chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 53-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (the patient had shingles two to ten times every year for the past 19 years). On 17th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th May 2018, 11 days after receiving SHINGRIX, the patient experienced shingles, swelling of eyelid and rash. On an unknown date, the outcome of the shingles was resolved with sequelae and the outcome of the swelling of eyelid was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the shingles, swelling of eyelid and rash to be related to SHINGRIX. Additional details were provided as follows: The patient said that everyone where she lives got the shingles multiple times. The patient received SHINGRIX in the left arm. The patient had an outbreak of shingles on her left eyelid on 28th May 2018 which caused her eyelid to swell. The patient had several outbreaks of Shingles, on eyeballs, eyelids and cheeks usually left side. It resolved within a few days. The patient had another outbreak of shingles on 5th July 2018 on her left cheek. It lasted until 23rd July 2018 and still appeared where the bumps were located. The patient did not have a physician at this time. The patient had denied permission to contact their physician.
Patient received 0.2 mL of undiluted orange cap pediatric Pfizer (30 mcg dose), no reported side effects when they left the clinic
About 2 days felt like a cold. Minor body aches, sore throat lymph nodes, stuffy head, slight headache, tired, difficulty sleeping.
A report was received from a health care professional on 11/10/03 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 10/20/03. On 10/20/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Moderna COVID-19 Vaccine  rash, redness, swelling around where the vaccine was injected. Started to appear 5-6 days after the shot was given. Itchy. All of these symptoms are starting to subside now: - Mar 28 - vaccine injected - Apr  3-4 - rash, redness, swelling appeared - Apr 10 - rash, redness, swelling starting to subside
10/2/18 Pt reports SOB, palpitations, fatigue, malaise, lack of focus, tingling in hands/face, chest "heaviness". Local site erythema at left deltoid. Vitals stable. 10/3/18 Reports continued fatigue, dizziness, weakness, SOB, headache. Left arm swelling/redness improved.
Patient called 1-14-10 said she received H1N1 vaccine 12/17/2009. Got headache immediately and has had them off and on ever since said she did see a doctor recently BP is okay
Information has been received from a certified medical assistant (C.M.A.) concerning a 12 year old female with no pertinent medical history or known drug allergies who on 26-JUN-2008 was vaccinated subcutaneously in the right arm with a second dose of VARIVAX (Merck) (Lot #659432/1918U).  On the same day the patient was vaccinated higher up in the right arm with concomitant HAVRIX.  On 27-JUN-2008 the patient was in office with injection site blister like bump with fluid underneath.  The patient had no adverse event after receiving the first dose of VARIVAX (Merck).  At the time of the report, the patient had not recovered from injection site blister.  The patient was seen in office.  This is one of several reports from the same source.  Additional information has been requested.
Migraine Injection site pain Pain in legs,  so bad I can barely walk Nausea Diarrhea
Both thighs swelled, turned red, had fever over 105, injection site had large lumps and small drainage hole along with petechiae all over the body. Dr thought it was a bug bite, sent to the ER. ER did Lymes - negative and ruled it an unknown infection. Sent home with BACTRIM. Returned to the dr for well visit 7/2/2018 as dr said it was OK to get shots. He then received Dtap & Hep B, days later he developed the same red legs and lumps. Continued to treat with compress and Mupirocin 2%. Went down some but baby had fever on and off throughout September, redness never went away, baby started to refuse to walk, grabbing and screaming at legs expressing he was hurt/hurting and in pain. On October 11th, fever spiked 105 again, red legs worse and now had rashes on his leg and torso. Went to the ER, where they diagnosed it as a cyst/granulomas from vaccines, baby was almost septic given high dose clindamycin to treat. Improving within days of treatment, redness still very slight. Unknown of any long term issues.
Information has been received from a health professional concerning a 51 year old female who in approximately August 2007, was vaccinated with ZOSTAVAX, lot # 656861/0329U). The patient called the office a few hours after she was vaccinated, in approximately August 2007 and reported that she experienced a fever and headache. As of 24-AUG-2007 the outcome was unknown. Additional information has been requested.
he develop some rash on his face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Jan2022 (Lot number: FK5618, Expiration Date: 31May2022) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: FK5618, Expiration date: 04Feb2022, Anatomical site of vaccine administration: Left arm.), administration date: 27Dec2021, when the patient was 5 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 17Jan2022, outcome "unknown", described as "he develop some rash on his face". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. No follow-up attempts are possible. No further information is expected.  Additional information: Treatment for Adverse Event (Rash): Reporter stated, "I just gave him Zyrtec."
