chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Roughly 12 hours after the administration of my 2nd COVID vaccine (8:30 PM on February 26th, 2021), I developed a fever, chills, body ache, headache, dizziness, and a rash the size of a softball around the injection site. The flu-like symptoms lasted about 12 hours. The rash is still present.
Tested positive for Covid-19/Mild Covid-19 symptoms; "only experienced sneezes" while being positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19/Mild Covid-19 symptoms) and SNEEZING ("only experienced sneezes" while being positive) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Tested positive for Covid-19/Mild Covid-19 symptoms) and SNEEZING ("only experienced sneezes" while being positive). At the time of the report, COVID-19 (Tested positive for Covid-19/Mild Covid-19 symptoms) and SNEEZING ("only experienced sneezes" while being positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.         The concomitant medication was not reported by reporter. Patient received Moderna 2nd booster Covid-19 vaccine in Apr-2022. Patient explained that 6 weeks later, patient tested positive for Covid-19 vaccine and had mild symptoms and only experienced sneezes while being positive. Patient called because in Oct-2022 was 6 months since 2nd booster and patient asked if patient could get a 3rd booster dose. The treatment medication was not reported by reporter.  Company Comment: This is a spontaneous case concerning a 75 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19, approximately 6 weeks after the second booster dose of mRNA-1273 vaccine. It was reported the patient tested positive for COVID-19 (without other details) and had mild COVID-19 symptoms such as sneezing. The outcome was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: Company Comment: This is a spontaneous case concerning a 75 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of COVID-19, approximately 6 weeks after the second booster dose of mRNA-1273 vaccine. It was reported the patient tested positive for COVID-19 (without other details) and had mild COVID-19 symptoms such as sneezing. The outcome was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient presented to the emergency department with weakness and dyspnea and tested positive for coronavirus.  She was fully vaccinated with a Moderna series.
Localized reaction of erythema, and mild swelling . Occasional itching at the site. No other symptoms reported
APAP was given prior to immun & every 4 hrs p/ @ approx 530PM; pt vomited & had been irritable prior to this time for about 1 hr @ 630PM; woke from 1 hr nap temp was 104.7 more APAP given & tepid bath given; seen by MD;
Headache and fever started about 1/2 hour after injection. It has been 7 days and I still have a very bad headache and sometimes fever up to 99.9.  I do get some relief if I take Tylenol every 6 hours but at night when I try to sleep is the worst. My head pounds so hard it keeps me up. I also can see a pulse when I close my eyes. I have never had a headache that lasts this long or this intense. I stayed home in bed for the first 5 days but had to return to work on 4-8-21. I cannot take much more of this headache, it is wearing me down.
Swelling in left hand and extreme throbbing pain went and had imagining down and they saw a small cyst in her finger. Extreme weakness in legs alot of pain in both knees been in ER 7xs. Gets real bad at night barley can move legs to get out of bed, severe nerve pain, cant go up and down stair has to turn side to go up and down, Night sweats, vomiting and diarrhea and migraine headache
Received shot - hard nodule red & hot - lasted about 14 days - has several shingles on body - was treating w/steroid cream thinking it was eczema.
Left arm deltoid with 5 cm x 6 cm purplish discoloration and warmth.  Denies itching (-) pain.  Excorated area also.
