chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 57 year old female, who is a physician, with a sulfonamide allergy who on 02-Nov-2006 was vaccinated in the left deltoid with a dose of varicella-zoster virus vaccine live (lot#652965/0622F). There was no illness at the time of vaccination. On 03-Nov-2006 the physician experienced injection site reactions of tenderness, swelling, warm, erythema, and pruritus on a 2x3 cm area. She experienced malaise, fatigue, low grade fevers and headaches for 36 hours. Unspecified medical attention was sought. Subsequently, the physician recovered. There was no product quality complaint involved. Additional information has been requested.
Red baseball circular size swelling in arm at injection site. Itching , hot to the touch.
Pt received DTaP to (R) deltoid on 6/29/10. Has a 7 x 11 cm duration erythema = red, warm and firm.
Initial case received on 04 January 2008 from a health care professional.  A 6-month-old female patient had received a second dose injection of Fluzone No Preservative 2007-2008, lot number U2481GA, on an unknown date.  At an "unknown" time post-vaccination, the patient experienced a cerebrovascular accident requiring hospitalization.  A CT of the head, MRI, and spinal tap were performed, but results were not provided.  Past medical history, illness at the time of vaccination, and other medications were unknown.  The reporter considered the event to be life threatening.  Per the reporter, details were limited at this time.  At the time of this report, the patient had not recovered.
Information has been received from a nurse practitioner, referring to a 17 years old female patient. The concurrent conditions included diabetes and hidradenitis. The patient had no drug allergy. Concomitant therapies included metformin, insulin lispro (HUMALOG), insulin lispro and insulin glargine. On 04-MAR-2019, the patient was vaccinated with first dose GARDASIL 9 (dose, strength,  lot# R017133 and expiration date not reported, but upon internal validation established as 29-APR-2021)  intramuscularly for prophylaxis. On 04-MAR-2019 (reported as immediately after administration), the patient experienced pain at the injection site. On 01-APR-2019, the patient experienced pain and swelling at the injection site and was treated for suspected cellulitis. The treatment included amoxicillin (+) clavulanate potassium (AUGMENTIN) 875mg for 7 days. The patient continued to have a painful bump under the skin at the injection site. The physician reported the patient was apprehensive and afraid to get the second GARDASIL 9 injection. There was no lab diagnostics or studies performed. The outcome of the events was reported as not recovered. The causality assessment with GARDASIL 9  was not reported. Upon internal review, suspected cellulitis was determined to be medically significant.
Patient came in to get advise of swollen red injection site on left arm 2 days post-vaccination.
This is a spontaneous report from a contactable consumer. This 20-year-old male patient reported that received on 03Mar2015 at noon a single dose of TRUMENBA. Medical history was not reported. Concomitant medications were none. On 03Mar2015, the reporter mentioned that experienced side effects: really bad headache and his body was cold and he had shivers and chills. The reporter mentioned that he did not take any medicine for side effects. Outcome was unknown. Follow-up (30APR2015): Follow-up attempts completed. No further information expected.
EMPLOYEE AWOKE IN THE MIDDLE OF THE NIGHT SWEATING PROFUSELY, MUSCLE/BONE PAIN, DRY THROAT.  EMPLOYEE WENT BACK TO SLEEP. AFTER AWAKENING, SHE WAS NO LONGER SWEATING BUT WAS FEELING FATIGUED WITH MUSCLE ACHES.
patient developed bilateral upper extremity flushing as well as facial flushing around 10:26 a.m after receiving the vaccine at 10:11 a.m.. Patient sat and drank a couple bottles of water, patient felt ok, no shortness of breath noted. Patients BP/HR were stable, 142/82, 80. Advised patient to go home after observation and take Benadryl if necessary.
This spontaneous report as received from the mother of the patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unknown dates the patient was vaccinated with GARDASIL (lot # not reported) for the prevention of HPV. The 1st and 2nd doses (dose and route unspecified) were received on schedule, but the 3rd dose of GARDASIL (0.5 ml, intramuscular) was received 5 weeks late. No adverse effects were reported. The patient did not seek medical attention. The outcome of the events was unknown. Additional information is not expected.
