chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gross hematuria resulting in blood clots in the bladder that blocked the urethra.(Note: on 29 April I did about 2 hours of lifting bags of topsoil, pushing wheel barrow and digging holes for plants. No hematuria until the morning of 30 April.)  RN and doctor at ER could not insert catheter into bladder. Transferred to Medical Center on 1 May. In ER there Dr, urologist tried 3 different catheters with no success. Taken to OR where catheter was successfully inserted. Cystoscopy revealed bleeding from prostrate. Was hospitalized for 5 days because bleeding would not stop.
Patient got the 1st dose of Pfizer vaccine at 1:58 pm on 5/6/21. Patient felt slightly dizzy about 3 minutes after getting the vaccine. Then he passed out and fell on the floor with seizure for about 5 seconds. He regain conscious and said he didn't remember anything. He also said his stomach felt upset. Later he felt chest tightness and blurry vision. We called 911 at 2:02 pm. They came in at 2:07 pm. They checked the patient's blood pressure. Patient had low blood pressure. He was sweating and felt hot. He didn't eat or drink anything before getting the vaccine. They transferred him to the emergency room for further check-up.
A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 11-Sep-2012. The patient experienced FLUMIST ADMINISTERED TO 22 MONTH-OLD which started on 11-Sep-2012. The outcome of event of FLUMIST ADMINISTERED TO 22 MONTH-OLD is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 23-Oct-2012: reporter page, administration date, event onset date were corrected, manufacturer name added.
Received Influenza and MMR vaccines on 9/20/18 at 0739 and 0738 and states on Saturday 9/22 started having a pinpoint rash on her left anticubital space. States on Sunday when she woke up had rash to both arms, thighs and hips. Rash itches. Today starting  to go up  her neck also. Started using Benadryl Cream Sunday night and then has used daily. Started Benadryl 50 mg PO at bedtime last night 9/27. Today the rash is going up her neck, on both arms, thighs and stomach.
My face and lips were tingling before I even made the full drive home. Within an hour I had one give. A few hours later my face was covered in hives. The next morning my face had more hives so did my upper back and the itching was unbearable.
she is pregnant as well; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020/tested positive for COVID-19; This is spontaneous report from a contactable Other Health Professional (patient) via a Pfizer Sponsored Program. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right deltoid on 23Dec2020 14:30 at single dose for COVID-19 vaccination while pregnant.  Medical history was none. Concomitant medication included ongoing ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin b12 nos, zinc oxide (PRENATAL MULTIVITAMIN + DHA, Prenatal Multi + DHA), one soft gel, every morning as prenatal medication. The reporter was asking for recommendations for her in taking the second dose as she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020. She received the first dose of the vaccine last 23Dec2020. She is asking if she should wait 90 days before taking the 2nd dose. Agent has a physical therapist on the phone. She had her first dose of the COVID vaccine on 23Dec2020. She started to show symptoms of COVID on 31Dec2020. She tested positive on 01Jan2020. Caller wants to know does she need to wait 90 days for the second dose. Caller wanted to add she is pregnant as well. She declined to include a healthcare professional for the report. The caller states she started to feel symptoms towards the end of the day on 31Dec2020. She clarifies she felt like she was having a cold coming on. She had some congestion. When probed for outcome, caller stated it had improved quite a bit. She had been improved but today, its kind of like she had a cold again, but that had improved. Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Prior Vaccinations (within 4 weeks): None within 4 weeks. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Relevant Tests: None. Investigation Assessment: Yes. Is a sample of the product available to be returned, if requested (Y/N): Vaccine was administered in hospital. No AE required a visit to emergency room and physician office.  The reporter stated her symptoms have been pretty mild. The patient underwent lab tests and procedures which included COVID Fast-acting (rapid) test: positive on 01Jan2021. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded
Had shots twice, still had shingles / Suspected vaccination Failure; still had shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shots twice, still had shingles / Suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had shingles 3 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by the patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Increased symptoms of seasonal rhinitis every year after receiving FluMist vaccine. Treatment with Perscription Zyrtec effective.
she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "she had a tiny bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: The patient already took the primary series and two booster shots from Pfizer and scheduled for the fifth shot. The patient been hearing reports that Pfizer and Moderna are planning on working with boosters that contain flu shots as well. The patient is suggesting that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200098882 same patient and event, different dose;
Covid arm occurred 7th day Itching, slight swelling  and redness in 2? diameter circle, at injection site,  very warm to touch,  no pain Went away completely after 3 days.
VACCINE TEMPERATURE EXCRUSION FROM 3.1 C TO 0.77 C TO 3.0 C WITHIN 30 MINUTES; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes, and incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes and incorrect product storage was not reported. This report was non-serious.
Pt recvd vax in 1983 & approx 1988 following return to US was dx w/breast cancer & was treated w/chemotherapy; lab eval on 23JUL93 revealed that pt was anti-HBs neg; addtl details are being requested;
4 hrs after vaccine administered my palms, bottom of feet and neck became red, itchy and swollen. Contacted primary care physician who ordered steroids. Within 30 hrs all symptoms were gone. Symptoms did not get worse after I started steroids which I had on hand from prior use for asthma. Joint pains, swelling have started since vaccines.
1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 13-Apr-2022, expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   One of COVID providers gave doses of Moderna COVID-19 vaccine after expiration of 4/2/22. They were properly stored the entire duration of time on site. The vaccines were removed from the freezer on the day of each respective immunization. No concomitant medication were given. No treatment information were given.
I developed symptoms of sore throat. I took a COVID-19 test and it was negative then I took 2 more the next day that was positive. My symptoms progressed to post nasal drip, congestion, cough. These lasted 5-6 days and now it has gotten some better.
I had sore throat, lethargic, chills, very inflamed nasal passages and ears. Vomited before getting on a flight. Went to see a doctor who recommended that I had the beginnings of an ear infection and to test self for COVID-19 in a further couple of days. The doctor prescribed amoxiclav for the infection. About 2 days later, I tested positive for COVID-19 on an at home COVID-19 test. I just stayed in quarantine, resting and drinking liquids. I still have a great deal of head congestion and have an appointment for an ENT 5/2, after the time of reporting.
20 year old white male received first Anthrax vaccine in 3/19/2004. Patient developed malaise, muscle aches, nausea 3/21/04.
Patient describes feeling bad and developing a red band around her arm. She had a Pneumonia and Flu shot at same time and does not remember which shot was given in the red arm. She then developed a fever of 102.5 that lasted approximately 1 to 2 days.
Patient returned minutes after complaining of SOB. Administered (1) dose of Epinephrine (EPIPEN) to (L) outer thigh area. Breathing improved.
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: dose 1-day 1 arm swelling/discomfort/ up to 14 d muscleache/ fatigue dose 2-arm swelling/pain; fever, chills,  restlessness, general malaise, body aches, fatigue, nausea, vomiting, weakness and joint pain.
I had it was hard for me to breathe, pain in her chest that went to her back; Problems walking and asthma flare ups
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: F51611) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pulmonary sequestration" (unspecified if ongoing); "Ovarian cysts" (unspecified if ongoing). Concomitant medication(s) included: PNEUMOCOCCAL 13 VALENT VACCINE, administration date 29Oct2021; ALLEGRA; JUNEL FE 1/20; VITAMIN D2. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM, No Events reported), administration date: 31Mar2021, when the patient was 28 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:30 AM), administration date: 22Apr2021, when the patient was 28 years old, for COVID-19 Immunization, reaction(s): "Began to have hives after 2nd dose". The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:30, outcome "unknown", described as "Booster"; URTICARIA (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "Hours after 3rd dose, began to see hives again, on arm, face, chest."; PRURITUS (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "A little itchy but not serious". Therapeutic measures were not taken as a result of urticaria, pruritus. Additional information;    Addition information:  Prior to vaccination, was the patient diagnosed with COVID-19, Since the vaccination, has the patient been tested for COVID-19. Results in death, life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect: was non serious.   Follow-up attempts are completed. No further information is expected.
Tired, achy leg muscles, cold last night. Shot site swollen and painful to touch. No pain relief taken.
My arm was sore for a couple of days but later that month my body started hurting real bad and I couldn't really walk or move. I was hurting in my ankles, my shoulder bones and my elbows. So I looked it over as arthritis but its never hurt like that before. I called the doctor who had me come in and gave me steroids  for inflammation. It didn't really go away so he put me on them again. I've been on them for about three or four months. Gland had swollen in my neck and had an ultrasound done on my neck to find the gland. I started to have a nose bleed off and on.
Arm sore 48 hours.  Day  4 post shot lymph nodes became very painful.  Saw Primary Care Doctor at 7 days after shot - Dr. ran blood tests, did not indicate vaccine could be the cause.  Bloodwork normal.  Day 11 (Sat Apr 3) and 12 (Sun Apr 4)  experienced cold chills and shaking about midnight.  Day 13 (Apr 5) at about 5:30 p.m. experienced cold chills and shaking and 101.5 fever - controlled by Tylenol.  Followed by sweats when Tylenol wore off over night.  Shaking lasts about 5-10 minutes, cold until heating pad applied - about 30 minutes.  Day 14 (Tue Apr 6), 15 (Wed Apr 7),  early evening chill and shakes - Tylenol stops it.  Pt. feels FINE during the day - with just sore lymph glands and some fatigue.   There has been only one episode of chills/shaking per day, always in the evening.  Experienced sweats overnight only on Day 13 and 15, so far.  Symptoms are alarming, and uncomfortable at night.  Daytime symptoms of fatigue and sore lymph nodes do not impair daily activities.  He continues to take Tylenol as needed.
