chrisvoncsefalvay/vaers-outcomes huggingface dataset:
continuous discomfort on her left arm; big rash 8 inches in length and 3-4 inches width; itching; hot; tender; sweaty; hot/She stated she woke up feeling hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PAIN (tender) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (tender), HYPERHIDROSIS (sweaty) and FEELING HOT (hot/She stated she woke up feeling hot). At the time of the report, VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (tender), HYPERHIDROSIS (sweaty) and FEELING HOT (hot/She stated she woke up feeling hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was mentioned. Treatment medication includes Benadryl and Cortisone cream.
Hallucinations  Sunday while watching TV Thought she saw mice running across the corner of the TV  Hallucinations only on Sunday approximately 48 hours after vaccine
Within a week of obtaining the 2nd vaccine, I had severe itching of hands, scalp, legs.  On January 18, I awoke to Sudden Hearing Loss and severe Tinnitus.
Mother stated that pt came home after receiving vaccines and that he complained of being tired and was talking slow. Pt had red blotches on his face also. Patient went to E.R. and received steroids and BENADRYL.
Patient was admitted 02/08/2022 for acute hypoxic respiratory failure secondary to covid-19 pneumonia. This is considered a breakthrough case.
PAIN AT INJECTION SITE; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 25th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Fluarix Quadrivalent 2019-2020 season in the right deltoid. The reporter stated that, after vacination, the patient complained for injection site pain for 48 hours. It was unknown, if the patient took any analgesic. The reporter denied consent to be followed up.
9JUL96 430PM pt became pale, limp, lips cyanotic, unresponsive;no sz activity;given 02 x 1hr;taken to hosp ER;became more responsive by 6PM; rectal temp 39.2;10JUL seen by MD doing well;to be observed by parent;med given & APAP;
Pt tested positive for COVID 7/23/21 by antigen test. She is fully vaccinated.
Resident describes localized pain to the injection site, stress incontinence, and exhibits an increase of confusion that occurred during the night time
devel high pitched cry lasting for hr-could not be comforted-had a thick coating of mouth & throat;
hives got worse; hives got worse; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation; Solution for injection), dose 2 intramuscularly, administered in Arm Left on 11Jun2021 (Batch/Lot Number: EW0181) as DOSE 2, SINGLE (at the age of 17-year-old) for covid-19 immunisation. Medical history included migraine chronic from 08Aug2019 (Pertinent details: Occipital nerve block 11Feb2020), eczema from 01Apr2020, ongoing anxiety and ongoing (ADHD) attention deficit hyperactivity disorder. Concomitant medications (drugs taken within two weeks) included lisdexamfetamine mesilate (VYVANSE) taken for ADHD, desvenlafaxine taken for anxiety and botulinum toxin type a (BOTOX) taken for migraine all from an unspecified start date and ongoing. Historical vaccine included first dose of bnt162b2 on 21May2021 (Batch/lot number: EW0173, intramuscularly in left arm) (at the age of 17-year-old) for covid-19 immunisation and experienced bouts of hives/Chronic Hives. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. started having bouts of hives within 2 days after her first dose of the covid 19 vaccine and they not realize they were hives because she has had skin issues in the past. After she got her second dose the hives got worse which stated on 23May2021 and we eventually got her into the doctor who diagnosed them as chronic hives because they had been present for two months. The event caused Physician office visit. The patient started taking antihistamines (Singular and zertec) the hives cleared up. Therapeutic measures were taken as a result of hives got worse. The outcome of event reported as recovered on an unknown date on 2021.  Follow-up attempts are completed. No further information is expected.
Swelling and red rash at injection site for about a week. Applied hydrocortisone cream.
The day following vaccinations with dT and HepB (#3), he experienced paresthesias that began in hand and ascended arm.  Subsequent symptoms included right facial weakness, slurred speech, and drooling.  These symptoms gradually resolved.  No seizure activity; unremarkable past medical history
Initially, mild arm tenderness noted. 11/3 & 11/4 fatigue noted. 11/5 stuffy nose, nasal congestion noted. 11/6 - increased nasal congestion and mild wheezing noted with activity. 11/7 - nasal congestion worsening, headache, intermittent vertigo, and moderate wheezing noted with any amount of exertion/activity.
minor discomfort; small raised area remain; July 2018, first Shingrix dose/Nov 2018 the patient received second Shingrix dose. /Feb/Mar 2020 the patient developed shingles; shingles across back, chest and under left arm; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 957J3, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 49R72, expiry date unknown) for prophylaxis.   Previously administered products included Zostavax (received zostavax years ago (past medical history)).   In July 2018, the patient received the 1st dose of Shingrix. In November 2018, the patient received the 2nd dose of Shingrix. In February 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced discomfort and swelling. On an unknown date, the outcome of the vaccination failure, discomfort and swelling were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, discomfort and swelling to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received 2 doses of Shingrix and in february or march 2020 experienced shingles across back, chest and left upper left arm and discomfort. The reporter mentioned that at the time of reporting shingles has greatly improved and patient was still experiencing minor discomfort and small raised area remain. The patient had received zostavax years ago for past medical history. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Pt developed pain L upper chest and back a few days after receiving 2nd GARDASIL vaccine.  Two days later developed rash in same area- papules/postules on erythematous base.  Cx pos felt zoster.  Treated with VALTREX.  Resolving.
3MAY noted itchiness on back & devel spots like chicken pox which cleared w/OTC cortisone cream-did not notify MD of this incident & had not informed MD of receipt of HBC#1 prior to dx of shingles p/1st dose;
Red /pink on torso, front only. Strip across mid torso above belly button and below bra line. Flat, not raised. No blistering, just skin discoloration. Not itching, not painful. Only noticed because dressing in front of a mirror.
Provided client with second dose Moderna, Covid-19 Vaccine per CDC guidelines. Mother in the office with client and agrees to second dose at this time.
I had symptoms of a panic attack the night of my 1st vaccine administration. I had to sleep sitting up or else I felt pressure on my chest. The next day my heart rate was still elevated.
I STARTED GETTING DULL HEADACHES AT FIRST, THEN AFTER  A MONTH OR SO IT GOT TO THE POINT WHERE I STARTED WAKING UP IN THE MIDDLE OF THE NIGHT WITH MIGRAINE HEADACHES. I'VE TAKEN UP TO 5 500MG OF TYLENOL IN ORDER TO DEAL WITH THE PAIN, IT HELPED BUT DIDN'T COMPLETLY GO AWAY.
Mother notice reaction the night that the vaccines were given. The area where shot were given was warm and red pt had no symptoms. R leg 80 x 40 cm left 30 x 10 cm.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-NOV-2017, the patient was vaccinated with an expired dose of ROTATEQ orally, (lot # M025565 with an expiration date in 06-NOV-2017), dose 2, for prophylaxis (dose was not provided). No adverse effects were reported.
A welt about a size of a quarter formed immediately when the vaccine contents went in. No redness occurred. The patient stayed and the welt went down to about the size of a nickel. He didn't experience any pain at the injection. He said he had no other symptoms besides the welt.
Chills; fever of 102°F until midnight that came down to 101; Later that afternoon started having temperature, and then a fever, and experienced nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102°F until midnight that came down to 101), NAUSEA (Later that afternoon started having temperature, and then a fever, and experienced nausea) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 03-Jan-2021 to 15-Jan-2021.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (fever of 102°F until midnight that came down to 101) and NAUSEA (Later that afternoon started having temperature, and then a fever, and experienced nausea). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, PYREXIA (fever of 102°F until midnight that came down to 101), NAUSEA (Later that afternoon started having temperature, and then a fever, and experienced nausea) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 102. On an unknown date, Body temperature: 101 midnight that came down to 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
Two weeks after receiving Booster I began to experience shortness of breath. I went to the local Emergency room Feb. 8, 2022. After blood was drawn and chest CAT was done it was determined I had developed blood clots in my lungs and was immediately admitted to hospital.
after getting vaccinated she got the covid-19 virus and was rushed to the hospital; after getting vaccinated she got the covid-19 virus and was rushed to the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "after getting vaccinated she got the covid-19 virus and was rushed to the hospital".  Clinical course: Reporter Stated that his fiancee got vaccinated in the country where they visited and after getting vaccinated she got the covid-19 virus and was rushed to the hospital.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Hospitalized 81 y.o male with a history of COPD, CAD, CKD stage III, aorta dilation, type II DM, HTN, OSA and restrictive lung dz with chronic respiratory failure on O2 that presents with chest pain today and some shortness of breath for the past few days. He was noted to have A fib RVR with rates in the 140s and was started on a dilt gtt. He feels his SOB and chest pain is improved since his heart rate is improved. He denies any jaw pain or arm pain. The pain was mostly in the left chest. He is on 4L O2 at baseline, though his O2 orders say 2L at rest and 4L with activity. He said he has had some coughing, but doesn't feel it's worse than baseline.
can't handle antibiotics or seafood, is now allergic to them; can't handle antibiotics or seafood, is now allergic to them; This is a spontaneous report from a contactable consumer (patient) from a. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), second dose via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient couldn't handle antibiotics or seafood, was then allergic to them on an unspecified date. Patient got both doses of the Covid vaccine and since then can't handle antibiotics or seafood. Patient stated he was then allergic to them. Caller stated his cousin was the same way. Provided PMI number and then because caller could understand what support team was saying interpreter hung up. Patient was about to transfer to the hospital for AE, but caller hung up while holding since they were having side effects after both doses. Clinical outcome of the events was unknown.  Follow-up attempts are possible. Information on Batch/Lot no. has been requested.
"Lost 3 days of work due to fatigue". Also reports "sore throat, stuffy nose, muscle aches, runny nose." Patient did not seek medical care or have symptoms documented but is now refusing annual flu shots required by facility. Please advise.
Administration error occurred, the orange top and grey top weren't mixed. Client was given the grey top vaccine bottle, this has the  C, W, Y. Client wasn't given the orange top vaccine bottle that covers A.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 03-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot # L044055, expiration date 02-MAY_2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Vomiting; Having chills, very cold and feeling very chilly; Having chills, very cold and feeling very chilly; This is a spontaneous report from contactable consumer or other non-healthcare professional. This consumer reported for a patient (reporter's wife).  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number and Expiration Date were not reported), via an unspecified route of administration administered in left arm on 07Aug2021 at 01:30 (52-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The reporter stated that they are trying to find out if the patient has asthma and they are not sure but the doctor says that she might have some asthma (Further not clarified hence, not captured in tab). The patient's concomitant medications were not reported. The patient had not received any vaccine within four weeks. On an unspecified date in Aug 2021, the patient experienced vomiting, chills, very cold and feeling very chilly. The reporter stated that he and his wife had (further clarification unknown) COVID shot today with Pfizer and the patient was vomiting and had chills. The patient was very cold and feeling very chilly. So, the reporter put a few blankets on the patient and she stopped vomiting but the reporter thought it is out of her system but she had spent several hours talking about maybe 7 or 8 hours ago when they took the shot. The patient did not receive any treatment but all she did was sit straight and that made her feel better and she had her chills right after. The reporter just wanted to know how serious it is, the patient's vomiting stopped but she is still getting some chills the reporter thinks but how will this go away. The outcome of the event vomiting was recovered on an unspecified date in 2021 and other event were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticarial rash face only, no SOB, no wheezing. Diphenhydramine 12.5mg/5ml 5 ml PO given.
Received the first dose of Heplisav-B, then received 2nd dose with Engerix; Initial Report Received on 24-Nov-2020  A registered nurse reported that a 44-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization and received ENGERIX-B as the second dose.  The patient has no reported know drug allergies.   No concomitant medications were reported.  On 28-Oct-2020, the first dose of HEPLISAV-B (Lot # 933837, expiration date 08-May-2021, Serial # 375853594193) was administered to the left deltoid.    On 24-Nov-2020, the second dose of a hepatitis B vaccine, Engerix-B (Lot # 5L27A, expiration date 11-Feb-2022), was administered to the left deltoid.    At the time of report, no adverse reactions to either injections had been noted.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Intense itching, swelling, redness, and painful to touch of injection site of upper left arm. Large red circle to upper left arm
At 3 am that night I woke up and my legs were suddenly numb. I was shaking uncontrollably , with chill like symptoms. My teeth were chattering. I was cold in a normal temperature room. This went on for 3 hours. Since then I am having different pains and symptoms in my body. ANA tests are coming back positive which I never had before. I now have a possible auto immune disease.
pt recvd vax 20SEP95 & 21SEP exp severe pain @ inj site & subjective fever x 2 dayys; highest documented fever was 100.2 assoc w/drenching noc sweat x1; 23SEP pain & fever resolved noted appearance of macular erythema 2" diameter inferior;
pt recv vax 7JAN99 3:30 & awakened @ 7AM 8JAN99 w/swelling of hands & feet;saw MD @10AM who said it was a rxn from hep b & should not recv #3 hep b;
I can send a picture of the vaccination record card as I cannot correctly determine the Lot Number  severe headache onset 03/11/21 lasting till treated 03/30/21 nausea and vomiting 03/28 severe chills without fever 03/28 and 03/29
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with 2018SA304921 same reporter. This case involves a 17-years old patient who received 0.5 ml dose FLUBLOK QIV lot no. QSAA1803, expiry date: 31-May-2019 via intramuscular route in the left arm on 14-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to inappropriate age at vaccine administration. (It was reported that the patient received vaccine FLUBLOK QUADRIVALENT vaccine under the age of 18). It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
TOOK THIRD DOSE ON 19-MAR-2019 AND LAST DOSE ON 02-APR-2019; This spontaneous case (PVX2019-800) was received from consumer on 03-Apr-2019. It describes a 36-year-old male consumer who "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019". The consumer was receiving Vivotif for an unknown indication   Case report: The consumer took three doses of Vivotif according to the schedule. The third dose was taken on 19-Mar-2019 but he took the fourth dose on 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019" was unknown.  Company's Comment: The causality of the event "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on 19-Mar-2019 and last dose on 02-Apr-2019" was considered as not applicable.