chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a office manager, via a company representative, referring to a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. Approximately in 2013 (reported as about 3 years ago), the patient developed shingles. The outcome of herpes zoster was unknown at the time of this report. The reporter did not provide a causality assessment between the event and therapy with ZOSTAVAX. Additional information has been requested.
Rash & itching over body, swollen face 9:41 AM injection was given, Mom called at 1:13 PM with pt's sx's - she was in call instructed to go to ER or call 911.
The patient fainted after 5 mins of getting the shot. he got back to consciousness in 2mins back.
Hospitalization 01/08/22-1/27/22 for COVID19, pneumonia, hypoxemia. Treated with baricitinib, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
Client had complaint of whelps after leaving clinic, itching, and rash covering body. Continues to have flares of whelps and itching rash.
2 days after immunizations of DTaP and IPV, right arm (upper arm) extremely swollen. Ice compresses (from elbow to shoulder).
Fever, chills, headache,  body aches, numbness and tingly feeling in all finger tips
I received my 1st shot in right arm. 3 days later and I've lost more than 50 percent of my strength in that arm to include shoulder. I have zero pain just no strength on my right side; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Oct2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 04Oct2021 at 07:00, 3 days after vaccination, the patient had lost more than 50 percent of his strength in that arm to include shoulder. The patient had zero pain just no strength on his right side. It has been 7 days and no improvement to his right arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost more than 50 percent of his strength in that arm to include shoulder and had zero pain just no strength on his right side was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient came to ED with dizziness, shortness of breath, and cough.  Patient admitted to hospital given his risk factors and comorbidities for Covid complications and treated with remdesivir.
09/16/15-mild, redness at site of vaccination. 09/17/15-thigh and knee got swollen and red to twice the size and this lasted x 48 hours-no fever, mild limping.
This literature marketed information has been received from a published literature article and refers to a 4-year-old boy with known pork allergy, with suspected gelatin allergy. The patient developed on an unspecified date in approximately 2014, disseminated erythematous rash with itching, aching, facial swelling and emesis after vaccination with M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccinations included DTaP/IPV. At the time of reporting, the outcome of the events was not reported. The author considered the events as reactions associated to M-M-R II and VARIVAX. This is one of several reports from the same reporter Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012066, US-009507513-1809USA012062). Sender's Comments: US-009507513-1809USA011156.
A medical assistant did not dilute the vaccine before administering. Patient was given a dose of 0.2ml of undiluted orange cap Pfizer vaccine. Complained of injection site pain and slight sore throat.
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
On Wednesday after vaccine mid-day I started having more abdominal cramps like period cramps I haven't experienced in over 2 years since IUD placement. I also started a period and haven't had one in 2 years since IUD placed. I had some spotting off and on each month with IUD placement which was normal but this was like a period ready to use pad or tampon. Pain is off and on and I'm still dealing with it and some days I have severe cramping and its debilitating and I take ibuprofen and use a heating pad and just crawl up on couch until it passes. It's ongoing but not every day. I haven't had any bleeding since and the period stopped. I feel like I might've had heart palpitations too but I do have anxiety so I've never seen a doctor for that issue.
Nurse administered vaccine. Paramedics were on site of facility and unsure of how patient fell on floor. Patient was eventually transported to hospital. Upon talking to paramedics after clinic, they stated patient was tachycardic and hypertensive. Initial complaints of headache/dizziness.
Injection site infection; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 (at the age of 66-year-old) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was received any other medications within 2 weeks of vaccination was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was not pregnant at the time of vaccination. On an unspecified date in 2021, patient experienced injection site infection. Patient received antibiotic as treatment for event. Due to event patient visited doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of injection site infection. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial misuse information was received from a healthcare professional in on 26 Sep 2013. A 20 month old patient whose demographic details, medical history and concomitant medications were not reported received a 0.5 ml dose of FLUZONE on an unspecified date. (Batch number not reported). It was reported that on an unspecified date patient received incorrect dose of vaccination. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: none
Patient suddenly died 4 weeks after the second dose of Moderna vaccine administration on July 27, 2021.
Varicella vaccine given 7-18-09 in Left arm subcutaneous. Sat 10 minutes in office, no problmes at that time.  Mother states child had a small red circle at injection site on 7-18-09 the evening of the injection   On 7-19-09 mother states that the injection site was red and the size of a peach.  Mother states 7-20-09, arm was red and very swollen, and child had itching at the site.  States took to the doctor and was given medication to prevent pruritis, and an antibiotic.
pain in her stomach; chest pain; aching; tenderness at injection site; headache; low grade fever; Inappropriate schedule of product administration; This spontaneous report as received from a consumer referring to herself a 71- year-old female patient. Information regarding patient's medical history,drug allergies or reaccions was not provided. Patient's concomitant medications included vitamins.     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular (strength, dose, frequency, lot number and expiration date were not provided).  Other suspect therapies included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) (strength, dose, frequency, administration route, lot number and expiration date were not provided). Both as prophylaxis.   Within 24 hours from the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23),  the patient experienced headache,   tenderness at injection site (vaccination site pain), aching , chest pain, abdominal pain upper and pyrexia (low grade of 105 (units not provided)). Also the patient reported that she had pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) about 2-3 years ago and did not has problems (inappropriate schedule of product administration).   At the reporting time the patient symptoms were better .The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided..
Fatigue, achy, can not stand on own, arms are swelling, can not raise arms, knee caps are swelling with a large knot.
The same day, my sinuses closed up and I had body aches and my hands hurt really bad. The next day, I still had the body aches, but also got a bad cough, and developed a temperature of 99.5 degrees.
Headache, Fever, fatigue, body aches, and chills. Narrative:  with c/o fatigue, body aches, chills and headaches. further endorsed symptoms subsiding at that time. encouraged to call 911 or evaluation by ED.
Covid Positive on 01/26/2022.  Presented to ED 02/03/2022 with complaints of SOB.  Pulse Ox on room air was 66%.  Diagnosed with Covid PNA. The patient was admitted and was given supplemental oxygen as well as started on COVIDo 19 therapeutics. The patient's oxygen requirements increased to BiPAP and patient became altered. The family elected to make the patient DNR/DNI secondary to her significant medical comorbidities and non-Hodgkin's lymphoma currently undergoing chemotherapy. The family ultimately decided as the patient's altered mental status continued for comfort measures. Comfort rnMsuros were put in place. The patient died subsequently. Patient died on 02/15/2022 with cardiopulmonary cessation d/t Covid-19.
Patient received 1st dose 18 days before he turned 18 years old.  Patient and mom reported that he was 18 years old since in their country he is considered 18 years of age in the birthday month.  Patient and mom gave consent for the vaccine.  Patient does not have symptoms or health concerns at this time.
Breakthrough case after three vaccines  pfizer 3/25/21  Lot# ER8727;  Pfizer 4/15/21 Lot# EW0158;  Pfizer 12/14/21 Lot# FE3594
Arm pain, fatigue and red rash at injection site for 1st three days; On 6th day, itching and small bumps at injection site,
c/o: dizziness, lightheaded, felt faint History of same symptom with venipuncture BP: 67/39, 74/44, 66/41 P: 60 Sp02: 99% Symptomatic hypotension, patient transported to ER by EMS
Patient received Varicella vaccine on 10/26/11 at 7:58am. Patient noticed very large red lump at site of injection next morning while taking a shower. 5 1/2 cm x 4 cm.
pt recv vax; rash, papules w/ pustules on back & chest appeared approx 2 hr p/ vax;
Localized 8x9cm erythematous area at site of injection within 8 hours of administration.
I had Sinus Tachycardia, which I've never had before to my knowledge.  I actually didn't even think about the vaccination as being related and am still not convinced it was, but when I did my weekly V-Safe check-in, that is when I thought maybe I should report it.   Friday evening Oct 7, I noticed my heartbeat, which caused me to look at my Fitbit, and for the next 15 hrs or so, my heart rate stayed mostly between 100-130.  That has never happened to me, I usually have an RHR of 60.  No sleep that night and the next morning, when it didn't subside, I called the Nurseline, and after extensive questioning, the nurse said I should go to the ER.  I was on vacation, and my friend took me.  I was there four hours, and all likely causes that would kill me were eliminated, so when I thought back on that, as I was doing my V-Safe check-in, that's when I decided I should report it.  I seem to be back to normal now.   Over the course of the next 24 hrs after being released from the ER, my heart rate started coming back down to normal.  I think I've been okay since.
A report received from a health professional on 01Nov02 concerning a 23 year old female vaccinee who experienced soreness and erythema at the injection site on the same day she received Fluvirin on 30Oct02. On 30Oct02, the pt experienced soreness and erythema, 1.5 inches in diameter, at the injection site. The pt has had no prior influenza vaccination and has no history of egg allergy. At the time of reporting the pt had not yet recovered. The reporter has assessed the relationship of the vaccine to the event as probable.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
Patient was given injection and 10 min after started itching and throat closing. Patient received epi, Benadryl, nebulizers all within 30min was transported to ER due to not getting better.
Mild Skin Rash on chest and neck, developed less than 24 hours after injection.
