chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a 13 years old female patient. In 2013 the patient was vaccinated with GARDASIL third dose (dose on schedule) lot # not provided. On an unspecified date in February 2014 patient presented to the physician's office with knee swelling. On unknown date in 2014 the patient had unspecified testing (unspecified date) and was diagnosed with lupus. Reporting person stated that the patient then had further unspecified testing and was determined to have "mixed connective tissue disease". The outcome of lupus and mixed connective tissue disease was reported as not recovered. Relatedness between events and vaccination with GARDASIL was not reported. Upon internal review the lupus was considered to be medically significant. Additional information has been requested.
This spontaneous report was received from a physician referring to a 13 year old female patient. The The patients medical history, concurrent conditions and concomitant medication ere not reported. The patient had an allergy to cephalexin (KEFLEX). In approximately 2005 (reported as when the patient was one year old), she was vaccinated with the first dose of VARIVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). In approximately 2008 (reported as when she was four years old), the patient received the second dose of VARIVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in June 2017, the patient experienced "shingles" (herpes zoster) and she was being treated with acyclovir at the time of reporting. No laboratory tests were performed. The outcome of the event and the causal relationship between the event and VARIVAX were not reported. No product quality complaint was involved. Additional information has been requested.
Systemic: swelling and pain below left armpit-Medium, Additional Details: Patients describes very noticable swelling and pain beneath her left armpit.
Pharmacist gave a 17 year old a booster shot today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist gave a 17 year old a booster shot today) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (The patient got the first two shots as Pfizer.) and Pfizer (The patient got the first two shots as Pfizer.). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist gave a 17 year old a booster shot today). On 21-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pharmacist gave a 17 year old a booster shot today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Tenderness, erythema at injection site 12 hours post adminstration.  Facial flushing, lightheadedness, dizziness, just weird 40 hours post admistration, followed by itching.  Patient given loratadine 10mg bid, diphenhydramine 25mg hs, hydroxyzine hcl 25mg 2 doses 72 & 96 hrs post admin.  Albuterol MDI started 48 hours post admin. Symptoms resolving six days after admin, still itching.
customer states she took her second shot of the vaccine and she has been having eye inches and running noise and not feeling well. Called her and she is ok.
Rash and hives all over body, itching, swelling skin. Used calamine lotion and anti histamine to treat.
woke up on 03Nov2021 with symptoms of a stroke went to the ER. It was a TIA stroke; woke up on 03Nov2021 with symptoms of a stroke went to the ER. It was a TIA stroke; Dose: 03; administration date: 18Oct2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-year-old non pregnant female patient received third dose(BOOSTER), of BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE Lot Number: Fe3590), via an unspecified route of administration in arm left on 18Oct2021 as SINGLE for (at the age of 66) covid-19 immunization (Pharmacy or Drug Store). The patient medical history was not reported. Concomitant medications included influenza vaccine (INFLUENZA) taken for immunization on 08Oct2021; pneumococcal vaccine polysacch (PNEUMOCOCCAL POLYSACCHARIDE VACCINE) taken for immunization on 08Oct2021, estradiol, pantoprazole, multi vitamin, calcium all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19 (received within 2 weeks of vaccination). Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6200) via an unspecified route of administration, administered in arm left on 18Feb20121 as dose 1, single and dose 2 of BNT162B2, PFIZER-BIONTECH Solution for injection, COVID-19 VACCINE Lot Number: EN6208) via an unspecified route of administration, administered in arm left on 11Mar2021 as dose 2, single (both at the age of 66) for COVID-19 immunization. The patient had dose: 03, administration date on 18oct2021, patient woke up on 03Nov21 with symptoms of a stroke went to the ER. It was a Transient ischaemic attack (TIA) stroke. The events resulted in Emergency room/department or urgent care, Hospitalization. Patient was hospitalized for one day from 03Nov2021 to 04Nov2021. Events was assessed as serious and seriousness criteria was reported as caused/prolonged hospitalization. The patient underwent lab tests and procedures which included nasal swab (covid 19,) test with negative result on 03Nov2021. Therapeutic measures were taken as a result of events (lots of medications). The outcome of evets was recovering.  Follow-up attempts are completed. No further information is expected.
Pt was seen in the office on 07/07/2023 for immunizations. Pt received several vaccines on that day. He received Varicella, MMR, Men B, and Hep B. MMR was given extra by accident. When asked CMA what happen she stated that she didn't double checked the vaccines and didnt question the doctor due to Varicella been low immunity but when entering vaccines in System I noticed pt had already received complete doses. When asking the Dr, he states that he ordered due to pt low immunity but the labs in EMR only states varicella was low, Doctor also states pt had came in with his own Lab report, but not really sure.
FULLY VACCINATED WITH POSITIVE COVID ANTIGEN TEST. SYMPTOMS ARE COUGH, NASAL CONGESTION, HOARSE. WAS ALSO EXPOSED TO COVID.
