chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced warmth and a swollen area that extends about 5 inches across upper arm over the site of injection.  Patient advised to use a cold compress, Benadryl and ibuprofen for discomfort and swelling.
diarrhea; trembling; very cold; arm is very tender; shivering; nausea; vomiting around 12pm; fever range from 101.5 to 102; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TREMOR (trembling), FEELING COLD (very cold), TENDERNESS (arm is very tender) and CHILLS (shivering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced DIARRHOEA (diarrhea), TREMOR (trembling), FEELING COLD (very cold), TENDERNESS (arm is very tender), CHILLS (shivering), NAUSEA (nausea), VOMITING (vomiting around 12pm) and PYREXIA (fever range from 101.5 to 102). At the time of the report, DIARRHOEA (diarrhea), TREMOR (trembling), FEELING COLD (very cold), TENDERNESS (arm is very tender), CHILLS (shivering), NAUSEA (nausea), VOMITING (vomiting around 12pm) and PYREXIA (fever range from 101.5 to 102) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided by reporter no treatment information provided by reporter
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 30-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 48, 800, 104, and 124 hours, with the lowest recorded temperature of 34, 29, 32, and 33 degrees Fahrenheit (1.11, -1.66, 0, and 0.55 degrees Celsius) respectively; and lasting for 72 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
loss of muscle; muscle weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE ATROPHY (non-serious), outcome "unknown", described as "loss of muscle"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness".  Additional Information: It was reported that event took place after the use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with expired dose of PROQUAD lot # L040412 with expiration date: 13-APR-2017 (route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Patient was administered a flu shot on 10/15/2008. Patient came in on 10/26/2008 and showed me her arm which was bruised in the deltoid area of her left arm. Pt stated she developed bruise 2-3 days after getting shot. Pt. said bruise is healing still as of 10/28/2008.
high fever, chills, vomiting, nausea, burping. most importantly -- her liver levels got so high. her ast and alt levels were up to 638 and 1176. they thought she may have been in liver failure.
Mother reported that on 8/5/08 her son began complaining of generalized muscle aches and pains.  She then noticed on the following day his skin tone darkened significantly.  In the early morning hours of 8/7/08 the minor had a seizure and was transported to the emergency room via ambulance. He  also had generalized weakness, paralysis of his  bilateral lower extremities, was unable to bear weight or walk, unable to speak and was vision impaired.  He was admitted to the pediatric unit. As of today the minor is still hospitalized.  9/22/2008 Medical records received for DOS 8/14-20/2008 with DX:  Encephalitis.  Pt presented to ER after 1st seizure witnessed at home and subsequent post-ictal altered mental status (confusion, disorientation, combativeness). Loaded with Dilantin, then Ativan & Versed which reduced the agitiation. Tx with Acyclovir with improvement in mental status, however ataxia/mild hemiparesis and muscle pain persisted. Ataxia resolved by 8/19/08.
Approximately 20-30 minutes after vaccination the patient begin having a significant rash on both hands.  This proceeded to spread upward on her arms.  The patient took some oral diphenhydramine that evening.  The following morning the rash gradually subsided.
Patient was given Flumist 2020-2021.  Expired vaccine from last influenza season.  Expired 12/29/2020
Nausea, vomiting and dizziness started when he got home.  No treatment administered currently advised patient to contact his private physician.