office manager that called to report a temperature excursion for V ARlV AX and states that it was administered to a patient; No additional AE; This spontaneous non-valid report was received from an office manager and refers to an unknown patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #T014309, expiration date: 24-APR-2022) (dose and route of administration were not reported) for prophylaxis. The vaccine experienced the temperature excursion of 9 degrees Celsius for 1 hour. Previous temperature excursion was reported as between 6 Fahrenheit degrees (F) to 14 F for 6 minutes, between 6 F to 14 F for 1 minute and from 6 F to 14 F for 1 minute. The event was reported due to digital data logger. The reporter did not have the patient information and was not sure exactly when it was administered. More information would follow. No additional adverse event (AE) was reported.  This case is considered non-valid due to no patient's identifiers.
JanssenCOVID-19Vaccine - Reported i have allergies, some anaphllaxis tosome food and drug.,  consulted with a Dr. on site before injection.  waited 30 and was dismissed.  I commented to my son I we drove off that my tongue felt dry. but no swelling.  later in the afternoon my tongue continued to concern me. it felt hot and tip was red.(note felt as if I had burnt it with a very hot drink. Day 2 it continued, 8 am I took Tylenal and 11:30am Benafryl. 4:30 pm called Dr. office, Call 911 , 5:00pm taken to ER.  Dr. on call Check my throat and tongue.was given  4mg. MethyIprednisolone. sent home.  Day 8, still have a slight feeling of dry tongue.
ROTARIX was diluted with sterile water; ROTARIX was diluted with sterile water; Injected IM into the Right Vastus Lateralis; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number YH345, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 16th June 2022, the patient received Rotarix lyophilized formulation (intramuscular) .5 ml and Rotarix Oral Applicator Device. On 16th June 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and wrong route of administration. On an unknown date, the outcome of the inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and wrong route of administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's comment: The reporter was a Medical Assistant stating that Rotarix was diluted with sterile water, then injected into the right vastus lateralis of the patient. The amount injected was 0.5 ml, the entire dose of the vaccine was administered per the reporter. No other adverse events were noted at the time of the call.  The reporter consented to follow up. Additional Supportive Information: The patient received Rotarix diluted with sterile water via intramuscular route, which led to inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and wrong route of administration.
Information has been received from a physician concerning a female pharmacist of unknown age who was a friend of the physician. The pharmacist had no concomitant medication, medical history and drug allergy. On 16-JUN-2017, the pharmacist was administering a dose of ZOSTAVAX to an unknown patient (route, lot# and expiry date were unknown) for routine vaccine, when some of the ZOSTAVAX squirted in the eye of the pharmacist. She had "pain in her eye" lasting for 5 minutes after the ZOSTAVAX squirted in her eye. The physician reported that she instructed the pharmacist to "flush her eye with water." And the pharmacist had fully recovered. Causality was not reported. The physician was unaware if the patient received the full dose of ZOSTAVAX (captured in a case MARRS# 1707USA001054).; Sender's Comments: US-009507513-1707USA001054:
Nurse, brought to attention that client was under 18 years old and had received one dose of MODERNA. Consulted with clinic supervisor regarding situation and whether to administer the second dose in the series. Per CDC guidance and clinic supervisor, second dose in the series was to be administered. Mother and child signed the consent form and were informed of situation, and online CDC guidance regarding situation was reviewed. Side effects and importance of waiting the 15 minutes was also reviewed. Second dose was administered. Child tolerated vaccine without any incident.
Thurs 12/17 :  aching in left arm infection site.          Later evening : ?flu-like ? symptoms Fri 12/18 :  04:30 am : vomiting , headache,              Started work at 06:00 am.  - continued nausea, chills/ warmth ( but no fever)      Around 1:00 -small pupils ( but dilating) , increased weakness, & dizziness begins.  No appetite.    Slept all evening. All vitals normal range. Took 2 capsules (200 mg) q 6 hr. Sat Dec. 20 : weakness in am . Increased appetite.
fever > 106 X 40 min , irritable.  APAP/hydration
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 19-JUN-2016 at around 18:05 the patient was vaccinated with a dose of M-M-R II (lot# M001200, expiration date 28-AUG-2016, therapy type rHA) subcutaneously. No adverse effects were reported. Temperature information was as follows: Last known time in correct storage range was on 19-JUN-2016 at 14:00 (24-hour clock). The refrigerator reached a high of 49 degrees Fahrenheit at the time that the dose of M-M-R II was removed from the refrigerator, which was on 19-JUN-2016 "around 18:00" (24 hour clock). The dose was administered to the patient "5 minutes later" (room temperature where the dose was administered was estimated to be at "around 73 degrees Fahrenheit"). Additional information has been requested.