxlovid.
Sore arm, but not as severe as the first shot. At 11:30 pm on the same day as the shot (April 1st), I started to feel sore around my neck and upper back, and had a severe headache. Starting at 12 am I had intense chills and heat flashes. Had a low fever of 99 and continued to fluctuate between 102. Experienced nausea until the morning of April 3rd. By the morning of April 3rd, most symptoms faded and I woke up with a minor headache, body soreness, and the occasional chill.
Pt came in 2 days following a DTaP received in (L) thigh. 8 x 10 cm area of redness, very tender & warm.
On day 7, s/p vaccination, he developed a red and swollen left arm from the shoulder to the elbow. Complained of arm and axilla pain and a fever of 102F for 2 days. Relates being ill and in bed for 2 days.
Per staff,  "Patient had blood draw and vaccine administration. patient then passed out and had seizure like activity. Notified provider that patient had seen. Patient given emesis bag and ice pack. After patient felt a little better, patient was transferred to exam room with wheelchair lay down. Had patient lay down. Patient's sister called to pick up patient. "
March 13, 2021 - Upset stomach; headache; fever & body aches March 14, 2021 - Fever; headache and tired March 15, 2021 - Tired & slight cough March 16, 2021 - Slight cough & minor rise in body temperature
on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left orbit down face on left side of nose, also a fever blister on bottom lip starting 2/22/2021,discomfort continues. have not called M.D. Lysine ointment on lip. no other treatment
1st dose 24Sep2022, 2nd 27Dec2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 57-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 9249L, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE.   On 27th December 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: The medical assistant reports that the patient received the Sanofi flu vaccine at a different facility on 24 Sep2022, and she was administered a dose of FluLaval QIV on 27th December 2022.  The reporter consent to follow up. Additional Supportive Information: The patient received extra FluLaval Quadrivalent, which led to extra dose administered.
arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported.  No relevant concomitant medications were reported.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
After vaccine, started feeing severe pain on my upper arm. I couldn't take a shower or put my clothes or used seatbelt. Now 08/09 still same pain can't sleep because pain is very acute. I have reported with my Family Dr. as soon as this happened, I was told go to Urgent care, with only adv take tylenol or go back to your doctor. Dr. adv report this issue and requested an MRI scheduled for 08/28/23. I feel that i have handicap instead to feel better is getting worse by the day. This is the first time I had a shingles vaccine.
Patient has rash that started on torso and radiated to entire body lasted about 10 days.  Patient developed fever greater than 100.4 for 2 weeks. Patient started to develop tachycardia approx 4 days after rash appeared.  1/11/21 patient saw Dr.  had a negative COVID test.  Started on Prednisone taper x 10 days.  Also taking diphenhydramine po bid.  Back to physician 1/21 due to rash and tachycardia (HR in 160's).  Rash resolved, fever subsided but patient referred to cardiologist .  Patient ordered an echocardiogram and stress test.  Patient had episode of afib and left bundle branch block during stress test.  Cardiac Catheterization on 2/18/21, structurally cleared. So causation considered electrical.  Patient currently taking atenolol.
Pt complains of anxiety related to receiving vaccine. No major symptoms. Pt requests closer observation.  Vital Signs: BP 126/78 HR 84 O2Sat 99 Pt observation Continued observation
Information has been received from a Licensed Practical Nurse concerning a 15 year old female patient, with no pertinent medical history and no drug reactions or allergies, who on 13-NOV-2010 was vaccinated with the first dose of GARDASIL (lot # 666595/0992Z, expire date October 2012), 0.5 ml, intramuscularly. There was no concomitant medication. The patient fainted 30 seconds after receiving her first dose of GARDASIL (on 13-NOV-2010). The patient fainted and exhibited "jerky movements with clenched fists". The patient was monitored and left the office fully recovered within 1 hour. The licensed practical nurse also added that the patient had not eaten that day prior to the vaccination. There were no laboratory diagnostics studies performed. Additional information has been requested.
About a week and a half after my second shot I noticed an itchy rash on my back and assumed it was a spider bite and treated as such. My GP diagnosed me with shingles on 05/10/2021.
pt recvd 1 dose of Engerix-B & had low grade fever, severe aching in joints, stiff neck;
administered Fluarix QIV via IV; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 85-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number t4jg7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2022, the patient received Fluarix Quadrivalent 2022-2023 season (intravenous) and Fluarix Tetra Pre-Filled Syringe Device. On 22nd November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Nov-2022 Reporter's comment: The registered reported did not had details regarding her own zip code but gave consent for follow up. Email address was provided. The reporter consented to follow-up. Additional supportive information: The nurse inadvertently administered Fluarix Quadrivalent via intravenous administration to a patient on the day of reporting, which led to intramuscular formulation administered by other route.
110/68 97% pulse83 Left arm injection.  Client reports heaviness in right arm pressure in her chest almost immediate  10:10 108/68- pulse 96 pso2 97% right arm heaviness- chest pressure resolved.  Client declined ER visit and requested to leave, spouse present will drive client home.
I got the first shot and got them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the first Shingles shot and experienced shingles. The patient said that, he/she never did get the 2nd dose, no way.
Patient was asked several times by 2 healthcare providers if she wanted a HD flu vaccination. After the vaccination was given, and patient had left. She stated that she was expecting a Shingrix vaccination. She had already received a flu vaccine at another location. She had no adverse reactions and will come in a couple weeks to get the Shingrix.