My periods have been extremely heavy and extremely clotty and I'm on my 3rd cycle now and no improvement; I'm on my 3rd cycle now and no improvements/ I'm also experiencing more cramping; This is a spontaneous report from a non-contactable consumer (patient). The 38-year-old female consumer reported that.  The 38-years-old female patient received dose 2 of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: Unknown) via unspecified route of admnistrtaion on 13May2021 at 08:00 AM as single for COVID-19 immunisation. The medical history and concomitant medication were not reported. The historical vaccine included dose 1 of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: Unknown) via unspecified route of admnistrtaion on 22Apr2021 at 08:00 AM as single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 Prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 28Apr2021 patient reported that since her first dose her periods had been extremely heavy and extremely clotty. She was on her 3rd cycle now and no improvements. She was also experiencing more cramping. She had to change a supersized tampon every 2 hours for the first 2-3 days of her period. Her period was never like this before. Prior to being vaccinated she had change a super tampon every 6-8 hours for the first 2-3 days and had maybe one or two clots. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
I woke in middle of night with serious chest pain, I called 911 and was taken by ambulance to the emergency room. They did an angiogram and found that my left anterior artery was blocked 90%, they put a stent in and put me on Plavix.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 13May2022 as dose 4 (booster), single (Lot number: FIC9894) at the age of 66 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Lot number: 011M20A), in left arm, on 13Mar2021 as dose 2, single (Lot number: 012A21A), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm COVID-19 immunisation. The patient's relevant medical history included: "Treated for moderately high blood pressure (under control)" (unspecified if ongoing). Concomitant medication included: LOSARTAN, start date: 15Mar2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (Oct2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (Oct2022) Negative, notes: Recovered from COVID. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Additional information: The patient has no known allergies.
This is a spontaneous report from a contactable consumer. A 2-month-old, male patient received the first dose of PREVNAR, the first dose of HIB, and the first dose of PEDIARIX all on 19Nov2008. Relevant medical history and concomitant medications were unknown. It was reported that since receiving the vaccinations, the patient experienced respiratory syncytial virus (RSV) infection, a rash protruding under the arm with white cheesy discharge coming out, immunological reactions, rash all over body, redness, extensive eczema, bronchiolitis (for which he was hospitalized for two days), gastroenteritis, watering eyes, fever, gastroesophageal reflux disease (GERD) and immune dysfunction, all in Nov2008. The patient underwent laboratory tests which included blood work done on an unknown date which revealed the patient had immunological reactions, chest x-ray (normal), and a test for cystic fibrosis (normal). Therapeutic measures taken for gastroesophageal reflux disease (GERD) included treatment with Ranitidine and the therapeutic measures taken for the other reported events, if any, were unknown. At the time of the report, the patient had not yet recovered from respiratory syncytial virus (RSV) infection, rash protruding under the arm with white cheesy discharge coming out, immunological reactions, rash all over body, redness, extensive eczema, and bronchiolitis. The outcome for the other events were unknown.
Beginning on the 4th day after my second vaccination I had shortness of breath, palpatations, irregular heart beat, hard time walking from chest pain
This spontaneous report as received from a office administrator refers to a 15 years old male patient. The patient was vaccinated with dose 1 GARDASIL (lot #, dose and route not reported) on 17-JUL-2012. On 08-AUG-2012 the patient was vaccinated with dose 2 GARDASIL (lot #, dose and route not reported). No adverse experience had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Injection site redness, tenderness, some red lines surrounding injection site. Red raised rash on trunk of body. Patient reported rash starting 10/24/2020 in the evening. advised patient to utilize ice at injection site and oral antihistamine to control rash.  Also advised patient to follow up with pcp. Sent notification to patient pcp.
Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for Covid.; Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for Covid.; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL9261), on 16Mar2021 as dose 2, single (Lot number: EPE955) and on 20Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (ongoing), notes: Asthmatic, Diagnosed too long ago, caller was in her teens. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Continued testing positive for Covid; (19May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (100mg).  Description of Product Complaint: Description of complaint: Additional PC discovered on additional product while completing report. Pfizer COVID-19 vaccine: Received 3 doses total of the Pfizer COVID-19 vaccine. Tested positive for COVID. NDC numbers, expiration dates for 3 doses: Unknown. Paxlovid: Didn't work for caller and she got the rebound COVID, has tested positive all along.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Vaccination failure and Covid 19 cannot be completely excluded.