Vaccine received at 4:40 p.m. on 03/11/21. Chills started at 2:00 a.m. the following day lasting about an hour. Then fever and hot sweats started around 3:00 a.m. Fever was 100.3 f in the early morning and then 102.2 around 9:30 a.m. on 03/12/21. Headache and some nausea in the a.m. of 03/12/21 and continued until this writing (03:45 p.m.). Current temperature is 99.4.
Patient was given 3rd dose of COVID vaccine. Patient was bring down by facility staff to get COVID vaccine. Patient already received 2 dose of Moderna COVID vaccine but due to improper organization at facility and record keeping; pharmacist doesn't realize that patient was receiving third dose. Upon further evaluation we figured out that patient got third dose of COVID Moderna Vaccine. We immediately called and informed facility staff. Patient is monitored for vitals every 2 hours. No adverse event reported until now.
Myalgia, RespDepression, Angina, pain at the spine to the left side neck pain Narrative:
Patients were given shots during excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions.). On 11-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter. No treatment information provided by the reporter.   This case was linked to MOD-2021-423303 (Patient Link).
5-7 days after receiving my 2nd dose of the vaccine, I began experiencing some very unusual and concerning chest pain on only the left side of my chest and what felt like a few instances of a "fluttering" heartbeat that lasted for a little over 72 hours. I have NEVER had any symptoms like this before, even after my first vaccine dose, but my mother and two of my siblings did have fairly severe reactions to their first dose so that may be useful background info. I started taking some aspirin at regular intervals for a few days just to play it safe in case what I was feeling was indeed myocarditis/pericarditis, but after about 4 days (around 18 October) I was feeling back to normal and no longer having any symptoms.
This spontaneous report was received from a 59 years old female consumer reporting on herself with allergy to penicillin and who on 11-JAN-2012, was vaccinated in her left arm with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included CRESTOR and LUNESTA. The consumer reported that on 11-JAN-2012, she experienced an injection site reaction after receiving ZOSTAVAX. The consumer stated the injection site on her left arm was red, hot, itchy and painful and she had a rash from her elbow to her under arm. BENADRYL was given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for injection site on her left arm was red, patient had a rash from her elbow to her under arm, injection site on her left arm was painful, itchy and injection site on her left arm was hot was unknown for ZOSTAVAX. Additional information has been requested.
approx 1 1/2 hr p/vax pt started w/crying which lasted approx 4 1/2 hr non-stop; fussy all noc; temp started next day 101-102 which lasted until early afternoon; By 3rd day  alright;
Rash started on 9/24/11; location - face, abdomen and all 4 extremities; itchy; mom with same rash. -> NP; raised vesicles and smaller papules.
BODY ACHE; MUSCLES GETTING LOOSE; WEIGHT GAIN; BODY ACCUMULATING FATS; BODY PRODUCING LESS SEMEN; FEVER; COLD; FLU; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 140 pounds, and height was 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 not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced flu. On an unspecified date, the subject experienced body ache, muscles getting loose, weight gain, body accumulating fats, body producing less semen, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fever, and had not recovered from cold, flu, muscles getting loose, weight gain, body accumulating fats, and body producing less semen. This report was non-serious.
Information has been received concerning an 11 year old male who on 24-JUL-2007 was vaccinated subcutaneously in the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot#654282/0776U). On 26-JUL-2007, the patient developed a red and swollen injection site. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
104.5 fever; Chills; Nausea; shaking/ trembling; cough (severe); loss of bladder control; joint pains; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 12:00 PM (Lot number: FC3180) at the age of 71 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies: codeine", notes: Allergies: codeine; Myocin chain drugs, reaction(s): "Allergies: myocin chain drugs", notes: Allergies: zinc; Zinc, reaction(s): "Allergies: zinc". The following information was reported: PYREXIA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "104.5 fever"; CHILLS (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "Nausea"; TREMOR (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "shaking/ trembling"; COUGH (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "cough (severe)"; URINARY INCONTINENCE (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "loss of bladder control"; ARTHRALGIA (non-serious) with onset 18Aug2021 01:00, outcome "unknown", described as "joint pains"; FATIGUE (non-serious) with onset 18Aug2021, outcome "unknown", described as "exhaustion". The events "104.5 fever", "chills", "nausea", "shaking/ trembling", "cough (severe)", "loss of bladder control", "joint pains" and "exhaustion" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pyrexia, chills, nausea, tremor, cough, urinary incontinence, arthralgia, fatigue. Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient did not receive other medications in two weeks of covid-19 vaccine. The patient had Covid prior vaccination and did not get tested for Covid-19 post vaccination.  Follow-up attempts are completed. No further information is expected.