chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms; hives are itchy; red rash is just a little tender; red rash on the injection site; red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms), PRURITUS (hives are itchy), RASH (red rash is just a little tender), VACCINATION SITE RASH (red rash on the injection site) and VACCINATION SITE ERYTHEMA (red rash on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced URTICARIA (breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms), PRURITUS (hives are itchy), RASH (red rash is just a little tender), VACCINATION SITE RASH (red rash on the injection site) and VACCINATION SITE ERYTHEMA (red rash on the injection site). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms), PRURITUS (hives are itchy), RASH (red rash is just a little tender), VACCINATION SITE RASH (red rash on the injection site) and VACCINATION SITE ERYTHEMA (red rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed red, spotty rash around his thigh where the injection was given. Lasted a few days.
Minor anaphylaxis and hives/heat rash behind underarms near shoulder blades. Sensitivity to sunlight.  Minor anaphylaxis-started about 2 hours after injection and lasted approximately 8 hours. Resolved fully by next morning.  Hives/heat rash behind underarms near shoulder blades-started about 3 hours after injection. Was made worse during sunlight exposure. Are minorly itchy.  Sunlight Sensitivity lasted for about 24-48 hours. Seems to have resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9262), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 20Feb2022; ALBUTEROL SULFATE HFA, start date: 31Dec2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (27Jun2022) positive, notes: Return of symptoms 5 days after completion of full paxlovid course and resumption of positive antigen results. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 18Jun2022 to 22Jun2022.  Clinical course: The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was unknown by the reporter Treatment medication include steroids  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Mother stated that bilateral thighs had a local reaction from the vaccines stated the Lt thigh had redness, warmth and the lump was a size of a nickel, the RT thigh had the same reaction but the lump had a larger size, the size of a goldball.
Severe sore throat - sharp pain; viral in nature of unknown origin. Nurse Practitioner at the Urgent Care - April 4th- said it looked like a stress reaction possibly to the vaccine - ant-viral was prescribed. The anti-viral resolved the symptoms.
w/in 3 hrs p/vax pt devel fever to 103; given APAP; then began crying inconsolably; despite APAP, cont to cry for the next 8 hrs; seen on the next day reported on 22OCT92; did not eval pt;
About 10 minutes after vaccination employee complained of numbness in left arm. Then felt dizzy and as if she was about to pass out. BP 180/112. Numbness in legs.
Patient called to let us know that she had passed out after receiving her vaccines.  Per phone conversation she stated, she remembers letting the dog out when she got home on Wednesday, the next thing she remembers is waking up on the floor face down and her knees are sore and stated she was down for 2 days.  States she feels better today.   She was instructed by staff to go to ER she stated she would have her brother take her.
Huge red hot arm where injection went in. Redness and swelling was 11 cm in diameter and on the fifth day post injection injection site had a darker red hotter center of approx. 6cm with 4-5cm ring on the outer edge of that red and swollen. Very itchy.
2 hrs p/DTP/HIB/OPV pt cried uncontrollably for 3 hrs, high pitched screaming; no sz or loss of consciousness;
Mon 12/21 - "passed out" for <1 min. - unable to hear wgt, good movement in legs. Tue 12/22 - pain in knees - temp 99.3 oral partial wgt bearing. Weds 12/23 - "can take a few steps" independently getting better.
Pt admit to hospital 5/25/22 w/ COVID+ infection (positive result from 5/22/22). Notes indicate she has received 4 doses of Moderna (2/24/21, 3/22/21, 10/27/21, unsure of 4th date). Of note, pt is immunocompromised on immunosuppressants/steroids s/p renal/liver transplants (liver in 2001, renal in 2017).
high fever (101.3 F), body aches, chills, headache, fatigue, sweating
fever; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 05-Feb-2021, PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Fainting spell/syncope, pulsatile tinnitus in the right ear & migraine with neurological symptoms - burning, tingling and pain in head, neck, face, left arm and left leg - for 3 weeks now. 1st Moderna shot was on 5/3. Symptoms started 5/9 and have not reduced or gone away. Been to the ER 3 times now in 3 weeks. Seen ENT, Neurologist, Primary and ER physicians. This came on abruptly with no prior history of migraines. Status migrainosus.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided. The vaccine was administered after 2 days from  time from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information included no new information.
Approximately at 20:30 09/25/2003, child had 2 episodes of seizures; was transported by EMS to ER; diagnosis was viral syndrome, febrile seizure.  His temperature at home was reportedly 103; at ER 104!  Motrin given, CSF normal, X-ray normal
Redness, swollen, sore at injection site. Body aches. Temperature = 100.7. Temp drops temporarily with Advil, peaks in evening. During day, body aches and cold sweats. Day 4 of symptoms. (This is day 4).
Pt recv vax on 12/1/98; on 12/3/98 pt exp additional use of inhaler for asthma/breathing, itchy rash over body, achey wrists, swollen lips
Patient had metal taste in mouth upon administration of vaccine that lasted the duration of patient's observation period of 15 minutes.
Patient has had ongoing issues with chest pain, palpitation, very high resting heart rate, hair loss, weight loss, menstrual irregularities
tested positive for the Covid virus on 02Feb; tested positive for the Covid virus on 02Feb.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 3rd of 3 reports. An 89-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138460 same drug/event, different patients
12/30/2020 12:30 PM Severe headache, fatigue, arm very sore at injection side and achy -- advil dose, headache mild. 12/31/2020 very tired, slight headache and arm still sore.
This spontaneous report as received from a medical assistant refers to an unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of ROTATEQ (lot # L002042, expiration date 28-JUL-2016; lot# L013188, expiration date 02-NOV-2016; lot# L008578, expiration date 14-DEC-2016). NO adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
About 5 minutes after the vaccination by our pharmacy student, the patient reported that he wasn't feeling well. He said he was hot and dizzy. His hands were clammy. He said he felt like his body was numb. We had him remove his mask and got him some water. He never actually lost consciousness. Eventually we had him lay down and put his feet up. His father was contacted and came to pick him up. We spoke to his mom later and she said he was feeling much better.
right hand swelling, right knee swelling, right ankle swelling, facial swelling of left cheek Narrative:  Following 1st COVID-19 vaccine dose on 12/17/20, patient seen at Emergency Department on 12/21/20- 12/22/20 for eval of new left cheek swelling and right hand/ankle swelling. Hand x-ray did not show signs of fracture, head CT did not show any signs of new strokes, and labs showed mild BNP elevation. Per ED note, "Based on the patient history, physical, and initial vital signs - the patient's initial presentation is concerning for heart failure/volume overload->pulmonary edema and bilateral pedal edema." He received ipratropium neb x1 and returned to facility. Neurology consulted (12/22/20), "It is difficult to determine whether the patient has a new facial palsy or whether this is recrudescence of his previous stroke deficits. Given the swelling of his left face it is quite possible that there is inflammation causing some partial left facial nerve dysfunction that would not include the forehead. The pattern of weakness is, however, also consistent with what would be expected from his documented right MCA stroke. At this point it is appropriate to consider this a possible complication of his vaccination (Bell's palsy has been reported in some after Covid19 vaccination). However, I would not recommend any specific treatment for the facial weakness as the etiology is still somewhat unclear." Patient admitted to hospital 1/2/21-1/8/21 for mild hypothermia with possible AMS and found to have adenovirus. Head CT negative for CVA. Sepsis/toxic/metabolic w/u was unrevealing. Given IVF for diarrhea; C diff negative. Discharged to facility. Patient received 2nd COVID-19 pfizer vaccine on 1/13/21 in Right Deltoid w/o complications (lot#: EK9231, exp. 04/30/2021)
Fatigue; Headache; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown. Not Provided          Concomitant information was not provided. Treatment information was not provided.
Subsequent to receiving the second dose of Engerix B the pt experienced an allergic reaction consisting of ear redness without itching or pain. Engerix B was discontinued. The most recent information received reports the condition of the pt as resolved.
NEUROLOGICAL ISSUES/NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced neurological issues/neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological issues/neurological symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20220234802.; Reporter's Comments: This case report concerns multiple patient's.
PT WAS ADMINISTERED BEFORE DISCOVERY CURRENT PREGNANCY AT ESTIMATED 9 WEEKS.
Patient developed redness and swelling at the site of injection of the Herpes zoster vaccine on the left arm. Area of redness and swelling measured ~5 inches. Swelling and redness stabilized by 2 days post vaccines. No fever or other signs of systemic illness.
swelling @ the site of vax;skin inflammed @ rt thigh p/few hr of vax;
Barely able to walk at time. Chills, muscle aches, cough and sore throat occasionally. Headaches
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-OCT-2015, the patient was inoculated with ZOSTAVAX vaccine (lot number and expiration unknown), unknown route, administered at a pharmacy. The inoculation was recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical facility, for the onset of painful vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX, and or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to with ZOSTAVAX vaccine. The outcome of the events was unknown. Additional information has been requested.
received a dose of Zoster vaccine back in October 8th 2018 and according to the records the patient missed the appointment 1 month after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 8th October 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Zoster vaccine back in October 8th 2018 and according to the records the patient missed the appointment 1 month after the first dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-Jun-2023 A pharmacist called in to request information about a patient which received a dose of Zoster vaccine back and according to the records the patient missed the appointment 1 month after the first dose.  The reporter assumed that the patient was immunocompromised since the appointment for the second dose was settle 1 month apart from the first dose. The reporter asked if the patient could receive the second dose or if the series needed to be restarted. The reporter did not provide information about the first dose (lot number, expiry date).  The reporter could not confirm that the Zoster vaccine administered in 2018 was Shingrix. Did not consent to follow-up Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
On May 17th patients mom reported fever that ranged from 101.8-102.5 temporal and did not normalize with antipyretic therapy. Then on day four of event she started having a maculopapular rash that started on her forehead and extended to her thorax. Rash peak was approximately on the 23rd and started resolving on the 24th. Currently asymptomatic.
Hives on thighs front and back, left bicep, left wrist and left foot
Initial report received from a consumer on 04Oct05. A mother reported that her 22 month old daughter had inconsolable crying (1/2 hr episodes at a time), showed signs of being easily frustrated, began spinning in circles, had facial contortions, showed hand gesturing and was patting herself on the chest, four days after receiving the intra muscular injection of Daptacel (dose four) lot number C2253AA in the left thigh on 26Aug05. The pt received in concomitant the IM injection of Prevnar lot number A94451K in the left thigh. Pt's mom states that her daughter had 3 doses of Tripedia at ages 2, 4 and 6 months. Dates of administration not reported. She showed signs of Autism at 7 months of age. At 12 months they had her hearing checked because she was ignoring her mom and dad. The pt's hearing was good. Pt received MMR dose one at 12 months of age and experienced crying, fever and listlessness which was never reported. Mom stated they are working with a neurologist to prove autism. No further information was provided by the reporter.
received first vaccination on 07 Feb 2021; not able to schedule the second appointment due to no vacant spaces; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first vaccination on 07 Feb 2021; not able to schedule the second appointment due to no vacant spaces) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-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 (received first vaccination on 07 Feb 2021; not able to schedule the second appointment due to no vacant spaces). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first vaccination on 07 Feb 2021; not able to schedule the second appointment due to no vacant spaces) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD21-060091 (Patient Link).   Reporter did not allow further contact
Fever 101, Headache, body aches, increased heart rate 140-160, chest pain.
A physician reported that a 46 year old pt received an injection of Pnu-Imune 23 on 4/5/00 and developed a "severe" local reaction. This is one of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot #466785.