chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received their second GARDASIL 9 four months after the first dose and then the third dose two months after the second dose.; Information has been received from a registered nurse, via a vaccine field representative who called to request information on behalf of a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unspecified dates, the patient was vaccinated with the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (administration routes, anatomical locations, lot numbers and expiration dates were not provided) for prophylaxis.   It was reported that the patient received their second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) four months after the first dose and then the third dose two months after the second dose (inappropriate schedule of product administration).  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse on 16-FEB-2022, referring to the 25-year-old female patient.  Patient's demographics were updated.  On 06-JUL-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) then, on 07-SEP-2021, the patient missed scheduled appointment for second dose of the vaccine so, the injection was given on 01-NOV-2021 (when she went to the office for an unrelated problem visit). Information regarding administration routes, anatomical locations, lot numbers and expiration dates was not provided for both first and second doses that were administered for prophylaxis. On 03-JAN-2022 (2 months after second dose, instead of 4 months), the patient received the third and last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection via intramuscular route in her left deltoid (lot # 1775809, expiration date reported as 17-AUG-2021 but upon internal validation established as 18-AUG-2023) (inappropriate schedule of product administration). As corrective action, all the staff was informed again on correct schedule (0, 2, 6 months) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The vaccine was used according to the instruction leaflet and was not available for return/evaluation. The current location of vaccine was sharps container. The vaccine was purchased with private funds and the patient was vaccinated at a private doctor's office/hospital.   This case is now considered valid since patient's identifiers were provided.
generalized numbness sensation, "tension with swallowing", feels "loopy" and "hazy"
1/7/14 Approximately 5-8 hrs post-vaccine administration Mom noticed right thigh swollen, hard to touch and immobile by infant. Patient taken to hospital ER. Mid thigh measurement at ER 26cm RT. Left thigh reference 22 cm. Patient followed up 1/8/14 with PCP. RT meas. 29cm. Ultrasound ordered.
Lips swelling, burning, peeling. Inside of mouth raw, tongue feels raw and burned. 2 to 3 week cycle since the beginning of Dec. 2009. After talking to co-worker with same symptoms since her shot, convinced this is the culprit.
Patient states that 2 hours after vaccine administration rash developed on forehead and sides of face. No other rash site. No shortness of breath or other symptoms. Patient applied topical Benadryl with some relief. Reported to us 11/22/06. Temp oral 95.7F.
This spontaneous report as received from a pharmacist refers to a 22 year old male patient. On 16-JUL-2013 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly, lot # not reported. On 06-JUL-2013, the patient experienced syncope, seizure like movements and cut on back of right ear, from falling after vaccination. The patient responded quickly and "sat on floor for 15 minutes". The patient refused medical treatment. The outcome of adverse events was unknown. The relatedness between GARDASIL and adverse events was unknown. Additional information has been requested.
cold like symptoms; chills; aches and pain; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold like symptoms"; CHILLS (non-serious), outcome "recovered", described as "chills"; PAIN (non-serious), outcome "recovered", described as "aches and pain"; MALAISE (non-serious), outcome "recovered", described as "feeling sick".  Additional information: Events lasted one day and was gone the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Acute STEMI presentation with chest pain and ST elevations inferior/posteriorly. Taken to cath lab emergently and chest pain resolved, ST segments cleared immediately upon injection of contrast into L coronary system. Cardiology and ID suspected arterial embolism had been present and was dislodged/dissolved by contrast injection.
Fever; rash began on right arm and traveled to upper torso down to about belly button; This is a spontaneous report from received from a contactable consumer (patient). A 34-year-old non-pregnant female patient received second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (lot number: EN6200) via unspecified route of administration on the left arm on 15Mar2021 at 15:30 (age at vaccination was 34-year-old) for COVID-19 immunisation. There was none medical history. Concomitant medication included sertraline hydrochloride (ZOLOFT) 50mg daily. Her historical vaccine included first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (lot/batch no: EN6200) via unspecified route of administration on the left arm on 22Feb2021 at 15:30 for COVID-19 immunization. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19 or not and since the vaccination, she had not been tested positive for COVID-19 as well. She did not have any allergies to medications, food, or other product and she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She has received recent COVID-19 vaccine administered in the Public Health Clinic/Veterans Administration facility. On 16Mar2021, she experienced fever and rash which began in the right arm and travelled to upper torso down to about belly button. Adverse event results in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient did not test for COVID-19. It was not reported if any therapeutic measures were taken to treat these events. The clinical outcomes of the event fever and rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
cognitive problems; loss of sense of smell and taste temporarily; loss of sense of smell and taste temporarily; Bodyaches; slight fever; heavier headaches; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), HEADACHE (heavier headaches) and MYALGIA (Bodyaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (heavier headaches). On an unknown date, the patient experienced COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), MYALGIA (Bodyaches) and PYREXIA (slight fever). On 24-Jan-2021, HEADACHE (heavier headaches) had resolved. At the time of the report, COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), MYALGIA (Bodyaches) and PYREXIA (slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: Positive. On 20-Jan-2021, SARS-CoV-2 test: Positive. On 24-Jan-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added new events.
