chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLU LIKE SYMPTOMS; CHILLS; FEVER; SORENESS ON INJECTION SITE; BURNING ON INJECTION SITE; 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, intramuscular, batch number: Unknown) .5 ml, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced soreness on injection site. On 11-MAR-2021, the subject experienced burning on injection site. On 12-MAR-2021, the subject experienced flu like symptoms. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of chills, flu like symptoms, soreness on injection site and burning on injection site was not reported. This report was non-serious.
I started feeling tired and weak and had chills.  I later developed a fever, general body aches, stiff neck, headache, nausea, light headedness, and fatigue.
Immediately after administering immunizations pt was observed to be sitting in chair, eyes were not focused and pt would not respond to his name or stimulation. Pt remained sitting in chair without assistance. Less than 15 sec later pt began to cry, held arms and said it hurts. Pt was not in any respiratory distress and talked to mother at that time. He did c/o throat hurting but not difficulty breathing. Pt and mother remained at site for 15 min without additional problems noted. When asked mother denied any previous reactions to vaccines, medications or seizures. Instructed mother to take pt to ER if any further problems. School nurse notified of incident on 9/22/04 9AM.
Nauseous; Body Aches; Joint Pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), MYALGIA (Body Aches), ARTHRALGIA (Joint Pain), CHILLS (Chills) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (Nauseous), MYALGIA (Body Aches), ARTHRALGIA (Joint Pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, NAUSEA (Nauseous), MYALGIA (Body Aches), ARTHRALGIA (Joint Pain), CHILLS (Chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: The patient reported that the events nausea, myalgia, arthralgia, chills and fever got recovered.
HAIR FALLING OFF DRASTICALLY/THINNING HAIR; FEELING WARM; TINGLING IN LEGS; FELT VERY TIRED/ FELT TIRED TO EXERCISE; HEADACHE LIKE PRESSURE IN THE HEAD; .This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 140 pounds, and height was 64 inches. The patient's concurrent conditions included: social alcohol drinker, non-smoker, and hair loss, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse/illicit drug use. The patient had no medical conditions and was not taking any medication except for the hair vitamins and local hair treatment. The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced feeling warm. On 06-APR-2021, the patient experienced tingling in legs. On 06-APR-2021, the patient experienced felt very tired/ felt tired to exercise. On 06-APR-2021, the patient experienced headache like pressure in the head. Treatment medications included: paracetamol. On MAY-2021, the patient experienced hair falling off drastically/thinning hair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm, tingling in legs, and headache like pressure in the head on 06-APR-2021, and felt very tired/ felt tired to exercise on 13-APR-2021, and had not recovered from hair falling off drastically/thinning hair. This report was non-serious. This case, from the same reporter is linked to 20211112231.
Information has been received from a Licensed Practical Nurse referring to an unknown number of patients of unknown age and gender. Medical history and concurrent condition of the patients were not reported. It was reported that since 30-JUL-2014 the patients were vaccinated with GARDASIL (dose, frequency, lot# and expiry date unknown) intramuscularly, which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a physician via Company Representative refers to a 15 unspecified patients of unknown gender and unknown age. The reporting physician informed the representative that a friend of his posted an unspecified link on Facebook stating that 15 unspecified patients died after receiving GARDASIL (dose, lot/batch number, expiry date and indication was not reported). The physician would like to know where the information was coming from. The representative did not have any further information by the time of the report. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
The top of my breast to the bottom of my stomach feels like that; There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there; There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there; The numbness is coming and going in my abdomen and when it gets unnumb then it hurts (if I touch it or move fast).; my mouth was numb (like when you go to the dentist get a Novocain shot and mouth is numb); body aches; bad headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: EW0176, Expiration Date: Aug2021) at the age of 34 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing), notes: Verbatim: migraines. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 01May2021, outcome "recovering", described as "bad headache"; HYPOAESTHESIA ORAL (non-serious) with onset 20May2021, outcome "not recovered", described as "my mouth was numb (like when you go to the dentist get a Novocain shot and mouth is numb)"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "The top of my breast to the bottom of my stomach feels like that"; HYPOAESTHESIA (non-serious), ABDOMINAL PAIN (non-serious), outcome "unknown" and all described as "There is numbness on the abdomen then it's sore. When the numbness wear off in my abdomen and hurts to be touched there"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "The numbness is coming and going in my abdomen and when it gets unnumb then it hurts (if I touch it or move fast)."; PAIN (non-serious) with onset 10May2021, outcome "recovering", described as "body aches".  No follow-up attempts are possible. No further information is expected.
