chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 22 year old female patient who in January 2009, was vaccinated with the third dose of GARDASIL (Lot # not provided). It was reported that the patient was diagnosed with an abnormal pap smear. Both: low grade and high grade HPV were identified. No further details were given. At the time of the report the patient's status was not specified. Follow-up information was received from a health care professional via medical records, concerning the female patient with no illness at the time of vaccination and no known drug allergies who in 04-OCT-2007 was vaccinated with the first dose of GARDASIL, (Lot # 0560U), IM into the left deltoid, on 13-DEC-2007 was vaccinated with the second dose of GARDASIL (Lot # 655154/1210U), IM into the left deltoid and on 06-JAN-2009 was vaccinated with the third dose of GARDASIL (IM into the left deltoid. On 09-MAR-2010, a pap Smear test was performed which showed high grade squamous intraepithelial Lesion, mild dysplasia with HPV effect and chronic cervicitis. The squamous dysplasia extended into the endocervical glands. On 05-APR-2010, a colposcopy was performed which showed epithelial cell abnormality. A low grade squamous intraepithelial lesion (LSIL) was shown. At the time of the report, the outcome of the patient was unknown. High grade squamous intraepithelial Lesion and low grade squamous intraepithelial Lesion were considered to be an other important medical event per investigator. No further information is available.
Information has been received from a 76 year old female with allergies to TYLENOL, ibuprofen and gluten and a history of car accident and an accident at her apartment (door fell on her) who in August 2007, was vaccinated with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included codeine and aspirin. On approximately 02-OCT-2007 the patient developed rash on her hands. No medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. No further information is available.
This spontaneous report as received from a registered nurse refers to a 12 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014:
Immediately after shot I was dizzy, shaky and had bad headaches that lasted 5 days- I had bad diarrhea on day 6. also, I usually get welts when I get bit by mosquitos or fleas- but the evening or next morning after I received the shot any bites that I sustained quickly turned into huge inflamed, red and hot welts that were the diameter of more that 10 inches.... also (still an issue till date) my legs/shins feel very heavy and achy and seem to pulsate....
At the time of vaccination it was approx 6 to 10 days past the 30 days window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065k21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (At the time of vaccination it was approx 6 to 10 days past the 30 days window) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  Patient allergic condition was unknown and patient was diagnosed with COVID-19 condition was unknown.  For patient acute illnesses condition at the time of vaccination and up to one month before was unknown.  Patient chronic or long lasting health condition was unknown.  Also for patient prescription over the counter medications ,dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event was unknown. For patient other vaccines given on the same day as Moderna Covid-19 vaccine as well as vaccines received within one moth  prior to any dose of Moderna COVID-19 vaccine was unknown. No patient have contacted  to reporter about any reaction. Treatment information was not provided.
Left arm swollen, hot. Pt temp 100 degrees F. Tender over biceps area & left axilla also tender. Pt c/o fatigue, chills & stiff elbow. Pt diagnosed with cellulitis. Reported by nurse
p/vax pt lt arm became swollen, reddened & sore;pt devel fever & chills;called MD & told to use APAP & Ibuprofen;ice packs used w/relief;saw MD & given steroid inj;advised not to take Td & pneumonia inj again by MD;
headache; aches; chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, pain and chills. On an unknown date, the outcome of the headache, pain and chills were unknown.   It was unknown if the reporter considered the headache, pain and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had headache, pain and chills. The patient wants to know how long can expect them to last.
Information has been received from a registered nurse concerning a 23 month old male who on 27-JUN-2007 was vaccinated with a first dose of ROTATEQ.  On 27-AUG-2007 the patient received a third dose of ROTATEQ (lot # 657668/1390U).  On 21-APR-2009 the patient developed vomiting that lasted 24 hours, followed by watery diarrhea that lasted for 4 days, the patient also experienced fever.  The patient had recovered.  Follow up information has been received from the registered nurse concerning a male patient, who on 21-APR-2009 experienced vomiting for 24 hours, then he had watery diarrhea that lasted for 4 days, the patient also had fever.  Subsequently, the patient fully recovered.  The patient's sister also had an adverse event after vaccination with ROTATEQ (WAES # 0905USA00018).  This is one of two reports from the same source.  No further information is available.
Discrete red ovoid rash with mild swelling and warmth to touch at top of right arm, around where injection was administered. Lacy red non-pruritic rash on rest of right arm. A slightly less prominent, but similar lacy red rash on left arm.   Initially noticed the rash on both forearms around 10 am. Noticed rashes becoming more prominent by early afternoon and  then noticed more discrete rash where injection was given.    Contacted pediatrician who advised urgent care because rash affected both arms. Dose of liquid Benadryl given around 3 pm at home.  Not much of a difference noticed in rash, maybe slightly less prominent.   No further treatment given at urgent care.
injection site pain on the left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 15th May 2019, refer linked case US2019131759).   On 18th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced injection site pain on left arm. Additional information not provided. The reporter consented to follow up.
