chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy hands and feet; Her skin is like she is digging in her skin; Left arm hurting at injection; Caller reports having her first dose of the vaccine on 07DEC2021. Caller reports on 08DEC2021 having itchiness; Caller reports having her first dose of the vaccine on 07DEC2021. Caller reports on 08DEC2021 having itchiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 10:30 (Lot number: FD0809) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: 2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "Caller reports having her first dose of the vaccine on 07DEC2021. Caller reports on 08DEC2021 having itchiness"; PRURITUS (non-serious) with onset 08Dec2021 12:00, outcome "not recovered", described as "itchy hands and feet"; SKIN DISORDER (non-serious) with onset 08Dec2021, outcome "unknown", described as "Her skin is like she is digging in her skin"; INJECTION SITE PAIN (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Left arm hurting at injection". The patient had itchy hands and feet. Her skin was like the patient was digging in her skin. The patient had the first dose on 07Dec2021 and just had a baby so she got it for prevention. The patient normally did not get vaccines, but got it because of her daughter. The patient then asked if they can pass antibodies through breast milk. The patient was breastfeeding her daughter. Since then, her daughter had been extremely fussy. The patient was crying all day yesterday and today and then stated she cries all the time anyway. Separate report created for her daughter.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101761084 maternal/child case
Dr office & pt/pt wife want reported that pt had wife give oral sex and now has dr diagnosed shingles on corner of mouth -> swelling & numbness & another lesion in mouth. Not herpes simplex. Pt got 1st shingles lesion on Tuesday 12/4/12 & dr on 12-8-12 Diagnosed. Again wife diagnosed w/shingles & wanted reported as a contagious issue. They wish this to be somewhat anonymous please.
I was itching all over for a good two hours. I put topical caladryl and it helped. I tried not to scratch. It happened 2 nights in a row.
Information has been received from a physician concerning a 17 year old female who on approximately 11-JUN-2007 (2 weeks ago), was vaccinated with a dose of Gardasil (lot number unknown). The physician reported that the patient developed pain to arm, tenderness and inflammation (3 cm) since being vaccinated with Gardasil. The outcome of the events were not reported. Additional information has been requested.
pt recv vax 18AUG95 & on 2MAY97 pt exp a rash w/52 lesions;
Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain). At the time of the report, NECK PAIN (Neck pain) outcome was unknown.            No concomitant and treatment medication information was reported.
Injection site is red, itching some warm to touch did not happen until a week later. It seems to be a little better. Just wanted to let you know I am to get 2nd dose 3-22-21
patients were administered improperly stored doses; no adverse effect; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown.  On 02-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R017626 and expiration date 18-DEC-2019 for prophylaxis (dose, strength, frequency and route of administration were unknown).    The patient experienced no adverse effects. It was reported that the vaccine was stored at a temperature of -9C to 8C (1C) during a time frame of 1 hour, 44 minutes. The vaccine had not experienced previous temperature excursions. Digital data logger was involved.; Sender's Comments:  US-009507513-1904USA010118: US-009507513-1904USA010119:
A vaccine administration error occurred as the patient inadvertently received the second dose 7 days later. The second dose of Jynneos 0.1ml was given on 10/10/22 on the left arm. The patient did not have any adverse reactions to the vaccine.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 27-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Patient was 4 years old at the time on December 03, 2021. He was given the second dose Pfizer for Pediatrics at the dosage of 0.2 mL by Intramuscular route in the Right arm. As of today patient has not reported of having no life threatening adverse effects or urgent care needed. This accidental vaccination at the time was caught by and brought to our attention.
Starting on March 15, 2022 he started with diarrhea. It was continuous. He said his diarrhea was bloody from the beginning. That continued until April 29, 2022 when he was put on Prednisone and Lialda because he was diagnosed with ulcerative colitis. He is better now. He didn't experience any fever or nausea.