My head is hot; Weak/tired; Mild headache; Weak/tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (My head is hot), ASTHENIA (Weak/tired), HEADACHE (Mild headache) and FATIGUE (Weak/tired) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (My head is hot), ASTHENIA (Weak/tired), HEADACHE (Mild headache) and FATIGUE (Weak/tired). At the time of the report, FEELING HOT (My head is hot), ASTHENIA (Weak/tired), HEADACHE (Mild headache) and FATIGUE (Weak/tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
got the flu; Initial information was received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who got the flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for Prophylactic vaccination.  On an unknown date the patient got the flu (influenza) 3 weeks later following the administration of Influenza vaccine.  It was bad.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
A few months after the initial two Covid vaccines that I received in March of 2021 I noticed I had times of irregular heartbeats, high pulse, palpations to a point I had to stop what I was doing until I could catch my breath and compose myself.  Then a month after receiving the booster in March of 2022 these conditions had increased in the number of episodes and the magnitude of them to a point I was very concerned. I saw my Primary Care Physician on 5/13/22 and wore an iRhythm Zio 14 day heart monitor from 5/29/22 to 6/12/22, 33 page report.  Due the severity of the data from this monitor I was immediately seen by my Cardiologist on 6/30/22 who immediately turned me over to an Electrophysiologist. I had an EKG and an Echocardiogram run.  I saw the Electrophysiologist on July 7, 2022 who noted I had a past history of First Degree AV Delay, but the monitor revealed I had Supraventricular Tachycardia (SVT) runs (over 1200 episodes) in 14 days along with pulse rates as high a 250.  I also had Ventricular Tachycardia and something new that did not show up in my October 2021 cardiology annual checkup which included an ECG and Echocardiogram which was Left Bundle Branch Block (LBBB). On July 25, 2022 I was admitted to the hospital for a Electrophysiology Study in which an ablation was performed. Currently I am feeling better than I have in the last year or more. Just so you understand I cannot prove 100% the Covid Vaccines had anything to do with my heart conditions that took place over the past year but looking back at the timeline of what took place and when I had gotten the vaccines, especially the Booster in March of 2022, I believe there is some correlation.  None of my doctors, my Primary Care Physician, my Cardiologist, nor the Electrophysiologist have an opinion on how these heart conditions came about, but to me I feel there is very good possibility the vaccines brought these things on in some manner or form especially after the booster in which case the severity of the condition increased immediately along with the magnitude of the episodes as they were not all there prior.
After receiving her Gardasil in her right arm and the Flublok in her left arm she asked me to wait a minute because she was feeling a little light headed. I instructed her to place her head between her knees and sit like that for a minute to see if that made her feel any better. She did feel better after a minute or so and I asked her if she wanted to postpone the Adacel  or continue with getting the shot. She said she wanted to continue with receiving the shot. After getting the Adacel the feeling came back and she lost consciousness for a brief moment. I had her place her head between her knees again and got her a cold pack.  I asked several times if she would like to lay down but she denied each time. After a few minutes of the cold pack on her forehead and keeping her head between her knees she began to feel better.  I waited with her until her family was able to come pick her up.
Approximately 2 months after receiving vaccine I developed a breakthrough case of COVID-19. Tested positive on July 10. Symptoms fever, cough, brain fog, headache, nausea, vomiting, diarrhea,  fatigue, dizziness, and congestion.
Increased asthma and very itchy red rash which continues to spread on scalp, entire back & sides, shoulders, and continuing to present.   Administered 40 mg. Kenalog 2/10/14, with no improvement.  Increased doses of prednisone.
This case was reported by a consumer via call center representative and described the occurrence of skin cancer in a 86-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 28th February 2021) for prophylaxis. Co-suspect products included valsartan for an unknown indication. The patient's past medical history included cataract extraction and skin cancer (years ago the patient had cancer removed from the same spot on the right collar bone area). Previously administered products included ZOSTAVAX. Concurrent medical conditions included glaucoma. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient started valsartan 320 mg once daily (320 mg daily). On 13th September 2018, 1 days after receiving SHINGRIX and an unknown time after starting valsartan, the patient experienced skin cancer (serious criteria GSK medically significant), localized erythema and pruritus. In November 2018, the patient experienced blurred vision. On 6th December 2018, the patient experienced glaucoma aggravated (serious criteria GSK medically significant). The action taken with valsartan was unknown. On an unknown date, the outcome of the skin cancer, blurred vision and glaucoma aggravated were unknown and the outcome of the localized erythema and pruritus were recovered/resolved. It was unknown if the reporter considered the skin cancer, blurred vision, glaucoma aggravated, localized erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient had glaucoma and cataract surgery in the past before she received SHINGRIX vaccine. The patient received SHINGRIX in the right arm. About a month ago she noticed that she was not seeing as clearly from one eye. The patient went to her ophthalmologist and 85 days after receiving vaccination, it was noticed that the pressure in one of her eyes was going up. The patient does not remember what eye. The day after getting the vaccine she had red spot on her right collar bone area which was flared up and itching. Years ago she had cancer removed from the same spot on the right collar bone area. Within few days after the patient visited her skin physician, he did a biopsy of the skin and it was diagnosed as skin cancer. A surgery was done and 2 by 2 inch of area was removed. During the time of surgery another biopsy was done for the area on the skin right below the elbow, about half way up the forearm area. This was diagnosed as skin cancer as well and it was removed. The patient also stated that she was on Valsartan 320mg one tablet every day manufactured by other manufacturer. The pharmacy had told her that they cannot refill the Valsartan for her since they were going to stop selling it due to concerns of it causing cancer. Therefore patient thought it could also be the Valsartan that could be causing the skin cancer. The reporter did not consent to follow-up. The Emergency visit was required. The patient had a follow up appointment with her skin doctor on 28th December 2018.
