chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with no pertinent medical history and no drug reactions/allergies who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (0.5 ml, IM). On 25-MAR-2010, the patient received the second dose of GARDASIL (0.5 ml, IM). On specified date, the patient called the office stating she had been determined to be pregnant. The LMP was unknown at the time of the report. There were no lab diagnostics studies performed. The patient scheduled for her first obstetrical visit in June 2010, At the reporting time, the outcome was unknown. Follow up information was received from the medical assistant concerning the 18 year old female with heart murmur who was vaccinated with the first and second dose of GARDASIL (lot # 661758/1480Y) on 14-JAN-2010 and 25-MAR-2010 respectively. The patient was determined to be pregnant before her initial screening was performed. The medical assistant will re-send the information after the patient has been seen initially and more information on her pregnancy is obtained. Follow up information has been received from the medical assistant concerning the 18 year old female with heart murmur (outgrown) and with no previous pregnancies and no spontaneous abortions who was vaccinated with the first dose of GARDASIL (lot # 661758/1480Y) in the right deltoid on 14-JAN-2010. On 25-MAR-2010 the patient received the second dose of GARDASIL (lot # 661758/1480Y) in the left deltoid. The patient was pregnant after the 2nd injection. The estimated conception date was 29-MAR-2010. The patient' last menstrual period was 15-MAR-2010. Estimated delivery date was 22-DEC-2010. Follow-up information was received from the medical assistant who reported the patient on an unspecified date was experienced urinary tract infection (UTI). The estimated conception date was 30-MAR-2010. On 22-JUL-2010 the patient had routine maternal serum alpha fetoprotein (MSAFP) test and the result was negative. On 30-SEP-2010 the patient had ultrasound which revealed within normal limits (WNL). The patient was treated with MACROBID on 30-SEP-2010 for UTI. From April 2010 to present the patient was treated with prenatal vitamins (PNV) daily. Follow-up information was received from an office worker reporting the patient with negative Rhesus factor (RF), on approximately 27-SEP-2010, at 28 weeks of gestation experienced bladder infection. The patient was treated with MACROBID, 100 mg, twice a day from 30-SEP-2010 to 06-OCT-2010 for urinary tract infection (UTI). Ultrasound performed in 6 weeks, 8 weeks, 28 weeks of gestation, all normal fetal anatomy. On 17-DEC-2010, the patient experienced 2 degree perineal laceration during labor/delivery. On 17-DEC-2010, 39 weeks from LMP, the patient delivered a male normal baby with no congenital anomalies and no other complication or abnormalities. The baby's weight was 7 pound 10 ounce, length was 21 inches, APGAR score 7/9, head circumference was 13. No further information is available.
Several hours after the vaccine I experienced the usual side effects: sore arm, fatigue, muscle aches; which have passed.  My big concern is that I also  suddenly developed dark, stringy images and blurry vision in my left eye. The eye symptoms are still present.
1st dose 1/28, second dose 2/21; each time had injection site soreness. 3/26/2021 had onset of pain, joint pain, neck pain, right knee swelling and fever.
Large area on left thigh is red and swollen at injection site. Pt was given Augmentin 400 mg/5ml and instructed to take Benadryl.
Pt developed petechiae in a traumatic pattern on upper arms, upper thighs CBC x 2 WNL. PT, PTT WNL.
large reddened area site of inj-lt upper arm;reported double vision, severe onset of tiredness immed;6/4/99 slurred speech, loss of balance, head pain combo w/rt eye pain;Dx=mild stroke; previous to 6/2/99, HTN was med regulated; Annual follow-up received on 09/29/2000 states there is still residual effects of CVA in speech. The pt slurs occasionally and hypotension upon standing. The pt states has had prior vaccinatios with no adverse reaction.
Local reaction, large erythematous inflammation of skin surrounding injection site. Uniform in color. Minimal induration. Well circumscribed. Approx 11cmx8cm. +tenderness and itching reported. Tx with hydrocortisone rx cream, ibuprofen 600mg TID PRN and Benadryl 25mg TID PRN. Will continue to monitor. Not anticipating further treatment.
fever 102-103 24 hrs after shot, rash circular erythematous macular with whitish center. Better with Benadryl and Tylenol. Fever/rash daily + 5days after shots.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penecillin" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was used for COVID 19 treatment. Treatment start date was 04Sep2022 and stop date was 08Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
NO ADVERSE EVENT; product storrage error; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 16-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # S005809 expiring on 02-NOV-2021, for prophylaxis (exact dose, frequency, route and site of administration were not reported). No adverse reactions were reported.  The hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was stored at a too low temperature of 3.0 degrees Fahrenheit (F) for the time frame of 3 hours and 30 minutes.The improper storage was recorded by Digital Data Logger. It was unknown if there was any previous temperature excursion. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005809; expirationdate: 02-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA010937: US-009507513-2011USA011543: US-009507513-2011USA010999: US-009507513-2012USA002966: US-009507513-2012USA006031: US-009507513-2011USA010974: US-009507513-2012USA002962: US-009507513-2012USA006027:
This spontaneous report was received from a healthcare worker refers to a 17 year old female patient. The patient's medical history included syncope. No concurrent conditions and drug reactions/allergies were reported. On 02-MAY-2016, the patient was administered with first dose of GARDASIL 9 (dose: 0.5 ml, once, lot # L038503, expiry date: 18-DEC-2017) via intramuscular route. No concomitant medications were reported. Healthcare worker reported that an unspecified time after receiving the vaccine, the patient experienced a near syncopal episode which lasted for about 10 seconds and then she returned back to normal. The patient required medical attention as the adverse event occurred in the physician's office. Healthcare worker also reported that the patient did not fully lose her consciousness, however, she did lose her memory for about 5 seconds and did not remember the episode occurring. No treatment was provided for the adverse events. Healthcare worker stated that they monitored the patient's vital signs for 15 minutes following the episode and all her vital signs were found to be normal. Outcome of the events were reported as recovered. Reporting healthcare worker had no assessed the causality of events with respect to therapy with GARDASIL 9. Additional information has been requested.
Vaccine in AM. That evening, lightheaded, then syncope. W/U (-).
Vaccine 1: dizziness, foggy, tiredness and sore arm Vaccine 2:  sore arm  During the process of both vaccines pts level rose up significantly February before vaccine was .65 .    August after both vaccines psa went up to 2.67.
Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very severe dizziness and lightheaded.
I started to feel a sore throat and ear pain pretty strong that started the late evening of May 21, 2022. I had a sinus infection for a couple of weeks. On June 24th, 2022 I noticed I had some sinus congestion again. Throughout the next couple of days I had fatigue, hoarse voice, burning in the throat, and brief loss of taste from 07/01/2022 - 07/03/2022 which reoccurred on the 07/09/2022 with sharp pain in the throat, jaw, and taste buds. I did two home COVID-19 tests at the same time which both came back positive and continued testing on July 5th, 2022, July 8th, 2022, and on July 9th, 2022 test was finally negative. August 19th, 2022 I started having pain breast and tenderness, arm pain, pelvic pain for one day. August 29th, 2022 through September 2nd, 2022 I was having shortness of breath and chest pain. September 3rd, 2022 I had more pain in my right arm and right breast. I had mild chest pain in the morning and went to see a doctor on that date. They did a chest X-Ray and an EKG which were normal. October 8th, 2022 through current I have been having heart palpitations, mild chest pain, and shortness of pain intermittently. I went to the emergency room on November 18th, 2022.
Sore R arm after vaccine received on 3/22/07. It has continued and not changed in intensity.
patient being administered YF-VAX that was not reconstituted with supplied diluent and a different sodium chloride diluent was used instead with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered yellow fever vaccine - [YF-VAX] that was not reconstituted with supplied diluent and a different sodium chloride diluent was used instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect yellow fever vaccine, solution for injection (strength; unknown) (Lot number:UJ683AA,Expiration Date :15-Sep-2023) via unknown route in unknown administration site for immunization that was not reconstituted with supplied diluent and a different sodium chloride diluent was used instead with no reported adverse event (product preparation error) (latency; on same day).  Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The arm in which the injection was given was swollen and red. Zyrtec 10mg ever day for 5 days was given.
pt exp stiffness in the inj site arm which radiates to neck;no tx has  given;pain r/t pinched nerves;rt shoulder discomfort noted;pt unable to abduct the arm & had pain on raising the arm @ 20 degree against pressure;poss rotator cuff tear;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 001B21A) for an unknown indication.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.         No concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Patient called clinic the day after receiving booster dose of Moderna Covid Vaccine.  The following is the transcript from call with nurse: Patient calls in to let you know that he had his COVID shot yesterday and made him very sick.  States he can't move his body again gravity.  Having trouble lifting his arms and everything hurts.  States in the middle of the night he developed a 104 degree temperature, body aches, and is just miserable.  He is only getting out of bed to go to the bathroom.  He is trying to push fluids.  He just wanted to let you know of his side effects.
I woke up early in the morning on 1/22 with my arm itching at the injection site.  I got up to check my arm and it was red, swollen, and hot to the touch in a pentagon shape around the injection site.  Over the next few days the redness, swelling, heat and itchiness spread over the top part of my arm making a bullseye; it became tender to the touch and broke out in hives.  The bullseye spread and started to dissipate yesterday and today it is almost gone.     I did not have a fever, and the rash/hives didn't extend beyond the upper part of my arm.
Day 1 - diarrhea x 2, Stomach upset, Headache, fatigue, short of breath with ambulation only, rash on left hand - dorsal aspect - pink - pinpoint - non itchy. Did not work (called in sick)  Day 7 - Rash is less but present - itchy on day 6 and 7.  Fatigue and headache continue. Shortness of breath with ambulation - subsides with sitting.  Sleep is normal. Attending work as usual - other than days 1 and 6 - went home after 4 hours of work on day 6. Eating normal - bowels and bladder normal. Denies fever and chills.
he could barely eat breakfast, nausea, sleepy, sweating, lethargic, and after seeing his HCP his blood work says he has liver inflammation; He is unable to walk now without a walker; This is a spontaneous report from a non-contactable consumer (patient's wife).  A 72 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine on 19Jan2021. After he got home, he could barely eat breakfast, nausea, sleepy, sweating, lethargic on 19Jan2021 and after seeing his HCP his blood work says he had liver inflammation. He was unable to walk now without a walker in Jan2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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 measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (HSA). It was unknown if the patient had sought medical attention. Follow up information has been received from the physician who stated that the patient received the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine (Wistar RA 27/3) (HSA) vaccine in the late 1970's. The physician did not remember the name or date of birth of the patient. The physician stated that the patient was an 18 year old mentally retarded female. The father of the baby was a 19 year old mildly retarded male. The physician stated that the patient decided to continue the pregnancy. The physician stated that the baby was normal. The physician followed the baby for two years and the child was developing "ok" with no sequelae from the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (HSA) vaccine.  This was one of the several reports received from the same source. Additional information is not expected.
