chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the shot, the second one required six months apart, on Feb 13 at approx. 9:30 am. By 7 pm that same night (approx) I began to feel feverish and had some rather severe muscle aches. I had no reactions to the first round of the vaccine six months earlier except for injection site soreness. I treated the flu symptoms with Advil which worked well. The next morning I noticed four blister-type sores on the inner left thigh! Two of the blisters looked to be about the size of dimes or slightly smaller. The other two were quite small and disappeared in a week. The larger two, however, slowly crusted over exactly like chicken pox and have slowly diminished in size. As of this writing two very small scabs are still there. I have taken a series of pictures over the time period in question if you would want me to share them. Two doctors have looked at them and said they were related the vaccine. I also had a few days of physical weakness and malaise after the vaccination which seems to persist to a lesser extent even now. The injection site soreness was worse than the first shot in the series given in Oct 2018. This  site soreness has gone away but is replaced with a deep ache in the shoulder joint (rotator?) near that injection site.
Bruise formed at injection site one week after administration. Patient also states there is a red patch below the bruise which appeared slightly after the bruise formed. Recommended patient notify doctor about the occurrence to be monitored and determine if a second dose of vaccine is warranted. Unsure if it is a reaction to the vaccine itself or if it is due to vaccine administration.
"PMH htn who c/o n/v/d and flu like symptoms. Patient received first dose of pfizer vaccine 12/23/20 at 3pm. A few hours later started having epigastric pain to his back with numerous episodes of n/v nbnb. +chills and myalgias. Denies having any prior adverse reactions to vaccines. Denies any nsaid or etoh use. Denies any abd surgeries. Took 12mg zofran, about 4mg which were IV w/o relief. Denies any itching or rash or hx pancreatitis or anaphylaxis. +mild sob. "
Excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.It was reported that, there was excursion from the freezer on 01-Oct-2021 and nurse used the excursion tool but there was no option for the excursion they experienced. The only tool gives the options for excursion above one hour and not less than that so the nurse dose not known about the analysis. The nurse stated that her team know the recommended temperature and wants to know if the vials were still okay to use because they were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature reached was as follows; minimum 4.2 degree F and maximum 5.7 degree F. It was also stated that excursion duration was 6 minutes. On visual inspection the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials/doses were impacted and they were moved from freezer to refrigerator only on day they were used and they were not returned to freezer or refrigerator for storage. No concomitant medications were reported.  No treatment information was reported.
Pt had local reaction at injection site and below, area approximately 6" x 7" red and warm to touch, slight discomfort to area - started evening 11/14/11 seen by physician - advised to use cold pack to area & TYLENOL and BENADRYL if area becomes itchy.
Pain in posterior shoulder and limiting AROM of the shoulder.  Mild swelling no erythema.  Tendonitis suspected
p/vax pt devel lt thumb pain which was warm & tender;sx progressed to pain in lt wrist on 8/15/99 & then on 8/16 to rt wrist & lt knee;generally feels achy & sore;tx celebrex & pred;referred to MD;
Patient reported "about a week later the injection site on my left arm got really swollen, red, hot and itchy.  it lasted 3 days, i took benadryl to control the itching"
Information has been received from a medical assistant via a company representative referring to an adult patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-NOV-2017, the patient was vaccinated with a pediatric dose of the VAQTA 25/0.5 (unit unknown) (route, lot# and expiration date were unknown) for prophylaxis (Incorrect dose administered and drug administered to patient of inappropriate age). No adverse effects were reported. No product quality complaints (PQC) involved.
Two weeks after receiving the 2nd Pfizer vaccine dose, I woke up to extreme muscle aches around my hip girdle and shoulder girdle.  I could not lift my arms up to brush my hair and get dressed.  After seeing a rheumatologist, I was diagnosed with probable PMR (Polymyalgia Rheumatica) and started a treatment of prednisone from February 2021-December 2021.  Symptoms eventually subsided.
08/14/02 Stated with pain in both arm- not swollen - denies fever, 08/15/02 wake up with pains in both arms and middle to lower back, Taking Tylenol and applying heat, if no improvement-see PMD
MOTHER WAS CHECKING OUT AT THE FRONT DESK APPROX. 5 MINUTES AFTER THE ADMINISTRATION OF THE INJECTIONS AND NOTED BLOTCHES APPEARING ON PATIENT'S SCALP. THE RECEPTIONIST CALLED ME UP TO THE DESK TO CHECK ON HIM. I NOTICED SEVERAL SEPARATE DEFINITE BLOTCHES ON HIS SCALP.  HE WAS MOVED BACK INTO AN EXAM ROOM AND THE DOCTOR WAS CALLED RIGHT IN TO CHECK ON HIM.  WHILE DOCTOR WAS  EXAMINING HIS SCALP I NOTED RED BLOTCHES APPEARING ON HIS NECK. PATIENT'S CLOTHING WAS REMOVED FOR FURTHER EXAMINATION.  THE INJECTION SITES WERE NOTED TO HAVE REDNESS AROUND THEM.  THE RIGHT PRESENTED GREATER THAN THE LEFT.  DOCTOR CONTINUED TO MONITOR THE PATIENT. NO MEDICATION INTERVENTIONS WERE USED. DOCTOR CONSULTED WITH ANOTHER DOCTOR. THE BLOTCHES DISAPPEARED AFTER APPROX 15-20 MINUTES.  HIS FEET TURNED BRIGHT RED AFTER THE BLOTCHES DISAPPEARED.  NO EDEMA WAS NOTED.  THE REDNESS DISAPPEARED WITHIN MINUTES AND WAS DISCHARGED HOME WITH NO FURTHER REACTIONS.
a customer who received first dose of GARDASIL 9 on 7/15/2020. The customer missed second dose timeframe.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 15-JUL-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot #, expiration date and route were unknown) for prophylaxis. The patient missed the second dose timeframe on an unknown date in 2020 (inappropriate schedule of product administration).
Initial unsolicited case received from a consumer on 20 Oct 2017. This case involves 19-year-old female patient who was vaccinated with a one dose of FLUBLOK QUADRIVALENT (Batch number, expiry date, dose, dose in series were not reported) intramuscularly in right arm on 13 Oct 2017 and also a dose of FLUZONE QIV (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On 16 Oct 2017, three days after the vaccination with FLUBLOK QUADRIVALENT and unspecified time frame after the vaccination with FLUZONE QIV, patient began having shortness of breath (SOB) due to weak chest muscle, and due to which she was seen in ER twice and seen by primary care. Diagnostic testing included CT scan, chest x-ray, EKG, blood work and pulmonary function tests, all tests normal and was referred to neurologist. Other lab tests were not reported. Corrective treatment was not reported. Outcome of both the events were reported as unknown. List of documents held by sender: none.
Pt began crying uncontrollably this night of receiving the injection which lasted around 12 hours. Physical exam was inconsolable.
Information has been received from a registered nurse concerning her daughter with no pertinent medical history, who on 23-AUG-2007 was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  On 24-AUG-2007 the patient experienced urticaria than began bilaterally on the legs.  On 25-AUG-2007 the rash progressed to her trunk, upper extremities, neck and face.  The physician was notified by telephone and the patient did not need BENADRYL.  On 27-AUG-2007, the patient recovered.  No laboratory or diagnostic tests were performed.  Additional information has been requested.
Psoriatic arthritis; Plaque psoriasis/groin area resistant; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for solution for injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant) and PSORIASIS (Plaque psoriasis/groin area resistant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) and PSORIASIS (Plaque psoriasis/groin area resistant) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medication were provided It was unknown if the patient was enrolled in COVID-19 trial. Reporter causality for event Psoriatic arthritis was not reported with Humira. There was no reasonable possibility for event Psoriasis with Humira. 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.  Company Comment: This is a spontaneous case concerning an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
he may have been given the Bivalent dose as the 1st dose.; No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (he may have been given the Bivalent dose as the 1st dose.) and NO ADVERSE EVENT (No Adverse Event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (he may have been given the Bivalent dose as the 1st dose.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (he may have been given the Bivalent dose as the 1st dose.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (he may have been given the Bivalent dose as the 1st dose.).    No concomitant medication was reported. No treatment medication was reported. the patient attempted to schedule an appointment and asked to wait for 60 days. upon speaking with pharmacist, the patient was told to be administered with bivalent dose as the first dose. The patient received no other vaccine in the 4 weeks prior to COVID-19 vaccine.
patient says they have redness at injection site which is warm and swollen. this happened about a week later. it looks like it might be cellulitis. the doctor told patient to talk to pharmacist first before coming back to their office
p/vax pt devel severe red rash around the entire upper arm of inj site area;also pt devel significant dependent edema extending from the pt elbow to the wrist;pt recovered w/in 48hr;
Severe chills (unable to hold a glass of liquid). Fever of 101.5. Inability to sleep until 5 am. Tiredness all day the second day.
This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from medical assistant via a company representative concerning the 26 year old female medical assistant who, on an unspecified date, was vaccinated with a dose of HPV. The medical assistant reported that after her vaccination with HPV, "her face turned very red and hot". The medical assistant recovered on an unspecified date. The patient (medical assistant) sought unspecified medical attention. Additional information has been requested. Information has been received from medical assistant via a company representative concerning the 26 year old female medical assistant with an allergy to LEVAQUIN who on 09-JAN-2007 at 5:00 PM, was vaccinated IM into the deltoid with a first dose of GARDASIL (Lot# 6353736/0868F). Concomitant therapy included CYMBALTA, PREVACID, LAMISIL and ZELNORM. There was no illness at the time of vaccination. The medical assistant reported that after her vaccination with GARDASIL at 5:00PM on 09-JAN-2007, "her face turned very red and hot". She also reported that she felt flushing sensation on her face, neck and chest turned beet red like a severe sunburn that lasted about 2 hours, recovered 09-JAN-2007. Additional information is not expected.
Left arm just distal to site of injection started getting erythematous, edematous pruritic and mildly tender patch. My thoughts were allergic skin reaction versus cellulitis and treated as such.
Covid-19; Covid-19; Vaccine brand other: Moderna/vaccine administration date: 26May2022; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26May2022, outcome "unknown", described as "Vaccine brand other: Moderna/vaccine administration date: 26May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Feb2023 at 14:00, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (09Feb2023) Positive, notes: Return of mild cold symptoms and positive test for Covid (14:00). Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient has no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a medical assistant concerning an 8-year-old female patient who on 20-NOV-1998 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Mom called July 3 stating noticed child smiling and talking from one side of face x 4 days. Doctor diagnosed patient with Bell's palsy post MMR/V vaccine given on June 26. Visit to office July 7,2007 with continued asymmetry of face but has improved. No treatment required.
Swelling of left arm; dizziness, numbness around the mouth, decrease in blood pressure. Tx: Benadryl 25mg po x 2. Cold pack.
severe hives, itching, wheezing with prolonged reaction resulting in "flare ups" for weeks with anylphylaxis. Recently escalated to a systemic reaction involving lymphs glands believed to be linked to original reaction which was never completely resolved.  8/24/09 PCP records rec'd for DOS  8/20/09 with Impression: sinusitis, allergic reaction, seasonal allergies. Pt presented with c/o allergic reaction after being around a cat with onset 8/13/09. Developed swelling feet and face, itching, H/A and ear popping. Still reporting allergic sx from Td vax 6 weeks prior.  PE (+) for wheeze, boggy turbinates and pharyngeal injection, and sinus tenderness. Tx: steroids, abx, antihistamine.
Patient was given Moderna 6m-5y vaccine outside of viability window. Multi-dose vial was first punctured on 11/18/22, and patient's vaccine was given 11/21/22--well outside of 12hr window from first puncture. Vaccine was also given outside of 30 day window viability for refrigeration storage. Patient's father has been informed and reassured there are no health risks to patient. Patient is well. Case created with manufacturer and we are awaiting their response on how to move forward with re-administering dose.
This case was reported by a physician via a sales representative and described the occurrence of gums red in an adult female subject who was vaccinated with TWINRIX, (GlaxoSmithKline).  Concurrent vaccination included poliomyelitis vaccine (manufacturer unspecified) given on February 2009.  In February 2009 the subject received unspecified dose of TWINRIX (unknown).  A few days after vaccination with TWINRIX, the subject went to her dentist for red and sore gums.  While at the dentist, the subject was told that she had white striations on her gums (white line on gum due to discoloration).  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 24 March 2009 indicated that the subject was a 65 year old female.  The events were reportedly resolved and indicated as possibly related to 2nd dose of TWINRIX, however, it was noted that a gum biopsy performed on an unspecified date indicated that the subject's gums and teeth were reacting to "filling" and not related to vaccine.  Additionally, it was reported that the onset of events was 26 January 2009, however, 2nd dose of TWINRIX was not administered until February 2009.  The 2nd dose of TWINRIX was given at 0.5 ml intramuscularly in the left deltoid.  Concurrent IPV vaccine (Sanofi) was given subcutaneously at 0.5 ml in the left arm.  Medical history reported included hypertension and PENICILLIN allergy (swelling).
Later in the evening about 4 hours after vaccine (11 PM), I got a cold but it didn't feel like chills and I was just cold. I got in bed with lots of blankets and I was also very sleepy so I went to sleep and slept for 12-14 hours which is unusual for me but when I woke up I was fine. I also had Right arm soreness and it was unusually sore a couple of hours after vaccine (approximately 9 PM) and that lasted around 24 hours.
About 30 min following for approximately 2 hours: dizziness (resolved). One sided headache behind right eye (resolved after 1-2 days). 11/18 - presented with 2 round, raised areas about the size of a penny that are painful one over right eye the other on top of head, slight blurred vision. 11/19 - MD prescribed 7 day course of valacyclovir.
sever headache at the back of the head with left arm and shoulder pain lasted 2 days after 7 days sever dizziness  which lasted 7 days and continues intermittently.  Laying down seems to Triger it .  I had my teeth cleaned and the chair position triggered it for 3 days
Starting roughly a month after the vaccine I began having hip pain being most severe in the morning. Slowly getting worse and migrating to different joint over the coming months. Currently, my right shoulder and left knee have the most pain consistently with it being most severe in the mornings and when sitting. However, I have joint pain in my toes, knees, hips, shoulders, and fingers on a daily basis with severity changing on a daily basis. After seeking PT for 10 weeks, I got a blood test confirming I am ANA positive. I have since gotten x-rays and sought opinions from rheumatology. No firm diagnosis has been made. However the only thing I had done prior to the joint pains onset was receiving the Bivalent vaccine.
Fever, malaise, chills, joint pain,  nausea, and vomiting
Client in HD on 12/6/16. Reported having a sore arm from the vaccines. Client reports, "it swelled to the size of a tennis ball or an orange, was red and splotchy and she couldn't move it for a few days. She had a fever 99-100 about 8 hrs after the vaccine. Checked arm, small bruise and a knot the size of a quarter present. Client moving arm without difficulty, no redness, edema, noted. Checked clients shot record and noted to have had HPV and BEXSERO in that arm. Instructed pt on signs of side effect per VIB such as soreness, redness, swelling, fever and difficulty moving arm. Client encouraged to keep moving arm and monitoring area and if any side effects become worse or persist seek medical attention. Verbalized understanding and very thankful.
Tinnitus very strong and getting worse month by month. Migrains, lack of concentration and dizziness after 3 mo. from shot