9/10 MAR: Fatigue, chills.  11 MAR: Diadiarrhea.  20/21 MAR: sharp pain between shoulder blades, pain in back of upper arms, back of thighs and legs.  22-Present Mar: Numbness in face, toungue, nose, &Total Pelvis area waist down to upper thigh.  24 - present MAR: Lower back pain.  Unable to sleep well due to pain.  26-Present MAR: Severe numbness in fingers, toes & Feet. 3 Days in Hospital: 20-22 MAR. hospital CSF cell count was normal.  Protein 60 glucose 105.  CSF culture normal.  CSF VDRL negative.  Serum ACE HIV Sjogren's antibodies and Lyme antibodies were negative.
Burning chest pain began late evening 1/31/04 and went away for 12hr and recurred on 2/1/04. Sweating. Went to ER-angioplasty and stent inferior MI.
injection site pain, swelling and redness Narrative: Patient received the vaccine at a non- COVID vaccine clinic. Called the call center 2.5 weeks after receiving the COVID MODERNA vaccine dose #1 on 1/21/2021. Patient reports he experienced fatigue and arm pain 2 days after receiving the vaccine. Then on day 12 he noticed localized red area and swelling accompanied by more pain. States on day 14 his symptoms resolved. No intervention or active treatment noted and thus noted as mild severity.
Loss of taste; Loss of smell; Sore arm; Light headed; Blurred vision; Weak knees; High BP (145); Swollen eyes; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Light headed), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Weak knees), HYPERTENSION (High BP (145)) and EYE SWELLING (Swollen eyes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FENOFIBRATE, SERTRALINE, LOSARTAN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (Light headed), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Weak knees), HYPERTENSION (High BP (145)), EYE SWELLING (Swollen eyes) and PAIN IN EXTREMITY (Sore arm). On 11-Feb-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 08-Feb-2021, DIZZINESS (Light headed), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Weak knees), HYPERTENSION (High BP (145)) and EYE SWELLING (Swollen eyes) had resolved. At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood pressure measurement: 145 High. On 16-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Seven days post vax, the pt developed two red raised bumps which look like chickenpox on his torso. The bumps look like dark red scabs. The pt did not see a health care professional. Additional information has been requested.
1 1/2wks p/vax pt devel arthritis joints, rash, fever, glands swollen behind ears & back of neck, & itching;resolved by mid-February
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender who since 08-SEP-2014 had been vaccinated with doses of GARDASIL (lot # J011272, expiration date on 21-APR-2016 and lot # K006449 with expiration date on 19-JUN-2016), (route was not provided). The doses were exposed to temperatures outside of the recommended range and assessed for stability. No adverse effect has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given the oral rotavirus and in less than 30 seconds child developed hives. Doctor cancelled the rest of the vaccines and had patient come back on another day to get vaccines.
Shingles; Feel tingly in a small area on her buttocks; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 2 episodes in 2019).   On 21st September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced shingles and tingling. On an unknown date, the outcome of the shingles and tingling were unknown.   It was unknown if the reporter considered the shingles and tingling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient after receiving vaccine started to feel tingly in a small area on her buttocks and the patient's physician diagnosed her with having shingles. The reporter consented to follow up.
Information has been received from a physician concerning a female patient who was known to be pregnant, in 1970 was vaccinated with a dose of MMR II. The physician mentioned that on an unspecified date, the patient had an abortion. At the time of the report, the patients status was unknown. Upon internal review, abortion was considered to be an other important medical event. This was one of the several reports received from the same source. Additional information has been requested.
Large area of redness (2.5x4.5"), heat , swelling to R arm occurring 7 days after injection until 14 day following injection
Knee and Lower back pain.   Fatigue.   Loss of appetite.   Headache.   Symptoms began 6 hours after vaccine on Monday 2-1-2021  and lasted all day the next day.   Symptoms started to subside Tuesday night,  2-2-2021.
Patient had flu shot on 10/23/02 in left arm pt came in on Saturday 10/25/02 with massive hematoma from shoulder to elbow.  I referred pt immediately to family doctor. Doctor said artery was nicked. I contacted the vaccine provider and also gave patient's doctor the info as well as the patient. I contacted the visiting nurse association and the vaccine's manufacturer.  Massive hematoma did not appear until Thursday evening as per patient.
