chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received unspecified dose of vaccine and experienced anaphylaxis; This spontaneous report was received from a nurse and referring to a female patient of unknown age. The information about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history were unknown by the reporter.  On an unknown date (reported as when the patient was a child), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection as measles, mumps rubella prevention (strength, and dosage schedule were not reported, route, lot number and expiration date were unknown by the reporter). The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with Merck sterile diluent (dosage schedule, route, lot number and expiration date were not reported).  Later, the patient experienced anaphylaxis (anaphylactic reaction). The nurse stated that she had very few details of this event as it was on patient's youth. It was reported that the patient sought unspecified medical attention and received an unspecified treatment for the event. On an unknown date, the patient was recovered from anaphylactic reaction.  Furthermore, it was unknown by the reported if any laboratory diagnostic or studies were performed.   The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and anaphylactic reaction was considered as related; and between the sterile diluent and anaphylactic reaction was not provided.  The event anaphylactic reaction was considered to be life threatening by the investigator and upon internal review was considered to be medically significant.   This is one of two cases received from the same reporter
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  An male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Feb2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pretty dizzy; sore throat; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (pretty dizzy), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included WARFARIN, LISINOPRIL, ROSUVASTATIN CALCIUM (CRESTOR) and METOPROLOL for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever). On 12-Mar-2021, the patient experienced DIZZINESS (pretty dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (pretty dizzy) had not resolved and OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) outcome was unknown.
This spontaneous report was received from a Physician Assistant regarding a 4 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 15-FEB-2016, the 4 year old patient was inadvertently administered with ZOSTAVAX, 0.65 ml, subcutaneous, lot number-L036822, expiration date-24-DEC-2016, this is outside the recommendations per the prescribing information. No adverse event was reported. The outcome of event was unknown. Additional information has been requested.
Patient received vaccination at approximately 10:39. At 11:05, patient c/o headache and chest tightness. Had visible heart monitor in place. States had chest pain x one week and just increased blood pressure and diabetic medications. Provided juice. Vital signs stable throughout the episode. Monitored for approximately 30 minutes and left on own accord.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no known medical history, nor drug reaction/allergies. On 15-JAN-2015, the patient was vaccinated with PNEUMOVAX23 lot # K009107, expiration date 21-JAN-2016 (dose and route were not reported). No co-suspect and concomitant therapies were reported. On an unknown date in 2015, the patient experienced injection site pain reported as soreness and tenderness at the site of injection. The outcome of injection site pain was reported as not recovered. No treatment was given for adverse events. The patient did not seek medical attention. The causality was not reported. Additional information has been requested.
Information has been received from a consumer concerning her daughter who in approximately 2001, "9 years ago" was vaccinated with one dose of VARIVAX (Merck) (Lot#: not reported). The consumer stated that her daughter had negative varicella antibody titers 2 weeks ago, on approximately on 28-JUL-2010. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Follow up information has been received from a physician who indicated that there was no reaction. This is one of several reports received from the same source. Additional information is not expected.
Patient fainted and shook for a few seconds and then became responsive again. Gave him water and Powerade and he sat until he felt well enough to go back to work.
Fast heart beat; Felt like I slept the whole day away; Dizziness; Weak forearms and calves; Soreness of injection site, sore/weak; Tingling forearms and calves; Sore forearms and calves; Fatigue; Slight nausea; General malaise; Headache; Not too sure if I had a fever, but it definitely felt like I did.; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 30Apr2021 at 13:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included generalised anxiety disorder. The patient had known allergic to some perfumes, dyes and was lactose intolerant. The patient received concomitant medications metoprolol succinate (MANUFACTURER UNKNOWN) 25mg and Womens 1 A Day daily multivitamin (MANUFACTURER UNKNOWN) for unknown indications, from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 i.e. next day after 2nd dose at 02:00, the patient experienced intense side effects like soreness of injection site, sore/weak and tingling forearms and calves, fatigue, dizziness, slight nausea, general malaise and headache. The patient was not too sure if  had a fever (she did not have a temperature checker), but definitely felt like had fever. The day after (02May2021) was the worst of the symptoms and it persisted for an additional 3 more days. Though her symptoms did gradually decrease in severity, it was very unusual and scary for patient. The patient really did not feel well or like herself. Day one and two after 2nd dose (01May2021), the patient felt like she slept the whole day away due to which also called sick to work. The soreness in forearms and calves were usual but they felt very weak the first two days and the third and last day (at the time of this report) felt tingly. The headaches, fatigue, and malaise were there till end. Though patient was awaken this morning (05May2021) around 9 am to very fast heart beat due to which patient had to take metoprolol succinate 25mg medication early. Therapeutic measure was taken for fast heart beat which included metoprolol succinate 25mg. The clinical outcome of the event soreness of injection site, weak forearms and calves, tingling forearms and calves, sore forearms and calves site, fatigue, dizziness, slight nausea, general malaise, fever, headache, felt like slept the whole day away and fast heart beat was recovering.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 21-JUL-2014 patient received improperly stored MMR II [lot # J010993/ exp. date 09/06/2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Parents report that baby was "not himself" for about 24 hours after vaccines. He was fussy, clingy and father states he was not making good eye contact.