At mass back to school vaccination clinic, 7 year old child was administered a DTaP vaccine when Td/Tdap should have been administered. No adverse event noted. Parent notified of incident and facility risk management forms completed. Immunization Branch informed of incident, no further vaccination needed until booster.
Urticaria to face, neck, upper extremities, thorax Itchy Rash Given Benadryl and observed for 2 hours in clinic. Rash & itching subsided.
Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
GENERAL MALAISE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced general malaise, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and general malaise was not reported. This report was non-serious.
pt recvd vax; inj site is hard, red & sore;? fever,swelling 5-6" all around site;severe sxs were relieved w/ apap;Ibuprofen taken for anoth problem;
Member began to have erythema and edema to location of injection.  Site is now warm to touch and extends 4-5cm in width and 3-4cm in height. Treatment: Per overseeing provider - use of Tylenol or Motrin and Benadryl at night before sleep to alleviate symptoms.
Patient is approaching their 42 days of the recommended interval of the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is approaching their 42 days of the recommended interval of the 2nd dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is approaching their 42 days of the recommended interval of the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is approaching their 42 days of the recommended interval of the 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not included Action taken with mRNA-1273 in response to the event was unknown; Reporter's Comments: This report refers to a case of Product omission issue(missed dose) for mRNA-1273, lot #  028L20A with no associated Adverse Events.
On March 25 I started noticing a light flare in my eyes, but more in the left eye. Even with eyes shut, it was still present. It started out as a small zigzag pattern in a crescent shape like the letter "C"; mostly white with colorful flares. It took about 45 minutes for the crescent to become wider, until it eventually disappeared. 24 hours later and it has not re-appeared.
I had numbness in left foot and right arm I was laying on the sofa watching TV went to emergency they said it's nothing the recommend to see my doctor  refer me to scrip's to perform Phlebotomy for several month because my red blood counts were above 6.55, at the time I was getting Testosterone cypionate 200 mg the last appointment for Phlebotomy end of July 2021 I  got worsen shorten of breath when walking by Sep i start having same  symptoms as in 2009 feeling chest pain by Sep 12 went to emergency were the doctor found blood clots they had nitric oxide in the blood  stayed for 2 days,  medication are metoprolol, Plavix, aspirin and atorvastatin to this day. currently I am on going EECP at cardiovascular. Currently I am on going to cardiovascular institute for the 5 days it 35 days treatment after I have appointment on June 27, 2022 with Dr. I feel cold even if the temp in the house is 73 I have to have blanket to keep my body and lower legs warm and the left arm and chest pain it still on going.
Pt recv vax on 9/4/98; on 9/8/98 pt exp persistent crying &irritability for 3 dys.
site of vax was inflamed w/tenderness & pain extended to rt side for approx 8 hrs; lump or knot was noted @ area of immun; no elevation of temp-APAP had been given as directed; piercing cry was noted during crying episodes;
Unknown feeding problems immediately. Reflux, constipation, digestive issues since 3 weeks old. Cold sweat, twitchy, red face, lots of passsing gas. Lasts 8-10 hours and happens up to once a day every week.
After few minutes she complained about itching, asked her to stay more than 30 mins and she said still itching. After an hour gave a Benadryl and she said she can fell that the itching is going down. Monitored for 1.5 hours and let her go with instructions to follow if needed.
Patient received her Covid 19 vaccines on 1/6/21 and 2/3/21.  On 3/3/21 at her routine prenatal visit, she was diagnosed with an intrauterine fetal demise.  Based on the fetal measurements, the demise happened at 17-18 weeks of gestation, which would be sometime between 2/6/21 and 2/13/21. Medically, I don't suspect that the demise is related to the vaccine, but for the sake of accurate tracking, I feel compelled to report the sequence of events.