Patient was seen in the drive-thru mass COVID vaccine clinic. Patient was given a different vaccine than what was started at another location (received Dose #1 Pfizer and Dose #2 Moderna or visa versa). Patient was contacted about the different administrations. Patient reports no adverse effects from receiving 2 different doses. Patient was observed on-site for the required observation period and no adverse reactions reported on site.
1.   Headaches  all week  2.   Flu on Thursday, March 4, 2021 (after receiving the flu vaccine in the fall)
redness and swelling at the injection site; redness and swelling at the injection site; his 4- month-old daughter was administered with GARDASIL 9 vaccine/ administered to the infant; This spontaneous report was received from the patient's father, and refers to a 4-month-old female patient. The patient's concurrent conditions included drug hypersensitivity. The patient's medical history included injection site erythema. Information regarding the patient's concomitant medications was reported as none.   On 14-SEP-2021 (reported as "7 days ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) at a dose of 0.5 mL, intramuscular, in the thigh muscle for prophylaxis (strength, lot number and expiration date were not reported).  It was stated that she was only supposed to get her 4-month-old shots and then the pediatric office informed him that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) was administered to the infant by accident.  On 14-SEP-2021, the patient had redness and swelling at the injection site (vaccination site erythema and vaccination site swelling). The patient sought medical attention and no treatment was provided. At the reporting time, the patient had not recovered form the vaccination site swelling and vaccination site erythema.   The reporter did not provide the causality assessment between the events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) and consider the events vaccination site erythema and vaccination site swelling not to be cancer or overdose.
pt recv vax 12OCT95 & pt presented in office on 15MAY96 w/approx 25 varicella lesions
Patient was given a second dose of Prevnar 20 one year after receving previous dose of Prevnar 20
tingling sensation at fingertips radiating down arms, ataxia, sluggish reflexes, increased BP, headache Tx'd with Neurontin and Percocet 11/20/09 Hosp. records received for dates 11/13/09, 11/14/09 and 11/19/09. Seen in ER on 11/13. DX: parasthesias, HA. Pt. c/o numbness/tingling in hands/feet, HA, increased BP. Assessment: (+)parasthesias. Pt declined LP.  On 11/14 Seen in ER for worsening sx. DX: peripheral neuropathy Presenting SX: c/o tingling, electrical feeling in hands and feet, generalized weakness x3 days ago. Pt. c/o HA, difficulty walking, fatigue/malaise, blurred vision, Pt states received H1N1 last week and gardasil vax this week. Pt admitted for neuro eval.  11/19/09 Pt seen in ER w/ c/o N/V, back pain. DX: post spinal HA. Pt tx for generalized HA and dc.  12/10/09  Hospital neurology consult, progress notes and tests received for DOS 11/14/09-11/17/09 Dx: Prob AIDP, microcytic anemia, back pain Complaint of tingling and numbness progressively worsening. Headache X3 days. Back pain and blurred vision. TX with percocet and ferrous sulfate.  12/11/09  Duplicate ER record for 11/14/09 received and ER record received for DOS 11/19/09 DX: Post spinal headache Patient presented with c/o nausea & vomiting, back pain and abdominal pain. Assess causes-ABD pain from vomiting, nausea caused by headache after lumbar puncture X2 (past week). Treated with Reglan, Morphine and IV fluids. Discharged home.   12/23/09  Hospital discharge summary received for DOS 11/14/09-11/17/09 DX: Possible Guillain-Barre Syndrome. Patient received HPV vaccination and H1N1 flu shot in the same week. Twelve hours after receiving H1N1, the patient experienced tingling and numbness of fingers and toes, which  progressed to wrists and feet. The patient then experienced headache, blurred vision, back pain and since morning of admission, experienced generalized weakness. Lumbar puncture and nerve conduction study performed. Discharged home in stable condition.
I continued to experienced chest pains and a stress test was done around the 02/22/2021. I went in again on 03/02/2021 for another test and then again on 03/08/2021 for acid reflex but the results came back negative. I was prescribed several medications for acid-reflux that did not work. I even tried changing my diet and still experience chest pains. My symptoms are still happening and none of the doctors can tell me why.
Parent self reported; followed up with physician. Per T.C. to doctor's office, no lab work, no treatment was given. Per doctor's office (R) thigh had redness and swelling the size of a dime.
After receiving HPV vaccine, pt reported dizziness and stated "I cant see right" Pt place supine position with ice pack to head & neck. Kept for 20 mins, felt better, driven home by girlfriend.
On Sunday morning woke up and while I was organizing my bag I noticed that the table that was in front of me was falling towards me. I jumped and scream to my husband since he was standing next to me. He immediately asked me what happened in which I was scared and told him that the table was falling when in fact it wasn't.  5 minutes after I started having more and more spells. I ended up going to the ER days after. Had a CT scan, blood work and prescribed medications. All test came back normal. I was referred to pcp AND pcp transferred me to ENT which I'm pending to be seeing  next week
Immunized at gyn office Mon 10/15/07 about 12:00, by 6 pm developed fever, chills, nausea, vomiting. Tuesday developed urticaria.
On 5/2/02, the pt rec'd her first injection of Engerix-B. One day later, on 5/3/02, the pt experienced confusion. According to the physician's assistant, it was" thought at first the pt may have had a head injury due to presentation of symptoms but no information to support that".Treatment, if any, was not specified. The reporter considered the events to be unrelated to Engerix-B. The most recent information, rec'd on 0/0/02, reported that the event resolved by 5/16/02.
administered a varicella vaccine that expired yesterday; This spontaneous report was received from a consumer referring to a patient of unknown age.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 13-FEB-2021,  the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S004091 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The vaccine had expired on 11-FEB-2021.
Information has been received from a healthcare worker concerning a female who  on 31-MAY-2007 was vaccinated with her first dose of Gardasil (lot# not reported). On 17-MAR-2008 the patient was vaccinated with her second dose of Gardasil (lot# not reported) and experienced injection site pain. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow-up was received on 16-MAY-2008 from the office manager who indicated she does not remember reporting this event and questioned who the patient was.  No other information was available.
BODY ACHES; PAIN ON BOTH LEGS AND PAIN ON BOTH THIGHS; HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 24-MAR-2021 16:30 in right arm,  for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced pain on both legs and pain on both thighs. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021 21:30, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from pain on both legs and pain on both thighs, and headache. This report was non-serious.
Soon after vaccine administration (about 1 hour) the child developed three (3) vascular tumors; two in the (L) axilla measuring 2 x 1 cm and 3.4 x 1.8 cm; and one on lower abdomen wall 1 x 1 cm. These tumors still remain.
About 30 minutes after immunization, pt's eyes were red and slight swelling under the eyes.  No reports of swelling of tongue/lips/or trouble breathing.  Pt states she was feeling ok.  Administered Benadryl to patient.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a six-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 15-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. 09-Mar-2011: Follow up call was conducted on 09-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Approx 8 hrs p/receiving DTP, baby developed a fever 105(r). MD was contacted by mom who was instructed to give cool water baths & continue w/Tylenol. Fully recovered within 24 hrs.
Initial misuse report received from a health care professional on 06 January 2014. This case is linked to case number 2044SSA009286 (vaccine and reporter are same). A 70-year-old patient received a dose of FLUZONE ID. No adverse event was reported. Documents held by sender: none
I received the bivalent vaccine in September 2022.  I am honestly not sure when I began having problems, but sometimes I would go to bed and feel my heart pounding really hard.  In January I started to monitor it with an oximeter and it seemed to fade away pretty quickly.   A typical reading in my home with my equipment might be BP 124/80 with a pulse of 75. On the morning of February 6, my pulse was 144.  I took my BP and it was 122/95 with a pulse of 120 (I'm looking at records I kept).  I called the doctor who had me come in.  She did an EKG in the office which showed I was in Atrial fibrillation.  She prescribed Metroprolol and Eloquis and in about two days I was out of A-fib.
A-Fib event for 8+ hours as measured by pacemaker. Pacemaker was installed June 2019 and V-Tach determined 2021. No prior history of A-fib until incident on 12/5/2022. A-Fib incident occurred ~18 days after Bi-valent booster (#5 shot for me) was received.
Patient came in on monday 9/18/17 evening presenting with a swollen left arm above the elbow and traveling around and under to the backside of the arm. She she was experiencing pain and said it was spreading. I touched her arm and it was warm to the touch, swollen and seemed  to be spreading on lower in the arm. I advised her to take aspirin and ice it and maybe even elevate  it when she was home. She said she was nervous about it and i agreed it did not look good and if she preferred she could seek medical attention at the ER. Not an urgent care. She said she was willing to do the above and if not better, she would go to hospital. I called today and she said the arm is better she did not go to  hospital but that she took aspirin, rested and iced it. Feeling much better.
I began to experience symptoms of GBS that I have just now figured out relate to the flu vaccine. Generalized malaise and pain, I hurt all over. My legs didn't work and had terrible pain in them. Trouble rising or sitting. Difficulty with use of toilet, couldn't get up or down. Unsteady gait. Bumping into things. Thick headedness. Charlie horses in calves and feet and one in back. I had to roll off of the couch because I couldn't get up. I could barely walk with cart at grocery store. Lower back pain. Painful feet. Progression from feet to calves and back, then hips. Incontinence. Night time bathroom trips. Symptoms appear to have peaked a few days ago, but I am not back to normal.
No adverse event; patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine).    No concomitant drug was reported. No treatment drug was reported. This case contains information for the fourth patient of 4 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-647518, US-MODERNATX, INC.-MOD-2022-647563, US-MODERNATX, INC.-MOD-2022-647562 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647518:patient 1 US-MODERNATX, INC.-MOD-2022-647563:Patient-3 US-MODERNATX, INC.-MOD-2022-647562:patient 2
Redness and bruising of entire back of left arm. Sore enough to not be able to lift it.
Seizure like episode when leaving clinic. Developed dizziness, eyes rolled back in head, and she starting jerking lasting around 40 sec.
started with itching and redness with swelling on my left arm at the injection site and its spreading up to my shoulder and down to my elbow.
Onset fever, night sweats 2d later. Now persistent 6wk. Working up as FUO; negative w/u so far.