chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/15/2021 9:15AM CALL FROM CLIENT AND REPORTS ON 1/11/21 FELT LIKE HER TONGE WAS NUMB.  ON 1/13/21 BOTTOM RIGHT LIP WAS NUMB.  ON 1/15/21 TOP RIGHT LIP WAS NUMB AND DROOPING..  DENIED ANY OTHER ADVERSE EFFECTS.  INSTRUCTED TO CALL PCP FOR EVEALUATION. TO GO TO ED OR CALL 911 AS NEEDED.  CLIENT VERBALIZED UNDERSTANDING.  1/19/21 SPOKE TO CLIENT AND REPORTS CONTINUES TO HAVE NUMBNESS  AND NOW HAS TENDER SWOLLEN RIGHT EAR .  REPORTS HAS NOT SEEN PCP.  ENCOURAGED TO CALL TODAY.   TO GO TO ED OR CALL 911 AS NEEDED.  CLIENT VERBALIZED UNDERSTANDING.  1/20/21 CALL TO CLIENT TO SEE HOW SHE IS DOING AND SEE IF WAS SEEN BY PCP.  LEFT VOICEMAIL TO CALL ME BACK. 1/21/21 CALL TO CLIENT.  REPORTS SHE DID CALL PCP AND WAS TOLD IF SYMPTOMS DO NOT IMPROVE OR GET WORSE TO CALL BACK.  CLIENT REPORTS SINCE  THE EVENING OF 1/19/21 SYMTOMS ARE IMPROVING.  TO GO TO ED OR CALL 911 AS NEEDED.  CLIENT VERBALIZED UNDERSTANDING.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date in December 2018, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N012134, expiration date 17-APR-2019 (exact dose, frequency and route of administration were not reported) for prophylaxis. The suspect therapy was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 15 to 46 degrees Fahrenheit (also reported as 24.6 degrees Fahrenheit) for 4 hours. Data logger was involved. There was no previous temperature excursion reported.
Initial report was received from a consumer on 27 October 2011, who is also the parent of the patient. A 17-year-old female patient had received an Intramuscular (IM) injection of INFLUENZA VACCINE (lot number not reported) in left deltoid on 25 October 2011. On 26 October 2011, the patient developed numbness and tingling in both hands, pins and needle feeling and tips of fingers were red across the palms of hands. The patient received corrective treatment with two doses of BENADRYL with no improvement. The fingertips are no longer red, however all other symptoms remain. The patient will see her primary care physician (PCP) "today". No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a health care professional on 14 March 2012. The patient received FLUZONE, lot number UH469AB. The patient recovered on 28 October 2011. No additional information was available at the time of the report. Documents held by sender: None.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were received as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX in late October 2018. It was stated that, the patient had another occurrence of shingles since the first part of January 2019. The reporter asked if the second schedule of SHINGRIX vaccine be given to the patient. This case was considered as suspected vaccination failure, since the laboratory confirmation for shingles was not provided.
I can't smell and still I can't smell today either; This is a spontaneous report from a contactable consumer (patient reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6499), via an unspecified route of administration on an unspecified date at an unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced I can't smell and still I can't smell today either on an unspecified date. Reporter stated, patient got the Pfizer vaccine on Tuesday and Thursday patient start experiencing, I can't smell and still I can't smell today either so, patient was wondering did the vaccine have anything is this one of the symptom, that's not listed. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Initial misuse report received from a healthcare professional on 8 May 2013. It was reported that a patient might have received 2 dose of MENACTRA vaccine on 7 May 2013. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
Patient's husband had Smallpox vaccination. Patient and her husband followed post-vaccination contact exposure precautions but she did wear a shirt he had worn while the left deltoid vaccine lesion was active.  She then developed a mild febrile prodrome (low grade fever and malaise) followed by development of a erythematous vesicular lesion over her left deltoid which eventually ulcerated.  She treated the lesion with topical antibiotics then sought care when the lesion failed to heal thinking the lesion was an "infected bug bite."  At the time of presentation to our office (12 Feb 03) she had a 1 cm slightly ulcerated lesion with mild surrounding erythema without drainage over her left deltoid without other systemic features.  She was treated conservatively with local care and received a course of dicloxacillin for possible secondary cellulitis.  No titers or other laboratory studies were drawn.  At telephone followup 19 Feb 03 patient reported that the lesion had nearly completely healed and she had no further symptoms or sequelae.  She has no other household contacts.
Shingles outbreak starting 6/5/22,  rash lasted for 3 months
From no pain, gradually to severe bilateral shoulder pain, a few hours after injection.  Vaccine administered in L deltoid, which became increasingly sore with increased limited range of motion.  R shoulder more painful (7 or 8 on scale of 1 to 10) both at rest and with movement, normal range of motion not possible without severe pain (8 or 9), and difficulty getting comfortable or sleeping.  This is the most my tendinosis has ever hurt throughout the night and most of the next day.  Pain at rest has improved to about a 3 level.  But currently, raising arm forward above 20 degrees without changing movement pattern or assistance is not tolerated.  I had been looking forward to completing a long-held physical goal next week (on my birthday), which I had been working toward for most of the year, but now will be impossible, so I am also extremely disappointed.
Redness at injection site; Itching at injection site; Swelling at injection site; Bruising around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE BRUISING (Bruising around injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE BRUISING (Bruising around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE BRUISING (Bruising around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Chest pain; Light headed; Nausea; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Nov2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Oct2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 07Nov2021 at 09:00, the patient experienced chest pain, light headed, nausea, and fever. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain, light headed, nausea, and fever was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
irregular heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (irregular heart beat) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder NOS (The patient has had some heart issues in the past, but nothing serious.). Concurrent medical conditions included Caffeine (sensitivity to caffeine).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (irregular heart beat). On 05-Feb-2021, PALPITATIONS (irregular heart beat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
S: pt returned to clinic 2 days after vaccination with erythema of upper left arm (where vaccine was given), tenderness and inablity to sleep on left side of body, pain level 2                   O: Upper left arm very red/warm/swollen and tender to touch--redness extends into the axilla halfway to elbow.     -sent to urgent care-       A/P: 1. probable allergic reaction to vaccine -use OTC analgesics if needed -apply moist heat to area several times daily -RTC if sx worsen
Severe cellulitis with fever at injection site of Varivax. Admitted and treated at hospital. IV antibiotics x 4 days and oral antibiotics subsequent. Discahrge summary rec'd on 07/18/2005 had no new terms to report.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, anatomical location, lot# and expiry date not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. The administered doses experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 10 days. There was no previous temperature excursion. The call was because of a data logger. There was no Product Quality Complaint (PQC) involved.
injection site swelling; chills; injection site rednes; tingling sensation in her fingers; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) for a Pfizer sponsored program Support (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "injection site swelling"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2021, outcome "unknown", described as "injection site rednes"; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "tingling sensation in her fingers". Therapeutic measures were taken as a result of vaccination site swelling, chills, vaccination site erythema, paraesthesia.  Additional information: The patient had 1st shot the previous day, she experienced injection site swelling, chills, injection site redness, chills, tingling sensation in her fingers. Also took Tylenol and her hand was coloured orange.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered to pregnant patient; Body ache; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), PAIN (Body ache) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. :25A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included BUPROPION for Depression, MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Jul-2020 and the estimated date of delivery was 23-Apr-2021. On 11-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), PAIN (Body ache) and FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 11-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, PAIN (Body ache) and FATIGUE (Fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were reported.   This case was linked to MOD-2021-069764, US-MODERNATX, INC.-MOD-2021-069764 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Internal review on 23-JUL-2021 resulted in update of  Prospective, Birth type and fetal outcome; Sender's Comments:  MOD-2021-069764:First dose case US-MODERNATX, INC.-MOD-2021-069764:Second dose case
4/16/19:@ 7pm night of Shingrix immunization, pt developed "flu-like" symptoms with fever and so she went to bed.  4/17/19:Patient stated she did not "feel well" 4/18/19: Patient felt better 4/19/19: Patient developed blisters on left side of face from nose down around mouth. tingling and prickly on left side of face and mouth. She called pharmacy and we told her to go to urgent care. She was seen and physician diagnosed her with shingles. Patient was prescribed Medrol, gabapentin, and valtrex. Over the next few days, the blisters dried up and she felt better. No signs of anything by the following Friday 4/26/19 when she saw her PCP.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M007762 with expiration date 07-DEC-2018 and lot # M014927 with expiration date 18-FEB-2019 (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 11.8 degrees Celsius for 1 hour 3 minutes. Data logger was involved. There was previous excursion of 10.2 Celsius for 1 hour 3 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Mid grade fever, heart palpitations, these palpitations continued for over a week lessening in duration and frequency over time
On 5/15/2001 (1 year well visit) received Varivax. On 05/23/2001 developed grand mal seizure activity and brought to ER. Had 1 episode of diarrhea on 05/22/2001, was "fussy" on 05/23/2001 and tactile fever (not documented) developed seizures. Treated with IV valium, afivar then when seizre ended transferred to Medical Center.
t102-103R, skin color, creamy yellow, screaming cont, fussy, v (4 times), rt leg swollen, clammy skin; APAP given;
Area was red, lump and itchy for a few days after injection and was fine.  On 1/29/2021, the area became red the size of a dime and on the next day, became about a two diameter and became itchy and hot.
Patient developed erythema and swelling over site of IM injection on right arm. No warm. Patient C/O minimal pain to palpation, had normal ROM, and stated arm felt itchy. Improved symptoms with hydrocortisone and BENADRYL given by parents. Afebrile throughout. Advised ice and antihistamines if helpful. No indication of infection of injection site. Spontaneously resolved with time.
Ulcer of right lower extremity - Procedures performed:  Split-thickness skin grafting from the bilateral thighs to the bilateral lower legs.  Internal medicine was consulted for assistance with medical management and she has received iron infusions for acute on chronic anemia. She will be discharged to skilled nursing for continuing wound care and therapy. Hospital admission within 6 weeks of receiving the COVID vaccine.
I experienced extreme vertigo and dizziness on 1/17/21, the day after my first vaccination.  It lasted most of the day and subsided later that evening.
Sore arm, fever (102.5), fatigue, body aches, nausea, and mild GI discomfort. My symptoms are very similar to when I had COVID-19 in November. I took Tylenol and am feeling a little better. Fever went down to 101.5 an hour after Tylenol.
The night of the 29th, I got really itchy and it was happening on my chest, stomach, legs, and everywhere. It was dark so I didn't realize it was hives; so I went to shower and moisturize to think it was would relieve the itch. I noticed it was hives and called my doctor who scheduled me an appointment for 12/05/2021. I was prescribed Loratadine and Hydroxyzine to help the itch and hives. Over the next couple of weeks, it was still intense itching that came and left on its own. 3 weeks later on 12/20/2021, I went back to the doctor's office and showed them pictures of raised skin reaction. They didn't change my medicine or anything, but informed me if anything gets worse to go see an allergist. They said I had dermatographism- histamine reaction if you scratch or put pressure on aching skin. On 01/03/2022, I stopped taking Loratadine and started taking Zyrtec. The Zyrtec is helping and has reduced the itching significantly.  If I do have an itch, it's not persistent as it was before and goes away.
Loss of smell and taste for 2 days Fever up to 101 for 24 hours Severe back pain continues Site of injection very swollen and bright red the size of a grapefruit, area very hot to touch. Less red and less hot and less swollen today
Seizure at the time of vaccination.  Mother in the car and recorded.  Known history of seizures and they will follow up with an epileptologist.  They are comfortable going home as this happened after the nasal swab as well and they suspected this would happen today.  No further information needed today.
This is a continuation from report completed on 3/22 by PT symptoms has worsened. On 3/22 my heart was in Tachycardia couldn't get my heart rate to go down. When the ER got there I was already passed out. At the ER had blood work, CT scan, EKG and Echocardiogram done I was hospitalized for 1 day. I saw my PCP on 3/29 after discharged, changed my medications, put me on different anxiety medications, explained my body is going through POTS and drink plenty of water with electrolytes. On 3/31 I had a PET scan at the hospital of my heart waiting for my results. I'm waiting on a phone call for a MRI from a HCF.
Patient states feeling pain on the stomach; Burning stomach; vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment; nausea; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach), DYSPEPSIA (Burning stomach), VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 53C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach) and DYSPEPSIA (Burning stomach). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach), DYSPEPSIA (Burning stomach), VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Treatment medication include blood pressure medicine.
10DEC97 onset of sz-infantile spasms dx 12DEC hyperarrhythmias;