chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Every 27-29 days since my last shot on March 8, I get a combination of headache, lethargy, no appetite and chills.
Information has been received through the Merck pregnancy registry, from a registered nurse, concerning a 31 year old female patient who in August 2006 and October 2006 was vaccinated with the first and second doses of GARDASIL, respectively.  On 07-JAN-2007 the nurse reported that the "patient has become pregnant during the 3-dose series."  The nurse added that "no adverse reactions have been reported for this patient."  Date of the last menstrual period was 7-JAN-2007 and the patient delivered on 07-OCT-2007 at 39 weeks estimated gestational age.  She had an uncomplicated vaginal birth and a healthy female infant.  The patient sought unspecified medical attention.  No further information is available.
Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night sweats, fever, Diarrhea
This spontaneous report was received from a other health professional referring to a 50 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route, lot# and expiration date were not provided) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1904USA003613.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, 1 total administered on 24-MAR-2021 to right arm for prophylactic vaccination. Age at time of vaccination 43 years old. The patient received additional non-company suspect Moderna Covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 051F21A, expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2022, the patient experienced dry throat coded with suspected covid-19 infection (Dose number in series 2). Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 14-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative (Dose number in series 2).  On 16-APR-2022, the patient felt crummy and also tested positive for COVID-19 by using JNJ supplied Binax now test kit, coded with suspected clinical vaccination failure (Dose number in series 1). It was reported that within 2 days on 18-APR-22 dry throat resolved and the patient felt 100 percent better (Dose number in series 2). On 19-APR-2022, the patient experienced loss of taste and recovered a week later (on 26-APR-2022)(Dose number in series 2). On 20-APR-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from suspected covid-19 infection on 26-APR-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000229316.; Sender's Comments: V0: 20220505772-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
No adverse effects reported; a dose of gardasil 9 was inadvertently administered to a 65 year old patient; This spontaneous report was received from a pharmacist, referring to a 65 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 19-AUG-2019, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621929, for prophylaxis (strength, dose, route, frequency and expiration date were not reported). No adverse effect reported.
Large hard swollen lymph nodes in neck primarily on the left side; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 05May2021 at 16:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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 metoprolol (MANUFACTURER UNKNOWN), spironolactone (SPIROLACTON) and valaciclovir hydrochloride (VALTREX). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 25May2021, the patient experienced large hard swollen lymph nodes in neck primarily on the left side .The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event swollen lymph nodes was unknown at the time of this report.
Patient called on 11/6/19 with following symptoms:  She woke up 11/6/19 and felt awful she felt like she was going to pass out. She felt so weak. She checked her BP on an old machine 81/65 HR 120. She feels very fatigued and freezing so she tried to warm herself up by putting on a lot of clothes and using heating pad checked her temp was 100.3.  She had mild nausea, headache.  Has some nasal congestion could be allergies per pt. .  Residual URI with cough is almost gone.  Weakness is significant enough that she feels like she can't get up from the bed.  6 hours later, patient stable, headache, improved with Tylenol.  Still feeling weak.
It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-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 (It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.) had resolved.        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.   No Concomitant medications were provided No Treatment information provided
I could walk those miles, I can breath better/ there was positive everything today there was no negative in what I am feeling today/ I feel so excited that I feel so good; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0182) via an unspecified route of administration on 15Jun2021 10:30 as 2nd dose, single for COVID-19 immunisation. Medical history included COPD, asthma, epileptic, depression all from an unknown date and unknown if ongoing. Concomitant medications included buspirone (BUSPIRONE) 10 mg taken for depression, start and stop date were not reported; topiramate (TOPAMAX) 200 mg twice a day taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) 15 mg once a day taken for an unspecified indication, start and stop date were not reported; lamotrigine (LAMICTAL) (Lamictal 150 mg, this is at the evening, and then I get 100 in Lamictal) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (LOT no.: EW0176) on 25May2021 for COVID-19 immunisation. On an unspecified date the patient reported that I had my second vaccination today and a lot have side effects and I had none of those today it was the opposite. I had lot of miles up to 4 miles I have to walk I had no choice. I could walk those miles, I can breathe better. I guess there was positive everything today there was no negative in what I am feeling today, and I find myself. That is just gone away. I just have my daughters know that I was going to let you guys know this is such the positive thing I got (Incomplete word) this morning. I am just excited that I feel so good. The clinical outcome of the event was unknown.
I received the first dose on 1/4/2021 in L arm and experienced some soreness only in arm for a day or so. I received the second dose on 2/1/2021 at 2:00 PM  in L arm .  . About 4 :00 I started to experience some soreness in arm By 6:00 PM the soreness went into the muscle on top of my shoulder and into that side of my neck . By 7;30 PM I could not move my arm and my entire arm was throbbing constantly . I began taking  acetaminophen -500 mg every 4 hrs . I had to take 1000 mg to be able to sleep at 10:00 PM  and was awaken from  pain at 2:00 AM . The next day I still could not move my arm and continued acetaminophen every few hrs and applied ice . The discomfort finally went away on the afternoon of 2/3/2021 .
Initial report was received on 13 November 2009 from a health care professional, who also provided follow-up information on 16 November 2009 and 09 February 2009. From new information received on 09 February 2009, it was determined a case narrative was required; therefore the following narrative has captured all case information received to date. A seven-year old female patient had received an injection of H1N1 (route and site not reported), lot number UP005AA on 23 October 2009 and eight days later, she developed a fever (reported as "low grade"). The patient was administered TYLENOL as corrective treatment and her temperature returned to normal; however, during the afternoon the next day, the fever returned and recurred for several days. The patient had no recent ill contacts prior to onset. On 10 November 2009, 18 days after receiving the vaccine, the patient developed a generalized red itchy rash that was mostly on her buttocks and face. By 12 November 2009, the rash was completely gone, but recurred when the patient ran around. The patient had no past medical conditions except for allergies to amoxicillin and OMINICEF and she had not been taking any concomitant medications. According to reporter, the patient's mother stated that approximately one week after she had initially reported this event, she took the patient to her physicians for a "bad sinus infection". The physician told the patient's mother that these events were probably from the child playing in damp leaves (molds, etc). According to the reporter, the patient recovered from the events. The patient subsequently received a second dose of H1N1 vaccine in December (manufacturer, lot number, route, site and exact date of administration not reported) with no adverse events experienced. Documents held by sender: None.
Pt recvd 2 doses of Hep B vax w/no adverse rxn; Pt recvd 3rd dose of vax ID instead of IM; Pt subsequently devel arthralgia, fever, & a rash;
Started passing out at school, incoherent and did not recognize people. Was taken to hospital emergency complete blood work including drug testing done, all came back negative.  CAT scan done came back negative.  Unable to recognize family member that came to hospital and friends. While in hospital she had what we now know 3 seizures.  She becomes completely quiet, tears running down face and does not respond to any one. They released her saying it was a reaction to her asthma inhaler.  Went to pediatrician next day who thought it may be drugs but drug panel at hospital was negative.  Her personality completely changed went from outgoing and friendly, to quiet and tired.  On Wednesday September 5 she returned to the pediatrician who suggested she see a specialist she suspected patient was having seizures and her memory had still not returned.  Started seeing Dr. on Sept. 6 and he confirmed seizures put on meds.  After seizures she becomes very aggravated and mean then take a nap that can last anywhere from a couple hours to all day. There were 2 occasions she lost control of her bodily functions.  In October she started have short term memory loss and would ask the same question over and over again.  She was taken out of school and put on hospital/home studies for the remainder of her sophmore year.  She was taken off all med in the spring of 2008 and her last seizure was in Nov of 2008. 12/16/09 Medical records received for dates 9/16/07 to 3/14/08. DX: seizures. Multiple f/u appts for seizure monitoring. Pt w/ active seizure disorder. 12/17/09 ER records received for date 8/30/07.  DX not documented. SX: c/o asthma attack, parents states pt not acting right since the asthma attack. Assessment: flat affect, disoriented.  1/4/2010 Ed note for 9/20/2007, patient with c/o's dizziness, no tx noted,
Had a general herpes outbreak; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Had a general herpes outbreak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 036A21A) for COVID-19 vaccination. Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.No Medical History information was reported.On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 20-Sep-2021, the patient started VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) at an unspecified dose. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENITAL HERPES (Had a general herpes outbreak). At the time of the report, GENITAL HERPES (Had a general herpes outbreak) outcome was unknown. Patient  was scheduled to get a booster (half dose) on 11 Nov 2021.No Concomitant medication were reported.No treatment medication were reported.