arm swelled up after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2) (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm swelled up after the vaccine".  Additional Information: This consumer reported for his wife.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BLOOD IN URINE; BLOOD CLOTS IN URINE; SLEEPY; SORE ARM; This spontaneous report received from a patient concerned a male 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: 1808609, expiry: 09-Jun-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the patient got the shot experienced sore arm. On 01-APR-2021, at morning he was very sleepy. On 21-APR-2021, the patient went to the bathroom he had blood in urine and again he noticed there were some clots in the urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and sleepy, and had not recovered from blood in urine, and blood clots in urine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s.Blood clot in urine and blood in urine. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 3-year-old patient of unknown gender. On 06-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
heart flutters; This case was reported by a consumer via media and described the occurrence of heart fluttering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced heart fluttering (serious criteria GSK medically significant). On an unknown date, the outcome of the heart fluttering was unknown.   It was unknown if the reporter considered the heart fluttering to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case or himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced some heart flutters since the day. The reporter asked if Shingrix could cause heart flutters or not. The follow-up would not possible as no contact details were available.
Chest pain; Palpitations; Intense hives; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 13:45 (Lot number: FE3590) at the age of 34 years as dose 3 (booster), single, administered in arm left, administration date 08Apr2021 (Lot number: EW0158) as dose 2, single and administered in arm left, administration date 18Mar2021 (Lot number: EQ7534) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I've had cocci meningitis" (unspecified if ongoing), notes: Other medical history: I've had cocci meningitis. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Chest pain"; PALPITATIONS (medically significant) with onset 2021, outcome "not recovered", described as "Palpitations"; URTICARIA (medically significant) with onset 2021, outcome "not recovered", described as "Intense hives". The events "chest pain", "palpitations" and "intense hives" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) negative, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of chest pain, palpitations, urticaria.  Additional information: The patient was a reporter and Received 3 Doses with covid-19 vaccine of Pfizer. The patient had Previous doses . The patient did not  other vaccine in four weeks. The patient had adverse event  First  chest pain and palpitations. Went to ER and cardiologist for over a month. Intense hives also started and hasn't stopped since the booster shot. Then patient was consulted Doctor or other healthcare professional office/clinic visit, Emergency room/ department or urgent care. The patient was AE treatment with Trying to get a referral for allergist. The patient was prior covid tested post vaccination and known allergies  Was not before but now she got hives often.  No follow-up attempts are possible. No further information is expected.
Runny nose; coughing; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2022 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available), administration date: 29Dec2021, when the patient was 45-year-old, for COVID-19 Immunization, reaction(s): "Coughing", "Runny nose". The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "Runny nose"; COUGH (non-serious), outcome "not recovered", described as "coughing". Therapeutic measures were not taken as a result of rhinorrhoea, cough. Additional information: the patient had runny nose and coughing ever since vaccinated.  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-202300281096 same patient/event, different vaccine dose;
Red & pink - given subcutaneously 4in by 3in area. Felt very warm and tired.
SWELLING IN LEFT ANKLE/RIGHT WRIST; SORE ARM; SWELLING AT INJECTION SITE; NAUSEA; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (SWELLING IN LEFT ANKLE/RIGHT WRIST), PAIN IN EXTREMITY (SORE ARM), INJECTION SITE SWELLING (SWELLING AT INJECTION SITE) and NAUSEA (NAUSEA) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (SWELLING IN LEFT ANKLE/RIGHT WRIST), PAIN IN EXTREMITY (SORE ARM), INJECTION SITE SWELLING (SWELLING AT INJECTION SITE) and NAUSEA (NAUSEA). At the time of the report, JOINT SWELLING (SWELLING IN LEFT ANKLE/RIGHT WRIST), PAIN IN EXTREMITY (SORE ARM), INJECTION SITE SWELLING (SWELLING AT INJECTION SITE) and NAUSEA (NAUSEA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Reduced inflammation.         No relevant concomitant medications were reported.   The reporter's causality for the event(s) of swelling in left ankle/right wrist, sore arm, swelling at injection site and nausea with humira and influenza vaccine was not provided.     No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna