chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The consumer mentioned her daughter had a severe adverse reaction to GARDASIL and asked how people have reported lupus. At the time of the report, the outcome was unknown. Upon internal review, lupus was considered to be an other important medical event. Additional information is not expected.
sweating for 4 days; fever of 103; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating for 4 days), PYREXIA (fever of 103) and MYALGIA (body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever of 103) and MYALGIA (body aches). On an unknown date, the patient experienced HYPERHIDROSIS (sweating for 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Mar-2021, PYREXIA (fever of 103) and MYALGIA (body aches) had resolved. At the time of the report, HYPERHIDROSIS (sweating for 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided.   This case was linked to MOD-2021-099496 (Patient Link).
SYNCOPE, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME. MEDICINE
Patient vaccinated x2 (Moderna): 3/2/21, 3/30/21  Patient admitted to Medical Center after testing positive for COVID19
Pt came three days later w/complaint of fever, chills for two days. Has large, warm, reddened area at site, swelling. States began the day after injection. 1/6/08. Pt given Medrol 4 mg as directed and also placed on Keflex 500mg course of treatment.
Syncope and brief seizure about 4 hours after vaccines at 1500 on 7/8/16. Took clonazepam prior to vaccines for anxiety.
The patient has extreme redness and swelling all over her upper arm from the shoulder to the elbow.
she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes; numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes.; she was getting intermittent headaches; This is a spontaneous report from a contactable Physician reported for a patient. A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 17Feb2021 (Lot Number: EN6201) at age of 69-year-old at single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medication(s) included atorvastatin (LIPITOR). The patient previously took first dose of bnt162b2 on 27Jan2021 (Lot number=EL3262) at single dose for COVID-19 immunization. On 20Feb2021, she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands. She reported after few days he started noticing in her bilateral toes. Patient also reported that she was getting intermittent headaches on 20Feb2021. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for 1 day. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab SARS-CoV-2 Antigen: negative  on 08Mar2021.  The outcome of the events was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events paraesthesia, hypoaesthesia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Arm hurts and itches.  Reddened, warm, induration getting larger.  No vesicles.  4-8 cm.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 13:00 as dose 1, single (Lot number: EN6206), in left arm, on 25Mar2021 at 13:00 as dose 2, single (Lot number: ER8727), in right arm and on 16Nov2021 at 12:00 as dose 3 (booster), single (Lot number: EW0175) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE, start date: 30Sep2020; VERAPAMIL, start date: 12May2022; SERTRALINE, start date: 30Sep2020; ALLEGRA, start date: 30Apr2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks Yes. antiviral details product COVID 19 Treatment, brand Pfizer Paxlovid, treatment start date 13Jun2022, treatment stop date 18Jun2022, indication Treatment of COVID-19. known allergies was reported as no. Adverse event Began testing positive again for Covid with symptoms: headache, congestion, sinus pain, cough, sore throat, fatigue adverse event start date 16Jun2022 adverse event Start time 08:00.
Cough, dyspnea, fatigue, headache, pneumonia, chest pain and wheezing
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) improperly stored over the last year (approximately 2013) (dose and lot number not provided). No adverse effects reported. At the time of the report, the outcome of improperly stored VARIVAX (Merck) was unknown. Additional information was received: All telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested.
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On an unspecified date in 2009 (reported as "sometime in 2009") the patient was vaccinated with the first dose of GARDASIL. On 25-SEP-2014, the patient wanted to receive the second dose of GARDASIL which would be late. No symptoms reported. At the time of the report action taken with GARDASIL was not reported. Additional information has been requested.
Patient presented to ED 2 hours after vaccine administration complaining of palpitations and elevated HR. Initial vitals showed HR of 155, and cardiac monitor appeared to show SVT. After 2 valsalva maneuvers, the patient's HR had lowered to about 120, and ECG showed sinus tachycardia with some ST depression in V1 & V2. CBC, CMP, and TSH were all normal except for mild hypokalemia (potassium = 3.1 mEq/L). Bedside ultrasound was performed as well. Patient received 1L of normal saline and was sent home after about 3 hours with a mildly elevated HR. In the following 24 hours, pt experienced headache, fatigue, and somnolescence, with brief episodes of mildly elevated HR without palpitations.
Had the Moderna vaccine on Tuesday, 3/16/21.   Had a major heart attach on Friday 3/19/21.
Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushed feelings.  Patient stated she did not eat breakfast and has not been drinking water.  Patient also states she has a history of panic attacks, anxiety, IBS, Cevo.  Patient did have c/o a slight headache however, felt it was due to lack of water intact today.  Patient sat for remaining 30 minute observation with nurse and provider on duty and was given water.  At the end of the 30 minutes patient had decreased symptoms and stated her husband drove her.  Provider gave ok for patient to take a prescribed Lorazepam when arriving home today.  Patient discharged home after 30 minute observation period was complete with husband.
REDNESS AND SWELLING AT INJECTION SITE, FEELING OF MALAISE AND OVERALL ACHIENESS AND FATIGUE
Redness & hives at MMR injection site right anterolateral thigh approx 5 minutes after MMR vaccine. BENADRYL 1mg/kg given PO. At 15 min post BENADRYL hives had disappeared & redness fading. Child active, running & playing.
This spontaneous report was received from a Nurse Practitioner and refers to a 16 year old male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 07-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Reportedly, event took place after use of product.  Treatment details were not reported by the reporter. Company comment: This is a spontaneous case concerning a female patient of an unknown age, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. No information disclosed about clinical course, lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. No information disclosed about clinical course, lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Daughter said arm hurt for 2 days; injection site was red and hot; injection site was red and hot; This is a spontaneous report from a non-contactable consumer (parent) via Pfizer sponsored program COVAX US Support. A 24-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing autistic. Concomitant medication was not reported. On an unspecified date of 2021 the patient experienced daughter said arm hurt for 2 days, injection site was red and hot. Patient was rubbing or itching but injection site was red and hot. Want to know what we recommend. Not clarified if daughter was Autistic before or after vaccine and for side effect. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
After a long drive g trip and subsequent calf and knee discomfort, I was diagnosed with a popliteal deep vein thrombosis in my left knee.  They determined that the clot had been there a while and had already begun to recanalize at the time of the diagnosis.
Large local reaction.  Area of redness and swelling around site of injection 9.5cm X 11.5cm on upper right arm.  Patient expected some swelling and redness, but became concerned 8 days after immunization when reaction seemed larger than he expected.  Reaction site itches.  No fever/chills, no other rash, no treatment needed.
Patient got redness and swelling at site of injection. She went to urgent care and doctor prescribed Cephalexin 500mg (1 tablet by mouth QID) as a precaution in case of cellulitis/infection. Pt came on 2/11/11 and says she is finally healthy except had a cold few days ago.
Headache dizziness weakness, persisted on office visit 11/23/2009 although better.
Tested positive for COVID; Chills; Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unspecified (EN6205 or EW6205) intramuscular, administered in left arm on 24Mar2021 at  16:30-17:00, as single dose (also reported as 0.3) for COVID-19 immunisation.  Medical history included high blood pressure. The patient was taking an unspecified concomitant medication for high blood pressure and was taking that prior to getting the vaccine. On 25Mar2021, the patient experienced chills, headache, tiredness and fever the day after getting the vaccine. On 05Apr2021, 13:30-14:00, the patient tested positive for covid. He tested positive and his wife also tested positive for COVID. He went and got tested not this past Monday, but last Monday. He later stated his wife received the Moderna vaccine and he did not have any other information to provide. The patient went to the physician's office to get COVID test on 05Apr2021. The patient had no additional vaccines administered on the same date as Pfizer vaccine. The patient had no prior vaccinations (within 4 weeks) and no events following prior vaccinations. He was supposed to take second shot after 14Apr2021. He would like to know if he can still get it or if he needs to wait. Outcome of event tested positive for COVID was recovered on an unspecified date; and outcome of the rest of events was recovering.   Information on the lot/batch number has been requested.
