chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some of the  vaccine came out of the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number D5754, expiry date 18th December 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 11th October 2021, the patient received the 2nd dose of Shingrix. On 11th October 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The patient received 1st dose of Shingrix on 12th August 2021. The patient was being administered the 2nd dose of Shingrix and the needle malfunctioned and some of the vaccine came out of the syringe part, which led to incomplete dose administered. The reporter was unsure how much of the vaccine the patient received. The pharmacist called to inquire and asked for further guidance on vaccination. The reporter did not consent to follow-up.
6/03 developed HTN; reported to ER with BP 185/112. Tachycardic with ABN rhythm. Put on Toprol XL 100mg da.
ittle itchy on my ankles; rash; received the second dose more than a month after the first one; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (ittle itchy on my ankles), RASH (rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose more than a month after the first one) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033L21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (ittle itchy on my ankles), RASH (rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose more than a month after the first one). The patient was treated with CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) for Adverse event, at an unspecified dose and frequency. In November 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose more than a month after the first one) had resolved. At the time of the report, PRURITUS (ittle itchy on my ankles) and RASH (rash) outcome was unknown.            No concomitant products were reported. The patient reported that never had something like this. Treatment medication Niesporm was put on a Monday and did not do any good.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Source Document contains no new information
nauseated; morning sickness; Feeling lightheaded; Upper arm was quite sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 16:00 (Lot number: EN6200) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart disease" (ongoing), notes: diagnosed for 30 years; "Stenosis", start date: 2000 (ongoing), notes: Started on the other drugs for her back when she saw the rheumatologist; "arthritis in her back", start date: 2000 (ongoing), notes: Started on the other drugs for her back when she saw the rheumatologist; "Triple heart bypass", start date: 2007 (unspecified if ongoing); "Had three separate stents in her heart" (unspecified if ongoing), notes: one in 2014, 2015, and 2018; "Hysterectomy", start date: 2001 (unspecified if ongoing); "Allergic to Penicillin" (unspecified if ongoing), notes: Diagnosed 40 years ago, had bronchitis and she broke out in hives, she has never taken it since; "Memory" (unspecified if ongoing). Concomitant medication(s) included: ISOSORBIDE taken for cardiac disorder, start date: 2019 (ongoing); METOPROLOL taken for cardiac disorder, start date: 2019 (ongoing); LOSARTAN taken for cardiac disorder, start date: 2019 (ongoing); PRAVACHOL taken for cardiac disorder, start date: 2019 (ongoing); FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE] taken for arthritis, stenosis, start date: 2015 (ongoing); OMEPRAZOLE taken for abdominal discomfort, start date: 2015 (ongoing); CELEBREX taken for back disorder, start date: 2015 (ongoing); DONEPEZIL taken for memory impairment, start date: 2020 (ongoing); BABY ASPIRIN taken for cardiac disorder, start date: 2007 (ongoing). The following information was reported: NAUSEA (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "nauseated"; MORNING SICKNESS (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "morning sickness"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "Feeling lightheaded"; PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "Upper arm was quite sore". The action taken for bnt162b2 was unknown. Therapeutic measures were not taken as a result of nausea, morning sickness, dizziness, pain in extremity. Additional information: Patient was taking Isosorbide, Metoprolol, losartan, Pravachol, and baby Aspirin for her heart. The patient started Flexeril taking about 5 or 6 years ago- about 2015 for arthritis and stenosis in her back, Omeprazole for stomach in order to take Celebrex, Celebrex will burn a hole in stomach so she has to take omeprazole and for her back, Donepezil for memory.  No follow-up attempts are possible. No further information is expected.
I experienced an itching rash with bumps on my scalp which later appeared on my elbows. It was dry and scaly on my scalp. My doctor told me that he could not give me a diagnosis. I previously had Dermatitis herpetiformis in my life, but it was years ago. He did give me a steroid oil that I have to rub on my scalp, which is helping, even though it's a mess. I think that it's treating psoriasis. I would like to mention that I did receive my flu shot one week after receiving my booster.