This spontaneous report was received from a certified medical assistant concerning a 72 year old male patient. There were no drug reactions or allergies at that time but currently refers to PNEUMOVAX23. Approximately on an unknown date in 1998 (reported as 10-15 years ago), the patient was vaccinated with a dose of PNEUMOVAX23 (25/0.5) (lot number, expiry date and route unspecified, typical dose). No concomitant medications were reported. Approximately on an unknown date in 1998 (reported as that day), the patient experienced injection site warmness, profuse sweating and chest tightness in the middle of the night after the vaccination. The patient sought medical attention for the same and on that unspecified night the patient went to a hospital and was admitted in the intensive care unit (ICU) where a heart issue (unspecified) was determined. It was unspecified if any lab tests were performed. On an unknown date, the patient recovered from all the reported events. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Initial unsolicited report received from consumer on 07-NOV-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: J97D2, expiration date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, post vaccination, patient had an allergic reaction. Lab data and corrective treatment was not reported. Outcome of the event was not reported. Upon internal reveiw, the company decided to consider the case as serious due to IMPORTANT MEDICAL EVENT : Allergic reaction. List of documents held by sender: none.; Sender's Comments: This is a poorly documented case in which patient experienced allergic reaction after vaccination. Time to onset is not known. More details regarding patient's medical history, allergic history, previous vaccination history, history of similar episode, vaccination details, confirmed diagnosis, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
pt started screaming @ 230Pm,APAP given called back in 1hr-pt sleeping;called next day & mom said pt was better & wasn't sure if was just hungry;29MAR96 came for 4mo exam & mom claimed that pt did not stop screaming & it was a very scary
From Providers note: She reported: Encounter Background Information: SP smallpox vaccination 7 May 2012.  Subsequent onset of painful left sided lympadenopathy on 12 May 2012, malaise, subjective chills W/O temperature check.  Pt seen on 16 May and rx'ed Medrol DP, Vicodin 5mg and Naproxen 500mg.  Currently C/O painful left sided neck, axillary and clavicular swelling.  Also C/O moderate throbbing parietal HA W/O hearing or vision changes. No N/V/D.  Denies sx on R side of upper body, denies lower extremity neuropathy.  Objective  O: Tender Left sided: submandibular, posterior cervical, axillary lymph node swelling without erythema or discharge. 3x 6cm oval shaped localized non blanching erythema around the smallpox vaccination site.  Vaccination site appearance consistent with post injection period, no significant concerning skin changes other than noted.  1. LYMPHADENOPATHY: D/C prednisone.  Continue Naproxen 500mg twice daily and Vicodin 5mg PRN pain.  RTC in 1 day for re-evaluation.  Note: Indurated erythema delineated in marker 0800 today. T3 profile for 10 days. 2. ADVERSE DRUG EFFECT OF VACCINES SMALLPOX: Vaccination reaction report submitted.  Dressing change today.
Site: Pain at Injection Site-Severe, Additional Details: Wife of PT contacted pharmacy; wife reports PT is experiencing severe, radiating pain down arm of administration (left arm); PT is having trouble moving arm due to pain; wife of PT suggests possible administration error (immunnization given higher up the arm near shoulder of PT)
Mom contacted office stating that her daugher had a local reaction from her vaccinations on 3/20/2006. She states that her right deltoid was red and swollen. Mom states child has no fever at present. Mom stated that she noticed the child's arm this morning. Child does not complain of severe pain at this time. The child's mother was encouoraged to give her Motrin for the swelling. Will follow-up with patient in 3 days.
25JUL97 mom reports illness in both children following 1st hep b vax;pt leg locked up, red, swollen;had n/v & dehydration;event reported because mom is considering completing series;ER MD apparently told mom illness d/t bad lot;
chills/pyrexia/myalgia (2nd dose); chills/pyrexia/myalgia (2nd dose); chills/pyrexia/myalgia (2nd dose); Vaccination site pain (1st dose and 2nd dose); This is a spontaneous report from a contactable consumer (patient). A 58-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0168) via an unspecified route of administration in Arm Left on 11May2021 at 10:00(at the age of 58 years old) as 2nd dose, single dose for COVID-19 immunisation at pharmacy or drug store.  The patient historical vaccine included first dose of BNT162B2 (Batch/Lot number: EW0171) administered in Arm left on 20Apr2021 at 10:00 for COVID-19 immunisation and experienced vaccination site pain. The patient medical history and concomitant medication were not reported. The patient did not received any other vaccine within four weeks of vaccination. The patient did not tested for COVID prior to vaccination. On 11May2021 at 22:00 the patient experienced chills/pyrexia/myalgia and vaccination site pain. The patient did not tested for COVID post vaccination. Outcome of all the events were recovered.  Follow-up attempts are needed. Further information is expected.
COVID Dose 1 was Pfizer Lot EL3249.     Recipient presented without card to a Moderna event and had belief that Moderna was first dose.  Further research after the vaccination event revealed he had Pfizer first dose and subsequent Moderna second dose.  No additional adverse effect noted.
Rash developed shortly after vaccine on right arm. About halfway between shoulder and elbow (not including the injection site). Rash is about 4 inches tall and 3 inches wide. Rash is itchy and warm. Pt informed pharmacy about the rash on 9/17/21 and is still present, not improving. Advised patient to take benadryl and call back if things develop further.
No difficulty at time of vaccine. Within hours increased redness, swelling and warmth. Pharmacist advised NSAID and BENADRYL at HS. Today area has increased in size presents for eval. Has taken no add'l. meds. Plan: NSAID 2-3 x 1D PO, cold compresses, BENADRYL PM. F/U if not resolved.
RECEIVED BOTH COVID VACCINES 01/27/21 & 02/17/21. ON 02/19/21 WENT TO ICC RASH ON ARMS X1 MONTH, AND ABDOMINLA PAIN AND WAS SENT TO THE ER.  ON 02/19/21 REPORTED TO ER AND ADMITTED INPATIENT AFTER BEING  DIAGNOSED WITH  ABDOMINAL PAOIN, UNSPECIFIED LOCATION, ABDOMINLA DISTENTION, CONSTIPATION, FECAL IMPACTION, AND MALROTATION OF CECUM.
Pt reports RSV vaccine given on 8/11, I do not have info on which vaccine or lot number.  Patient developed B/L leg pain and weakness beginning 9/26, presented to hospital 2 days later. Weakness got progressively worse and he was dx ascending flaccid paralysis - Guillian Barre Syndrome. He was given 5 days of IVIG, is on ventilator - trach and peg.
This spontaneous report was received from a physician refers to three patients of unknown demographics. On an unknown date all three patients were vaccinated with (Oka/Merck) VARIVAX subcutaneously. On an unknown date all three patients experienced reaction (not specified). The outcome of reaction is unknown. Causality assessment was not provided. Additional information has been requested.
Fatigue; This is a spontaneous report from a Pfizer sponsored program regulatory authority support via contactable consumer (patient) and contactable physician A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Apr2021 as a single dose (at the age of 76-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Apr2021 as a single dose at the age of 76-year-old for covid-19 immunisation. Medical history included ongoing breast cancer. Concomitant medication included tamoxifen taken for breast cancer from an unspecified start date and ongoing. The patient states that both of her vaccines went very smoothly, and she only had some minor side effects, which includes fatigue. The patients antibodies test is negative and wanted to know if she can do another test to check the antibodies. Also wanted to know what she can or cant do there after the vaccination. The outcome of the event was unknown.    Information about batch/Lot number has been requested.
Really bad chills; fatigue; 3 inch rash on right arm, which itched for a little while; 3 inch rash on right arm; High fever of 101.3 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (3 inch rash on right arm, which itched for a little while), VACCINATION SITE RASH (3 inch rash on right arm), PYREXIA (High fever of 101.3 degrees Fahrenheit), CHILLS (Really bad chills) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 007MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (3 inch rash on right arm, which itched for a little while), VACCINATION SITE RASH (3 inch rash on right arm) and PYREXIA (High fever of 101.3 degrees Fahrenheit). On an unknown date, the patient experienced CHILLS (Really bad chills) and FATIGUE (fatigue). On 11-Mar-2021, PYREXIA (High fever of 101.3 degrees Fahrenheit) had resolved. On 25-Apr-2021, CHILLS (Really bad chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (3 inch rash on right arm, which itched for a little while) and VACCINATION SITE RASH (3 inch rash on right arm) had resolved and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.3 (High) High fever of 101.3 degrees fahrenheit.         No concomitant medication was reported  It was reported that patient had persistent really bad chills and fatigue 'to beat the band', which started after the first dose of Moderna COVID-19 vaccine, that continued after second dose   No treatment medication was reported   This case was linked to MOD-2021-020152 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information
Since my first dose on 4/21/21 I was experiencing dizziness. After my second dose the dizziness got a lot worse. I had to go to the hospital because I experienced numbness down the entire right side of my body. Since then the dizziness has not gone away and on 6/21/21 I was diagnosed with vertigo. I have never had any of these issue before receiving the vaccine.
Local inflammation at injection site, which was the left deltoid, accompanied by a temperature of 99.2 for a duration of approximately 1 hour. Redness at site lasted for six days. At maximum size it was approximately 4inches in size. Returned to school health center on 2/1/06 with c/o non itching, lacy rash to right arm which was hot to the touch.
Sore throat followed by fever, sores in mouth, sores turned into blisters, turned into abscesses.  For the next 7 years recurring abscesses in mucosal linings and after tonsillectomy and adenoidectomy the healing time took over 8 months.  Severe weight loss.  05/2009 onset of rectal bleeding with perirectal abscesses.  Stomach cramps, diarrhea, polyps, blisters from oral and nasal cavities to anus.  3 months in the hospital led to eventual diagnoses of fistulizing Crohn's disease with no family history of bowel disease.  Immuno-suppressant therapy failed and steroids, antibiotic, anti-TNF, etc. therapy all failed.  Counseled to look into medications previously taken.  None.  Only vaccines administered throughout life on schedule with major injection series during entrance into the military.  Onset of symptoms following mass injection and nearly 7 years before final diagnosis.  Complete colectomy, removal of large intestine and anus.  Ostomy bag need for life.
Patient called at 1:50 and reported numb and tingling right arm, right leg and top of left leg
18 hours after vaccine wakened with severe headache lasted aprox 18 hours then was just mild for remainder of 30 hours.
After receiving 2nd shot. next day I woke up early morning around 7 AM. I felt the bottom of my intestine constantly swirling / spinning. Another symptom at the same time throughout the whole day, back of my tongue or throat was constantly building up saliva.
Information has been received from a physician concerning a 19 month old female pt who on 7/22/03 was vaccinated with an IM third dose of Comvax (645488/0142N). Concomitant therapy, "also administered" on 7/22/03 included an IM fourth dose of Infanrix (596A2). On 7/22/03, the pt developed a "papular rash-generalized" and a moderate fever of "101." The pt was treated with Zyrtec syrup. It was noted that the pt still had the rash. Follow up info revealed that on 7/26/03, the pt had recovered. No further info is expected.
Painful body aches, uncontrollable shivering, breaking out in sweats, rash on arms
This spontaneous report as received from the patient's mother refers to a 1 year old female patient with no known allergies. The patient had none medical history. On 03-FEB-2015, the patient was vaccinated with a dose of M-M-R II (albumin status was not reported) and a dose of VARIVAX (Merck) (dose, lot#, expiration date, site and route of administration were not reported for both). There was no concomitant medication. On 03-FEB-2015, in the evening, the patient developed fever (highest reading was 104.3 F). The event was ongoing despite use of MOTRIN. On 06-FEB-2015, the patient developed rash on her face. The patient was seen by her physician on 06-FEB-2015. Strep test and flu evaluate were negative. In February 2015 (reported as over the weekend), the rash progressed to generalised all over child's body. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and M-M-R II and VARIVAX (Merck) was not reported. Additional information has been requested.
Redness and swelling since vaccination limited to vaccination area less than 1 cm wide. I have applied neosporin.  Vaccination administered at work through Centro Med and paid by employer.
Rec'd vax on Wed 8MAY91; @ about 9PM developed choking, difficult breathing, very pale, stomach very hard, skin moist; EMS called; Taken to Hosp;
Patient came about a week after administration with a rash extending from the arms to the back and legs. No trouble breathing.
Itchy rash at the injection site that appeared about a week after shot. Seems to be getting larger at 2 weeks out. No treatment. Condition still active.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 2:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient took Moderna booster dose.  Vaccine administration time reported as 14:23:26.  The patient was administered booster dose that went into 2 to 8 Celsius thaw state on or above 24-Dec -2021.  This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   This case was linked to MOD-2022-542869 (Patient Link).
recurrent and migrating urticaria with pruritus lesions occur daily and usually form at points of contact with clothing (waistband, shoulder/neck)
Pt is complaining of an oblong bump about 1 & 1/2 inches in diameter at injection site. She could not sleep or lay on it. Slight chills and a mild fever (100.3F) 24 hours after.
She had atrial fibrillation return and it was after she received the Covid-19 booster.; She had atrial fibrillation return and it was after she received the Covid-19 booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US212084.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "atrial fibrillation" (unspecified if ongoing), notes: atrial fibrillation return. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "She had atrial fibrillation return and it was after she received the Covid-19 booster.".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.