This spontaneous report as received from a 56 year old female patient with abnormal blood pressure and none drug reactions/allergies refers to herself. The patient's medical history included very bad case of chickenpox when she was a child. The patient stated that on 21-MAY-2014 was vaccinated with ZOSTAVAX (lot#, expiration date not provided, one time vaccine (1 DF), injection). Concomitant therapies included PROCARDIA (blood pressure medication). The patient also stated that "last night (on 21-MAY-2014) noticed 10 itchy red dots, warmth and red at injection site". On approximately 07-MAY-2014 the patient had blood work and urine test done with unknown result. The patient stated that "everything came back fine". The patient did not seek medical attention. The outcome of noticed 10 itchy red dots, warmth and red at injection site was unknown. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Vaccine Name -  Pfizer Vaccine Date - ?  05/05/2021 Is this your first or second dose- 2nd Date of symptom onset - ? 05/06/2021 Symptoms - ? Nausea, vomiting, diarrhea, taste and smell altered, fatigue, tachycardia, high blood pressure (167/109) Last day of work and shift - ? unknown Home remedies- Is seeing a team of doctors at hospital COVID center of excellence. Employee has to wear a cardiac monitor for 4 weeks and was put on low dose beta blocker (propranolol). Any improvement- Employee stated it seems to be getting better but is unable to return back to work for 4 weeks due to cardiac monitor. Recommendation- Advised employee to keep following up with hospital doctors and let us know of new or worsening symptoms. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
I am very ill and cannot work now; Joint soreness; Severe muscle soreness; Restricting movement; Night sweats; Lack of appetite; Cutaneous; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Restricting movement), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Lack of appetite), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Cutaneous) and ILLNESS (I am very ill and cannot work now) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Reaction to previous exposure to any vaccine (Get sick from Flu shot).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HYPOKINESIA (Restricting movement), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Lack of appetite), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Cutaneous), ARTHRALGIA (Joint soreness) and MYALGIA (Severe muscle soreness). On an unknown date, the patient experienced ILLNESS (I am very ill and cannot work now). On 19-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Cutaneous) had resolved. At the time of the report, HYPOKINESIA (Restricting movement), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Lack of appetite), ILLNESS (I am very ill and cannot work now), ARTHRALGIA (Joint soreness) and MYALGIA (Severe muscle soreness) had not resolved.            No treatment information was provided.  Patient would have a COVID test tomorrow because now his symptoms were quite severe. He was not sure what was ailing him, but he need to get tested and see a doctor and find out what was wrong. His life was difficult and it was just whatever he could get accomplished during the day. Right now his main priority was identifying his health problem and regaining his health.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received. New event was added.
Within 15 min of shot, started with mild cramping, within 45 min had stronger cramping and nausea. Cramping and nausea resolved within 3-4 hours. Fatigue for 2 day.
12/23: Sore throat, Persistent productive cough, nasal congestion. 12/24-27: Sore throat, productive cough, nasal congestion, headaches, fatigue, muscle aches, chills 12/28-1/1: Improving symptoms, occasional cough/congestion.
pt recv vax 25OCT95 & 27OCT95 pt exp fever & a red hard area over the inj site the size of an egg;pt recovered;no further details were provided;
Patient's Mother reports swelling around the injection site. Warm and hard to the touch. Mother reports that around 5-6 pm 2/16/2016 he started to think bad things, feel angry/agitated, feeling suicidal and he fainted. Once he fainted and woke up he felt fine. Patient's Mother didn't take him to the ER. She contacted the CDC and contacted our office the following day on 2/17/2016. Dr. was informed and advised that the swelling at the injection site was normal and if he wasn't having the other symptoms at this time he should be fine. Mother was advised to monitor the patient. Spoke with Mother today reports that he is doing much better. He still has the warmth at the injection site and the area is pink. Pt continues with normal activities.
a 15 years old patient was given Flublok inadvertently/ No AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to 2020SA273791.  This case involves a 15 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2005, expiry date: 21-May-2021), via an unknown route and administration site inadvertently, on 25-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were unknown.  It was a case of an actual medication error due to the inappropriate age at vaccine administration (latency same day).  At the time of reporting, the patient had no adverse event.  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.
BURNING SENSATION AT THE BACKSIDE OF HEAD AND FOOT; CRAMPS IN RIGHT LEG; FOOT GETTING HOT; FEELING DIZZY; HIGH BODY TEMPERATURES; HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Batch number was not reported. per procedure, no follow up will be requested for this case. No concomitant medications were reported. On JUL-2021, Laboratory data included Body temperature (NR: not provided) High. On 06-JUL-2021, the subject experienced burning sensation at the backside of head and foot. On 06-JUL-2021, the subject experienced cramps in right leg. On 06-JUL-2021, the subject experienced foot getting hot. On 06-JUL-2021, the subject experienced feeling dizzy. On 06-JUL-2021, the subject experienced high body temperatures. On 06-JUL-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, high body temperatures, burning sensation at the backside of head and foot, cramps in right leg, foot getting hot and feeling dizzy was not reported. This report was non-serious.