Vaccine was expired at time of administration, it was past the 10 weeks in fridge.  Vaccine expired on 3/30/22.  Patient has been advised that cdc recommends re-vaccination, he is thinking about it and will get back with me.
On day 10 after vaccination, my left arm had a small red spot which was warm. When I applied an ice pack for 15 minutes, the redness spread halfway down my arm. Skin started forming welts or lumps and burning sensation. Currently treating with Benadryl and cortizone cream.
Left arm was red, painful starting PM after receiving IM Influenza vaccine. Pt. also experienced nausea and vomiting.
Vision was blurred all week long; Blind; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Blind) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced BLINDNESS (Blind) (seriousness criterion medically significant). On an unknown date, the patient experienced VISION BLURRED (Vision was blurred all week long). At the time of the report, BLINDNESS (Blind) and VISION BLURRED (Vision was blurred all week long) outcome was unknown.            Concomitant medications were not reported . Treatment information was not provided.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
approx 5x4 inch red, swollen area on rt arm;area warm to touch;
Diarrhea, followed by terrible cold sensation and shaking all over. Unable to warm up. Almost asked wife to take me to Emergency Room.
body aches same day of vax, couldn't sleep, headaches, heart was racing, horrible stomach pain, vomiting, left eye became red, vision became much worse, losing vision in both eyes
Headache Local injection site cellulitis, treated by PCP with  doxycycline Narrative:   Other Relevant History:
Covid test result= Positive; Covid test result= Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 12:00 as dose 1, single (Lot number: EP7543), in left arm, on 26Apr2021 at 12:00 as dose 2, single (Lot number: ER8729), in left arm and on 08Feb2022 at 12:00 as dose 3 (booster), single (Lot number: FK9729) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Surgery" (unspecified if ongoing), notes: Surgery at 14, otherwise perfectly healthy. Normal BMI, former college athlete.; "COVID-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid test result= Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Took 20 different ones. Clinical course: Patient did not received any other vaccine in four weeks, not received other medications in two weeks  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225413 Same patient/drug, different dose/events;
I had never had any joint pain prior to the vaccine.  I take my health very seriously, eat healthily and exercise at least 5x/week.   I woke the following morning with pain in my joints - elbows, wrists, knees, hands.  The pain would  change from being in all listed joints to sometimes no pain at all within the same day.  Some days/moments the pain would be unilateral in some joints and not in others.  It was completely random.  I was seen by Dr. (Orthopedist) on 5/4/2023 for pain in my hands/wrists.  I was prescribed Prednisone for 10 days.  The pain went away completely for a couple months.  It's now 10/7/2023 and the pain has been back for months in all of the joints I listed, with the exception of my elbows.  The pain gets more severe as time goes on.
PATIENT CAME IN FOR SECOND DOSE OF PFIZER VACCINE,  BUT WAS ADMINISTERED JASSEN
This spontaneous case was received on 10-Nov-2021 from a pharmacist via Med Communications (reference number: SEQW21-05255) and concerned a 72-year-old, male patient. The patient's medical history was not reported. The patient's concomitant medications included Crestor (rosuvastatin calcium), lisinopril, Propranolol (propranolol hydrochloride) and Xanax (alprazolam), all used for an unreported indication. On 25-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left deltoid and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 312828 and expiry date was 23-Apr-2022. On the same day, after receiving Fluad Quadrivalent, the patient experienced pain in the arm. On an unspecified date in 2021, the patient went to see his doctor who put him on steroids, prednisone at a dose of 20 mg, that worked for a while, but the pain came back fairly quick. At the time of initial reporting on 10-Nov-2021, the patient had not recovered from the event. The reporter did not provide a causality assessment. The reporter assessed the case as non-serious. Company Comment: A 72-year-old, male patient was vaccinated with Fluad Quadrivalent. On the same day following vaccination, the patient experienced pain in the arm. Information regarding medical history was not provided. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: A 72-year-old, male patient was vaccinated with Fluad Quadrivalent. On the same day following vaccination, the patient experienced pain in the arm. Information regarding medical history was not provided. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
Three days after receiving the Moderna Booster, I woke up with tinnitus and a feeling of fullness in my ears. I made an appointment with my ENT doctor where the audiologist tested my hearing, which is within normal limits. The specialist has prescribed a course of prednisone to prevent subsequent hearing loss that he said has happened to some post- Covid-19 vaccinated patients with tinnitus.
Storage unit temperature excursion, vaccines deemed non viable by manufacturer: Contacting patients for re-vaccination.
This spontaneous report as received from a healthcare worker who received the information from a physician refers to a patient (referred as third unspecified child) of unknown age. About a year ago approximately in 2013 the patient was vaccinated with VARIVAX (Merck) (lot information, dose strength and dose number was not reported), via subcutaneous route. No concomitant medication was reported. About a year ago approximately in 2013 the patient developed cellulitis (hospitalization). Patient's parents sought medical attention. The patient was admitted over night to an unspecified hospital. The outcome of cellulitis was reported as recovered/resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt complained of injecting hurting when given, then around 7pm her right arm started to swell up.  The right arm swelled up from the shoulder to the fingers, pt c/o not being able to hold a pen.  The arm was painful and warm to the touch.  The incident was reported 7/30/19 around 1pm. Pt also contacted her Dr. and left a message Pt was directed to take her oxycodone for pain, keep her arm elevated and to apply the diclofenac gel to her arm.
Almost immediately after receiving influenza vaccine, pt started experiencing significant acute onset chills, nausea, shakiness, erythema and a scratchy voice. This continued to progress into SOB, wheezing, throat swelling, pruritic erythematous rash on arms, chest and abdomen in the emergency department. Initially given BENADRYL 25mg IM x 1 in the office without response, but pt became more nauseous and drowsy. At 1525 500mcg of epinephrine was administered and EMS was called, after about 10-15 minutes the erythema started to recede from the face. Vitals remained stable throughout entire clinic course. Second dose of epinephrine 500mcg was administered at 1540, with continued improvement in symptoms but did not entirely resolve. Erythema returned and began to worsen during discussion with EMS and pt was transported to the ED for further care. Additional anti-histamines and epinephrine were administered during ED course and pt was monitored overnight.
Patient requested IM injection into left buttock since she had a double Mastectomy and prefers injections in other muscle than her upper arm.
Sever vertigo has been lasting for a week after final shot. Medical provider prescribed meclizine hcl 25 mg tab
Patient states the day after shot which was given 10/1/21 she had headache, pain in the arm and fatigue, but those resolved, but about 1 week after the shot, she started getting migratory pain and dysesthesia in different parts of her body including both legs, and arms though pain and dysesthesia which consisted of burning pain, numbness and tingling migrated to different areas and continues to do so now
I had extreme skin itching all over my body for a few days after and massive migraines. This was my first vaccine and haven't had my second yet. I had to put cortisone all over and also had to keep taking Benadryl to relieve the itching. I was itching so bad til I was bleeding.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. The following is current information regarding the possible adverse reaction to the Anthrax vaccine. A military reservist  who was a orthopedic nurse (10 years). He received the Anthrax vaccine (2 doses) while overseas, approximately 30 days between doses. Approximately one month following the last dose, paralysis develops in facial area, left arm and left leg. Transferred to a hospital for evaluation of possible cerebral vascular accident. Stabilized and transferred again to another hospital. Currently being evaluated by a neurologist. I will forward any further information I receive. Please advise on your assessments and/or opinions of the possibility of this event being related to the vaccine for our records. Follow up on 4/22/91 regarding Anthrax Vaccine possible adverse reaction.  Angiogram was performed on 4/15/91. Results are as follows: From radiology, three vessel cerebral angiogram via right femoral artery performed with 60cc of dye. Both intracranial arteries and vertebral artery branches seen. No complications from procedure. Preliminary results - normal. From medical records pre-discharge, patient regaining strength.
Flu like symptoms; PAIN IN ARM; Joint pain; Body pain; CHILLS; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (PAIN IN ARM), ARTHRALGIA (Joint pain), MYALGIA (Body pain) and CHILLS (CHILLS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (PAIN IN ARM), ARTHRALGIA (Joint pain), MYALGIA (Body pain) and CHILLS (CHILLS). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (PAIN IN ARM), ARTHRALGIA (Joint pain), MYALGIA (Body pain) and CHILLS (CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Pain deep in left deltoid. Piercing pain from nerve or muscle when the arm is moved. Aching pain when arm is at rest.
patient  received 2nd dose of covid 19 vaccine at 21 days, scheduled for 28 days
Swelling and knot at injection site starting day of injection and still there as of 2/8/2019. Somewhat painful, rates 2/10 on numeric pain scale. No erythema noted at site, skin is intact, warm, dry. Able to visualize and palpate knot approx. size of quarter at injection site. States pain increases a little with palpation to injection site.