High Fever of 103; Extreme body aches and pains; Chills (was extremely cold); Cough; Unable to take a deep breath; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastric bypass and vsg surgery (sleeve gastrectomy). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included iron (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12), curcuma longa rhizome (TURMERIC) and vitamin d nos (MANUFACTURER UNKNOWN) and multi-vitamin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 26Mar2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 08:00, the patient experienced high fever of 103(unspecified units), extreme body aches and pains, chills (was extremely cold), cough and unable to take a deep breath. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events high fever of 103 (unspecified units), extreme body aches and pains, chills (was extremely cold), cough and unable to take a deep breath was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
patient started to itch all over the body - and noticed rash on chest, left side of the neck below ear lobe . - benadryl was taken and pt had relief for approx 24 hours. itching started again and benadryl was taken but pt has continued feeling itchy for the last 24 hours without relief from the benadryl
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 26-JUN-2016, the patient was vaccinated with GARDASIL 9 (lot#, expiry date and dosing details were unknown) dose 1 for prophylaxis. On 18-NOV-2016, the patient was vaccinated with second dose in vaccination series of GARDASIL 9 (lot#, expiry date and dosing details were unknown) (inappropriate schedule of drug administration). No adverse effects were reported.  The outcome of the events was unknown. There were no product quality complaints.
Slight muscle discomfort; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (Lot number: EL3247), via an unspecified route of administration from 20Jan2021 11:15 to 20Jan2021 11:15 at single dose in the left arm for COVID-19 immunization. Medical history included blood pressure (BP) abnormal and high density lipoprotein abnormal (HDL). The patient has no known allergies. Concomitant medication included rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASP), losartan, ubidecarenone (COQ 10), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) and isosorbide mononitrate (FLO). The patient experienced slight muscle discomfort on an unspecified date with outcome of unknown. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Immediate arm pain, loss of range of motion due to pain continuously and ongoing. Per Employee Health physician, heat pad, prescription for physical therapy. First appointment one week from now.
lower lip was numb; rapid pulse; weakness; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lower lip was numb/Hypo aesthesia, rapid pulse/ heart rate increased, weakness/asthenia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: didn't wanted to provide that) via unknown route for prophylaxis of COVID-19 infection.  On 3 Mar 2021,10 minutes later  the patient experienced the event lower lip was numb and one half later had a rapid pulse, weakness.  Treatment was provided included Benadryl before second dose  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), lower lip was numb, rapid pulse, weakness was unknown.
Diagnosed with irregular heart beat on November 2, 2022 when attempting to donate blood at a Blood Drive. Unable to donate due to skipped heart beats exceeding guidelines. No previous indications.
03/31/2021:  began feeling aches/pain/feverish about 10 hours after receiving the first Moderna vaccine and had a temperature of 100.3 F. 04/01/2021:  continued feeling aches/pains/feverish and had a temperature of 99 F. 04/02/2021:  aches/pains/fever subsided. 04/03/2021:  left leg began to hurt and kept feeling worse throughout the day; took ibuprofen for pain. 04/04/2021:  left leg continued to hurt; took ibuprofen for pain. 04/05/2021:  visited Urgent Care clinic and an ultrasound confirmed the presence of a blood clot in the left leg.  Urgent Care Doctor prescribed Eliquis for treatment. See Continuation Page for subsequent events/treatments.   04/07/2021:  Meeting with Primary Care Physician (PCP).  PCP changed treatment for the blood clot [acute deep vein thrombosis (DVT)] from Eliquis to Lovenox/Coumadin.  Additional tests ordered:  CBC with Differential; PTT; Comprehensive Metabolic Panel; Protime INR; Sedimentation Rate.  04/08/2021:  Meeting with PCP to discuss DVT.  PCP ordered Noninvasive Vascular Imaging - External Scan.  04/15/2021:  Meeting with PCP to discuss DVT.  PCP instructed to continue treatment with Lovenox and keep appointment with hematologist on 04/20/2021.  PCP ordered the following tests:  CBC no Differential; Comprehensive Metabolic Panel; Protime INR.  04/20/2021:  PCP changed recommended treatment of DVT from Lovenox to Eliquis.  04/20/2021:  Meeting with hematologist to discuss DVT.  Dr. agreed with PCP to change treatment from Lovenox to Eliquis.  Dr. ordered the following immediate tests:  Antiphospholipid Ab Panel; CK Total; Comprehensive Metabolic Panel; Dilute Russel Viper Venom Confirm; Fibrinogen; Lupus Anticoagulant Profile; NT-PRO BNP; Phospholipid, Hexagonal Phase; VAS Porto Hepatic Duplex.  Additional future tests were ordered as follows:  Antiphospholipid Ab Panel, CK Total; Fibrinongen; Lupus Anticoagulant Profile; NT-PRO BNP.  04/23/2021:  Meeting with hematologist to discuss DVT.  Dr. suspects the DVT is related to pre-existing conditions (includes vitamin K deficiency) plus the effect of the first Moderna vaccine.  Dr. concluded that vitamin deficiencies (due to malabsorption issues) are the root cause of several ills.  Dr. ordered an injection of vitamin K and recommended continued treatment with Eliquis.  Dr. also stated "I think no to second vaccination #2.  She might be vaccinated later if vitamin def are resolved."  Dr.  plans to review the case in three months to determine if Eliquis treatment can be discontinued.  Dr. also ordered an "ECHO Complete" to rule out additional clots in the heart/lungs.