chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via filed representative refers to a male patient of unknown age who was also a physician. on unspecified date in April 2014, "about one month ago", the patient was vaccinated with a dose of ZOSTAVAX (injection, strength, lot#, dose, route and duration were unspecified. On an unspecified date in 2014 the patient developed cellulitis at injection site. Patient had sought unspecified medical attention. He was treated with unspecified antibiotic therapy. Unknown of event resolved. Additional information has been requested.
Inadvertent temperature excursion, vaccine was stored in freezer temperatures (-50° C to -15° C)   beyond the allowable two-week excursion then administered to patient.  No patient issue to report from vaccine.
sweating, irritable, crying, swollen inj site, hard to console;pt sent to sleep 2AM & was found 4AM dead;paramedics tried to revive pt;pt was taken to hosp but all attempts to revive pt were fruitless approx 16hr p/vax;
Increased redness swelling and warmth to area of vaccine administered on 8/20/13 requiring evaluation. Treated with Medrol dose pak.
Sxs began as localized swelling, increased warmth of Lt. deltoid, aching pain of Lt.upper arm, the Lt. shoulder/neck pain, stiffness, mild headache, nausea, mild dizziness/lightheadedness, then extreme fatigue, lethargy, persistent nausea, myalgias, slept over 12 hrs. last evening until this morning, feel very tired, as if I had not slept or cannot fully awaken, nor feel refreshed after sleeping, no other GI sxs, no fever, but feel warm.
Vertigo ,severe dizziness, Can not walk straight, fell 4 times . Had MRI MRA. visited ENT <Neualogist They found nothing to cause dizziness . Also blurred vision , headache. At witts end. Citizens should know of this adverse reaction
Went hiking and got a blood clot; beyond 36 days since first dose without receiving second dose; Interfered with work; Glands got super swollen; Trunk Rash; Excruciating headaches for three days; Extremely fatigued; High temperature; Nauseous; Ringing in ears; Taste buds changed; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went hiking and got a blood clot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Grover's disease. Concurrent medical conditions included Allergy NOS (allergies for which she has an epi pen) and Premenopausal symptoms (Rashes with premenopausal condition).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous). On 30-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose). On 01-May-2021, the patient experienced THROMBOSIS (Went hiking and got a blood clot) (seriousness criterion medically significant). On 30-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose) had resolved. At the time of the report, THROMBOSIS (Went hiking and got a blood clot), TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided. Company Comment  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of rash, fatigue, pyrexia, lymphadenopathy and headache.
Dizziness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.   A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (right arm shoulder-pending clarification) on 17Jan2021 at singe dose for Covid-19 immunization. The patient's medical history included high blood pressure. There were no concomitant medications. It was reported that the patient got the shot on Sunday (17Jan2021) along with her husband. All of the sudden she was getting dizzy, otherwise they had no problem. She even made a second appointment. The dizziness started today (19Jan2021), a couple hours ago. It concerned the patient. She thought maybe because she didn't eat breakfast, but she ate and that hasn't helped. She would like to know if dizziness is a side effect because she really doesn't want to go to the hospital. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061667 same reporter/drug/event and different patients.
include headache, sore throat, cough, chills, body aches, diarrhea, ear pain, nasal congestion. starting 1/16/2022
Given ROTATEQ vaccine po 12/15/08, on 12/17/08 started with excessive crying, sent to hospital ER, KUB showed ileocolic intussusception, contrast enema performed which reduced intussusception.  1/12/09 Reviewed hospital medical records of 12/17-12/18/2008. FINAL DX: Intussusception, enema reduced Records reveal patient experienced cramping abdominal pain, excessive crying.  Admitted for overnight observation s/p enema reduction.  Progressed well & D/C to home in AM.
Inflamed; Ankle pain/knee pain; Swollen; This case was reported by a physician via call center representative and described the occurrence of joint inflammation in a adult patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 30th April 2021) for prophylaxis.   Concomitant products included cefalexin (Keflex).   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced joint inflammation, pain ankle and swelling. On an unknown date, the outcome of the joint inflammation, pain ankle and swelling were unknown.   It was unknown if the reporter considered the joint inflammation, pain ankle and swelling to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix experienced the rare side effect of ankle, knee, joint pain with inflammation and swelling. No additional details were provided. The reporter refused to provide more data and referred to the patient's physician.
pt recv vax 16MAY96 & the next day pt exp diarrhea, nausea, weakness chills & joint aches;
administered Fluzone Quadrivalent into the gluteal of an adult female/no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient (age not reported) who was vaccinated with vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled Syringe  0.5 ml (lot UJ295AA and expiry date: 30-Jun-2020) via intramuscular route in administration gluteal site on 02 Dec 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Vaccine administered at inappropriate site. It was reported that new employee accidentally administered Fluzone Quadrivalent into the gluteal of an adult female patient.  At the time of reporting, 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.
6 DAYS AFTER THE MMR VACCINE, PT'S LEFT SIDE OF HIS FACE AND NECK BECAME SWOLLEN.  I COULD TELL HE HAD A VERY LARGE LUMP IN HIS NECK.  I TOOK HIM TO THE DR'S OFFICE ON THURSDAY SEPTEMBER 4TH, AND THEY TOLD ME THAT THIS WAS NOT DUE TO THE SHOT, THAT THE LUMP WAS TOO LOW AND BECAUSE HE WAS NOT RUNNING FEVER AND IT DID NOT HURT HIM THEY BELIEVED THAT IT WAS A "MASS" IN HIS NECK THAT WAS ALWAYS THERE AND THAT IT FINALLY BECAME LARGE ENOUGH FOR US TO NOTICE.  I THOUGHT THAT WAS ODD SINCE I HAVE BROUGHT HIM IN OTHER TIMES AND THEY NEVER NOTICED "A LUMP" THERE BEFORE.  I NEVER NOTICED A LUMP AND I'M ALWAYS CHECKING HIS EARS AND NECK. THEY ORDERED BLOOD ON THURSDAY AND AN ULTRA SOUND ON FRIDAY.  I WAS TOLD THAT THEY WOULD HAVE THE RESULTS ON MONDAY SEPTEMBER 8TH. PT STARTED RUNNING FEVER OR ABOUT 102.6 ON FRIDAY SEPTEMBER 5TH AND FEVER OF 101 ON SATURDAY.  SUNDAY THE SWELLING STARTED GOING DOWN AND MONDAY WE COULD BARELY SEE THE LUMP IN HIS NECK.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases:  A0756483A - A0756528A, A0756530A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Hello. I had a localized rash at the injection site day after vaccine administration. The next day the rash increased in size to approximately 2.5 inches by 2.5 inches with swelling surrounding the area. Call place to pharmacy who advised antihistamine administration. Rash not gone by day 4 post vaccine but has not gotten worse.
Anaphylaxis, Urticaria  Patient was transferred to the Emergency Room @ 14:14 via EMS,After 1st vaccination patient experienced tingling of the tongue. After 3 mins of observation patient began to have hives around her neck. Epi was given 14:07 lot# 9fm640. Exp apr 2021  Vital Anaphylaxis
No adverse reaction. Pt 17 yo, was given dose #1 off- label initially with parental consent and consent of the patient as he was almost 18 y/o. First dose of moderna  given on April 08 2021. He also will be working in a public facing position as a lifeguard for  the public pool. He had no significant adverse events with the first vaccine. VAERS report for deviation was subsequently entered. The second dose of moderna was administering on 27 May 2021 per current CDC recommendations. This is why the VAERS is being completed. So far, no reports of any adverse  reactions to the vaccine from patient patient.
Injection site: Red, Hot, swollen, painful. Flu like symptoms- full body ache, fever, chills, severe fatigue. Unable to perform daily activities 3 days. Missed work. Took TYLENOL 1 gm. Q 6 hrs. for 3 days.
20-30 hours post vaccine developed hive on face, then abdomen & chest. This was after 50mg Diphenhydramine administered. Sandpaper rash 48 hrs post vaccine
Dose 1 - Itching and lightheaded. Developed palpitations 10 min after receiving vaccine RRT called -> pt taken to ED (Emergency Dept) Tx: benadryl, EKG 2nd injection received 1/11/2021 - No adverse reaction
This spontaneous report was received from a male patient of unknown age, was reporting on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date one month after the vaccination, the patient experienced pruritus. The outcome of pruritus was reported as not recovered by the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there were no contact details provided.
I woke up at 3:10am and had severe chills and a fever of 102°F. My fever didn?t go down to 99° until 11 hours later. The following day I was really shaky and dizzy. I had to take off two days from work then went to work on Friday and was weak and exhausted all day.
GOT REALLY SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got really sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got really sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220105023 and 20220105183.
Patient received the vaccine on 9/7/19 and started getting chills that evening.  The next morning the patient noticed painful welts on arms and a lump around the injection site.  Patient has been lathargic the following the 5 days.  The pharmacy left a message with the patient physician to make them aware of the fact that patient and the physician followed up with the patient.
This 29 year old patient was given Fluad (a high dose flu shot for elderly patients). No symptoms at the time of the injection.
Sudden onset of muscle weakness in legs. Unable to walk without support.  Developed severe neuropathy. Still having trouble walking and severe neuropathy pain after 3 1/2 months.
One day after first dose she had pink urine that changed to dark red over next couple of days. Treated for presumed UTI with Bactrim and symptoms resolved. Next day after second dose she had pink urine, chills and body aches. Urine darkened to red over next two days and then resolved by 6/1/2021.
Patient reported headache and stomach ache to family doctor. Patient has appointment with doctor on 6/7/21. Patient stated that adverse effect started one week after vaccination.
Developed swelling, "size of large 50-cent piece at site of Varicella vaccination.  Deep red in color and hot to touch.  A little discomfort. That evening redness was progressing down the arm toward the elbow, still hot to touch.  No fever. Cold compresses applied. PCP suggested Benadryl, ibuprofen and warm compresses. Follow up phone to Mom on 10/06/2009 (6 days after vaccine given):  states redness and swelling "still a little there."  No fever, Bendadryl helped a lot.  Warm alternating with cold compresses applied.  Upper arm now light pink in color and swelling is "way down".  Instructed to call HCHD/PCP prn.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported for any of them. The reporter informed that on unkonwn dates, an unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB Intramuscular injection (dose number, route, anatomical location, batch/lot # and expiration date not reported). No adverse effects were reported. This is one of several reports coming from the same source. Additional information is not expected because neither the reporter nor the responsible physician wished to be contacted for further follow-up.
Patient was fine at time of injection. Patient stated he started feeling the vaccine throughout his body and that he was going to pass out. Patient passed out and came back to quickly; patient drank a bottle of water once he came to. I had the patient wait for 30 minutes in the pharmacy; he was fine at the time he left. Called back at 3:11pm; he states he is doing fine. He passed out with the first vaccination as well.
Mild breakthrough case of COVID, tested positive on Sunday; drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mild breakthrough case of COVID, tested positive on Sunday) and DRUG INEFFECTIVE (drug ineffective) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J22A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced COVID-19 (Mild breakthrough case of COVID, tested positive on Sunday) and DRUG INEFFECTIVE (drug ineffective). On 14-Nov-2021, DRUG INEFFECTIVE (drug ineffective) had resolved. At the time of the report, COVID-19 (Mild breakthrough case of COVID, tested positive on Sunday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient started having symptoms 4 days ago and tested positive on Sunday. He had no treatment or hospitalization. No concomitant medications was reported. No treatment drug details was reported.  Company Comment: This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19; drug ineffective was considered as an additional event. The event occurred 9 months 26 days after the first dose of mRNA-1273 vaccine and 8 months 28 days after the second dose. It was reported that no treatment or hospitalization was required. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19; drug ineffective was considered as an additional event. The event occurred 9 months 26 days after the first dose of mRNA-1273 vaccine and 8 months 28 days after the second dose. It was reported that no treatment or hospitalization was required. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Hot and swelling - shoulder to elbow with pain. 3+ days fever (101 degrees to 102 degrees)/chills. Bad headache; itching neck, face, under arm, and facial swelling. Vomited - 1x next day after shot. Fatigued, dizzy, weak following 3rd day. Used Ibuprofen B.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 13:00 as dose 5 (booster), single (lot number GH9702) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 18Feb2021 as dose 1, single (lot number EL9262), in left arm, on 20Mar2021 as dose 2, single (lot number ER2613), in left arm, as dose 3 (booster), single (lot number 30145BA), in left arm, and on 26Apr2022 as dose 4 (booster), single (lot number FK9896), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received the third booster dose on "01Oct2022" (as reported).
I began to feel very weak each day all thru the day very heavy legs could not walk well forced my steps
Information has been received from a pharmacist via Pfizer (mfr # 2017116407) referring to a patient of unknown age and gender. Information about concomitant therapy, concurrent condition and medical history was unknown. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced skin reaction after the vaccination. It was also reported that the patient experienced allergic reaction to PNEUMOVAX 23. The pharmacist was asking if there have warning or precautions regarding administration of PREVENAR 13 in patient with previous reactions to PNEUMOVAX 23. The outcome of the events was unknown. The causality assessment regarding the event "skin reaction" was unknown. The reporter considered the event "allergic reaction" to be related to PNEUMOVAX 23. The pharmacist did not provide additional information. Additional information has been requested.
Red rash on forearms and legs made up or individually identifiable round lesions. Non-itch. No fluid. Rash size varied from millimeters up to 1 cm. As of this date, rash is 90% resolved.
Pt rec'd MMR on 8MAY91; on 27MAY woke up w/swelling lt side face, around ear & neck, had sl fever, & pain; Seen by MD; Had red throat, some tenderness to area; MD dx parotitis;
Dizziness, chest pain, lightheadedness. Pt complained of dizziness approximately 15 min after vaccine sat & rested for approximately 45 min had dizziness, tightness in chest. BP 140/80 started to feel better approximately 1.5 hrs after vaccine.
Pt. reported that he was feeling light headed immediately after the vaccine and passed out momentarily.  EMT's arrived on scene and monitored patient for about 20-30 minutes.  Pt. was OK after monitoring and was fine to leave after the EMT's did their assessment.