A spontaneous report had been received from a physician concerned a 5 year old, female patient. The patient's concurrent diseases included cerebral atrophy and epilepsy. The patient was prescribed nasal Fluenz tetra started on 15-Dec-2015. It was reported that misuse which started on 24-Feb-2016. The outcome of misuse was unknown. The company physician assessed misuse to be non serious.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Localized pain; chills, fatigue;swollen glands
Slight nausea, slight headache, extreme fatigue (I couldn't do anything but sleep for 17 hours straight), heaviness on chest
she's scheduled for the 2nd dose today, 18Apr2021, and she's unable to take it because she had a car accident today; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROAD TRAFFIC ACCIDENT (non-serious) with onset 18Apr2021, outcome "unknown", described as "she's scheduled for the 2nd dose today, 18Apr2021, and she's unable to take it because she had a car accident today". Additional Information: The patient was scheduled for the 2nd dose today, 18Apr2021, and she's unable to take it because she had a car accident today. She got the 1st dose on 28Mar2021, and she's asking if it would still be ok to take the 2nd dose anytime this week since it will be more than 3 weeks when she got the 1st dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tenderness at reaction site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Tenderness at reaction site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness at reaction site). At the time of the report, VACCINATION SITE PAIN (Tenderness at reaction site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Rapid heart beat, tightness in chest, tightness in left torso, headaches
Patient vaccinated x2 (Janssen/Moderna: 03/10/21, 12/09/21) Patient admitted to hospital and tested COVID positive 11/27/22
pt recv vax 25MAY95 & 7JUN96 pt devel a mild rash w/30-40 papules & a low grade fever;pt was prescribed med @ mom's request;
Vaccine given 10/3/18 at approx. 0940 - Went home and had nausea/vomiting shortly after with seizure at approx 6:30PM - Hx seizures and GI upset so unclear if reaction. Dc'd hospital 10/5/18.
APROXIMATELY 25 MIN AFTER RECEIVING VACCINE DOSE C/O FEELING LIGHTHEADED, SOB,C/O FEELING WHEEZY, HAD NON PRODUCTIVE COUGH. VS 121/71, HR 66, RR24, O2 SAT 100% ON RM AIR. STATED SHE HAD SIMILAR SYMPTOMS A FEW YEARS AGO AFTER RECEIVING FLU SHOT WITH PRESERVATIVE BUT HAD FLU SHOT PAST FEW YEARS WITH NO PROBLEM,PATIENT WAS TAKEN TO ED AT MSMHC
Shortness of breath with and without exertion. Feeling like she cannot take a deep enough breath.
Had a sore throat and a fever. Took a Home COVID-19 test and it was negative. After a couple of days I went to my doctor and he concluded that I had the Flu.
Several hours after reciving my second dose of the Moderna vaccine I noticed the site of the injection was painful, red and swollen about an inch around. I monitored the site over the next two days and the swelling increased in size to over 4 inches. It was also itchy at times. On Sunday 2/28/2021 I contacted urgent care and was prescibed five days of antibiotics. After the first dose taken that day the pain stopped and the rash did not get any bigger. After five days of antibiotics the rash completley dissapeared.
Patient came 1/7/2022 to get Pfizer booster. Patient called Monday 1/10 to report sore arm and her arm was hot. A pharmacist talked with her to recommend Tylenol. Pharmacist also advised patient if it got worse to seek medical assistance.
Twelve hours after injection, symptoms of chills/hot flashes started throughout the body. Muscles began to feel tight and sore throughout the body. Tingling was felt down the arms (most significantly in the left arm) and into the hands. Lightheadedness, fatigue, and general discomfort followed. Sleep was interrupted with severe pain in the left arm at injection site, increasing temperature (recorded starting at 100 deg F at 2:30 a.m. up to 101.3 24 hours after injection time). Fever and chills, headache, light nausea, and severe muscle cramping continued throughout the day. Symptoms did not cease until 48 hours after injection. 48 hours after injection, left arm at injection site is swollen, hard at the center with pain and heat to the touch, and a 3" diameter red ring/circle surrounding injection site.
Information has been received from a 63 year old female consumer who was vaccinated with a 1st and 2nd dose of Hep-B vaccine. It was reported that "after the 1st shot, she felt fine. Subsequently, after the 2nd shot, the pt started feeling different, discomfort and pain. She went on a trip to Asia after her 1st shot. On her way to China after the 2nd shot, she started feeling pain under her ear." It is unknown if medical attention was sought. She was scheduled to receive the 3rd dose of Hep-B in 11/00. Additional information had been requested.