11/23/18 AM Parents brought child into Outpatient Clinic. Child has a spotty rash on left cheek and both legs that started on 11/22/18. No fever, no respiratory Sx, no other Sx. Parents stated that last week they had soaked the child's sheets for 24 hours in OXYCLEAN and that the child does sleep on her sheets with her left cheek on the sheet. Parents think might be a contact rash? Child had received her #2 Japanese encephalitis vaccination on 11/15/18. Informed parents that a rash is not a common side effect to the Japanese encephalitis vaccination. Family is leaving for their trip on 11/26/18. Advised parents to go to a walk-in health clinic today to have child's rash evaluated by a provider. 11/23/18 PM Telephone call from FOC. Child was taken into a walk-in clinic for evaluation of the rash. Per FOC, provider did not think rash was bacterial, viral or related to the vaccination. Provider felt rash was a contact rash and advised parents to obtain some hypoallergenic detergent, and to get some CLARITIN and cortisone cream for the Sx. FOC to call clinic on 11/25/18 to inform if Sx have resolved. 11/26/18 No return call from FOC. Family left early this AM on their trip until 12/28/18. PHN to call family after they return from their trip to see if child recovered from the rash. 1/2/19 TC to FOC. FOC states cortisone cream was put on the rash for Sx relief, family switched to a hypoallergenic detergent and the rash did resolve.
Pt developed Diffuse Hives on anterior/posterorir chest, neck and forehead.
Lethargy starting 48 hours after 1st injection. Fever, sweats/chills, nausea and shortness of breath starting 63 hours after 1st injection. I had a strange compulsion to pant. These symptoms lasted for 4-5 hours then disappeared and I was left feeling just lethargic again. I was completely done with all adverse reactons 77 hours after 1st injection. The second dose was uneventful other than a sore arm for a day.
Two minutes after getting it I got a major heat wave; Pressure in my chest; difficult to breath; Really bad chill; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in left arm on 16Sep2021 at 4'O clock(at the age of 22-year-old) as dose 1, single for covid-19 immunisation and Influenza vaccine via an unspecified route of administration on 16Sep2021 4'O clock (Batch/Lot number was not reported) as dose number unknown for immunization. No relevant medical history reported. There were no concomitant medications. Patient reported, on 16Sep2021, two minutes after getting her first shot she got a major heat wave and like pressure in her chest like it was kind of difficult to breath and then right after that it was really bad chill and she just have not a heard of anybody that she know that has had a reaction so quickly after getting it. So, she was kind of concern and scared her. Patient took Influenza vaccine at the same time of Pfizer vaccine on 16Sep2021. Outcome of the events was unknown at the time of reporting.  Follow-up attempts are completed. No further information is expected.
arm pain; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (arm pain) in a 93-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Oct-2022, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE PAIN (arm pain) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Left sided pain in armpit/scapula area and little bit of swelling in L armpit area
"A mother reported that her 5 month old son, post vax, developed constipation, was irritable and had 1 episode of vomiting, 7 days later. He recovered."
I sat at the hospital for 15 mins after my vaccine shot and was ok. However minutes after I got in my vehicle and started driving, I started to experience hot flashes and a migraine. I had to pull over because I was unable to drive myself. Later in the evening, I continued to have hot flashes and started having chills. My fever became 100.6. I?ve taken Tylenol and ibuprofen as recommended but it hasn?t relieved any of the side effects. After trying to sleep, I woke up with a burning sensation in my stomach. I vomited and have had abdominal pain, aches in muscles and soreness at the injection site.
pt says he woke up next day and he had a sore arm and other common flu like symptoms that subsided the same day.  On 4/25/2021 he woke up w/ Bells Palsy on the left side of his face.  He called his PCP .  He had a tele-visit and was prescribed Valacyclovir 1gm every 8 hrs and prednisone 3 20mg tabs once daily.  On 4/29/21 he had a tele-health visit w/  NP .  He was prescribed some sleep meds.  Today 4/30/20 he has a headache behind his left ear.  He will FU w/ his PCP Magen Mallet on 5/3/21.
I developed pain and swelling in my right index finger. All of the muscles and tendons in my finger were swollen. It worsened between October 2021 and January 2022. I made an appointment to see my rheumatologist. I was prescribed prednisone, and I took it for a month. It had no effect, and the swelling actually got worse. The rheumatologist ran many test and diagnosed me with dactylitis which is a form of psoriatic arthritis. I was prescribed Methotrexate and Humira.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
11 year old receiving Vaxelis; This spontaneous safety report was received by the partner on 14-Mar-2022 and forwarded to Agency on 15-Mar-2022 from an other health care professional.  Due to the nature of the event, the causality between the event "11 year old receiving Vaxelis" and the product is not applicable.  Further information is expected.