chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported swelling and redness around the injection site that started 1 day post vaccination.  On day 2 (today), patient presented to clinic with  an erythematous, indurated area approx 22 cm x 14 cm over the R lateral upper arm extending superiorly to the acromion and inferiorly almost to the elbow.   Area was warm but not tender.   The area was marked and pt was recommended to apply ice, take diphenhydramine, follow up with PCP in 3-4 days and return to clinic sooner if symptoms worsened (increased area of erythema or swelling, pain, or fever).
Exact time of onset unknown, above time it was reported to us by pt. Fever 101 and sore arm at site of injection day 1,  Fever 102 on day 2 with general body aches, slight swelling at injection site.
This spontaneous report was received from a back office lead and refers to a 48-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (in deltoid, route of administration, dose number, lot number reported as L035449, expiry date: 26-JAN2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I felt nauseated and tired on day 2 (4/10), better on day 3 (4/11) but had serious vertigo on day 4 & 5 (4/12 & 4/13).  I couldn't lift my head off the pillow without almost falling on 4/12.  Had steady improvement on 4/13, and was walking around by end of day. By 4/14, I felt back to normal and went back to work.  I have had vertigo in the past, but never such a severe case and unrelated to a migraine
Normal symptoms including chest pain soon after each vaccination. I'm starting to worry now because the chest pain has continued on an irregular basis for months afterwards. It's only once every couple of days but it can last from 5-15mins, and occasionally up to 5hrs.
fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), on 18Jun2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 18Jun2022, outcome "unknown", described as "fever".  Additional information: Reporter said that his daughter received the Pfizer Biontech Covid 19 vaccine two days ago. She is 6 years old. She began having symptoms yesterday of a fever, etc. They did a rapid test today to see if she had Covid and it is positive and asked if this was side effects of the vaccine, causing someone to test positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023; No adverse event; a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date) and PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023).    No concomitant medications were reported.     It was reported that Spikevax of 5.5 mL was initially stored in the refrigerator on 13-Mar-2023. The vial did not undergo any temperature excursions. The vaccine was administered to 2 patients after the expiration date. No adverse reactions had been reported by any patients for this invalid dose.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715267 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715267:other patient, same reporter
I went to bed for 12 hours before I could even get up and function, its kind of stroke'; nauseous; lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown  (booster), single for covid-19 immunisation. Relevant medical history included: "Enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN HYDROCHLORIDE taken for prostatomegaly. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Lot number and vaccination date unknown), administration date: 06Mar2021, for Covid-19 immunisation, reaction(s): "No adverse effect". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of stroke'"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; BALANCE DISORDER (non-serious), outcome "unknown", described as "lack of balance"; HYPERSOMNIA (non-serious), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; WHITE BLOOD CELL DISORDER (non-serious), outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times"; ILLNESS (non-serious), outcome "unknown", described as "ill". Therapeutic measures were taken as a result of hypersomnia.  Clinical course: Patient want to report an adverse effect from Pfizer booster shot and that Pfizer number 2, that he got definitely ill on both of the shot, terribly ill. The booster shot which he had in last month got terrible adverse effect from it and he had the same reaction to Pfizer 2 shot, he had nauseous, lack of balance, essentially, he went to bed for 12 hours before he can even get up and function, it's kind of stroke and he had speeding up a clear substance looks like white blood cell or something 'flams' it comes up all the times. The Concomitant medication include Flomax, it is used for enlarged prostate and there is a technical name for it he can read it off here, Tamsulosin HCL.  Patient said that he didn't take any treatment for any adverse event except sleep.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Diagnosed with COVID on 8/27 at outside hospital after cough, shortness of breath and diarrhea x 2 weeks. Treated with steroids and remdesivir. Transferred to Medical Center on 9/2 with COVID pneumonia and intubated. continued to decline with increased respiratory support, septic shock, dual pressors and worsening renal failure. Developed new Afib and EKG showed evidence of acute MI/mycardial injury. Multi organ system failure. 9/7 family chose comfort care.
BOOSTER: approx 12 hours after vaccinated high fever began and convulsions last 3.5 hours. Fever spike to 106 dropped to 102.5 Fever kept going and coming for over 18 hours. Body aches, massive headache for 1.5 days arm red & swollen hard bigger then a golf ball.  2nd Dose in March 2021 Arm swell from shoulder to elbow extreme pain and bright red
Sever headache, severe muscle pain, vomiting, fever, chest pain, sob, increased heart rate, decreased 02 sat (95%).
MALAISE; ACHES; This case was reported by a nurse via other manufacturer and described the occurrence of malaise in a 68-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced malaise and pain. On an unknown date, the outcome of the malaise and pain were recovered/resolved.   It was unknown if the reporter considered the malaise and pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient previously administered products included Equate Acetaminophen started in 2020 till 6th January 2021 from (batch number 0FE3257A, expiry date April 2022), with dosage 3000mg and sometimes at the 4000mg daily. The patient had Flu vaccine and she had milder symptoms and she did not have nausea or decreased appetite or no appetite, for about 5 days vaccination. The patient just felt malaise the little bit, did not even thought, she had headache, she might have had aches which lasted for about 5 days. The patient did not think to call the physician or anything about the symptoms with Flu vaccine because she kind of knew that was the body creating an antibody response. The information regarding consent to follow up was not reported. This case has been linked with case US2021AMR007111, reporter for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR007111:Same reporter, same patient, different vaccine (Shingrix)
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a female subject of unspecified age who was possibly vaccinated and FLULAVAL (GlaxoSmithKline) for prophylaxis during pregnancy. On an unspecified date the subject possibly received unspecified dose of FLULAVAL TETRA (unknown). Her last menstrual period was 10 January 2014 and estimated date of delivery was 17 October 2014. On an unknown date, at the time of vaccination with FLULAVAL TETRA, the subject experienced vaccine exposure during pregnancy during the 1st trimester. At the time of the report the subject was 4 weeks pregnant and the pregnancy was ongoing. Additional information received: Reporter called from doctor's office stating that they are unaware of patient referenced in safety follow-up form. They do not plan to fill out paperwork due to the fact that they are unable to identify patient. No further details to provide. The pregnancy was lost to follow up.
No adverse effects reported; a dose of PEDV AXHIB inadvertently had DILUENT injected into the vial; the dose was administered orally to a 4 month old child; This spontaneous report was received from a physician. It was reported that on 15-JUL-2019, a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB) for prophylaxis (lot number and expiration date were not provided), inadvertently had sterile diluent (STERILE DILUENT) (lot number and expiration date were not provided) into the vial and the dose was administered orally to a 4-months-old patient of an unknown gender (product administration error and incorrect route of product administration). Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications was not provided.  It was reported that the child was in office for well-baby check. No adverse effects were reported. It was mentioned that the baby was doing fine.
About 5 minutes after administration,  patient experience brief syncope (recovery within 10 seconds). When sitting, patient experienced confusion and pallor. Patient denied history of DM, but mentioned history of hypoglycemia. Provided 15 grams glucose tablets and water. Monitored patient until cleared by EMS. No additional ADRs.
hives; blister from corner of mouth; high stressful days; This case was reported by a consumer and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date January 2023) for prophylaxis.   On 19th January 2023, the patient received Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced stress. On 26th January 2023, the patient experienced hives and blistering of mouth. On an unknown date, the outcome of the hives and blistering of mouth were not recovered/not resolved and the outcome of the stress was unknown.   It was unknown if the reporter considered the hives, blistering of mouth and stress to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-Jan-2023 Reporter's Comments: This case was self-reported by the patient. The patient experienced hives that were blister like going from corner of mouth on my left side starting to sweep out and up towards my eye and still ongoing. The Shingrix manufacturer provided unspecified expiry date of Shingrix. The patient experienced high stressful days after vaccine. The symptoms were not treated.  The reporter had gave the permission to contact you.
Pt had low grade temp 99.5 prior to vaccination with no c/o illness, or SB /c/o - Very shortly after vaccination pt c/o dizziness which persisted. EMS on site decided to transport pt to ED. While in ED pt received hydration & at one point had decreased level of verbal response. Pt remained in hospital for observation for about 24 hrs. Hospital course uneventful, pt's only c/o was vertigo & headache. Physician felt patient had concurrrent viral illness and SB, not vaccine related. 10/26/2009 hospital records for date 10/8/2009. Patient presents with sx of dizziness,lightheadedness, nausea, decreased responsiveness, paleness and somnolence. PE normal, admitted for observation.  DC DX; Adverse reaction to flu shot, viral syndrome.     current viral illness and SB - not vaccine related.
Day 1: Severe muscle cramping Day 2: Headache Day 3 - Current: Persistent headache of varying degree and intensity
Within 24 h. pt broke out in rash. All over body. Called me on 10/28 she has been taking BENDRYL and is better. Rash on legs, thighs, arms; chest.
This spontaneous report as received from a healthcare worker, practice manager refers to an unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (dose and route not provided). The health care worker reported, the storage compartments that contained VARIVAX were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site pain in addition to above symptoms Narrative:
2 hours after injection nausea and dizziness with slight vertigo. 14 hours after injection shooting pains from the injection site up the shoulder and through the jaw bone. 22 hours after injection fever of 102 with chills and muscle aches. All passed after the 36 hour mark. Now at the 48 hour marker the site is swelling larger with mild bruising and continuing to get larger.
Mother reported child's date of birth as exact date.  When staff checked the Registry to confirm spelling of last name child's date of birth was listed as a different date.  Telephone call made to mother to confirm date of birth but no response received from mother to confirm date of birth.  Per the registry records client was not age eligible for vaccination.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Patient stated that tinnitus got worse, It was so loud and was like having crickets, like when you step outside in the summer in her head 24/7. She states when there was other noise like the TV playing or her CPAP machine noise it wasn't as noticeable, but when she sits down to read it was really bothersome.
3010/29 Itching under armpits 10/30 red and itchy under arms, down side of breasts, on stomach and down to the pelvic area. 10/31 went to stat care saw 2 Dr.s sent her to Dr. Advised prob. reaction to flu shot. Gave predisone and "itch" med. Had Hx. of hives from boiled eggs when 2yrs eats eggs now and has had flu shot for 10 years without problems.
Site injection area was red, swollen and uncomfortable and feverish until 10/24/2016. Today I received a yellow jacket sting near the injection site, so it reswelled, and became red and swollen.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid-19 symptoms) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (had Covid-19 symptoms). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (had Covid-19 symptoms) outcome was unknown. No concomitant medications were reported. Patient had Covid-19 symptoms after second dose which were mentioned as chills, upset stomach and diarrhea. Company Comment: This case concerns an 80-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid 19 Symptoms (mentioned as chills, upset stomach and diarrhea) unspecified days after receiving second dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-451541, MOD-2022-451531 (Patient Link). Sender's Comments: This case concerns an 80-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid-19 Symptoms (mentioned as chills, upset stomach and diarrhea) unspecified days after receiving second dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Swelling, tenderness and painful skin at injection site.  Site is discolored and Pt. complains of malaise and achiness.
Patient stated pain upon initial administration of PNEUMOVAX, not with AFLURIA QUAD which was administered first. She called 1.5 days later complaining of pain all over right arm. Was instructed to take Tylenol and try applying heat and cold had already been tried with no success. Patient went to urgent care as arm had started to swell and felt like her bones were being crushed. She was prescribed acetaminophen 500, diphenhydramine 50, and methocarbamol 500. Patient then started developing large silver dollar sized hives all over body as well as swelling in extremities. Advised patient to double up on diphenhydramine and visit emergency room for possible steroid injection or further treatment and observation.
Narrative: Myalgia, Rash, NauseaVomiting, red, raised & warm area at vaccination site 4 1/2 inches wide x 2 inches length
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 02-NOV-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
I started running a fever the first evening at least 102 degrees for 3 days and had a horrible headache. On the 3rd day the fever broke however the headache was still for about three more days. I felt fatigue and ill. Spoke to doctor after symptoms subsides and was told that I might of have had a super reaction to the vaccine.
Area of shot red, hot and itching. No fever. Little headache - may be allergy. No nausea/vomit.