Increased pain in left arm beyond expected beginning evening of 10/4/17. Redness and swelling noted on 10/5/17 and continued pain. On 10/6/17 redness & swelling had increased/spread & warmth had developed. Saw Occ Health nurse, called primary care provider that day as well and began applying cold compresses. Borders outlined on 10/6. The following morning (10/7) the redness extended slightly beyond the  drawn border & swelling remained the same. By the evening of 10/7 both redness & swelling had reduced. 10/8 redness gone & swelling minimal & no longer warm. All symptoms resolved by the evening of 10/8/17.
"Bilateral arm tremors". No alteration in mental status. Similar reaction after receiving 1 yo vaccines per mom.
High fever - sweating -  tremors headache - unable to sit up - shivering.
Left arm where Varivax and DTaP were given became swollen.  Child then broke out in a diffuse maculopapular rash all over trunk and a few lesions on extremities.  No fever, no breathing issues.
Hive swelling at injection site, redness extends almost to elbow. Slightly painful to touch. Notice approximately 24 hours after injection. Swelling and discomfort worsened over course of next day.
pt devel great fatigue & general aches & pain;pt was unable to get up & function in regular pattern for approx 7 days;
Pfizer Pediatric 5-11y Monovalent vaccine administered as a booster instead of Pfizer Pediatric 5-11y Bivalent vaccine. Called Pfizer and CDC for advice. They recommended to not re-administer. If Bivalent vaccine still desired, then may administer after 2 months. No adverse effects reported by patient's family.
Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph nodes enlarged on right neck \extremely painful even without touching; Right leg:  joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Right leg:  joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; difficult swallowing due to the pain; Right ear painful, feeling like too much pressure on it; Right ear painful, feeling like too much pressure on it; Right head painful, excruciating pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0185 and Expiry date: Unknown), via dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin [penicillin nos] for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. On 21May2021, the patient experienced right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; lymph nodes enlarged on right neck (multiple places: under chin, above collar bone, beside right ear), extremely painful even without touching, difficult swallowing due to the pain; right ear painful, feeling like too much pressure on it and right head painful, excruciating pain. The patient was not received any treatment for the events. The outcome of events was not resolved.
It made my fibromyalgia flare up incredibly bad. I'm still in a flare up to this day. Muscle pain in entire body in addition to joint pain. My hands and feet were tingling for days. My feet, hands, knees, hips, back, stomach, shoulders and neck hurt very badly.  Brain fog. Extremely tired for 3 days.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient called regarding new onset of chest pain and was referred to get evaluated. He is currently at Hospital.
This spontaneous report was received from a registered nurse refers to a 7 month old female patient. The patient's current condition included eczema. On 29-JUN-2012, the patient was vaccinated with live, oral ROTATEQ,(lot number (672075/1711AA), expiration date 13-JUL-2013, route not reported). No concomitant medications were reported. The reporter stated that the patient might have aspirated a dose of oral ROTATEQ during administration. No adverse effect was reported. The patient did not receive any treatment. The patient sought medical attention. (reported as happened in office). Follow up information received the patient. The patient had no pre existing allergies. On 29-JUN-2012 at 10:00 a.m. the patient was vaccinated with a dose of live, ROTATEQ orally. On 29-JUN-2012, the patient was also vaccinated with PENTACEL, (lot number C7193AA, route intramuscular administered on the left thigh) and PREVNAR 13, (lot number FLA178, route intramuscular, administered on right thigh). The reporter stated that the patient choked on live, oral ROTATEQ vaccine. No adverse reactions occurred. The patient completely recovered. The patient had no relevant diagnostic tests done. The patient had no illness at the time of vaccination. Additional information is not expected.
