chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sick with flu-like symptoms for 4-5 days. Symptoms were headache, achiness, malaise, anorexia, temp of 100.2. Cellulitis type redness and swelling in arm where Td injection given (right) for 6 days. Size of lesion was 4-5 inches. Symptomatic treatment, Ibuprofen, heat to arm continuously. I am an RN, so didn't call anyone about it.
This spontaneous prospective pregnancy report has been received from a nurse referring to a 25 years old female patient. The patient's concurrent condition included alcohol abuse (binge drinking past weekend) ("alcohol abuse" reported as concomitant medication by reporter but processed as concurrent condition to make it more reasonable). Information about pertinent medical history or drug reaction/allergies was not reported. On 28-JAN-2019, the patient was administered the first dose of VARIVAX (lot # R011807 with expiration date of 23-APR-2020, subcutaneously in the left arm) for no immunity to varicella (prophylaxis). On 04-MAR-2019, the patient return to the office and received her second dose of VARIVAX (lot # R011807 with expiration date of 23-APR-2020, subcutaneously in the left arm). On the same day, after administration of the second dose of VARIVAX, she asked for pregnancy test which was positive (maternal exposure during pregnancy; first trimester). The last menstrual period (LMP) was reported as 21-JAN-2019. Gestation Period at Exposure was 1 week. The pregnancy outcome was pending. The present status was reported as not recovered (outcome was captured as unknown in field per internal rule). She did not seek medical attention and no treatment was given for the event. No product quality complaint (PQC) was reported.
cellulitis; Redness of legs; swelling on the legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), ERYTHEMA (Redness of legs) and PERIPHERAL SWELLING (swelling on the legs). At the time of the report, CELLULITIS (cellulitis), ERYTHEMA (Redness of legs) and PERIPHERAL SWELLING (swelling on the legs) outcome was unknown.            On 29 Mar 2021, the patient went to emergency room (ER) and was diagnosed with cellulitis. Treatment information was not provided. No relevant concomitant medications was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who experienced sore leg, redness around the injection site and swelling from his groin to his knee, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU VACCINE VII in 2016 and FLU VACCINE VII in 2017. The patient's past medical history, medical treatment(s) and family history were not provided. Details of concomitant medication was not provided. On 11-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI982AB via intramuscular route in the left thigh. On 11 October 2018, the patient developed a non-serious event of sore leg following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 12 October 2018, the patient developed a non-serious event of redness around the injection site 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 13 October 2018, the patient developed a non-serious swelling from his groin to his knee 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was sore leg, redness around the injection site and swelling from his groin to his knee. Details of lab date was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling from his groin to his knee, sore leg and redness around the injection site.
About an hour and a half after I had my shot my nose started bleeding - took maybe 15-20 minutes for it to finally stop.  Happened again about 2 hours later, also quite spontaneously.  I took my blood pressure after second bleed and it was relatively normal . Three measurements within a few minutes of each other ranged from 128 - 145 over about 80.  This is a bit high for me, since I started BP meds but not unknown.  Also arm soreness such that I could not sleep on my left side.
This report was received from Research Group and was assigned manufacturer report number MD003. A 19 year old female patient approximately 2 years ago, in approximately 2008 was vaccinated with a dose of GARDASIL. Three or four days after receiving the vaccine, the patient experienced seizures and was hospitalized. The action taken regard GARDASIL and the outcome of the patient were not reported. The reporter felt that seizures was related to therapy with GARDASIL. This was originally reported by a family practitioner. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a patient of unknown age(gender unspecified). On 11-MAY-2011, the patient was vaccinated with first dose of GARDASIL, (lot number, expiration date and route was intramuscularly) and would be administered the second dose of GARDASIL, (lot number, expiration date and route was not reported) on 31-JAN-2013. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Numbness of vaccinated arm about 5 minutes after, convulsing of the bicep and/or tricep muscle for about 10 minutes, then distinct soreness for approximately two hours and mild soreness for 24 hours.
Approximately 26 hours after booster shot (first two doses were Pfizer and had no adverse reactions), I experienced very mild lethargy and tender breasts, with mild pain at the injection site in L arm.
Hospitalized for pneumonia on 3/1/2022 following hospitalization for COVID-19 2 weeks prior 2/13/2022.
flush/diffuse flushing; itch; blister; vomiting; diarrhea; irritability; This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 2-month-old male patient. No information regarding the patient's medical history was provided. His concurrent condition included maculopapular cutaneous mastocytosis (MPCM).  At 6-month visit, the patient's vaccines included 3rd dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), polio vaccine inact (IPV), pneumococcal vaccine conj (PCV13), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (vaccination date, exact dose, vaccination site, route of administration, lot # and expiration date were not provided for all). The number of lesions at initial visit was greater than 100. His tryptase level was 5.8 micro-g/L. On an unknown date, the patient experienced cutaneous symptoms and signs: flush, itch, blister; and systemic symptoms: vomiting, diarrhea, irritability. Cutaneous reaction location was within prior MPCM lesions, diffuse flushing. Time interval was reported as hours. As a treatment, he received oral antihistamines. The outcome of the events was unknown.  The authors considered the events to be related to the suspect vaccines.  A copy of the published article is attached as further documentation of the patient's experience.
Rash(arms & legs grannoloma annulare), anemia, bleed in my upper intestine
Getting COVID After the Vaccine, Symptoms of covid after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting COVID After the Vaccine, Symptoms of covid after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced COVID-19 (Getting COVID After the Vaccine, Symptoms of covid after vaccination). At the time of the report, COVID-19 (Getting COVID After the Vaccine, Symptoms of covid after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment were provided.
Large areas of hive-like patches on arms & legs on 8/6 gone with BENADRYL 8/7.
red, raised lesion covering ant lt thigh @ inj site devel on day 10 p/vax;t102;resolved by day 13;tx DPH;no resp sx
Patient developed redness and swelling on LD injection site. No fever, area is hot to touch. Symptoms developed on 08/14/15.
pins and needle sensation of tops of both feet, perceived edema of both feet  started 2/9/21 in the morning and still persisting all day 1 day ealier with some muscle pain and L deltoid pain and swelling (expected)
pt recv vax & exp nausea,vomiting,diarrhea,& fever which persisted for 2 days;It was noted that pt had no adverse exp following the first 3 vaccinations;
Until 1 week after Moderna 1st dose (030M20A) on Sat. 2.13.2021.  Within few hours, developed dry cough and later slight fever, runny nose, and pimple like on the back of the tongue.  Bleed start when scraping the tongue after brushing teeth.  One week later on Sunday 2.21 the coughing started and stay consistent (over the counter cough and flu med did not do anything) until the week of 2nd dose...Called doctor on March 9, 2021 with chronic dry coughing.  I had concerns abt 2nd dose due date but he approved and told me to take allergy med and prescribed  benzonatate.  The benzonatate was useless against the cough and only the allergy helped stopped the coughing!
My arm began to develop strong pain and a small red area with swelling where the shot was administered. At around 10:35pm I began experiencing a strong headache and intense heart burn or acid reflux. At around 1am or 2am the acid reflux was so intense I begain feeling restless and could not sleep. In the morning I woke with maasive pain in my joints, a migraine that lasted all day, followed by liquid diahrreas and fever. I spent the entire day with a head and overall body ache. pain in joints, diahhrea and fever. The swelling and pain in my arm continued as did the size of the swelling and red bump on my arm. Today, almost 63 hours later the swelling and red bump is almost as big as my entire arm.
right arm was tender to touch; was a little puffy, swelling; red; hot; rash; feverish; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (right arm was tender to touch), SWELLING (was a little puffy, swelling), ERYTHEMA (red), FEELING HOT (hot) and RASH (rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced TENDERNESS (right arm was tender to touch), SWELLING (was a little puffy, swelling), ERYTHEMA (red), FEELING HOT (hot), RASH (rash) and PYREXIA (feverish). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, TENDERNESS (right arm was tender to touch), SWELLING (was a little puffy, swelling), ERYTHEMA (red), FEELING HOT (hot), RASH (rash) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Half-Dollar sized skin rash on right back, similar to Shingles - skin tenderness along rib cage under right breast
I was given the flu vaccine in my shoulder area. Ever since, I have this horrible pain down my arm to my elbow. The pain is now in my shoulder area, upper back, and outer shoulder. I can't raise my arm above my head - it hurts too much. It also hurts at night. In all the years I've received the flu vaccine. I have never had this kind of persistent pain in the shoulder area. Usually, it is in my arm muscle and last only a couple of days. I think the nurse did not administer it correctly. The shot was given in the upper shoulder area. I think it may be tendonitis. I'm not sure if it is an administration error or a bad lot of vaccine that I was give. I hope the pain goes away. It has been going on now for 2 weeks and has become worse. I can hear my shoulder joint pop as well when moving it. I didn't have any issues with this shoulder prior to the vaccine. Per 60 day follow up: Still have arm pain & muscle pain. Arm is painful & can't lift things over my head. This has been going on for 4 months now. Is this happening to others? The Dr. office should be made aware that this problem is still going on. When will it go away. 1/15/2010 Arm pain.
Case number PHEH2012US014340 is an initial spontaneous report received from a medical assistant on 19 Jul 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that he was vaccinated intramuscularly only with the MenCYW-135 component of MENVEO (batch number: M11033) on 19 Jul 2012 and did not receive the Men A lyophilized component. No adverse event was reported following the medication error.
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The reporter stated that on an unknown date, unspecified number of patients may have vaccinated with unspecified number of doses of PNEUMOVAX23 (lot number, expiry date and route unspecified) that was exposed to 9 degrees Celsius (C) for 63 hours. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a registered nurse concerning an 8 year old male who on 18-Jan-1997 was vaccinated with a dose of varicella virus vaccine live (lot #619273/1357D). Subsequently, the patient developed a case of breakthrough varicella/chicken pox with a fever of 99.9 degrees F, pruritis, and a pox-like rash all over his back, chest, arms and legs. Unspecified medical attention was sought and the patient was treated symptomatically with calamine and diphenhydramine (Benadryl). No product quality complaint was involved. On 10-Feb-2004 the registered nurse reported that she does not remember who the patient was. The patient was not seen in the office. The nurse had received a phone call from the patient's mother reporting break through chicken pox. No additional details of the adverse event can be provided. It was also reported by "someone in the office" that a 4 year old female was diagnosed with breakthrough varicella "10 days ago". There was no vaccination information available for this patient. No further information is expected.
This spontaneous social media report as received from a consumer (patient's mother) refers to a male patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, lot#, expiration date and route of administration were not reported. On an unknown date, the patient had an unspecified injury that led to a scary year. The patient's mother reported that then he was fine and "put right back on the schedule". The outcome of the event was recovered on an unknown date. The relatedness between the event and M-M-R II was not provided. Additional information is not expected as there was no consent for further contact.
I woke up in the middle of the night after my vaccine; experienced a rapid heartbeat; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she received the first injection of the vaccine on Monday and experienced a rapid heartbeat on Monday night (unspecified dates). She further stated that she woke up in the middle of the night after her vaccine with her heart rate at 127. She wanted to know about this side effect if it was the true side effect and if it could happen again after receiving the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 13 year old male patient who on 13-MAR-1997 and on 01-AUG-2000 was vaccinated with the first and second doses of MMR II, respectively. On 22-NOV-2009 the patient experienced parotitis and was diagnosed with mumps on 24-NOV-2009. At the time of the report, the patient's outcome was unknown, this case was non-serious. Follow-up information was received from the physician indicating that on 16-NOV-2009 the patient experienced right mumps and mumps was diagnosed on the same day. The patient was afebrile. The first blood work was done 16-NOV-2009 and the results indicated IgM negative, IgG 7.22 and serum amylase 287. Additional information has been requested.
Within 2 hours I laid down and felt as though my lungs were half full of air and had to sit up. I had slight wheezing and kept trying to clear my throat. I drank a hot liquid - used menthol cough drops and deep breathing techniques.
joint &  muscle pain/pressure, to touch, in upper thighs/back; foot numbness; weakness, h/a & bilat arm numbness;hosp dx: bilat myalgia;sx cont w/ fatigue; dx: myalgia, arthralgia-?p/neuritic w/ resolving p/viral synd;condition imp w/ PT
Had Rotateq with 2 mos vaccine-developed fever up to 101.4, vomited, r/o septic work up- sent home then developed diarrhea which went away but reoccurred 1/07 and got worse after 2nd Rotateq vaccine
Left arm swelling, raised bumps, at injection site,arm hurt, arm hot, arm tingled down to her fingers Otc tylenol /Motrin as needed, monitor symptoms, rest (Item 17: she also received flu vaccine at same appointment on other arm, not sure which flu vaccine)
Persistent allergic rash/hives.  Patient developed rash on 3/12. Even with oral steriods rash would return in the evenings and once course was completed rash was present on/off throughout day.
pt recvd vax & back of arm @ MMR site devel large raised white wheel size of nickle & redness size of orange-immed p/inject of MMR;
SWELLING INITIALLY ARM SIZE AND SPREAD DOWN TO TRICEPS AND DISAPPERED. NOW THE RASH APPEARS DRY AND PEELING OFF. ROUGHLY THE SIZE OF FIST.
Diarrhoea; Vomiting; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date (Saturday) in Jun2021 (at the age of 25-year-old), as DOSE 1, SINGLE for Covid-19 immunization and took it from the facility. The patient past medical history and concomitant medication was not reported. On 01Jul2021, the patient experienced Diarrhea and vomiting, a week ago when took Pfizer vaccine. The patient stated that the schedule date for second dose was "22 or 21 days after". When probed if the patient was still experiencing adverse event to which he responded that he was still experiencing, everyday like, two times a day, diarrhea. The patient did not take any treatment for the reported events. The patient stated "Did you poop? This makes me happy. I watched videos women pooping." The patient hung up the call hence limited information was available over the call. The event outcome Diarrhea was not resolved while the outcome of the other event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
didn't notice the diluent expired 5 days before/no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that didn't notice the diluent was expired (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.  It was a case of actual medication error case due to expired medical agent used.   On 30-Oct-2019, the patient received a dose of suspect Act-HIB (PRP/T) VACCINE lot U6057AA expiry date of vaccine lot- 18-Nov-2019 for vaccine and lot number U6057AA, expiry date 24/Oct/2019 diluent via unknown route in unknown administration site.  It was unknown whether adverse event was experienced or not.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Redness/itching rash around injection site. Approximately 4 inches in diameter. Presented within 24 hrs of injection-pt reported to pharmacy 3 days post-injection. Hydrocortisone cream used. Currently ongoing; not worsening.
Patient reported on 4/21/21 that she had been hospitalized 5 days after having COVID vaccine.  Vaccine 4/9/21, 8:15a.m.  By noon started feeling bad; pain all over, headache, eyes hurting, low-grade fever.  Eyes bloodshot later in afternoon.  Symptoms progressed, including worsening fever (102.2)  4/10 and 4/11.  treated conservatively at home.  4/12/21 fever 106.2, indescribable general pain, headache, eye pain.  Went to ER.  Elevated blood pressure, low potassium, neck stiffness during hospital stay.  Hospital course included COVID testing, LP; both negative.  Anti-coagulants given.  Discharge home 4/16/21.
Immediately after I got the shot,   My nose started running and. Lips felt  big and tingling. ( MD did not see visible swelling).  And roof of mouth was numb,     throat felt like it was closing up,    Started getting hoarse,  chest tightening.        MD gave me 25mg Benadryl and  after 30 minutes starting relaxing,   Coughing up phlegm.          My left arm was very sore and swollen like a lemon...        Today. My lip feels kind of burning  (like pre herpes outbreak).  and roof of my my mouth is still numb.   I noticed that I lost sense of taste completely!
Patient got a low grade fever several weeks after getting the vaccine and wouldn't eat for a couple days then she got a rash all over her body (starting on her trunk) that has lasted for two days so far.
Menorrhagia - heavy continued vaginal bleeding starting 1 week after receiving Moderna Vaccine for 4 months (so far). Can not rule out other causes at this point.