chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; CHILLS; VOMITING; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 05-OCT-2021, the patient experienced body aches. On 05-OCT-2021, the patient experienced chills. On 05-OCT-2021, the patient experienced vomiting. On 05-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, vomiting, fever and body aches was not reported. This report was non-serious.
Developed DVT in left leg around January 9. Developed pain, redness and swelling in left calf
Information has been received from a health professional concerning a female who on 08-MAY-2007 was vaccinated IM 0.5mL first dose with GARDASIL vaccine (yeast) (lot# 657006/0188U).  Concomitant therapy included VARIVAX (MSD).  Subsequently the patient experienced swollen arm and arm redness after the Gardasil injection.  Subsequently, the patient recovered from swollen arm and arm redness.  The patient sought unspecified medial attention.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from s health professional concerning a female student who on 08-MAY-2007, in AM was vaccinated IM 0.5ml first dose with GARDASIL vaccine (yeast) (lot# 657006/0188U). Concomitant suspect therapy included one dose  of VARIVAX (lot# 656078/0169U. Other concomitant therapy included MENACTRA vaccine . The patient experienced swollen arm and arm redness after the GARDASIL vaccine (yeast) injection. Subsequently , the patient recovered from swollen arm and arm redness. The patient sought unspecified medical attention. In follow up it was reported that on 08-MAY-2007, "patient said that her arns hurt" and then redness, swelling appaered on 09-MAY-2007 and redness was approximately quarter size. The patient recovered. Additional information is not expected.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' drug reaction and medical history were not reported. On unknown dates the patients were vaccinated with GARDASIL (lot # K006960 with expiration date 19-FEB-2017) (dose and route unknown). which have been exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse effects were reported. At the time of the report, no adverse effects were reported. Additional information has been requested.
redness; sore; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but was captured as adult as per vaccine indication. The healthcare professional (HCP) stated, the patients (no more than 2 or 3 patients) that experienced redness and were more sore after dose 1 of Shingrix then were just fine following dose 2. The reporter consented to follow up.  No additional details were available regarding the event.
7/26/21 8:50 AM Well son in law tested positive for covid Friday (no vaccine).. female family member became symptomatic and tested positive for Covid Sunday (FULLY vaccinated) LAST Wednesday I became achy and fever 101. Over course of weekend fever hung around 100 nasal congestion and Saturday lost my taste and smell. Yesterday first day  with no temp. Feeling better but still no taste or smell. I do not need to be seen. No dyspnea pulse ox 98 room air . Mild cough but do you want me to be tested even though I am on the mend. If so enter order and I will go to a lab.  Thanks Note    ----- Message sent at 7/27/2021 7:50 AM ----- Please let patient know that her Covid test was positive.  She was exposed through an unvaccinated family member although she has been vaccinated.  We believe the current positives are most likely related to the delta variant although people who are vaccinated seem to get fairly mild illness.  When patient contacted as she was already noting improvement but if she is having symptoms please help her to arrange appropriate follow-up either in office or via video visit if necessary.  She will still need to keep the usual quarantine of 10 days from onset
At 2:15pm patient was seated in the observation area after receiving vaccine.  Patient was observed while his head fell back and appeared to have fainted. Patient stated he had not eaten since yesterday. Vital signs were taken blood pressure noted at 117/56, pulse 62, 02 sat 99%.  Patient was given a snack and verbalized he felt better. Vital signs were taken again fifteen minutes later and were noted at blood pressure 118/70,  pulse :82, O2 99%.  Patient was driven home by a friend.
This spontaneous report was received from a license vocational nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an unspecified doses of ROTATEQ, oral, lot # K023532 and expiration date 21-JUN-2016, which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
I felt fine, but around 9:00 pm  Friday, I started feeling slightly ill.  My throat got scratchy, and my nose began to get plugged up.  The following Sunday, I had a full on sinus infection.
ERYTHEMA, HEAT AND SWELLING AT SITE OF INJECTION 3X3CM2 ON BACK OF RIGHT ARM.  NO FEVER NOT SYSTEMIC EFFECT.
I started to feel very tired, felt sick, and head congestion. I took a COVID-19 test at home and it was positive. Later, I developed a cough, running nose, and chest rash. I took ibuprofen, SUDAFED, antihistamine, and TYLENOL. I still have a cough, nasal drip, and fatigue.
Fever for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever for 4 days) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Fever for 4 days). On 14-Apr-2021, PYREXIA (Fever for 4 days) had resolved.            The patient was taking Menacycline as concomitant medications.  No treatment medications were reported by the reporter.  The patient had not taking any medication at the time of vaccination and had not experienced any side effects after receiving 1st dose of Moderna COVID 19 vaccine.   This case was linked to MOD-2021-400090 (Patient Link).
temp ranging from 101.8 to 103 ax from evening of vax until 1JUl93; crying episode throughout entire noc which stopped @ intervals when mom held pt; 1JUL93 pt has sx of nasal congestion, gurgling in nose & throat, no temp;
Fever, malaise, aches.  severe swelling, redness, warmth, tenderness of mid 1/3 of L arm.
Pain and swelling in the left armpit to the left breast. I had pain and inflammation for almost 1 week and my doctor prescribed ibuprofen that helped me get better quickly.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter had talked to many people who also had unpleasant reactions. This case has been linked with US2019GSK018910, reported by same reporter.
joint pain, joint stiffness, extreme burning in both hands, numbness to all fingers on each hand ASA 325 mg every day Burning in hands has become less severe and less frequent numbness to fingers continues to this date
COVID; COVID; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 6 patients. This is 5th of six reports.   An unknown age and gender patient received 1st of BTN162B2 (Pfizer BioNTech Covid 19 vaccine) on 22Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. it was reported that patient contracted COVID after receiving the 1st vaccine dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient, who contracted COVID after receiving the 1st vaccine dose, cannot be completely excluded.
Patient received HPV, TDaP, & Varicella in the left arm, and Hepatitis A, and Meningitis vaccines in the right arm. Immediately after vaccine administration patient was alert and oriented and talking. Approximately 2 minutes later patient fell out of chair hitting head on floor. Patient began seizing and posturing, I rolled her onto her side and stayed with her. Called for help. Patient had period of apnea and cyanosis followed by spontaneous breathing. A second seizure happened immediately afterward followed by a second period of apnea and cyanosis. Patient spontaneously began to breathe again and began to cry. She was aware of her surroundings- "a doctor's office". Patient had head injury with swelling and bruising on forehead from hitting the floor. Ice pack applied to head injury. Oriented to person, place, and time. Juice box given to patient for fluids. Patient's grandfather was present at the time of event and called mother on cell phone to update her. Advised patient and her family to go to emergency room or primary care provider immediately.
This spontaneous prospective pregnancy report was received from a nurse and from a currently 19-year-old female patient, reporting on herself. Her concurrent condition included nausea. The patient did not have any pertinent medical history and had a drug allergy/reaction to BENADRYL. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). On 17-JUN-2013, the patient was vaccinated with the second dose of GARDASIL. It was reported that the patient received her last GARDASIL on 10-DEC-2014. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. (captured in MAARS # 1806USA004948). On an unknown date, the patient became pregnant. The last mentrual period (LMP) and estimated date of deliver (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The fetal outcome was unknown. On an unknown date, the patient developed hyperemesis gravidarum. The nurse stated that the medical staff had only been seing the patient since 19-SEP-2017. The patient had a history of hospitalization for headache beginning 08-JUL-2017 (not further specified). They had been treating her for chronic fatigue, migraines, reactive airway disease, allergic rhinitis, abnormal weight gain (captured in MAARS # 1806USA004948). Treatment medications included ZOFRAN, clonazepam, sertraline and PRO-AIR (not further specified). The outcome of hyperemesis gravidarum and the causality assessment were not reported. Upon internal review, the event of hyperemesis gravidarum was determined to be medically significant. This is one of two reports regarding the same patient. Sender's Comments: US-009507513-1806USA004948.
Information has been received form a physician concerning a 10 year old female who on 28-JUN-2000 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 26-DEC-2009, the patient experienced mumps (diagnosed on 30-DEC-2009). The patient was afebrile and had R parotitis. The outcome for mumps was not reported. No further information is available.
Client's hands both hands, turned a purplish color, they were bilaterally pale and mottled. Client reported that they were cold before the immunization. pulse oximeter reported 99%, and 82 bpm. Given juice crackers, and  sucker. Client reported that she had a yogurt for breakfast.  After juice hands were more of normal color. About 3 hours after vaccination it was reported that client had one small hive spot under her chin. Client stated that it was itchy. No other hives indicated anywhere else.
My first Covid vaccine was June 15,  2021. I started having period cramps a few days later. I keep track of my monthly periods over the pat 2 years. I am always regular and never have issues, STI's etc, I am monogamous and my partner is female.  I have been having a light period with my regular more heavy period in between, from June 24th to today 7/17/21. and cramping ranging from 2-7 out of 10 pain level started earlier than the 24th of june.
The patients were vaccinated with 3 dose of RECOMBIVAX HB (Lot number unspecified) (vaccination site unknown) on an unknown date and not seroconvert. The nursing students had completed the 3 dose series and it had been greater than 6 months since completion. These nursing students were given additional 1 booster dose of hepatitis B vaccine (manufacture unspecified) and a repeat titer on an unknown date. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome was unknown. This is one of three reports from the same reporter. All telephone attempt to obtain follow-up information have been unsuccessful. Additional information has been requested.
Hives starting under right breast, by Thursday 10/15/2015 AM was all over trunk/abodmen/back. Already taking Zyrtec, added Pepcid and Benadryl. Urgent care added steroid injection IM and prednisone 20mg BID * 4 days. Hives have not reduced or gone away as of today 10/16/2015.
I woke up the next morning after receiving 1st dose of vaccine with high pitched ringing in my left ear.  My ear is still ringing and it is constant all day.
Large erythematous skin rash at site of injection. Size approximately 10 x 5 cm (4X3 inches) Area is swollen, warm to the touch, and itchy.
HEADACHE, Arthralgia, Fever, Rash & NauseaVomiting  Narrative: 1/12 chills, HA 1/13 HA, temp 100 , joint pain, chest pain, nausea 1/14 HA, chest pain, rash
Headache; Hard Injection Site; Sore Right Arm; Rash (3.5" ) on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PAIN (Sore Right Arm), VACCINATION SITE RASH (Rash (3.5" ) on the Injection Site) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PAIN (Sore Right Arm) and VACCINATION SITE RASH (Rash (3.5" ) on the Injection Site). On 24-Feb-2021, the patient experienced HEADACHE (Headache). On 26-Feb-2021, HEADACHE (Headache) had resolved. On 01-Mar-2021, VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PAIN (Sore Right Arm) and VACCINATION SITE RASH (Rash (3.5" ) on the Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
3 days after injection severe pain in left hip joint. Within a week left index knuckle became red, hot swollen, within days of that both knees became warm and  very painful, then right middle finger and ring finger and over the past 8 months the joint pain moved to both shoulders, both wrists, and intermittently my right foot.  Pain worst in the morning and worsens with inactivity.  Have seen PCP, infectious disease , 2 rheumatologists. I take NSAIDs and on 2 occasions prednisone. 20 mg prednisone did take pain and swelling away but returned as soon as I stopped taking it. Bloodwork for auto immune diseases (RF, ANA and others ) are negative. I have had an extensive list of blood and stool tests. The only Abnormal results are elevated CRP and ESR. MRI shows joint erosion in my fingers and wrists. Diagnosis initially was reactive arthritis and now 10 Months later it?s polyarticular inflammatory arthritis. All Drs have advised I begin methotrexate for treatment. As of now, I have not had the booster.
Case number PHEH2014US024292, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up received from nurse on 21JAN2015. This report refers to a 14 years old male patient. His medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. He was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 15411P, expiry date: MAR2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05NOV 2014. Nurse reported that PFS of FLUVIRN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21JAN2015: updated site of vaccination and reporter comment.
Pt recvd OPV/Typhoid & p/1 wk of travel devel cold sx w/plugged ears, fever & chills; upon return devel fever, chills; 1 mo later 21MAR92 devel ankle, knee & shoulder pain & bone pain;
Information has been received from a medical assistant concerning a 23 year old female with a history endometriosis (laparoscopic surgery 29-Oct-2007) and no known drug reactions/allergies who on 03-DEC-2007 was vaccinated intramuscularly in the right deltoid muscle with the 1st 0.5ml dose of GARDASIL vaccine (lot#659439/1267U). Concomitant therapy included leuprolide acetate injection (LUPRON DEPOT) received on 03-Dec-2007. Subsequently, post vaccination (date was not reported), the patient experienced nausea, vomiting, a fever and developed a unspecified rash from the waist down. The patient was seen by the physician on 18-Dec-2007 and received unspecified medical attention. No diagnostic lab test were performed. At the time of this report it was unknown if the patient recovered. Additional information has been requested.
5-year-old received the wrong dose of vaccine. She received 0.25mL of the adult vaccine equaling 50mg dose versus the 25mg she was supposed to get. Her mom called. Currently no issues. No symptoms. No complaints.
Patient denied receiving previous monkeypox vaccine and stated today was 1st dose. When documenting administration, it was noted in the immunization registry that patient had a previous dose <28 days ago.
Left arm numbness with mild pain. Episode of vomiting x1. Reportedly skipped breakfast and lunch; and had a great deal of anxiety about getting injection. Observed for 1 hour. Besides subjective reports, neurological exam was benign. Stayed in observation until patient could keep liquids down, and she reported she was safe to drive home.
Patient administered incorrect COVID-19 vaccine. Patient supposed to be given 6 month to 4-year-old, but given 5 years to 11-year-old. Manager contacted Pfizer and received information to provide to patient and guardian. Details were provided that usual symptoms may be slightly increased where the patient received a more concentrated dose of the vaccine.
Lack of appetite, injection site pain throughout the day.  Approx 4pm onset of fatigue and dizziness.  Approx 10pm through approx 5am fever, chills, restlessness, joint pain, headache.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 11-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. called 9-27-10 c/o 2" diameter swelling (R) deltoid -Warm to touch and bright red. States sx started (5) hr. after adm. with difficulty moving arm. 9-25-10 - 2" raised, red, warm to touch - 9/28/10: redness, swelling, firm 4 cm subQ nodule, very tender to touch - R arm/deltoid. Rx: Clinda 300 mg PO q 6h. 9/29/10: Swelling and redness much improved. As of 9/29/10 improving on Clinda.
fever 101 @ home (afeb in office);eyes rolled back, went limp, turned blue, vomited duration of episode 30seconds-witnessed by mom;sz type activity witnessed by MD & nurse @ hosp;
The same day post vax, this pt experienced a sore arm around the injection site. The following day, the reporter noted, "didn't bother her."  Two days post vax, she experienced swelling, redness, heat and tightness from the armpit to wrist. The pt sought medical attention and was placed on therapy with cephalexin, double dose for 24 hours. It was noted that her "hand was involved and the pt is being sent to ER." Follow-up information received from the physician indicated that the pt was seen in the ER where CBC and BMP were negative. She was instructed to keep her arm elevated, use ice and to take diphenhydramine HCl. She recovered.
Pt was given DTaP #5 in right deltoid IM on 08/06/03. Reaction started 08/07/03. 7.5cm x 7cm swollen red area on right deltoid. Was seen in office on 08/08/03 and was given 1.5 tsp of Benadryl.