chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO ADVERSE EVENT... But she had gotten Pfizer on 02/25/2021 for first Covid Vaccination
Pt's arm became hot, red and swollen over area that extended beyond deltoid according to mother and pain lasted for over 3 days. Pt. had to be given pain meds.
Information has been received from a registered nurse concerning a 11 year old female with rhinitis allergic and no known drug allergies who on 27-MAY-1998 was vaccinated with a second dose of Varivax (lot # 625387/0313H). There was no concomitant medications. On 07-JUN-2006 the patient developed 17 fluid filled vesicles and bumps. Unspecified medical attention was sought. Supportive care was recommended. No laboratory diagnostic tests were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was seen on 09-JUN-2006 with a dozen 'or so' red bumps and some vesicles x2 days. There was no complaint of fever or itch. The patient's mother phoned the office on 10-JUN-2006 and started that the spots had all "faded" away, except for one. There was no scabbing and the patient was acting fine. It was unknown if the patient had actual chickenpox. There was no scabbing and the patient was acting fine. It was unknown if the patient had actual chickenpox. There was no illness at the time of vaccination. There were no adverse events following vaccination. Additional information is not expected.
A red rash started approximately 14 - 19 days after the first injection. It was in the center of my chest, between my breasts, initially about the size of a silver dollar.  Small blisters began within a few days. The rash grew daily until it completely covered my chest from neck to below my navel by the end of March 2021.  I saw several doctors. Two biopsies were taken. I was prescribed two (three?) courses of antibiotics, anti-fungal ointments, etc., but nothing worked. Finally I saw a dermatologist who prescribed steroid ointment. I immediately saw results. Within about ten days the rash was gone.
10 days after vaccination, I developed a large red circular rash around the injection site.  The rash is approximately 7 inches by 4 inches, is warm to the touch, slightly swollen and sore.  From what I have read, this should resolve itself.  I simply wish to report it in order that the CDC can have valid data for statistics.
Information has been received from a medical assistant concerning a 13 year old female patient with no pertinent medical history and with allergic reaction to ERYTHROMYCIN who on 18-APR-2008 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly.  There was no concomitant medication.  On 16-JUL-2008 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # 659439/1267U) intramuscularly.  It was reported that the patient has been having symptoms after receiving GARDASIL.  It was reported that the patient experienced dizziness and blurry vision in the office after receiving the second dose of GARDASIL.  The patient went home after the recovery.  It was reported that the patient has been having occasional fever and back pain since receiving the second dose of GARDASIL.  The patient was seen by the physician.  Additional information has been requested.
pt to ED with confusion/altered mental state; hx of recurrent UTIs; found to be positive for COVID; UTI; started on antibiotics and O2 High flow 15L; pt's condition worsened over his stay; found unresponsive in bed; pt died inhouse hospice.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 23May2022 as dose 3 (booster), single (Lot number: FP4554) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 2, single (Lot number: 039F21A), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 07Apr2021 as dose 1, single (Lot number: 042A21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Nickel, reaction(s): "Known allergies: Nickel", notes: Known allergies: Nickel. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: COVID-19 Treatment Include Brand: Paxlovid, Treatment start date was 07Jul2022 and stop date was 12Jul2022. Adverse event reported as Congestion, sneezing, fever (100.3), runny nose.Adverse event start date was reported as 16Jul2022. Patient was Recovering. Patient taking any other medications/products within 2 weeks of starting COVID-19 treatment reported as no. Patient previously receive a COVID-19 Vaccine.
Constant itching all over. If I itch it, it turns to welts and hives.
Swelling, itching, grew to the size of about 3" x 3" injection site lasted a week and w/ the adverse effects hot to touch, sore.
Information has been received from a nurse concerning an 81-year-old (born in 1926) female who on 02-OCT-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  On 03-OCT-2007 the patient developed a low grade fever, rash and blisters on her lips.  At the time of the report the patient was currently in the emergency room.  The patient's status at the time of the report was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FACE.THROAT NUMBNESS AND TINGLING-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Initially I had joint and muscle soreness. On April 3, 2021 when I went to stand up after being seated my left knee made a grinding sound and I had pain shooting up the outside of my left leg to the hip area. I was able to bear weight on the left foot but the affected area  was very painful.   I treated myself with ice packs and additional Tylenol (I normally take 2000 mg daily but increased it to 4000mg for several days for break through pain) rest, and elevated my legs.  Today is day 15 since my symptoms began and I still occasionally  have pain in the left upper outer thigh which seems to be telated to positioning but am back to my usual dose of Tylenol.
Patient stated she began to feel scared dizzy with blurred vision and the arm (left) vaccine was administered felt as though something was running down it. Patient was also anxious prior to administration. Resolved in 5 min. No treatment given.
Pt should have received proquad vaccine but nurse administered zostavax vaccine. This wasn't noticed until 4:45 pm. CDC and Merck manufacturer notified.  07/18/2007 attempts were made to contact parent by phone to notify them of this, home phone was disconnected, work phone number there was no answer, several messages were left on voicemail in spanish and english with numbers to call back the clinic nurse manager with an after hours phone number. Home visit attempted on 07/18/2007 @ approximately 6:45 pm, no one answered the door, a letter was left requesting the parents to call the clinic nurse manager with clinic phone number and an after hours number.  On 07/19/2007 we again attempted to reach parent by phone, no answer message left for parent to contact nurse manager at clinic.  Another home visit made person that answered the door said no one lived there by that name. Certified letter sent on 07/20/2007 to notifiy parent. Other sources were contacted to obtain current address unable to obtain current phone number or address from these sources.
PATIENT HAD PFIZER COVID VACCINE ON Dose 1 date: 01/15/2021      Dose 2 date:   01/26/2021, TESTED POSITIVE TO COVID ON 8/31/21.
About ten minutes after administration, the patient developed transient left hand tingling, numbness, and weakness, as well as pain at the injection site.  The patient was monitored for another 15 minutes, but it appears that her symptoms, other than the injection site pain, was abating. She denied systemic symptoms.
This spontaneous report has been received from a medical assistant referring to a 23 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided. On 22-FEB-2019 the patient inadvertently received a dose of ZOSTAVAX (lot # R031825, expiration date: 13-JUN-2019, dose details, strength and frequency were unknown) instead of VARIVAX subcutaneous for prophylaxis (wrong product administered). The patient also received a dose of M-M-R II (lot #: N008365, expiration date: 13-MAR-2019, dose details, strength and frequency were unknown) during the same office visit. Both vaccines had experienced a temperature excursion of 82.4 degrees Fahrenheit for 4 hours 30 minutes (product storage error). There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported in the patient.
Pt presented to clinic very anxious stating that he needs Hep B vaccine. He stated that he is on his lunch break and drove to receive his Hep B vaccine (Initially he stated Hep C vaccine, which we clarified quickly, and I was able to confirm the right vaccine on the voucher the pt had on his phone). He stated that he was told that today is the deadline and his employer asked him to receive it ASAP. He stated that he never had Hep B vaccine before and denied any SE to any medications. After administering the vaccine through the portal, I saw in his chart that he just received his 1st dose in December 2021 and the 2nd dose yesterday. When questioned about his visit yesterday he stated that he wasn't seen in the clinic then stated that maybe he was seen but vaccine wasn't given to him, then he said: "the provider gave him something he doesn't remember".  The story kept changing and was inconsistent. It seems that the pt was trying to receive all 3 vaccines before the deadline regardless of timing between the vaccines.  Pt left the clinic in stable condition. Pt made aware of potential SE and appropriate f/u if he develops and adverse reactions. Called vaccine hotline. As per hotline recommendations pt needs no further follow up but will possibly need 3rd dose.
administered infanrix /, Date of birth Feb 13th 2008; administered infanrix, /Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered infanrix to a patient of age 13 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201378:same reporter
Pt had bruise and bump on deltoid after 1 hour of injection. Pt had fever and chills later that day. 9/21/17 pt went to Dr. office and assistant told her she didn't need antibiotics and pt didn't see MD on 9/21/17. I recommended Ibuprofen for fever 9/22/17. Pt feels a lot better today. Said daughter had same reaction a year ago but she never had that reaction.
Pt received a booster 12/9/21 when not indicated for his age group. 1st dose 5/19/21, 2nd dose 6/10/21
Large local reaction, redness induration (possible cellulitis to skin). No fever. Fussiness-involving about 8cm of skin around injection area.
About 30 minutes after the vaccination a became nauseated, dizzy and strange feeling, I had the feeling of being on some type of drug.  It impaired my vision a little - things were a bit out of focus.  I felt like I was high on something.  This was a temporary feeling that resolved after about 2-3 hours.
Case number PHEH2015US022307, is an initial spontaneous report received from a health care professional on 29 Oct 2015. This report refers to a 31-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 158202) intramuscularly on 21 Oct 2015. On 23 Oct 2015, two days after vaccination, the patient experienced rash all over the body. The patient had seen an MD and was prescribed BENADRYL. The patient still has the rash. The outcome of the event was not recovered. Seriousness and causality was not reported. Seriousness of the event "rash generalized" was upgraded based on information available in the source document.
Patient presented with a red, swollen rash that felt somewhat warm to the touch.  Patient states she applied an ice pack the first night but the rash has grown. It is somewhat itchy and benadryl didn't improve it. This was the second patient this week to present with the same rash.
Injection site pain; Injection site swelling; Cold sweats; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling and cold sweat. On an unknown date, the outcome of the injection site pain and injection site swelling were resolved with sequelae and the outcome of the cold sweat was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and cold sweat to be related to Shingrix.  Additional details were reported as follows: The reporter stated that, the patient received the first dose of Shingrix and went to emergency room complaining of swelling and pain at the injection site and cold sweats. The symptoms have subsided. Emergency room visit was required.
Information has been received from a physician concerning a 19 year old female with penicillin allergy who was vaccinated with a dose of GARDASIL. Concomitant therapy included YASMIN. On 30-AUG-2007 the patient experienced erythema nodosum which was confirmed by biopsy. Unspecified medical attention was sought. At the time of the report the patient had not recovered. The physician was not certain that the GARDASIL was responsible or involved with the erythema nodosum. Additional information has been requested.
Patient experienced twitching in his legs and neck turned involuntarily. He is currently still experiencing some twitching 48 hours following vaccination, he developed a few hives on his arm and toes. Currently has hive on arm, but no longer itches.
10pm: Nausea Midnight: uncontrollable chills, teeth chattering and shaking. Could not get warm, lasted over 3 hours. 4am: woke up having sweated through pajamas... With a temperature of 101.5. 7am: temperature broke, was able to sleep. 11am: temperature back up to 100.4, horrible headache 1pm: temperature broke, headache more tolerable, body aches, very weak. Felt better Monday morning, but had alternating shivers and sweats on and off throughout the day, tired  By Tuesday I was close to being back to normal.
I started out with a left back pain that I hadn't experienced before.  I have a history of Kidney stones in the past but have gone quite a while without one.  After the pain literally didn't let up for an entire day I went to urgent care.  I was sure it was probably a stone.  I had urinalysis, blood work, xray, cat scan, and an ultrasound that were all negative.  They felt it could be a kidney/urine infection and sent me home with medication.  I continued to hurt worse without any urinary symptoms so went back again just sure something was missed on a scan.  I explained at this point to a different ARNP than I saw originally and she lifted my shirt to examine the area that I was complaining and found two small bumps that she assumed to be the beginning outbreak of the shingles.  Over the next two days I broke out into a terrible case of the shingles that ended up wrapping around from my spine to my belly button.
21 hours post injection patient feeling body aches, arm soreness at injection, headache, and short of breath with exertion
day p/vax pt exp left arm red & warm & red streak to elbow. temp 102 & appetite full rom
clear nasal/discharge;pharyngitis w/+erythema;VS 100,20,97.5;ant cerv nodes sl enlarged, NT;R>L;rt parotid w/+edema & tender;
Information has been received from a physician concerning a 71 year old male patient who on 27-FEB-2009 was vaccinated with one dose of ZOSTAVAX (Merck) (lot # not available).  "Shortly after receiving ZOSTAVAX (Merck)" on 05-MAR-2009 the patient developed an active case of shingles.  The patient had sought unspecified medical attention.  The outcome of the patient's shingles was not reported.  Additional information has been requested.
nausea; malaise; flu-like symptoms; mild fever; chills; body aches; gastritis; diarrhea; Fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist. A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 06Jan2021 09:00 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 17Dec2020 via intramuscular at left arm with lot number: EK5730 for COVID-19 immunization and experienced mild arm tenderness. Second dose administered 21 days after 1st dose resulted in adverse effects (AE) approximately 40-43 Hours after 2nd dose was administered. On 08Jan2021 08:00, AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. acetaminophen was taken during first experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced. The patient received treatment for the events. The outcome of the events was recovered in Jan2021.
Swelling of arm on the side of vaccine and severe pruritis.  The face also swelled on that side.
Swelling & itching of eyes & face.  Itching on hands & feet.  2 tsp Benadryl given.  Watched for 1 hour in clinic.
Sudden onset of 103.8 deg fever, rash, febrile seizure.
It was discovered a couple of hours after vaccine was administered that the vaccine had not been diluted per package directions. Patient tolerated the vaccine well here in the office, I reached out the the family but was not able to connect with them. Will notify parents and check on patient.
sore arm; Administration error: only half dose given of bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm) and ACCIDENTAL UNDERDOSE (Administration error: only half dose given of bivalent vaccine) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     Concurrent medical conditions included Coronary artery disease, Hypertension, Sleep apnea and Drug allergy (ophthalmic drops for pupils dilatation). Concomitant products included APIXABAN (ELIQUIS), LATANOPROST, SPIRONOLACTONE, LOSARTAN POTASSIUM, CHLORTALIDONE (CHLORTHALIDONE) and ATORVASTATIN for an unknown indication.    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced VACCINATION SITE PAIN (sore arm) and ACCIDENTAL UNDERDOSE (Administration error: only half dose given of bivalent vaccine). On 12-Sep-2022, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: only half dose given of bivalent vaccine) outcome was unknown.            No treatment medication was reported. The patient received the 1st dose of Moderna vaccine on 02-Mar-2021, second dose of vaccine on 30-Mar-2021, first booster dose on 25-Oct-2021, second booster dose on 01-Apr-2022 with batch numbers 12A21A, 021B21A, 27C21A and 002M21A respectively.
About 1 hour after injection became dizzy and had severe headache.  This lasted 9 hours.  About 9 hours after injection, had fever of 102.1 and felt nauseous.  Vomited times three.  Fever and vomiting lasted six hours.  Didn't feel well for an additional 12 hours.
Patient complained of a "rash" on left arm; noticed it 2 days after receiving HBV #1 on 07/1/2004.  The rash lasted for 2 days.  No complaint of itching, soreness.  Stated the rash was on the entire left arm and was "little white spots".  She also stated she gets this same rash on her arm when it is hot outside, especially on her left arm because she has it in the window while driving the car.  She has over the counter medicine she uses for this rash.
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.