about 4hrs p/vax given pt began to feel strange,lightheaded,nauseated & overall feeling of numbness but no loss of functioning x/was talking differently wasn't able to talk normally in room w/room-mate;sl strange feeling next day
Sore throat, hoarseness, hives, cough. Treatment: Benadryl
A non-serious spontaneous report of flu-like symptoms has been received from a physician concerning a nine-year-old male, subsequent to FLUMIST. Medical history and concomitant medications were not reported. The patient received FLUMIST on 07-Oct-2009. On 12-Oct-2009 the patient returned to the clinic reporting flu-like symptoms of fever of 101 F, cough, chills, and stomach ache. The patient has not received any treatment. The outcome of the event is unknown.
10 days after vaccine, papules appeared on limbs, 9 in total. Appetite decreased. Used vitamins to boost immune system. Feeling better. Lesions improving.
dose administered from a vial that was greater then 12 hours post puncture at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature). On 07-Oct-2021, PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Pharmacist was unable to provide that at time of call if this was each patients first or second dose.   This case was linked to MOD-2021-354712, MOD-2021-354432, MOD-2021-354517 (Patient Link).
Patient became dizzy, clammy and was having trouble walking.  Had patient lie on the floor for about 5 minutes and was feeling better.  He then sat in a chair for about 15 minutes and felt fine to leave.
Symptoms began with nausea, soreness at the injection site, and malaise. Six hours after the injection, I developed a global headache, body aches, fatigue, and a low-grade fever.
3 hours after vaccine I got diarrhea one time only. maybe about 8 hours later injection site was very mild discomfort. Next day I was tired all day. All symptoms were over after 2 days.
The patient is a minor and has a history of Keloid Scarring. The patient was administered the monkeypox Jynneos vaccine intradermal of 0.1 mL, instead of receiving the CDC guidelines for individuals younger than 18 years of age which is 0.5 mL dosage with route of subcutaneous.
Pruritic rash on trunk and proximal arms; anterior cervical lymphadenopathy; throat irritation with oropharyngeal erythema.
redness at injection site; pain in left arm and hand/ pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and pain in extremity. On an unknown date, the outcome of the injection site erythema and pain in extremity were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and pain in extremity to be related to Shingrix.  Additional details were provided as follows: After receiving the first dose of Shingrix on left deltoid, the patient returned to the pharmacy the next day and reported to his pharmacist that he was experiencing pain and redness that has radiated from the injection site down to the bicep and hand.
Under the age required for the vaccine. Was given the second dose of Moderna as it was not an option to switch between MRNA vaccinations at the time of administration.
More prolonged periods of bilateral tinnitus; vertigo; occasional nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8732) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "known allergies: PN" (unspecified if ongoing); "Adhesive allergy" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; ESCITALOPRAM; TEMAZEPAM; VIT D [COLECALCIFEROL]; VIT C; CALCI [CALCIUM CARBONATE]. Past drug history included: Bactrim ds, reaction(s): "allergy"; Claritin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6205, vaccine location: Left arm), administration date: 09Mar2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Bilateral intermittent tinnitus, ranges from low hum to high screech". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "More prolonged periods of bilateral tinnitus"; VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "vertigo"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "occasional nausea". It was unknown if therapeutic measures were taken as a result of tinnitus, vertigo, nausea.  Additional Information: The facility where the most recent COVID-19 vaccine was administered was reported to be "other". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Events did not result to death, was life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Since vaccination, the patient has not been tested for COVID-19. Primary care physician has been notified.  No follow-up attempts are possible. No further information is expected.
Smallpox vaccination on 02/08/2003.  By 02/20/2003, red, blister, itch, scab.  States tender "cold" Took DayQuil x 4 days.  No further complaining of problems.  On 03/13/2003-dry put in the min on blister.  Called clinic to give cream.  On 06/07/2003 complained of dry rash, no blisters.  Referred to MD on 06/08/2003.  MD stated not related to SP vaccine.
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a 28 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known prior issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died after vaccination from unknown cause of death. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211154617.; Sender's Comments: V0: 20211154559-Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH