chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #21 of 32, a 47 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 47 year old female on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of retinopathy. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02345, WAES # 1004USA02347 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Service Member has experienced continued pain and cramping in the arm of the injection site, does not present in the other arm. Has demonstrated symptoms of physical fatigue, migraine headaches, mental fatigue and fogginess.  Additional symptoms observed show increased heart rate, muscle cramping, and patient states presence of trouble sleeping and increase in cold sore frequency.
Pain in shoulder; arm turned red from shoulder to elbow; chills and fever night of injection; feeling faint next morning (resolved with coffee).
I started shaking hard and it lasted for 5 hours. My blood pressure went up to 161/80 and pulse 122.  Temp was 100.9 At 11:38 p.m. my temp was 101.9 and my blood pressure was 142/100 pulse 111. I had a terrible headache that lasted until the afternoon of August 18th. My temperature went to 102.1. Today is August 19, 2021 and I feel drained and still have a headache.
2/15/20 - Patient  reported  continued left arm pain after receiving Flublok on 1/21/2020.  She doesn't have any other chronic conditions.  She used aspirin, but with no relief.  She says she's had difficulty sleeping on that arm, and hinders her job as a school teacher. (e.g. can't lift projector, etc.)   They went to urgent care today, the NP told her to see the pharmacy, and we'd refer them to a place.   I told her we don't have a clinic/prescriber for referral.     I advised her to see her primary care provider (PCP) ASAP, and I'll also be calling the PCP on Monday.
Pt had local swelling and redness at site of DTaP right arm. Mom instructed to use warm compresses and give Ibuprofen. Mom to call in 24 - 48 hours if no improvement.
shortness of breath; Dizziness; sweating; fever; nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating), PYREXIA (fever) and NAUSEA (nauseas) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     NO INFORMATION WAS UPDATED.  Concomitant products included PYRIDOXINE HYDROCHLORIDE, TRYPTOPHAN, L- (TRYPTOPHAN [PYRIDOXINE HYDROCHLORIDE;TRYPTOPHAN, L-]) from 01-Jan-2019 to an unknown date and LEPIDIUM MEYENII ROOT (MACA 2H) from 01-Jan-2019 to an unknown date for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PYREXIA (fever) and NAUSEA (nauseas). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (Dizziness) and HYPERHIDROSIS (sweating). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (shortness of breath), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating), PYREXIA (fever) and NAUSEA (nauseas) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol for 2 days.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: follow-up received and added patient demographics, concomitant and treatment information, event outcome updated to recovered.
Information has been received from a licensed practical nurse concerning a 22 year old female with no allergies, who on 09-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (lot#, and route not reported). There was no concomitant medication. On 17-Jan-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (lot# 655237/1287U) (route not reported). In the evening of 17-JAN-2008, the patient experienced nausea, body aches, vomiting, and weakness. On 18-JAN-2008, the patient had mild discomfort at the injection site and also vomited in the morning. The reporter noted that the patient's symptoms lasted fro a day and on half and them resolved. On 21-MAR-2008, the patient returned to the office for another vaccination, but the vaccination was not administered due to the adverse reaction on 17-JAN-2008. The office was still deciding if they would administer another dose of GARDASIL vaccine. No other information was available. Additional information has been requested.  Follow-up information. Additional information is not expected.
A ball appeared in my axilla, it is swollen, and it hurts a lot ¨; Pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (A ball appeared in my axilla, it is swollen, and it hurts a lot ¨) and VACCINATION SITE PAIN (Pain in the arm of the injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL and METHIMAZOLE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced AXILLARY MASS (A ball appeared in my axilla, it is swollen, and it hurts a lot ¨) and VACCINATION SITE PAIN (Pain in the arm of the injection). On 27-Mar-2021, VACCINATION SITE PAIN (Pain in the arm of the injection) had resolved. At the time of the report, AXILLARY MASS (A ball appeared in my axilla, it is swollen, and it hurts a lot ¨) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Passed out after getting simultaneous Hep B vaccination and Anthrax booster.  Cold, clammy, tunnel vision prior to passing out.  Only out for a few seconds.  Cold, clammy, thirsty, fatigued, and dizzy afterwards for about an hour.
Patient noticed a little swelling the first night after vaccine. The next morning her arm was red,swollen and warm. Patient felt ill that day (day after injection). Patient feels better today, but arm is still red and swollen.
raised bumps on shoulder and bodys left side; rash on left side of back; This case was reported by a consumer via call center representative and described the occurrence of papular rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2023, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced papular rash and rash. On an unknown date, the outcome of the papular rash and rash were unknown.   It was unknown if the reporter considered the papular rash and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments: The patient self-reported this case.  The patient who received his 2nd Shingrix dose approximately two weeks ago.  About one week after the vaccination, he developed raised bumps on his back low shoulder blade area and low back on the left side of his body.  He was asked if this could be a side effect of the vaccine.  He had an appointment with his HCP tomorrow.  The reporter was consented to follow up.
I caught COVID after being vaccinated. Hospitalized for four days and put on oxygen. Numbness in my toes and tingling. Lack of energy.
Developed redness 8/14/02 R deltoid 1/2" x 1" long circular pattern with "white blister" "circle of redness size of a pen" 1st noticed 8/14/02 am c/o pain 8/13/02. Ice packs and Tylenol were given. No temperature developed (cont Tylenol and ice packs).
11:30 AM fever 99.6, chills 2:00 PM swelling above collar bone - moderate 3:00 PM red & hot at injection site
Moderate headache, low grade fever highest being 101.3, body aches, chills and nausea  Tylenol for the fever 600mg q8hrs prn Cool compress for headache with fioricet on standby if gets worse Zofran for nausea q6hrs prn  Gatorade and blackberry gingerale
Varicella form lesion approximately 6 cm in diameter left upper back at the T3 distribution. Some mild papular & vesicular lesions are noted in the center.  Some blistering is noted that is unilateral.
A report has been received from a Health Professional concerning an 8 year old, female subject, who received Nasal FLUMIST Quadrivalent, 0.2 milliliters, on 22-OCT-2015 then approximately 6 days later on October 28, 2015, they each received another single dose of FLUMIST at the clinic. FLUMIST Quadrivalent  started on an unknown date. The outcome of the event of patient received 2 single doses of FLUMIST almost one week apart is unknown. The report was considered to be non-serious by company physician.
Pt presented to ED s/p ground level fall slipping out of his wheelchair falling to the ground.  Workup in ED included CT of the head and CT of the cervical spine that was negative for acute pathology.  Chest x-ray showed coarse bilateral interstitial opacities; pt tested positive for COVID-19. Tx w/O2, abx, remdesivir, steroids, Vit C, zinc.  Dc'd back to assisted living w/HHC.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L035129, expiration date 14-SEP-2017, subcutaneously (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 21.18 degrees Fahrenheit for 10 minutes. A digital data logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, as the reported was unable to provide any further information.; Sender's Comments:  US-009507513-1702USA007303:
Patient called and said she had "covid arm" per ER. Her arm began swelling approximately two days after vaccine and she went to er. They treated with iv antibiotics.
Chills, fever, malaise - began 24 hrs p/inject - lasted 48 hrs;
Patient called today to inform us that she has had a sore arm since she received her vaccine on 11/7/21.  It is not getting any better and she can not lift her arm above her head.  Her doctor told her to call us.  I asked if she had had any reaction to her first dose of the Janssen and she said no.  She is concerned since she is not getting any relief.   She has taken a pain reliever, used ice and heat with no improvements.
Originally received a shot in July-August of 2021, and shortly moved in to a new residence. Started getting breakouts of hives, mostly on my left shoulder, my upper back, and the insides both arms/forearms/armpits. They would always flare up especially bad late at night, shortly before going to bed  Originally believed it was some other element, such as a food or fragrant chemicals that I may be having a reaction to, or that it may be stress-induced hives. Took a regimen of medication (cannot recall at the moment the exact intake, but it was about twenty pills over six days) that helped boost my immune system, and then wean me off to a point that it could "calm down" again, and hopefully the hives would go with it, as was described by my nurse. After the regimen, my hives calmed down but never went away completely, though they never flared up like they had been. On February 8th, I received the booster for Moderna (the vaccine listed on this report), and by the end of the week (the earliest I can remember it happening was on the Sunday following), my hives started flaring up again, same pattern as before, but much worse than last time. Now, they're all down my back, down the sides and inside of my legs and knees, on the top of my feet, the backs of my hands, on my upper chest and belly, on my forehead and back of head underneath my hair, as well as all the same places they were showing up before. They also itch much worse, to the point that it is sometimes difficult to fall asleep because of them. Due to the similar time both flare ups occurred after getting a vaccine, my nurse came to the conclusion it was happening due to the vaccine or an ingredient in the vaccine.
Myalgia, Fever, fatigue, chills Narrative:  Fatigue, fever, myalgia, chills; taking tylenol.
Shingles; Rash; vaccination failure; Pain underneath right shoulder blade; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2018, the patient received the 1st dose of Shingrix (intramuscular). On 4th September 2018, the patient received the 2nd dose of Shingrix. In November 2019, less than 6 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shoulder blade pain. On 3rd December 2019, the patient experienced shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles, shoulder blade pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, shoulder blade pain and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: After vaccination with 2nd dose of Shingrix, the patient experienced pain underneath the right shoulder blade in November of 2019. On 3rd December 2019, the patient had strip of rash appeared across the back and right breast. On 26th December 2019, the patient confirmed with shingles. and on 7th January 2019, confirmed by health care provider. No further details were provided. The reporter consented to follow up.
pt recvd vax & c/o arm  soreness for 2 days; exp chills on & off w/ fluctuating t since 22oct94; advised see MD;
parent reports eyes rolled back, color black, stiff body & extremities for 1 1/2 minutes then became flaccid & didn't know parents;  took to MD; sz on 7OCT93;
Extreme exhaustion started at 5:30 pm. Chills and nausea the morning after (almost threw up making eggs). Active bowel movements, muscle stiffness, feeling "drugged", severe headache, decreased ability to communicate clearly and swollen painful lymph nodes left of my pubic area.
pts wife reported pt was experiencing a "pins and needles" sensation that was moving around his neck and head
Apneic event requiring moderate/vigorous stimulation, CPAP, rule-out sepsis
Patient received Influenza vaccine - a 6 mo and older vaccine at 2 mo. Has experienced vomiting x1 and loose stools for 2 days. Tactile fever but Tmax 99F. Managing with Tylenol PRN.
Mild nausea and fatigue after approx 2 hours, mild swelling and painful to touch for approx 3 days.  Day 8 started with mild pain, day 9 pain increased and swelling is visible, again firm to touch, with large red area around injection site
Hot feeling arm; unbalanced; brain fog; headache; body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot feeling arm), BALANCE DISORDER (unbalanced), CONFUSIONAL STATE (brain fog), HEADACHE (headache) and MYALGIA (body ache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING HOT (Hot feeling arm), BALANCE DISORDER (unbalanced), CONFUSIONAL STATE (brain fog), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills). At the time of the report, FEELING HOT (Hot feeling arm), BALANCE DISORDER (unbalanced), CONFUSIONAL STATE (brain fog), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not reported.
I have been post menopausal for three years and just had a full on menstrual cycle.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other Non-healthcare professional). The reporter is the patient.  A 51 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170) via unspecified route of administration in arm left on 20Apr2021(age at the vaccination:50 years) as dose 2, single for covid-19 immunization. Patients medical history includes: Post-menopausal for three years from unknown date and month of 2018. Concomitant medication(s) included: WELLBUTRIN (BUPROPION HYDROCHLORIDE). Patient previously received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7533) via unspecified route of administration in arm left on 30Mar2021(age at the vaccination:50 years) as dose 1, single for Covid-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 22Nov2021, outcome "unknown", described as "I have been post menopausal for three years and just had a full on menstrual cycle.". Therapeutic measures were not taken as a result of postmenopausal haemorrhage.  Follow-up attempts are completed. No further information is expected.
Patient complains of dizziness and balance concerns. This lasted for at least 5 days following vaccine administration. He has not been able to drive.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/14/2023 ACUTE RENAL FAILURE, UNSPECIFIED T78.40XA ALLERGIC REACTION, INIT 3/6/2023 ACUTE RENAL FAILURE, UNSPECIFIED I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/14/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN T78.40XA ALLERGIC REACTION, INIT 3/6/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/14/2023 HEMATURIA T78.40XA ALLERGIC REACTION, INIT 3/6/2023 HEMATURIA
Pt received 0.5ml instead of 0.25ml Moderna 6M - 11yrs covid vaccine.
arm is feeling a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is feeling a little sore) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm is feeling a little sore). At the time of the report, VACCINATION SITE PAIN (arm is feeling a little sore) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Patient was 17 years old when received the first of two Moderna COVID vaccine doses instead of Pfizer COVID vaccine
Red; itchy papules and generalized itching in random areas of arms/torso/neck. Treatment included oral antihistamines and topical steroids
HIGH FREQUENCY RINGING IN EARS (OR IN HEAD), IT HAS BEEN 24 HR A DAY, EVERY SINGLE DAY SINCE LAST DOSE OF VACCINE
Hearing loss; tinnitus; I feel off balance; headache; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 62-years-old as DOSE 2, SINGLE for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on 03Feb2021 at age of 62-years-old for covid-19 immunization and experienced Hearing loss and tinnitus. The patient medical history was not reported. Concomitant medication included fluconazole.  The patient experienced hearing loss, tinnitus, feel off balance on an unspecified date with outcome of recovering , headache on an unspecified date with outcome of recovered.  Ear nose and throat doctor prescribed prednisone. Seriousness criteria reported as disabling and incapacitating. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.  Information on the lot/batch number has been requested.
administering an expired dose of Fluzone HD; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from  a consumer/non-hcp.  This case involves a 65 years old female patient who received expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 16-Apr-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI995AB (expiry date 01-Apr-2019) via intramuscular route in the right arm.  It was of actual medication error case due to  Expired vaccine used..  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Pain, swelling, redness, urticarial wheals, slight temp 99.2 to (R) arm/shoulder.