chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt given shot at 14:10. at 2:16, pt was observed mid-faint (vasovagal syncope). pt was given bottle of water & ice pack for back of the neck (it was only slightly warm in the room, but he was clammy). pt reported the "curtain coming down" with hearing loss and tingly and was aware of faint, as he spilled the contents of his 1st bottle of water.  pt's bp taken 118/78. pt reported his norm usually 125/85. pt was observed for an additional 35-40 minutes. syx resolved spontaneously, and pt released but cautioned about operating machinery & what further syx to look for. pt returned to clinic 3 days later to say hello and mentioned persistent nausea & extreme fatigue ("like deep in my bones"), for which he had visited PCP in the interim.
Initial low grade fever and chills in first 48 hours followed after about 5 days with gradually worsening rash. Burning itchy papular rash on back, arms, legs and trunk.
Myalgia, Fever, Chills, Temp. 101.8 Narrative:
11/30/19 @ 2am felt feverish and pain to left arm, red from shoulder to elbow and very swollen. 12/1/19 - left hand was swollen, arm more swollen and red 12/2 - 12/3/19 - Puffy, pink in color and itchy @ the site
PREFILLED SYRINGE VACCINE WAS GIVEN 9 HOURS AFTER BEING DRAWN INTO SYRINGE; STORED AT ROOM TEMPERATURE FOR 9 HOURS BEFORE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204B21A expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced prefilled syringe vaccine was given 9 hours after being drawn into syringe. On 01-DEC-2021, the patient experienced stored at room temperature for 9 hours before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the prefilled syringe vaccine was given 9 hours after being drawn into syringe and stored at room temperature for 9 hours before administration was not reported. This report was non-serious.
Patient is fully vaccinated. ED visit on 12/23/2021 and COVID positive. Patient is a 56y.o. female presenting to the emergency department for abdominal pain. Patient states she had a headache, however has since resolved. Patient denies chest pain, difficulty breathing. Patient does admit to cough and fever. Patient states she has a history of cerebral palsy and uses a wheelchair. Patient states she has been exposed to people with COVID-19. Positive for appetitie change, fever, rhinorrhea, cough, leg swelling, abdominal pain and headache and tachychardia.  Temperature improved with Toradol. Heart rate improved in the emergency department after lowering temperature and IV fluids.  Patient's vital signs are within normal limits.  CT: Bibasilar regional groundglass opacities concerning for infectious infiltrate, such as atypical viral pneumonia. Large hiatal hernia. Large amount stool throughout the colon and rectal vault with circumferential rectal skin thickening. Correlate for constipation and fecal impaction. Patient is well appearing and is resting comfortably in no acute distress. Discharged.
Received vaccine AM of 4/9/19. That evening had pain and local reaction at site (L) deltoid. Woke in AM with sore throat, vomiting, diarrhea. Came to office approximately 4 pm on 4/10/19. All symptoms resolved except feels ill and (L) arm hurts. (L) deltoid greater than 1/2 dollar size erythema, tender and indurate at site of injection.
Lightheaded; Skin color pale; Dry mouth; This is a spontaneous report from a contactable consumer (patient himself).  This 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 27Jan2021 (at 09:30) at a single dose on the left arm for COVID-19 immunisation. The vaccine was administered at Clinic. No relevant medical history was provided. No known allergies. Relevant concomitant medications included atorvastatin and tamsulosin. On 27Jan2021 (at 09:45), the patient was lightheaded, she had skin color pale and dry mouth. The events were assessed as non-serious and lasted approximately 1.5 hours. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed.  No treatments were given for the events. The events resolved on 27Jan2021.
Lupus; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lupus on an unspecified date. The lupus patient who received second dose of product on 06Apr2021, and resulted in a negative antibody tested in May2021 for Sars-COV-2.  The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event systemic lupus erythematosus and the suspect drug BNT 162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt devel a fever of 104, chills, muscle aches, h/a, nausea w/no vomiting, w/in 12hr of vax;sx resolved in 72hr;
She couldn't swallow 30 minutes after receiving the vaccine/difficulty swallowing; light headiness; dry mouth; This is a spontaneous report from a contactable nurse (patient).  A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm at age of 75 years old on 22Jan2021 (Batch/Lot Number: EL1283) as single dose for covid-19 immunization. Medical history included anaphylaxis. The patient's concomitant medications were not reported. After receiving the first dose of the vaccine on 22Jan2021, patient reported extreme dry mouth and light headiness. She couldn't swallow (difficulty swallowing) 30 minutes after receiving the vaccine. She wasn't sure if this was related to the dry mouth or not. It all went away the same day. Patient wanted to know if she can receive the second dose of the vaccine or not. The patient had odd symptoms after the vaccination, after she left the clinic area. The first symptom she experienced was extreme dry mouth. She was slammed with dry mouth. Right after she left her 15 minutes wait period. She also experienced light headedness. Then, on the way home about a half an hour (30min) after the injection (she only stayed 15 min) she couldn't swallow. She went to take a sip of water because of her dry mouth and couldn't swallow. Then, 10 minutes later she was fine. It could of been because of the dry mouth that she couldn't swallow. She stayed light headed at home for an hour. She took Benadryl and went to sleep. This all happened the same day on 22Jan2021. She recovered completely. She hasn't received the second dose because of the odd reaction. It has been 3 months this week from her initial dose. She is not sure whether to go have the second injection or not. This report was provided as non-serious. Therapeutic measures were taken as a result of dry mouth, light headiness, couldn't swallow and included Benadryl. The outcome of the events were recovered on 22Jan2021.  Follow up needed, further information was requested.
Right knee numbness and weakness.  Feels unsteady on the leg with walking.  No sx in other areas of the body.  Physical exam reveals normal sensations all areas of the body other than the right knee.  Normal deep tendon reflexes in lower and upper extremities.  Symptoms are not ascending or progressive at this time, so is no obvious evidence of systemic neurological dysfunction.  Patient was placed on steroids and given dexamethasone injection, will follow up in the next week to determine final outcomes.
Rashes and bumps on elbows, knees, fingers, hands and feet. Very itchy and some with small whiteheads or bubbles.   Started with bumps then turned into red swollen rashes.  Took benadryl and Zyrtec and applied Cortizone cream, but don't really help much with stopping the rashes or itchiness.
my side effects with first one, tired, nauseous; my side effects with first one, tired, nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "CHF" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METHADONE taken for dependence. Past drug history included: Methadone for Past addiction. The following information was reported: FATIGUE (non-serious), NAUSEA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "my side effects with first one, tired, nauseous".   Additional information: Patient reported that his side effects with first one were tired and nauseous; wasn't bad went away quick. Felt more like after the second vaccine, it was almost an antidote to the first one. Patient was really started feeling better after the second one, all energetic. Patient stated that he takes lots of medications(no further information).  No follow attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 62-year-old female patient who received SHINGRIX (batch number C523T, expiry date unknown) for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, weakness of arms and injected limb mobility decreased. The patient was treated with Physical Therapy (Nos). On an unknown date, the outcome of the muscle pain, weakness of arms and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, weakness of arms and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The pharmacist had reported adverse event to VAERS a couple of weeks before the reporting date. The pharmacist said that, one of her patient started experiencing muscle pain, limited mobility and weakness in the arm where she received the injection. The pharmacist clarified that it was not only at the injection site, but the whole arm. The patient was doing physical therapy to treat the events.
DVT/ Blood clot found incidentally when receiving MRI for back pain. Pain had been escalating, and also progressing with a severe flare of groin pain. The MRI was ordered to look for signs of inflammation, as ESR and CRP labs showed elevation.  DVT in left groin was found.  Extensive testing was then done to determine the cause of the blood clot (ultrasounds, MRIs, CTs, bloodwork for clotting disorders, etc), and no underlying disorder was found other than the increased risk of estrogen birth control. After 3 months of treatment with Eliquis/blood thinner, CT scan on 11/2 confirmed resolution of the clot.
N/A, Client receive Pfizer dose 6m-4y instead of 5m-11y
I have the typical side effects but I also have testicular pain. A bit over 48 hours now.
a patient was administered a dose of improperly store VAQTA; No adverse effect reported; This spontaneous report was received from a medical assistant referring to a patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot #S009943 has been verified to be a valid lot number hepatitis a vaccine, inactivated, expiration date reported and establish as 26-JUL-2020) (strength, dose, route of administration and frequency were not provided).   The temperature of storage and time frame of the excursion were above 47° Fahrenheit and 37 minutes. A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
This spontaneous report was received from a 74 year old patient of unknown gender, reporting on her/himself; via Pfizer. The patient's medical history included pneumonia or the flu every winter, concurrent conditions and concomitant medication were not reported. In October 2016 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (unknown manufacturer), (strength, route, dose, lot# and expiration date were not reporter) for prophilaxis. Approximately in June 2017 (reported as: this summer) the patient experienced atrial fibrillation. Additionally, the patient reported that approximately in December 2016 (reported as: every winter) the patient experienced pneumonia or the flu even after receiveing pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of atrial fibrillation, influenza and pneumonia was unknown. The causal relationship between PNEUMOVAX 23 and the events was not provided. Upon internal review atrial fibrillation and pneumonia were determined to be medically significant events.
1020 Mother called from car, just received varicella - throat itching. See attached.
Report received from a healthcare student on 30-SEP-2010 (received via Merck WAES: 1010USA00052). A 59 year old female patient (date of birth unknown) received AFLURIA (batch M52308, expiry 30-JUN-2011) for vaccination on 29-SEP-2010. The patient had no pertinent medical history or allergies. The patient was on hormone therapy. On 29-SEP-2010, the day of vaccination with the suspect drug, the patient developed shaking, sweating, felt cold, nausea and headache. By 30-SEP-2010, all symptoms resolved except for the headache. The adverse events improved, the patient was on therapy unspecified. The patient sought medical attention by calling the pharmacy. The event outcome was recovering at the time of reporting. The reporter did not provide a causality assessment. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Pain Left Arm (Left Shoulder to elbow); could not raise her left arm; Stiff Left Arm; Left Hand Swollen; Left leg weak; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm), MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen) and MUSCULAR WEAKNESS (Left leg weak) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)), VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm), MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen), MUSCULAR WEAKNESS (Left leg weak) and GAIT DISTURBANCE (could not walk). On 28-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff Left Arm), PERIPHERAL SWELLING (Left Hand Swollen) and GAIT DISTURBANCE (could not walk) had resolved. On 29-Mar-2021, MUSCULAR WEAKNESS (Left leg weak) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain Left Arm (Left Shoulder to elbow)) and VACCINATION SITE MOVEMENT IMPAIRMENT (could not raise her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up received on 12-MAY-2021, no new information
Patient received flu and pneumonia vaccine at public clinic 10/17/2003 PM.  That PM (7-8 PM) noted itchy and redness with a raised, red, firm area 3-4 inches in diameter.  Left upper extremity around injection area.  Itching and raised firm area continued until her call to us 10/22/2003.  RN observation area 10/22/2003.  No systemic symptoms.  Patient used cool then warm compresses to area and topical benadryl for itching.
Pain in arm; He is in some level of distress/  really bothered by it, and this was something that is unusual for him; did not feel good for a couple days; His son felt very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), EMOTIONAL DISTRESS (He is in some level of distress/  really bothered by it, and this was something that is unusual for him), MALAISE (did not feel good for a couple days) and MYALGIA (His son felt very sore) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (6 to 8 weeks before vaccination. Got quite sick at that point and recovered). Concomitant products included VITAMINS NOS for an unknown indication.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), EMOTIONAL DISTRESS (He is in some level of distress/  really bothered by it, and this was something that is unusual for him), MALAISE (did not feel good for a couple days) and MYALGIA (His son felt very sore). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), EMOTIONAL DISTRESS (He is in some level of distress/  really bothered by it, and this was something that is unusual for him), MALAISE (did not feel good for a couple days) and MYALGIA (His son felt very sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received and added start date of vaccine, added concomitant medication. added new events.
Experience pain where shot was administered that in the following weeks travelled down to my arm into my hand. Could lift arm over head. Diagnosed Parsonage Turner Syndrome, brachial neuritis.
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. In August 2022, the patient experienced ARTHRALGIA (shoulder pain). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). In 2022, ARTHRALGIA (shoulder pain) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.            Concomitant medications were not reported.   Patient received Moderna covid-19 vaccine (details unknown).  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the events of Flu like symptoms and shoulder pain with Adalimumab Solution for Injection was No Reasonable Possibility.  The reporter's causality for the event(s) of Flu like symptoms and shoulder pain with Moderna COVID-19 vaccine (Elasomeran) was No Reasonable Possibility.  AbbVie's opinion was that the causality for the event(s) of Flu like symptoms and shoulder pain with Adalimumab Solution for Injection was Not Provided.  AbbVie's opinion was that the causality for the event(s) of Flu like symptoms and shoulder pain with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.  HUMIRA 40MG/0.4ML Shoulder pain, Non-Health Care Professional, Not Related  Treatment medications were not reported.
SINUS INFECTION; CHILLS; FOGGY FEELING IN HEAD/ DID NOT FEEL LIKE HERSELF; DIZZINESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, anxiety, seasonal allergies, and drug intolerance. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced foggy feeling in head/ did not feel like herself. On APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced sinus infection. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 03-APR-2021, had not recovered from foggy feeling in head/ did not feel like herself, and dizziness, and the outcome of sinus infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
A patient experienced mild chills with first dose; A patient experienced sore arm with first dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (A patient experienced mild chills with first dose) and MYALGIA (A patient experienced sore arm with first dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (A patient experienced mild chills with first dose) and MYALGIA (A patient experienced sore arm with first dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain and Chills, at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) for Vertigo, at an unspecified dose and frequency. At the time of the report, CHILLS (A patient experienced mild chills with first dose) and MYALGIA (A patient experienced sore arm with first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.