Per patient's mother, baby had 4 days of "not being herself, staring off into space.  We thought she just had become autistic, but then it went away and she has been fine."  Per Dr., baby ok on exam, done 07/08/09, with negative autism screen. Also, per Dr., we are to hold all vaccines for now.
2 1/2 hrs p/vax pt started developing hives on face & then down to trunk & umbilical area;
HYPOTENSION 2/8/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
15:10 Patient verbalized feeling lightheadedness, sweating and left hand numb. Vital signs taken at: 15:15 Bp 150/90 HR 80 Spo2 99 Temp: 97.1 F @ 15:20 Bp 147/93 HR 76 Spo2 99 @ 15:25 Bp 145/91 HR 82 Spo2 99 @ 15:30 BP 149/83 HR 71 Spo2 100 @ 15:35 BP 155/91 HR 72 Spo2 100 15:50 patient stated "feeling better" repeat vitals before releasing, BP 152/91 HR 78 Spo2 100 Patient was advised to follow up with PCP prior to recieving second dose of Covid vaccine. Patient left with daughter. (Initials) LVN
I am experiencing continuous buzzing/humming in my left ear, decreased hearing and mild dizziness.
Site injection reaction resulted in swelling. Unable to injected at the site with swelling the size of a pencil eraser.
Soon after receiving the shot, I felt tired, low energy.  Within a few hours, I started feeling ill, unwell.  As expected, the injection site was sore, but it had also started to develop a lump - the muscle felt hard and warm to the touch.  By evening, I developed a fever, horrible headache, body aches, nausea and lethargy.  The second night, I woke with a racing heartbeat.  The illness lasted 2 days.  During this time, my entire upper left arm (the injection site and surrounding area) continued to redden, swell and feel hot to the touch.  The immediate injection site felt hard and the surrounding area was puffy and swollen.  I called and was told over the phone that the reaction was normal, to use an ice pack and take Tylenol - no one examined me or requested photos or asked to see it on video.  While I was sick, I took Tylenol for headache and fever.  After the fever subsided and the upper arm continued to get worse, I called again and was again told over the phone that the reaction was normal and to use an ice pack and Tylenol, again with no one examining the arm or requesting to see photos or video.  I added Ibuprofen to help with swelling and allergy medication, in case it was an allergic reaction, and a steroid cream I have on hand for eczema.  The upper arm swelling, redness, and heat continued for about a week.  During that time, the surrounding skin started looking puffy.  At one point, my left arm started to tingle as though blood flow was being restricted.  Luckily, an ice pack helped resolve it within 30 minutes, or I would have gone tor and insisted on being seen.  I was constantly applying ice packs as it seemed to be the best way to keep the swelling and heat under control.  It took about two weeks for the upper arm symptoms to subside - so one week of progressive worsening, and two weeks of subsiding and returning to normal.
got the Covid19; Got the Covid19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's sister) reported that a male patient (reporter's brother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), on Feb2021 as dose 1, single and then on Mar2021 as dose 2, single, both via an unspecified route of administration for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Jul2021, patient got the COVID-19 virus. The consumer was calling on behalf of her brother and took both doses of the vaccine. Consumer mentioned the first dose was Feb2021 and the second dose was Mar2021. The patient got the Covid19 virus in Jul2021 and he needs to travel in Sep2021. The consumer wants to know if her brother will be tested in Covid19 test if it will have a negative result. She wants to know as well if you're trying to travel how many days you should turn negative to Covid19 test, is it 90, 60, 30 days. Outcome of the event of COVID-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Initial report received from a consumer on 22 September 2010. A 55-year-old female patient, with a history of hypertension and seasonal allergies, received (dose 5) on 16 August 2010 an intramuscular (IM) injection (site not reported) of IMOVAX Rabies, lot number not reported, for post exposure. The previous dates of the doses of IMOVAX Rabies were not reported. She had no illness at the time of vaccination and had no other vaccinations within 