Severe arm pain, including sharp stabbing sensations on hand; severe headache confined to the left side near the ear; fever; fatigue Lasing for 3 days.
Patient was given a dose of Janssen vaccine that was stored at room temp longer than 2 hours. (less than 6)  Manufacture was contacted and they had no stability data on this vaccine for this window of time at room temperature and suggested we use our clinical expertise. We were advised to revaccinate and consider dose as invalid.   Patient was notified of error and stated they did not have any side effects from the vaccine dose that was administered besides feeling a little tired the following day. They are scheduled to come back in to get revaccinated.
hives itchy headache nausea rash  swollen face fatique mouth hurting g
1st shot last July. Is too late to get 2nd dose?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-Apr-2022 Reporter's comments: This case was received from Shingrix. This case was reported by the patient. The patient received first shot of Shingrix last July before the date of reporting. The reporter asked if it was too late to get 2nd dose or need to start all over. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
1/19 vaccination 07:15 AM By 3:.30PM,  I felt extremely fatigued, flu like symptoms, body aches, fever; 103-104 x 3days. Severe body aches, chills, I was rotating between motrin / Tylenol.  1/20 spoke to telehealth following day. Keep monitoring temperature, no breathing issues.  By end of 3-4th day, temp broke. I was super fatigued for another 24 - 48 hours. Struggled at work.  ER consult with one of the doctors; given clear to work. 24 hours no fever, no flu like symptoms, that I could go back to work.  *CO VID +;  7-3-2021
Bitten by a snake and hospital suggested it since I can't remember the last time I had one. At site of injection it is swollen and red, at about 10 hours post injection I started with itching and hives, and my glands on my neck have become swollen and sore.
hair falling/ her hair has always been full and now it's thin; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 20:00 as DOSE 3 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 27 years old, administered in the left arm for COVID-19 immunization; influenza vaccine inact sag 3v (FLUCELVAX), on 14Oct2022 as DOSE 1, SINGLE (batch/lot number: unknown), administered in the right arm for immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included: METFORMIN. Vaccination history included: BNT162b2 (first dose, at 04:00 PM, via an unspecified route of administration, administered in the left arm, (lot number: EY0584) as DOSE 1, SINGLE), administration date: 29Jun2021, when the patient was 26 years old, for COVID-19 immunization; BNT162b2 (second dose, at 03:00 PM, via an unspecified route of administration, administered in the left arm, (lot number: EW0180) as DOSE 2, SINGLE), administration date: 20Jul2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 06Nov2022 at 14:30, outcome "not recovered", described as "hair falling/ her hair has always been full and now it's thin." The events "hair falling/ her hair has always been full and now it's thin" required physician office visit. The patient underwent the following laboratory tests and procedures: tests: normal. Therapeutic measures were not taken as a result of alopecia.  Additional information: Patient was not diagnosed with COVID prior vaccination and has not tested for COVID post vaccination. Patient has not received any other vaccine in four weeks. The patient noticed her hair falling in 06Nov2021 when she sent her mom a message, because she was worried, and then Dec was worse, and keep falling, a lot. She never had issues with her hair, her hair has always been full and now it's thin. She went to the doctor at the end of Jan2023 to see what this can be, she made all tests and return normal. The doctor asked her if she had COVID, but she had only the shots. Then she reminded and searched about the dates when she took her last COVID shot, and when started to fall. And now looking at the Twitter she saw a lot of people with the same problem. She asked, "By any change that you know how long this will take or all my hair will fall?"
Fever reported 101-103 degrees redness/soreness of admin site from shoulder to elbow light head/dizziness - (sick) - OTC ALEVE.
Symptomatic since 12//21/21. Covid positive on 12/21/21. Both daughters tested positive as well on 12/20 and 12/21/21. Currently, in isolation until 12/31/21. Antibody testing requested after isolation period ends.
My son woke up the day following his vaccine and had mild complaints of headache and ?feels like I have a touch of the flu?. He hydrated with water that day very well and I gave him 500 mg of Tylenol. On Sunday (2 days after vaccine) we were at church celebrating outdoor Mass. about 20 minutes into church my son said he didn?t feel well and needed water. He was standing at the time he said this. He had been standing under and umbrella the entire time to shade him from the sun. About 1 minute later he fainted. He visually looked very pale at the time. We treated him with by having sit down, moved him to air conditioning. It took about an hour before he felt back to baseline.
pt recv vax 29SEP97 & 1OCT97 pt devel a rash;
Developed chicken pox 10/15/2009. 8 - 15 insect bites like rash noted tongue, face and waist
This is a spontaneous report from a contactable consumer. A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown) (non-pregnant at the time of vaccination), via an unspecified route of administration on 13Feb2021 at 16:15 as single dose for COVID-19 immunization. There was no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient's medical history included hypothyroidism, IBS. Past drug event included NSAIDS, bentyl, sulfa, inhalant for allergies. Concomitant medications included levothyroxine 112 mcg and Zyrtec. After vaccination on 14Feb2021 at 02:00, the patient had muscle/joint pain (achy, light burning), mild nausea, mild headache, fatigue. The patient did not receive any treatment for the events. The outcome of events was recovered/resolved.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Temp 101, not eating, listless, hard to wake up, incontinent, local rxn @ inject site;
pt recvd flu vax & devel a knot & redness @ the inject site, & a fever;
This spontaneous report was received from a Registered Nurse and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates since 14-MAR-2017, the patients were vaccinated with improperly stored GARDASIL 9, lot number M036059, expiration date 03-JUN-2019, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The vaccines experienced a temperature excursion between 47 to 77 Fahrenheit Degrees during 30 minutes and previously on an unknown date, during 1 hour between the same temperatures. Digital data logger was involved. No adverse effects were reported. Product quality complain was not involved. No other suspect or concomitant therapies were reported. Additionally, the reporter stated that the "Outcome: all supported". This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012119: US-009507513-1703USA012119: US-009507513-1703USA011942.
Screaming for 3 hrs p/vax administered; t101.4 in ear (by MD report-unable to contact parents per phone);
Second COVID vaccine given 30Aug21 and on 04Sep21 woked up around 130AM with severe abdominal pain.  Soon after sever diarrhea and vomiting began (up to 10 times a day) .  Also, extreme fatigue and body/muscle aches were experienced.  Fatigue/body aches resolved aprox 12Sep but diarrhea and vomiting continued.  Vomiting resolved 29Sep and diarrhea continues.  HCP visited 22Sep21 , testing done but no diagnosis given.  HCP visited again 28Sep21 with testing done and diagnosis of pancreatitis give.
A 54 year old male pt experienced encephalopathy following treatment with RabAvert for post exposure prophylaxis. the pt was bitten and scratched by a stray cat. He had previously received two full courses of human rabies immune globulin and 5 injections of post exposure rabies vaccine in the US about 9 to 10 years ago. He had not received any rabies booster shots since that time. The pt received one dose of post exposure RabAvert without human rabies immune globulin on 30-JAN-01 after stray cat bite. He did not receive his second dose because he experienced "encephalopathy" after the first RabAvert dose and the pt was hesitant to obtain either RabAvert or Imovax for the second dose. No titer was taken prior to the first dose and at the time of this report, it had been 7 days since the first dose. Follow up information is pending. ADDITIONAL INFORMATION: Follow up information was received on 27-FEB-01. The pt was 56 years of age (correction). Twenty-four hours after his last dose of RabAvert on 30-JAN-01 at 1600, he experienced tachycardia, a fever 100 degrees F, and chills which lasted 24 hours; menigismus which lasted 2 to 3 days; and difficulty concentrating which lasted 5 days. His diagnosis was mild encephalitis and he recovered on 21-FEB-01.