Fever to 104 degrees, joint & muscle pain, headache nausea, treated in Emergency Dept.
Developed face flushing within 3 hours of vaccine. Saturday, 11/6/04, developed raised, itchy rash from head to foot including palms of hands and soles of feet. "Looked like chicken pox without the blister". Took Benadryl / Zantac 11/6/04 and 11/7/04 and relief. Seen by MD 11/8/04. Allergist, Prednisone and Zantac 11/20/04 resolving.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old patient of unknown gender who received 0.5 ml expired dose of vaccine TENIVAC (lot number: U5525AA, expiry date: 07-Jan-2019, frequency once, dose in series not reported) via unknown route in left deltoid on 24-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Patient received no concomitant medication. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the vaccination. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. unknown if patient had Chronic or long-standing health conditions.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient age was reported as 56 years 2 months. It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.
I have to adverse events to report. First noticed, was change in menstruation, first menstruation after second dose. It continues to this date every cycle. The changes are cramping. I never had cramping with menstral cycles before, except when I first started period at age 16ish that was only for a couple years, and then disappeared. Other is that cycle is heavier, and darker in color. I did not report earlier due to it already being reported.   My second adverse event, was on 11/28/21, I experienced a herpes outbreak. It is not unusual for me to have an outbreak every now and then. Usually mild, one blister, no pain relievers, normal process of healing after initial outbreak. I have had oral herpes about 18 years old. This particular outbreak is not like any other. Instead of one blister, there are several (3-4 of them) clumped together, in same location I would normally get one. The pain is intense, like I've never felt, and the blisters are not healing as they normally would. I also have severe swelling, and pain. Usually I feel pain along nerves right before cold sore shows up, then the pain goes away, the sore then starts clearing. With this outbreak, the pain has not dissipated. I'm having to take over the counter medication. It seems to not be budging with clearing up. This is by far not anything I've experienced in the past.
Pt reports chest pain that started roughly 12 days after receiving Pfizer COVID vaccine. Did not report any other causes/circumstances, or symptoms.
For about 4 days, I had a splitting headache, blurry vision, and  elevated heart rate
expired dose of ACTHIB was administered to a patient with no reported AE; Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 months old female patient to whom expired dose of HIB (PRP/T) vaccine [ACT-HIB] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 31-Jan-2023, the patient received a dose 3 at dosage 0.5 mL of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, at once (lot number: UJ585AAA; expiry date: 16-Oct-2022) via intramuscular route in the thigh nos along with diluent (lot number: U7146AB) for prophylactic vaccination (immunization) with no reported ae (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and "OTC vit" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine).  The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced "brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". Treatment for the event "headache off and on" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events "brief period of pain in my right bicep" and "tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.
Patient was given an inadvertent dose of Moderna Spikevax COVID-19 vaccine on 10/15/23. Patient had registered and intended to receive an influenza immunization, but was erroneously given a COVID-19 vaccine dose. Patient had received a previous Pfizer/Comirnaty COVID-19 vaccine on 9/21/23. Patient is reporting body aches/pains, general fatigue, feverishness, nausea, headache, and pain/tenderness at the injection site (left arm).
10 minutes after administering the vaccine the patient was concerned she was experiencing a skin irritation (welt) on her left wrist. She had no breathing issues or any other adverse effects.  She was asked if she wanted a generic Benadryl capsule and agreed. Her caregiver said this happens often when she receives vaccines but did not indicate that on the VAR. After 10 more minutes, the welt subsided and she was comfortable with leaving.
Information was received on 14-OCT-2016 from a medical assistant who reported that multiple unspecified patients received either VARIVAX (confirmed lot no. M028553, expiration 07-JUN-2018) M004330, 26-JAN-2018; M009766, 23-FEB-2018; M017290, 07-APR-2018; M024683, 18-MAY-2018), or PROQUAD (confirmed M006107, expiration 01-AUG-2017; M007962, 15-AUG-2017; M017337, 05-OCT-2017; M029599, 10-DEC-2017) that were improperly stored. No adverse effects reported. All fields pertain to all unspecified patients and all products. No further information was provided. This is one of two reports. Additional information has been requested.