4 weeks of the IMOVAX. On 16 August 2010, she began itching at the injection site and developed pustules on her lower back. The patient complained of feeling lethargic and possibly depressed. She felt like she had no get and go and sleepier than usual. The pustules have cleared up. The outcome was reported as not recovered. Documents held by sender: None. Follow-up information received from a nurse on 18 October 2010: The patient had been bitten by a dog in another country on July 22, 2010. She had received rabies immune globulin and her first and second dose of rabies vaccine on 02 August 2010 and 05 August 2010. The patient received her fourth dose of rabies vaccine (batch number D0792, expiration date 04 September 2011) in the right deltoid on 09 August 2010. She received her fifth dose of rabies vaccine (batch number D0792, expiration date 04 September 2011) in the right deltoid on 16 August 2010. On 11 August 2010, the patient called the nurse reporting that she had a rash on her back. She did not report rash elsewhere and stated that she had not had any other symptoms such as wheezing or shortness of breath. On 16 August 2010, when she was seen for her final dose, she was examined. The rash was located in the middle of her back and had a vesicular appearance which is not characteristic of hives. Follow-up information was received 06 December 2010 from a health care professional who reported that only four doses had been administered to the patient in accordance with the MMWR March 19, 2010 / 59(02);1-9. An update in the patient's recovery status was not provided at the time of the report. Outcome remained not recovered. Follow-up information was received 14 January 2011 from a health care professional. Vaccination dose numbers were amended by the reporter. The patient received IMOVAX Rabies dose three (previously reported as dose four) on 09 August 2010, and dose four (previously reported as dose five) on 16 August 2010. The reporter amended the patient's recovery status from not recovered to unknown and they had no additional information at the time of the report. Documents held by sender: None.
No additional adverse event reported; 08-JUL-2020, the patient was vaccinated with an accidental 4th dose of GARDASIL 9; This spontaneous report was received from a nurse, referring to a 18 year old female patient (conflicting information, also reported as "19 year old"). The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 08-JUL-2020, the patient was vaccinated with an accidental 4th dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). The nurse stated that they just found this error looking at her records. No additional adverse event reported
Pain in upper left arm during injection of Fluvirin and pain continues as of today - I have limited range of motion in left arm.
Upper arm was swollen and red; Upper arm was swollen and red; Got kind of lumpy; Hurt quite a bit; Headache; A spontaneous report was received from a consumer, concerning  a 84 years adult female patient, who received Moderna COVID-19 Vaccine and experienced 2 doses.  The patient's medical history was not provided.  The concomitant products was  bisprolol 5mg daily verapamil ER capsules 100 mg daily candasartan 16mg daily Symbicort 160-4.5 mg inhaler Spiriva inhaler  On  25-Feb-2021,prior to the onset of events,the patient received the first dose of  mRNA-1273(lot number: 012M20A) and route of administration is  intramuscular route for COVID-19 infection prophylaxis.  Patient received the first dose of Moderna COVID19 Vaccine on 27Jan2021 in right deltoid and second dose on 24Feb2021 in left deltoid. Patient states her upper arm was swollen and red for about 4-5 days and got kind of lumpy and hurt quite a bit for about 4 days. The second one started out that way - it hurt and had a headache, but it seems to be letting out some now.    Treatment history was she has been taking Tylenol.  Action taken with mRNA-1273 in response to the events were not reported.  The Outcome of the event(s)  was considered to be not resolved at the time of this report.
The following day, about 2 inches below the injection site, her arm had a lump slightly larger than a Quarter, and was a little sore to the touch, and was slightly red and slightly warm to the touch. I instructed her to put ice on it, take tylenol or ibuprofen, and if it got worse as the night went on or in the morning, she was going to go have it checked out at her Dr office.
pt recvd vax;next day,began chest pain & muscle pain'w/in hrs muscle pain progressed upward & downward until exp muscle weakness;was adm to hosp & tx w/ IV corticosteroids & ibuprofen for pain;discharged 10jan;improving;
Pt having signs/sympathy of Pneumonia for 2 weeks, went to urgent care and received antibiotics. Progressively got worse and was admitted to Medical Center July 11, 2021.  At that time, the only test result pt grew was in her sputum culture, Photoehabdus Luminescens. Pt received both Covid-19 vaccines in April of 2021, they were both Pfizer.     During pts stay the ICU, the pt was going into renal failure and having multiple cardiac arrhythmias, despite multiple IV antibiotics.   Pt was transferred to a higher level of care on July 19,  2021
No additional AE reported; Patient who was previously 'unvaccinated' and who was 'meant to get' separate MMRII Vaccine and separate VARIVAX Vaccine was instead administered STERILE DILUENT Reconstituted PROQUAD; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The patient was meant to get vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiry date, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, lot #, expiry date, and route of administration were not provided), but on 13-MAR-2023, the patient was instead vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #W028565, expiration date: 06-MAR-2024) reconstituted with sterile diluent (strength, and route of administration were not provided) for prophylaxis (Wrong product administered). No additional adverse events (AEs) were reported.
A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.
The vial of Pfizer vaccine was not diluted prior to administration.  The patient got 0.3 ml of concentrated vaccine.  We called the manufacturer and they did not see any increased side effects other than local site pain at high concentrations.  I notified the patient, warned about possible issues and told them to call if they have any side effects.
Child became blue around her face stopped breathing for a few seconds and then seem to air hunger for additional few minutes then became limp all over body. Then regained composure back to normal.
Patient developing necrotizing enterocolitis. Admitted 4/3/14 for projectile vomiting, dehydration, partial venous system air (admitted 4/3-5/2014). Readmitted 4/6-20/2014. Dx: NEC.
Sore arm; Temp 102.8 to 104.1; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), PYREXIA (Temp 102.8 to 104.1) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Temp 102.8 to 104.1) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm), PYREXIA (Temp 102.8 to 104.1) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 102.8 to 104.1 (High) 102.8 to 104.1. On 02-Apr-2021, SARS-CoV-2 test:. On 05-Apr-2021, Body temperature: 101.8 (High) 101.8. On an unknown date, SARS-CoV-2 test: negative (Negative) Two COVID tests that came back negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on 26-JUN-2021 - No new information
Immediate pain in right arm Loss of motion in right arm Extreme Pain in right arm Visited orthopedic doctor on 12/8/2021
Very mild heart attack; Touch of pneumonia; Aches and pains; Vomiting; Congested cough; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07May2021 given around 19:00 or 19:30 (Lot Number: EW0177) as single dose (at the age of 71 years old) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 07May2021 patient experienced very mild heart attack, touch of pneumonia, aches and pains, vomiting and congested cough. The patient was hospitalized for five days for very mild heart attack and touch of pneumonia from 07May2021 to 12May2021. The events very mild heart attack and touch of pneumonia resulted in Emergency Room visit. Patient stated she has had a very mild heart attack started the day of the vaccine a couple hours afterwards (she will go to see the cardiologist the day after the report), touch of pneumonia, aches and pains, vomiting, and spent five days in the hospital. Patient stated she does not believe the pneumonia is still going on. She stated but she does have a congested cough. Patient stated this stopped sometime in May2021 since she was given a strong antibiotic and it kind of kicked it out. Patient is not sure of the outcome since she has never been rechecked on it. Treatment: Strong antibiotics. Patient also stated that her cardiologist said she should not get the second dose. Patient had not recovered from touch of pneumonia and congested cough, she recovered on 08May2021 from aches and pains and vomiting and the outcome of very mild heart attack was unknown, at the time of the report.  Information on Lot/Batch number was available. Additional information has been requested.
Medical Assistant calling from HCP office to report a temperature excursion for V ARlV AX. One vaccine was administered to a patient; 0.5mL IM x one dose; This spontaneous report was received from a medical assistant from the physician's office concerning to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 04-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (ml), one dose intramuscularly for prophylaxis (formulation, strength, vaccination scheme and anatomical site of vaccination were not provided); lot number T021826 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported and validated as 25-JUN-2022.   The administered vaccine had a temperature excursion of 17.5 degrees Celsius (°C) for a time frame of 83 hours. It was reported that the data was not recorded by a digital data logger. It was also reported there was not a previous temperature excursion. No additional adverse events were reported.
nausea, very achy all over, swelling in arm, large red spot @ least 4 inches;