Started experiencing abdominal pain x 2 days. Started giving her Miralax as she had been previously constipated. On day 3 she returned to school and  vomited twice. For the following 4  days she had no appetite. I took her to Urgent care where she was tested for Influenza, Strep, RSV and COVID, all were negative. The following day I took her to the Pediatrician practice. The Nurse Practitioner stated that it was an adverse reaction to the vaccine and if she
Fever, general weakness during night and following day; Fever, general weakness during night and following day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fever, general weakness during night and following day) and PYREXIA (Fever, general weakness during night and following day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007M20A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Cholesterol. Concurrent medical conditions included Blood pressure high and Seafood allergy (Shrimp). Concomitant products included METOPROLOL and LOSARTAN for an unknown indication.   On 16-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021 at 2:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021 at 7:00 PM, the patient experienced ASTHENIA (Fever, general weakness during night and following day) and PYREXIA (Fever, general weakness during night and following day). At the time of the report, ASTHENIA (Fever, general weakness during night and following day) and PYREXIA (Fever, general weakness during night and following day) had resolved.            The patient haven't received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
immediate adverse events: dizziness, nausea, panic, stuttering, sweating, shaking, loss of muscular control continued adverse events: blurry vision, vertigo, continued to stutter, hallucinations, confusion, memory loss, worsening of peripheral neuropathy  The above events cause the patient to fall and break a hip. Upon return from the hospital and continuing adverse events, another fall occurred and patient broke the other hip. The first time at the hospital, the staff stated she was diagnosed with pneumonia, whereas she had no symptoms previously of even being ill. Consequently, she remained in the hospital for 3 days in excruciating pain before they would operate while they put the patient on antibiotics.
Mom state infant had 103.3 degrees/ax temp 12/14/05 then developed "hives" around injection sites on right leg. Mom phoned PCP instructed to give infant Benadryl in addition to Tylenol.
Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 11 Mar 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 11 Mar 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 1:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 1:29 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 11 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 11 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had received booster dose. It was reported that patient had received lot 066H21A past its 30 days expiry date. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Started with Stomach Ache on 11/21/2020, Fever of 101.3 started on 11/22/2020 combined with headache and muscle aches.  Fever on 11/23/2020 combined with headache. Extremely tired and Low grade fever on 11/24/2020. We alternate Advil and Tylenol to keep the fever down.
At 2:45 woke up and started to have severe shivers like shuttering. Patient was shaking severely so used deep breathing technique to control them and go back to sleep. These episodes repeated throughout the night. At about 5:30am shivering stopped, and finally got to sleep until 11:30am.  Patient had severe headache in temples; it started at night but severe by the time he woke up. Patient was very tired and fatigued--it felt like a sinus headache.   Around noon, patient called doctor who recommended Advil instead of aspirin.  Medicine helped but he still felt fatigued, sore and did not eat until 5-6pm because woke up with nausea.  Patient took Advil again by 5pm to prevent the headache. At night patient had to wake up every 4 hours to urinate but was able to get a good rest.  After first dose of shingles did not have any problems to cause trepidation about getting the next dose. Patient has received several vaccines overtime with no problems because he traveled overseas and has military background. In addition, patient is relatively active. Today felt most like himself but still fatigued.  Arm still is sore at vaccine site.  Recovery is at 95%.
Retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive; Retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: other medical history: High blood pressure; "Cholesterol" (unspecified if ongoing), notes: other medical history: cholesterol. Other medication in 2 weeks concomitant medication(s) included: LOSARTAN. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Known allergies: None. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2022 at 15:00, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022 at 15:00, outcome "recovering" and all described as "Retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Apr2022) Negative; (22Apr2022) Negative; (25Apr2022) Positive, notes: retested with a home antigen test and came up positive for Covid. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that, on Thursday 21Apr felt much better and took home antigen test which showed negative for Covid. Retested on Friday again showed negative. On Monday 25Apr developed a scratchy throat and cough late in the day retested with a home antigen test and came up positive for Covid. Retested again an hour later to make sure and came up positive. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 15Apr2022, Treatment stop date: 20Apr2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse refers to an adult patient (gender unknown). On 05-FEB-2013, the patient was vaccinated with RECOMBIVAX HB, 40 mcg, intramuscular (lot number not reported). Concomitant medication was not reported. It was reported that the patient who was not a dialysis patient received the dialysis formulation of RECOMBIVAX HB and the patient did not experience any known symptoms. Additional information has been requested.
Patient was hospitalized for COVID Aug-Sept 2021. He asked his Pulmonologist if he was able to receive a COVID vaccine.  His doctor said, yes.  On Nov 4th, he was within the 90 day window of receiving antibodies when he received Moderna.  At that time,  Patient stated he did not know he had received antibodies while in the hospital when he received his vaccine.  4-5 hours after he received his vaccine, he became short of breath and O2 sat dropped to 85%. He spent approx. 5 hours at the hospital on additional O2 and then was released. Patient stated his Pulmonologist did not notice he had received antibodies in his record when he asked if he could receive the vaccine.
Slight headache; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) and FATIGUE (general fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Slight headache) and FATIGUE (general fatigue). At the time of the report, HEADACHE (Slight headache) and FATIGUE (general fatigue) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-081490 (E2B Linked Report).; Sender's Comments:  MOD-2021-081490:dose 2
pt states approx 6-630PM on 16SEP93 began to notice hot red rash on arms & chest, went & got non-drowsy allergy OTC med & began taking; next AM felt generally lowsy; rash w/hives; could not keep down food or water;
Patient complaint of shortness of breath and chest discomfort.  Patient assessed by EMS.  SVT detected and transported to Hospital.
Chills, fatigue and headache from 12-32 hours after vaccine was administered.
Immediate vasovagal response. She was treated at the scene by EMS and released. She came back into the pharmacy to pick up her receipt and seemed fine. She had indicated in her form that she had previous dizziness after vaccines, however she stated that it was mild. Allergic to pcn, latex and contrast dye. This vaccine is packaged latex-free.
Considerable Swelling, red rash around administration site - growing in size, itchiness and tingling in arm, area is hot to touch.   Local reaction on arm appears to be worsening by the day.
She got her vaccine, had some dizziness and got real sick to her stomach, which went away.  She went for a routine mammogram on 3/23/22 and was supposed to get her booster that day and they told her that she had a swollen lymph node under her left arm due to the vaccine, and to not get the booster.  They told her that she would have to have  another test, which was more than likely an ultrasound.  She was not told about the possible side effect of the lymph node swelling, and was told that she should not have gotten the vaccine due to her history of breast cancer, and that she should not have gotten it in her left arm.  She said that she would not have gotten the vaccine if she had known there would have been a problem with lymph nodes.  She is very upset, and she may have to had more chemotherapy.  All she does is cry since she got her vaccine.
No adverse event; Vaccine administered after beyond use date (07-Jul-2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date (07-Jul-2022)) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date (07-Jul-2022)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date (07-Jul-2022)) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date (07-Jul-2022)).    No concomitant medication was reported.  Reportedly, the vaccine BUD date was 07-Jul-2022.  No treatment information was provided.
Pt received vaccine and went to sit for 15 mins.  After about 5 mins she walked over to Drop Off and stated she wasn't feeling well.  She began to faint and the technician who was close to her ran over and caught her as she fell.  I immediately called 911 while technician took care of pt.  She regained consciousness in less than 2 mins.  EMS arrived and took her to the ambulance for observation.
pt devel local rxn @ site of inj (rt deltoid); 5cm tender mass; no fever; consistant w/sterile abscess
Pt started sneezing right after immunizations given. Phone call later from mother who states about 15 minutes after they left office his hands and feet began to itch, he broke out in hives and started having trouble swallowing.  He was seen at ER immediately and was given Benadryl and steroids.  Diagnosis was acute allergic reaction.
Other than feeling very tired and experiencing chills about 16 hrs after the shot I felt no ill side effects until 3 days later when I developed 3 cold sores on my bottom lip.  I have never experienced cold sores before so I feel this is an adverse reaction to the Moderna vaccine.
Day 5 noted a tiny red bumpy rash on front and back of torso that is very itchy. Still red and itchy today on day 6 but has medicated with Benadryl at the advice of her doctor.
Child began to be real fussy and temp up to 102.9 temp broke on 4-1-07 pm child still real fussy on and off no sleep. Tylenol for fever
pt exp no immed rxn but w/in  1 1/2 hr returned to clinic w/red hive looking lesion on neck & arms;
Patient was administered a vaccine that was 6 days after the beyond use date of 6/30/2022. The patient may not have adequate efficacy from this dose.