went to get second  shingles shot broke out on left cheek and side of nose below eye and lip and gum on that side
Had Gardasil shot in 2006/2007 (late reporting - probably had original Gardasil shot). Immediately after getting shot, had extreme shooting pains in spine for approximately 10 seconds, followed by a numbness and inability to move left leg and left arm for approximately 1/2 day. Felt fine and had no symptoms the day after. Tried to report issues to nurse at the time of the vaccination, but they did not seem to be concerned.
administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. It was reported that vials did not undergone any temperature excursion.  Total of 173 doses were given from LOT 070H21A. Date of administrations were reported as 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received includes updated reporter information.
rash on her hands; disrupted her sleep; itching; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient (daughter).   An adult female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unknown date in Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Feb2021, one week after receiving the vaccine patient developed a rash on her hands, that has disrupted her sleep ever since and itching. Patient took treatment with bendaryl to attempt to alleviate the itching with little success. The event itching was recovering and the outcome of rest other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
vaccine given 2/6/2009.  patient states she noticed swelling. Today 2/11/2009 she reported it to the clinic.  She had local swelling at the site measuring 1 inch wide by 3 inches long with erythema into inner forearm with no lymphadenopaty.  No other symptoms.  Denies fever, difficulty breathing, swelling of lips or tongue, dizzyness, itching.
I had the normal flu like symptoms about six hours after the vaccine on 4/01/21. They subsided the next morning 4/02. On Saturday night 4/03, I developed a rash on the creases of my arms. I woke up on Sunday 4/04 itching like crazy on my legs. The rash moved around my body throughout the week: back, torso, legs, arms. Everywhere except for my face and feet. It seemed to be hives, as I would have the urge to itch and then the rash would flare up. This went on from 4/03 to about Friday 4/09 and then it subsided. I was advised by a GP to take Zyrtec twice a day and could use a topical steroid until the rash subsided and to avoid an oral steroid. I have had a handful of rashes throughout my adult life so I could tell this one did not look very serious. Like the standard rash, I was so itchy at night. It felt like my skin was crawling.  I suspect it was my body's delayed reaction to the vaccine shot.
10/28 Upper arm got very hot & red - swelled then was very sore could not lay on arm or move it.  In the a.m. upon waking- could not raise hand.  Called doc. office was put on CEPHALEXIN 500 mg.  (10/29).  On 10/30 lower part of arm and hand swelled, very hot and red.  Saw Dr. was put on CLARITIN & BENADRYL & continue taking CEPHALEXIN.  Applied ice.
This spontaneous report was received from a Licensed Practical Nurse referring to 18 patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of PEDVAXHIB lot # L038501 with expiration date of 16-JUN-2018; lot # L051122 with expiration date of 12-OCT-2018 and lot # M001813 with expiration date of 14-OCT-2018 (anatomical route of vaccination and dose number were not provided). It was stated by the reporter, that the vaccine was exposed to a temperature excursion of 9 degrees C for 35 minutes. The vaccine has not been exposed to any previous temperature excursion and a data logger was stated. Furthermore, no adverse events were reported due to PEDVAXHIB and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccines were given at 3pm. Child cried unconsoleably until 8pm.  Fever 103.2F, listless. Mom called ER & was given a nurse hot-line. Gave Tylenol alternating with Motrin. Child went to sleep. When awake fever down & no crying.
Mother reports infant was "sleepy" most of the afternoon after immunizations. Developed fever to 103.8 that night and had poor appetite / nursing throughout the night. Appetite improved within 8 hours. Fever continued, 101-102 with Tylenol, for approx 24 hours. The day after immunizations, she developed "large red bumps" at all 3 injection sites, that lasted approx 3 days. Residual "bumps under the skin" persisted for approx 1 month afterward.
First 2 shots in March 2021. Slight hair loss noted but nothing to cause concern. Booster received in March 2022. Hair loss increased to worrisome rate. Visited doctor. All blood results were negative for reasons for hair loss.  Not sure if it is related to covid vaccination as the only new element was my booster shot