chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High fever 102.3F; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021. The most recent information was received on 30-Apr-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (High fever 102.3F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had COVID around November and December).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced PYREXIA (High fever 102.3F). At the time of the report, PYREXIA (High fever 102.3F) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: action taken with drug updated
A couple hours after administration, patient reported feeling hot and was experiencing a headache. Her relative noted that her face looked red. Her relative took her temperature and noted it was a little high. She called the facility and we consulted her to take an NSAID to reduce the fever. Spoke to the patient on February 7 and she reported fatigue the following day as well as a sore arm.
pregnant; nausea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) and NAUSEA (nausea) in a 41-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant) and NAUSEA (nausea). On 23-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, NAUSEA (nausea) outcome was unknown.            No concomitant medication was provided. No treatment information was reported.
Severe chills began at about 11 hours (11:30 pm) and lasted 4 hours(3 am). Following morning (6:00 am) severe headache, drowsiness, heartburn, low grade fever.  Drowsiness, heartburn, fever lasted until around 11 pm. Headache is still present, but very minor.
Pt was given three vaccines. As I pulling needle out of arm on third vaccine, he instantly started to look pallor and stated "I feel weird" and his head started to tilt downward. He started to become diaphoretic and would not talk back to me. Cracked ammonia and pt came back to. Pt layed down and was given juice and crackers. BP was 100/50. After monitoring, pt stated he feels much better. BP rechecked upon leaving and was 110/68. Patient advised that he will need to lay down for further injections. He understands.
Fever Cervical lympnode swelling on left Narrative:  Saw her primary care, did not require medications, was tested for flu, COVID and labs - all negative
C/O LEFT ARM SORE, RED, PUFFY AND ITCHING X6 DAYS AFTER 2ND VACCINE GIVEN ON 2/16/21.  CLIENT WENT TO URGENT CARE AND WAS DIAGNOSED WITH CELLULITIS.
Initial unsolicited report received from a physician on 17-Mar-2017. This case involves a 62-year-old male patient who was vaccinated with a dose of Fluzone QIV (batch number, expiry date, dsoe form, frequency route and site of administration not reported) on an unspecified date. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were not reported. Illness at the time of vaccination was not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, two weeks following the vaccination, it was reported that the patient experienced high fever and muscle weakness. The patient was subsequently seen to the physician and was diagnosed with non-specific viral illness. Subsequently, the patient developed subsequently developed chills, rigors, further muscle weakness and was again referred to the emergency room (ER). It was reported the on an unspecified date, that the patient's creatinine Kinase (CK) level of 400 or 500 and with it, the patient developed muscle weakness of left arm and left leg. On an unspecified date, the patient's complete blood count was revealed as normal, however the sedimentation rate was elevated. Subsequently the patient was referred to a neurologist who thought that symptoms were related to myopathy following which the patient was seen by a neuro-rheumatologist. Other laboratory investigations and corrective treatment were not reported. On an unspecified date (reported as "patient had symptoms over next 4 weeks which then resolved") the patient recovered from the events. List of documents held by the sender: None.
Contracted COVID-19 and starred showing symptoms on 07/28/2022. Due to being on immunosuppressive medications, I scheduled an appointment at the Clinic. The doctor prescribed Lageviro and I followed up with my PCP,  Dr..
Higher heart rate, 100 bpm while standing. Heartrate at least 10 beats higher than average. Started 24 hours after shot and continues. Costochondritis started about 24 hours after shot and continues.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored ROTATEQ, orally, (which had a lot number of L038536 and an expiration date of 19-AUG-2017; however, the dose, dosage number and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Alternative email.  2 vials that were first punctured on 30-Nov-2021 and put on the refrigerator since then.  Concomitant medications were not provided.  Treatment information was not provided.
Information has been received from a physician concerning a 14 year old female who on 14-APR-2008 was vaccinated with the first dose of GARDASIL. On 16-JUN-2008, the patient was vaccinated with a second dose of GARDASIL. Patient then went to the emergency room on 19JUN-2008. It was unspecified if the patient was hospitalized that day. The next day, on 20-JUN-2008, the patient came in the physician's office with petechial rash, hot flashes and muscle pain. The office did a complete blood count, high mono, and esosithil count, and a high alcoholine phosphate count. The next visit was on 21-JUN-2008; the patient had no bleeding but had a low white count and petechial rash on legs. On 23-JUN-2008, the patient's spleen tip was enlarged. The patient physician gave the patient a possible diagnosis of Ehrlichiosis. The patient was ordered a complete blood count(CBC), serum antinuclear antibodies test (ANA) and anti- DNA testing. The patient was tested for cytomegalovirus, rheumatoid factor, and Rocky Mountain spotted fever. A complete blood count showed low white count, negative serum antinuclear antibodies test (ANA) and normal rheumatoid factor (RF). Cytomegalovirus test (CMV) came back low white count; negative serum antinuclear antibodies test (ANA), and normal rheumatoid factor. Cytomegalovirus test (CMV) came back high, erichias, West Nile and Rocky Mountain spotted fever came back negative. Epstein-Barr came back high at 5.31. On 09-JUL-2008, the patient's rash was still present. On 14-JUL-2008, the patient had hives on her arms, constipation, and positive cytomegalovirus test. At this point the patient was referred to the infectious disease specialist. On 23-JUL-2008, the infectious disease physician ordered the patient not to receive the third dose of GARDASIL. The patient's history of persistent malaise, fatigue, and low platelet count had resolved by 09-JUL-2008. Additional information has been requested.  11/4/08 Reviewed PCP medical records of 6/16-7/29/2008. FINAL DX: none provided Records reveal patient received 2nd dose of vaccine 6/16/08.  RTC 6/20 after experienced petechial rash, hot flashes, myalgias.  Exam revealed enlarged lymph nodes.  Dx w/possible viral syndrome.  Labs ordered.  Seen in Er 6/19/08 for rash & dx w/'low count'.  Dx w/viral syndrome w/improving plt & wbc counts.  RTC 6/23 w/hives all over, myalgias, fever.  Dx w/possible erlichiocia & additional labs ordered.  RTC 7/14 w/recurrent hives, malaise, constipation.  Dx w/CMV & possible HPV reaction. Referred to ID on 7/23/08 for persistent fatigue, malaise, leukopenia.  No dx provided & advised not to receive final vaccine.  RTC 10/13 w/reactive airways disease, croupy cough.  Tx w/nebs & antibiotics.
Mother called to report child had developed fussiness on the evening of 10/19/2023 "felt warm, but no temperature". When she woke up patient on 10/20/2023 approximately  8am noticed his left thigh was red "like a patch" and was swollen and warm to touch.  Seemed to swell more as the day went on-developed a rash and hives on his leg. Had a video call with PCP. The doctor suggested baby Benadryl which mother went to get and gave at approximately 1pm. Client was feeling better by the evening-rash faded.  Client continued to get better by the next day redness was fading. Today there is only a faint bruise per mother. States PCP suggested she call and report the reaction. Informed mother it was the Vaxneuvance that was given in the left thigh.
unable to focus; headache; onset of burning; sore throat; bilateral ear pain; head congestion; lethargy; body aches; 9/10 fever/9/11 fever; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Sep2021 11:00 (Lot number: FC3181) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEXAPRO; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Past drug history included: Ceclor, reaction(s): "Allergy:CECLOR"; Keflex, reaction(s): "Allergy: KEFLEX"; Biaxin, reaction(s): "Allergy:BIAXIN"; Percocet, reaction(s): "Allergy:PERCOCET". Vaccination history included: Bnt162b2 (lot number: EW0173, administrator route: Intramuscular, administration time: 14:00, dose number: 1, vaccine location: Right arm), administration date: 20Aug2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 13Sep2021, outcome "recovering", described as "unable to focus"; PAIN (non-serious) with onset 11Sep2021, outcome "recovering", described as "body aches"; BURNING SENSATION (non-serious) with onset 12Sep2021, outcome "recovering", described as "onset of burning"; OROPHARYNGEAL PAIN (non-serious) with onset 12Sep2021, outcome "recovering", described as "sore throat"; EAR PAIN (non-serious) with onset 12Sep2021, outcome "recovering", described as "bilateral ear pain"; HEAD DISCOMFORT (non-serious) with onset 12Sep2021, outcome "recovering", described as "head congestion"; LETHARGY (non-serious) with onset 11Sep2021, outcome "recovering", described as "lethargy"; HEADACHE (non-serious) with onset 13Sep2021, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 10Sep2021 17:00, outcome "recovering", described as "9/10 fever/9/11 fever". The events "unable to focus", "body aches", "onset of burning", "sore throat", "bilateral ear pain", "head congestion", "lethargy", "headache" and "9/10 fever/9/11 fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of disturbance in attention, pain, burning sensation, oropharyngeal pain, ear pain, head discomfort, lethargy, headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received MV within 2 weeks of vaccination. Treatment received for the adverse event was with steroids. Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
body ache; chills; low grade fever/102.5 fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), PYREXIA (low grade fever/102.5 fever) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (low grade fever/102.5 fever). On 09-May-2021, the patient experienced MYALGIA (body ache) and CHILLS (chills). On 11-May-2021, MYALGIA (body ache), PYREXIA (low grade fever/102.5 fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Body temperature: 102.5 (Inconclusive) 102.5.         No information regarding treatment medications was provided by the reporter.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number M73CE, expiry date 30th June 2019) for prophylaxis. Concurrent medical conditions included fruit allergy (berries) and drug allergy (rocephin and penicillin). On 11th September 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 11th September 2018, less than an hour after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site swelling, injection site itching, injection site wheal, injection site bruising, injection site lump, injection site induration, flushing and extremities hot feeling of. In September 2018, the patient experienced tongue thick, skin tightness, ocular discomfort, wheezing and nasal congestion. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the injection site swelling and injection site bruising were recovering/resolving and the outcome of the injection site itching, injection site wheal, injection site lump and injection site induration were recovered/resolved and the outcome of the tongue thick, skin tightness, ocular discomfort, wheezing, nasal congestion, flushing and extremities hot feeling of were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site wheal, tongue thick, injection site bruising, skin tightness, ocular discomfort, wheezing, nasal congestion, injection site lump, injection site induration, flushing and extremities hot feeling of to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was previously reported to a doctor. The patient received FLUARIX QUADRIVALENT 2018-2019 season on the right deltoid. The Patient stated that within 10 minutes of receiving vaccine, she experienced swelling, itching, and welts at the injection site.  The patient stated that she also felt flushing or hotness in both arms and later that evening, she noticed a bruise (4 inches wide by 3 inches length) at the injection site. The patient stated that within 10 minutes of vaccine, she had a hard knot underneath her skin at the injection site that was like a golf ball. The patient stated that she went to the emergency room within 30 minutes following the injection.  The patient stated that she was prescribed Benadryl, prednisone and hydroxypropionate to took at home. The patient stated that whenever it was time for her to took prednisone, right before she took the medication, her face and eyes felt tight. The patient stated that if she did not take the antihistamine, her tongue feels thicker, she experienced wheezing and her nose felt congested. The patient stated that she would went to an allergist later on the reporting day. The patient stated that when it was time to took the medication, she also felt flushing in both arms between the wrists and the shoulders. The contact details of the physician was reported.
TOOK TWO CAPSULES OF VIVOTIF IN A ROW INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-1688) was received from a pharmacist on 28-Jun-2019. It describes a 53-year-old male consumer who "took two capsules of Vivotif in a row instead of every other day" (Inappropriate schedule of vaccine administered). He was receiving oral Vivotif capsule (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif in a row instead of every other day.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two capsules of Vivotif in a row instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two capsules of Vivotif in a row instead of every other day" was considered as not applicable.
No known adverse effects; A patient received a dose ofGARDASIL 9 into the gluteal area on an unknown date in September 2018 and in December 2018; A patient received a dose ofGARDASIL 9 into the gluteal area on an unknown date in September 2018 and in December 2018; This spontaneous report has been received from a registered nurse and referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.        The patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot number and expiration date were not reported) into the gluteal area for prophylaxis on an unknown date in September 2018 and in December 2018 (vaccine administered at inappropriate site). No known adverse effects were reported. There was no product quality complaint involved.
pt received Janssen Covid Vaccine on 5/13/21. Discovered in system that pt received 1st dose Moderna from a Walmart Pharmacy on 4/24/21
A pharmacist reported that a 70 year old female, with a history of multiple myeloma and recurrent bactermia, received a dose of Pnu-Imune 23 vaccine in January, 2002. The patient developed bacteremia subsequent to vaccine administration. No further information was available at the date of the report
loss of appetite lasting 36 hours; chills; complete loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Unknown), via an unknown route of administration in the left arm 19Mar2021 at 11:30 (at the age of 66 years-old) as a single dose for COVID-19 immunisation. Medical history included progressive multiple sclerosis, radical prostatectomy and basal cell carcinoma. The concomitant medication included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), tolterodine (MANUFACTURER UNKNOWN), donepezil (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN), all for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food or other products. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On, 20Mar2021, the patient experienced chills, loss of energy and loss of appetite. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event, chills, loss of energy and loss of appetite was recovered on an unknown date in Mar2021.    Information about lot/batch number cannot be obtained. No further information is expected.
Starting 3/25 evening I experienced severe fatigue, then next day severe body aches, fever 101,, headache. All stated as  known side effects. Then on Sunday 3/28 I woke to find my mouth felt like I had burned the roof of my mouth starting behind my front teeth all the way up the roof.  As I continued to improve with the body aches, I was left with the mouth issue and a fever blister on my lip.  The burning mouth continued and did not start improving until Friday 4/2. It made it very difficult to eat anything other than soft foods. It is about 90 percent cleared up as of today 4/3. I had tried to find if anyone else had reported this mouth issue online but only found swollen lips, so wanted to report  my experience.
He woke up with shortness of breath, Fever, sore throat, nasal congestion, cough, body aches, and sore throat.
Reported by wife became dizzy and fell EMS summoned and no abnormality was noted.  Fine now
1652 Patient c/o feeling nauseous and like he was having a ?panic attack?. 1658 his BP was 162/92, retook and it was still 162/90, HR 98. History of VTACH on iv lomadine or laprazole which he was given in the hospital for his blood pressure, and it sent him into VTACH. He was not sure what the medication was. When asked if she takes Bp medication he said that he was Verapamil up until 3 months ago but it make his heart rate too low. States they told him not to take until his HR came back up. Then stated he is not taking anything now. 1706 took HR 103, RR 18, BP 152/99. Pt states he is feeling better but wants to stay for another 5 minutes or so. RN said he could stay if he needed to. Recommended pt f/o with his PP re: BP and provided EDUCATION. Pt signed understanding and left 1723.