chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of VAQTA for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, 5 months to 5 and a half months after being vaccinated with the first dose of VAQTA, the patient received the second dose of the vaccine. No adverse effects were reported for the patient. This case is non-valid due to lack of patient identifiers. Follow up information has been received from the pharmacist on 15-APR-2018. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This report refers to a 71 year old male patient. The patient's concomitant medications included potassium chloride (KCL) as potassium supplement, irbesartan, atenolol and amlodipine for high blood pressure, and atorvastatin for high cholesterol. On an unspecified date in 2017, reported as "5 months to 5 and a half months before first vaccination", the patient received the first dose of VAQTA. On 13-JAN-2018, the patient received a second dose of VAQTA, lot # N005605, intramuscularly in the left side. It was not illness or pre-existing physician-diagnosed allergies, birth defect or medical conditions at time of vaccination. Additionally, the patient had not history of adverse event following prior vaccination.
No fever prior to outbreak. Abd, hairline, face outbreak 5/15/03. About 25-30 lesions.
Low grade fever (100.7), persistent cough, slight nasal congestion, increased fussiness, decrease in appetite
ADMITTED TO HOSPITAL FOR HIP FRACTURE FROM NURSING HOME. INITIAL COVID TESTING NEGATIVE...4 DAYS LATER TESTED POSITIVE.
21 hours after injection my hands started felling like they were on fire but not hot to the touch, then the body aches, extreme joint pain in my back and right leg started, then my hands started to freeze I had the chills bad body aches, the chills and a fever.   Very fatigued.   That lasted until about 7:30 pm.   Only symptom on Saturday was fatigue , I still get winded when I do physical stuff today (Monday)
fever; chills; aches; lethargy; abdominal pain; vomiting; blistered mouth and gums; blistered mouth and gums; This is a spontaneous report from a contactable consumer (patient herself). A 74-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 24Feb2021 11:45 (age at vaccination: 74 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included arthritis, neoplasm malignant, psoriasis, cardiac disorder and ibuprofen hypersensitivity. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982) via unknown route in left arm on 03Feb2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient was administered vaccine in a public health clinic. On 24Feb2021 18:00, the patient experienced fever, chills, aches, lethargy, abdominal pain, vomiting and blistered mouth and gums. The patient did not have any other vaccine in four weeks. The patient did not have covid prior vaccination nor was tested positive since vaccination. The outcome of all the events was recovering.   No follow-up attempts are possible. No further information is expected.
pt presented to hosp w/rash & high fever 2 days p/immun; this was the only evnet mom could attribute to situation;
Headache RUNNY/ITCHY EYES Narrative:   Other Relevant History;
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency.  Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
A 16-year-old female with a history of ulcerative colitis status post total colectomy being admitted for headache, palpitations, neck pain, and rash on 10/13/21.  History is provided by patient and her family at the bedside, as well as review of the ER records.  Patient first began having a headache on Wednesday (10/6) after which she received a dose of Remicade, technically her second dose, but first dose in the last 4 years.  She also received her second Covid vaccine just this last Saturday (10/9).  Patient reports that she has had pain in the subclavicular region on the left side, the same side as her vaccine.  She is also complained of palpitations, and feeling her heart beating in her throat.  The symptoms began Sunday, 24 hours after her vaccine, along with chills and body aches.  Over the next few days, she was also noted to have redness around her eyes, pain behind her eyes, blurry vision.  Tuesday (10/12), patient developed hives on her chest that then spread to her extremities.  She had an episode of presyncope in the bathroom, with her ears ringing and vision darkening, but no loss of consciousness.  PCP was unable to see the patient on Tuesday, so she was taken to an urgent care, where they prescribed prednisone 40 mg daily x5 days.  She received 1 dose of this, but during that appointment she developed tenderness in the anterior neck, itchiness, and puffiness of her face and neck.    Mom reports that she recently had COVID-19 infection approximately 2 weeks ago, but no one else in the family has had symptoms.  Patient was doing better during her hospital stay: benadryl helped with the rash, tylenol for pain control, and short course of steroid. She was discharged home on 10/15, much less pain, still achy, able to move head and neck, no fever.
Information has been received from a pharmacist concerning a 70 year old female who on 24-OCT-2006 was vaccinated with Pneumovax 23 (Lot # 654981/0674F).  The patient was seen in the emergency room (ER) a couple of hours after receiving the vaccination.  The patient had upper arm swelling and an area 3 inches in diameter at the injection site with redness, swelling and warmth.  The patient was sent home from the ER on 24-OCT-2006 with BENADRYL.  The patient called the next morning 25-OCT-2006 to report that the red area had extended from the marked area from the previous day.  The patient was seen and prednisone was added on 26-OCT-2006.  The patient's current state is unknown.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Anxiety after 2nd Shot; Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot; Warm Head 99F after 2nd Shot,Low grade fever; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (Anxiety after 2nd Shot), PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness). On an unknown date, the patient experienced ANXIETY (Anxiety after 2nd Shot). At the time of the report, ANXIETY (Anxiety after 2nd Shot), PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 110/70 mmHg (normal) normal. On an unknown date, Body temperature: 99 °F (High) HIgh. On an unknown date, Heart rate: 120 beats (High) elevated and 110 (normal) normal.         Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
The patient got a rash on the upper chest and neck approximately 3 hours after vaccination. The rash was self limiting and no treatment currently needed.
I have my left arm with pain, where they put the vaccinate is very hot, strong and my skin is all red very hot inside. Yesterday, at night I felt dizzy and I wanted to throw up but nothing happened. Today my arm is painful and very red with all inside very warm.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines (hemophilus B conjugate (meningococcal protein conjugate) and COMVAX (dose, route and lot # not reported) that were exposed to  supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report the status of patients was unknown.This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning a 68 year old female with Sulfa and Erythromycin allergy and no pertinent medical history who on 04-MAR-2011 was vaccinated Subcutaneously in the right arm with a 0.65ml dose of ZOSTAVAX (Merck) (Lot # 669408/1384Z, expiration date 19-JAN-2012). There was no other concomitant medication. On 04-MAR-2011 the patient developed swelling at the injection site following vaccination with ZOSTAVAX (Merck) (Lot # 669408/1384Z). The swelling was reported to be red and warm to the touch. The swelling started to develop immediately after the patient received the vaccination. The swelling had traveled down the arm from the injection site to the elbow. The patient sought unspecified medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of this report, the patient had not recovered. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired. On an unknown date, the outcome of the sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's mother. The age at vaccination was not reported. About 4 months before the time of reporting, the patient received SHINGRIX on an unknown arm. The patient experienced fever, was sick the next day, missed work, nauseous, felt lousy and his arm was sore and swollen. The symptoms lasted a couple of days. No additional details were available. The reporter did not consent to follow-up.
Information has been received from a licensed practical nurse referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 06-FEB-2019, the patient was administered an improperly stored VARIVAX with lot number R012531 and expiration date on 01-MAY-2020 (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis. The sterile diluent used for reconstitution of the vaccine was properly stored. It was reported that on an unknown date, the vaccine was exposed to a temperature of -8.1 Celsius degrees for 2 hours and 54 minutes. There was a previous temperature excursion of -10.9 Celsius degrees for 2 hours and 10 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-00950751-1902USA006651.
A few weeks after vaccine - severe burning mouth and tongue and oral sores.   Also tinnitus worsened - tinnitus first occurred after 2nd covid vaccine.   Increased neuropathy in extremities.  New buzzing/nerve pain in chest and heart palpitations  Insomnia
Weakness, muscle fatigue started after 1st dose. 3 days after second dose had labs and elevated ANA. Rheumatology work up unremarkable, except increased anti-thyroid. Full body Tremors and involuntary movement started 3/16. ER visit.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; vaccine administered past its 30-days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 4:07 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 4:07 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, vaccine was administered on 06-Feb-2022 at 16:07:47. Vaccine dose reported was booster. No treatment details were reported. Ethnicity was given.   This case was linked to MOD-2022-542869 (Patient Link).
19 yo female with S/S numbness, weakness of left leg and (R) leg thigh 4-5 days after receipt of hep A (lot# G499B SKB), IIV (U55306 CSL), adenovirus (#34600212 BRR), MCV4P (#U5180AA PMC), Tdap (#AH4LF SKB) and varicella (#L036831 MSD). Vaccines were received 3 JUN 2016. Symptoms included cramping in legs and sudden weakness with a (R) foot drop. She had an EMG on 07 JUL 16 which demonstrated upper extremity sensory and motor latencies, and loss of sensory and motor responsiveness to her lower extremities. She received 5 days of IVIG and Is currently receiving PT services. Last progress notes state some improvement in hamstring but otherwise plateaued. Genetic testing positive for HNPP. We have been unable to contact this patient for further assessment, info based on chart review.
CIRCUMFERENTIAL SWELLING OF INJECTED ARM,  General Appearance: alert and oriented, well nourished and hydrated, NAD.  Skin  L upper arm w large IZ reaction- 7-8 inches diameter of red, raised generalized swelling, a few blisters at the IZ site.  HEENT: TM's normal, nose clear, pharynx and tonsils normal.  Neck, Thyroid : no thyromegaly, no lymphadenopathy.  Heart: Regular rate and rhythm, no murmurs.  Judging by the site of the blisters, appears to be site of the Varicella vaccine.
Information has been received from a family member concerning a 6 year old female family member with no known allergies and asthma associated with colds who in 1996 was vaccinated with varicella virus vaccine live. On 02/14/1996 the pt developed 40-50 lesions. The pt did seek medical attention. Additional info has been requested.
8:30 a.m. received Menactra IM RA and Td IM RA. Patient reports the left side of her face feels swollen and left jaw beginning at 2:00 p.m. Denies wheezing denies, itching denies shortness of breath, denies swelling around eyes and or mouth.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shellfish (vomit)" (unspecified if ongoing); "Known allergies: shellfish (vomit)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pencillin, reaction(s): "Rash", notes: Known allergies: Penicillin (rash); Percocet, reaction(s): "vomit", notes: Known allergies: Percocet (vomit). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had received Paxlovid as a treatment of COVID-19 on 11Aug2023 to 15Aug2023".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300282577 Same patient, different drug, different event;
CHILLS; HEADACHE; FATIGUE TIRED AND SLEPT A LOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fatigue tired and slept a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and headache, and the outcome of fatigue tired and slept a lot was not reported. This report was non-serious.
Initially, my left arm had a red spot for 10-11 days. Then clear. 14 days later I went swimming in a lane I had reserved at my club. Lanes are reserved for 45 minute swims. This was my second swim after my first Covid vaccine. About 15 minutes into this second swim, the outside of my throat began stinging and itching. Soon my chest was stinging and itching. A friend was swimming in the adjoining lane. I told her I was going to cut short my swim because of stinging. She reported that my throat and chest were very red. About 6 minutes later I was home, took an  OTC anti-inflammatory (Zyrtec), took a shower. I believe it was vaccine belated because I also had a large, thin ring around the injection site. Over the course of the next hour the stinging, itching, redness subsided. I told my Dr. She told the allergy dept. They suggested I take a Zyrtec prior to my next swim, which I did. No reaction. I did NOT have a similar reaction the first time I swam after the injection. It was exactly 2 weeks later that I had the rash and stinging.
3 hours after vaccine: beginning of body aches, arm soreness at injection site  10 hours after vaccine: severe body aches especially in lower back and buttocks, pounding headache, skin sensitivity and chills  Over night:  inability to sleep, tossing and turning, unknown fever but skin felt very hot with all past symptoms  0430 next day (1/11):  nausea, dizziness, pounding headache, severe body aches and sensitivity but no chills   36 hours after vaccine: uncomfortable body aches are still present, most of symptoms have resolved  48 hours after vaccine:  body aches are slightly noticeable but resolve during the day