Information has been received from a physician concerning a 4 year old patient (gender not reported) who on 22-JAN-2007 was vaccinated ProQuad (upgrade process) (lot#655752/1122F). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. On an unspecified date, the patient experienced severe anaphylactic reaction. The patient sought unspecified medical attention. The patient required an overnight stay in hospital. Physician was performing allergy test. The patient's outcome and action taken were not reported. There was no product quality complaint. Additional information has been requested.
88 years old man who came with abdominal pain, constipation. The patient reports that his last bowel movement was on December 27. He has been having on and off abdominal pain that is severe at times. He had used multiple medication including laxity is coli stool suppository, Fleet enema with no success. A CT scan done in the emergency room showed fecal impaction, stercoral colitis and severe constipation. He has past medical history of hypertension, diabetes, systolic and diastolic CHF, paroxysmal atrial fibrillation, carotid stenosis status post carotid stent, coronary artery disease status post CABG, aortic valve replacement, chronic kidney disease stage 3,  history of CVA and Ulcerative colitis.  He also reports history of severe confusion secondary to narcotics.  He denies any history of tobacco, alcohol or drug abuse.  Family history is reviewed and noncontributory. Tested positive on 01/11/2022
This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine (dose number in series 1).  The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The 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 patient experienced hives (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Information has been received from a physician concerning a 17 year old female who on 20-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported). On 28-FEB-2008 the patient was vaccinated with her second dose of GARDASIL (lot# not reported). The patient feels she may be pregnant, but she has not missed her period or had a positive pregnancy test at the time of the vaccination. No problems reported. Additional information has been requested.
had problems with their periods they started get them again after they had the Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "had problems with their periods they started get them again after they had the Pfizer".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had a bug bite in the middle of the red/swollen area, this bite occurred roughly around the same time as the patient's NP reported it as a "systemic reaction," the patient reported she was scratching it in the middle of the night and a friend recommended she visit the doctor but the patient waited 2 days before seeking any medical attention. She claims the bug bite had nothing to do with the reaction yet the redness was more towards the bug bite than the administration site. She took benedryl and applied some ice, the "internal itch" stopped upon benedryl admin. but the swelling/redness took an extra day to diminish.
Common side effects of injection site rash and swelling, headache, muscle/body aches, neck ache, chills and fatigue.  This was dose two.  Dose one was just inj site rash and swelling.  I had chicken pox in 1956 at ten months old. Mom gave me aspirin and I became very I'll and hospitalized.   Parents told I was dying. Had blood transfusion. Obviously, I lived.  Just throwing that in for chicken pox reaction.  Shingles at 47.
Chest pain with pulse rate vacillating between  60 - 160 rapidly back and forth
pt recv vax 6NOV98 & 2 days later pt devel swelling of the rt axillary & cervical lymph nodes, as well as an inj sit rxn characterized by sl redness & mild tenderness;
Patient woke up with a golf ball sized lump at injection site that lasted four weeks and a very aggravated eczema patch at injection site that lasted six weeks. Ever since, she has had severe eczema all over her body, requiring long-term use of corticosteroids to control itching. She has scratched her skin off several times and constantly has scratches on her body where she has scratched so hard she bleeds.
Blood sugar elevated for over a week; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar elevated for over a week) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included INSULIN, PREGABALIN (LYRICA), ROPINIROLE HYDROCHLORIDE (REQUIP) and VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar elevated for over a week). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar elevated for over a week) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood glucose: unknown (High) Blood sugar elevated for over a week.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058631 (Patient Link).
Temperature, swelling, sore. Cellulitis - cephalexin 500 #20 1 capsule twice a day for 10 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. In 2010 "2 years ago" the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# and expiration date were not reported). No other co-suspects were reported. No concomitant medications were reported. The patient is in the office to receive the second dose today (on 17-JUL-2012). NO adverse effect reported. Additional information has been requested.
I received my injection on 12/29/2020 with no symptoms. The next morning, I woke with minor side effects body aches, chills, slight fever and arm sore from injection. As the day progressed, my symptoms got worse. By body aches were so severe that it hurt to stand, sit, bend and curl my toes. My head was so full of congestion by the end of the night. I was meeting with a small group of family for New Year's and thought that I would get checked to make sure that it was nothing. I was tested for COVID and for Influenza. I came back positive for Influenza A. I was sent home with a sample of Xofluza. I was in bed for 2 days and symptoms started subsiding. I went back to work the following week.