chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose number-2 Administration date:17-Feb-2021 Dose number-1 administration date:31-Jan-2021; had a rash near the injection site; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EL9296 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 17:00 (at the age of 66-year-old) as single dose for COVID-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration on left arm on 31Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included, hypertension, hypercholesterolemia, coronary artery disease, neoplasm malignant. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and received other vaccine within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 5 days after receiving the second dose. On 22Feb2021, the patient had a rash near the injection site and an area lower on that arm where she had basal cells removed that was swollen and itchy. The patient did not receive any treatment. Outcome of the events was not recovered.  No follow-up attempts are needed. No further Information is expected.
Swelling at/around injection site, Hard bump developed, rash that was 2in.x2in. developed around bump - Post injection rash and bump lasted for 9 days, Upon clearing of rash a bruise remains, along with what appears to be damaged capillaries
Information has been received from an office worker concerning a 21 month old white male with no allergies or medical conditions who on 11/20/03 was vaccinated SQ in the right thigh with a first dose of varicella virus vaccine live (lot # 646237/0545N). Concomitant therapy included a first dose SQ in the left thigh of MMR (lot #645521/0297N). There was no illness at the time of vaccination and no other concomitant medications. On 8/31/04, the child had a fever, was not sleeping well. Two days later the patient experienced bumps that started on the body in the morning and then spread quickly. The rash was on the anterior thigh and right hip and was described as a vesicular rash with an erythematous base. The child was treated with Acyclovir, mupirocin, and bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate. The patient recovered days later. Additional information has been requested.
Information has been received from a nurse concerning a 14 year old female patient who was vaccinated IM with the first 0.5 ml dose of GARDASIL. There were no concomitant therapies. Subsequently the patient passed out and started seizing, the patient experienced a full blown seizure, blacked out, could not hold her bladder and then came to and could not remember anything that had happened. The patient was in office while it happened. At the time of report the patient's status was recovered. Upon internal review, seizure was determined to be an other important medical event. No further information is available.
Fever 103.3 F Treated symptoms with acetaminophen Patient uncharacteristically fatigued next day. Loss of appetite, uncharacteristic separation anxiety
I have to use inhaler because I can't breath; my cough is very just wheezy sounding; my cough is very just wheezy sounding; Little stuffy nose and everything; I have like all of the symptoms of like COVID and its like progressively getting worse; Little stuffy nose and everything; I have like all of the symptoms of like COVID and its like progressively getting worse; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. On 03May2021, the patient had a little stuffy nose and everything but she have like all of the symptoms of like COVID and its like progressively getting worse and patient reported that everybody was telling me that these symptoms were normal to get like this. She thought she was on her day 3 now or something, which it should probably be gone because she kept reading everywhere that they only have symptoms for like 1-3 days but it's been getting worse. On 04May2021, the patient had to use an inhaler because she can't breath and her cough was very just wheezy sounding. She was not sure if she should go get the COVID test or was that normal to have these symptoms. Treatment for the events included over the counter medicine like Advil and inhaler. Outcome of events was unknown.  Information about batch/lot number has been requested.
upset stomach; body aches; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
arm very sore after Covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm very sore after Covid vaccine) in a 55-year-old male patient 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 PAIN IN EXTREMITY (arm very sore after Covid vaccine). At the time of the report, PAIN IN EXTREMITY (arm very sore after Covid vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown.       NO Concomitant and treatment drugs were given by reporter.
On 011/16/02 child dev rash generalized all over body. Some papules no vesicles. (+) macules and papules.
Mom called to report swelling to rt arm 3" x 3" where DTP recvd; 4 days p/DTP given ice to area; pt ok otherwise; pt using arm w/o problems;
I95.9 HYPOTENSION 12/9/2021 ACUTE RENAL FAILURE, UNSPECIFIED
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/23/20 2nd dose01/13/21 Diagnosed covid positive:08/16/21 Symptom onset:08/16/21 Exposure:work Symptoms HA, sinus pressure.
Medical vein pain; Really swollen; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR PAIN (Medical vein pain) and SWELLING (Really swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced VASCULAR PAIN (Medical vein pain) and SWELLING (Really swollen). At the time of the report, VASCULAR PAIN (Medical vein pain) and SWELLING (Really swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided  No treatment medications provided
It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No relevant medical history/conditions, allergy, concomitant diseases and risk factor were reported.     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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    This case contains information for the 6 of 6 patients described by the reporter.  No concomitant medications were reported. It was reported that vaccine was expired on 08-Jun-2023 (30th day). and 6 doses of Moderna Covid-19 bivalent were administered. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
This spontaneous report was received from a medical assistant via company representative refers to approximately 11 year old female patient. On 07-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # and dosage regimen unknown), meningococcal vaccine (unspecified) (lot # and dosage regimen unknown) and HEXAVAC (also reported as tdap) (manufacturer unknown) (lot # and dosage regimen unknown). On 07-NOV-2013, a few hours after administration of the vaccines the patient developed rash on her chest. Reportedly the rash resolved after 1 week (approximately 14-NOV-2013). Reporter's causality was not provided. Additional information has been requested.
ADMINISTERED THE SHOT TO PT ON 05/01/2019 AT 2.29 PM THEN PT CAME BACK NEXT MORNING TELLING ME HER ARM IS SWELLED AND SORE AND YESTERDAY IT WAS RED AND ITCHING THEN CALLED MD AND REPORTED THE CASE TO DR AND TOLD ME PT TO TAKE IBUPROFEN EVERY 6HOURS AND USE ICE PACK ON THE AFFECTED ARE THEN CALLED PT ON 05/03/2019 AND PT SAID IT GOTTEN BETTER NOW JUST LITTLE SORE
This is a spontaneous report from a contactable consumer reporting for her son. This is the 1st of 2 reports and regards the 2nd vaccination dose. An 18-year-old (other ethnic group unknown) male patient received the 2nd dose of TRUMENBA via an unspecified route of administration at 1 DF, single on an unspecified date less than 2 weeks before this report in 2016 (because he was going to college and he would be on campus) and after the first dose received in 2016 only 3 months before this report. The vaccinations were supposed to be three and he would take one more in two or three months. The patient medical history was not reported. There were no concomitant medications. The patient previously took TRUMENBA and experienced chills, pyrexia, influenza like illness, and feeling cold. On an unspecified date in 2016 (around 2 days before this report) the patient experienced stiff neck with outcome of not recovered, he had received the vaccine, the first one 3 months before this report and the second one was given a week before this report on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of stiff neck and TYLENOL and ADVIL were received. The patient had undergone lab work for his physical.
Patient felt lightheaded after vaccine. Noted excessive sweating. Initial vitals BP: 90/60, HR: 49, Sp02: 97% R: 18. Second set of vital signs BP: 110/61, HR: 51, Sp02: 98%, R: 18 and T: 98.7.  EMS was called when vitals did not improve and patient was transported to a local medical facility at 10:10am.
tested positive for Covid and received positive test result 2/9/21; tested positive for Covid and received positive test result 2/9/21; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested for Covid and received positive test result on 09Feb2021 when she was supposed to receive 2nd vaccine so did not go. First location no longer had any doses left. Trying to find out what she should do next. Event reported as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt seems to be very colicky; very gassy;had regular BM today; parents concerned constant crying at night; mtr giving mylecon drops for gas; color pale; hypotonic
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 30-years-old non-pregnant female patient who was a new employee (healthcare worker) of reporter's facility. The nurse reported that the patient had no pertinent medical history and no drug reactions or allergies. On unspecified dates, the patient was vaccinated with doses of M-M-R II (number of doses, frequency, route of administration, indication and lot numbers were not provided). On an unknown date, patient's mumps titers were measured and assessed as "low". On 13-JAN-2015, the patient was vaccinated with pre-employment booster of M-M-R II (dose: 0.5 ml, frequency was not reported, subcutaneously in the left arm, lot # K004948, expiration date: 04-APR-2016) due to having "low mumps titers". No concomitant medication was reported. On 13-JAN-2015, almost immediately after administration of M-M-R II, the patient began to feel symptoms of lightheadedness and nausea. She also reported tingling in the fingers of her left hand, as well as tingling in her lips. The patient's skin became clammy, and the nurse recorded her heart rate to be 120 beats per minute (reference ranges were not provided). Her blood pressure at that time was also 108/54 (units and reference ranges were not provided). The patient rested, and when her heart rate was reassessed after an unspecified period of time, also reported as "a few minutes", her heart rate was recorded to be 86 beats per minute. At the time of that report, the patient was still in the nurse's care under observation. Though the patient reported "feeling better", the nurse was considering asking her to go to the emergency room for further evaluation. The patient was sitting upright and speaking during this report. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering. The relatedness between the events and M-M-R II was not assessed by the reporter. Additional information has been requested.
Tenderness in the arm of vaccination; Inflammation at injection site; Redness in the arm of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation at injection site), ERYTHEMA (Redness in the arm of vaccination) and TENDERNESS (Tenderness in the arm of vaccination) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation at injection site) and ERYTHEMA (Redness in the arm of vaccination). On 10-Apr-2021, the patient experienced TENDERNESS (Tenderness in the arm of vaccination). On 10-Apr-2021, VACCINATION SITE INFLAMMATION (Inflammation at injection site) had resolved. At the time of the report, ERYTHEMA (Redness in the arm of vaccination) and TENDERNESS (Tenderness in the arm of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Information has been received from a Licensed Practical Nurse concerning a patient who on 13-AUG-2009 was vaccinated with a dose of GARDASIL (lot # 661766/0652X). The nurse mentioned that the patient pulled away during vaccination and with GARDASIL and the vaccine ran down the patient's arm. It was unknown how much vaccination was actually received. The patient's skin was turned a splotchy red; however it resolved within 15 minutes. The patient was upset about injection. At the time of reporting, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. No further information is available.
She had little bit of dryness and crustiness around her eyes but does not have any actual hives or rashes.  I explained to her that the vaccine is causing those reactions in some patients but not anaphylactic and that treatment with antihistamines around-the-clock at the dose of 2 pills of Xyzal as per day, one morning and one evening, helps in controlling the symptoms and preventing worsening reactions.
Uncontrollable shivering in the middle of the night about 11 hours after receiving the vaccination. The patient used several layers of blankets to warm up, which helped calm down the shivering, eventually allowing her to sleep.
Initially, redness and itching at injection site (half-dollar size) reported 10/29 (2 days after 10/27/15 injection). Patient refused biopsy offered by Merck. PCP treated patient w/valacyclovir and acyclovir. Injection site still discolored 11/25/15 and patient has seen PCP 4 or 5x since vaccine. Complains of joint pain and "internal shingles".
Dose was given after expiration date. Expiration date was on 07/13/2022. Dose administered on 07/26/2022.
1/21/09 pm fever, hot to touch, pain at injection site, shortness of breath, redness and swelling at injection site.
Initial report was received from a consumer on 21 January 2013. A female child (age and date of birth not reported) had received an injection of FLUZONE, Sanofi Pasteur, (lot number, route and site unknown) on 14 January 2013. On 21 January 2013, the patient tested positive for A strain with the Sophia test. It was unknown if the patient had any illness at the time of vaccination or past medical history. Outcome was not recovered. Documents held by sender: None.
Threw up a couple of time and passed out; I just feel really sick; Extremely tired and weak yesterday and last night I started having numbness and extreme weakness on the right side of my body; Extremely tired and weak yesterday and last night I started having numbness and extreme weakness on the right side of my body; Threw up a couple of time and passed out; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: F3183) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced extremely tired and was weak the previous night and last night he/she started having numbness and extreme weakness on the right side of his/her body and then threw up a couple of time and passed out. The patient still had significant numbness and weakness on his/her right side so, he/she is trying to identify, if he/she need to go into an emergency room or anything or what to do. The patient just felt really sick. The outcome of all the events was unknown.
1st had Trumenba and then Bexsero; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In June 2022, the patient received the 1st dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: The reporter was the mother (nurse) of the patient.  The reporter wanted to remain completely anonymous and would not provide any demographic information.  She did not even want an adverse event report filed. The patient just got her vaccination for Meningococcal B, but they actually gave her the wrong one.  She had a Trumenba vaccination in and was supposed to get her second dose in December (2022).  The patient went and the pharmacist gave her the Bexsero. The reporter stated that she had the lot number for Bexsero but refused to provide it. The reporter provided limited information The reporter did not consent to follow-up. Additional Supportive Information: The patient received Bexsero instead of Trumenba, which led to Interchange of vaccine products.
2 days after receiving Dtap vaccine woke up 9AM fluid retention with swelling and redness at deltoid area 2 days after he received vaccine.
He also stated that some were splashed onto his skin on his hand; it leaked from the needle due to human error during the administration. He also stated that some were splashed onto his skin on his hand; This spontaneous report was received from a male pharmacist (patient of unknown age) referring to himself. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 21-DEC-2021, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U010533, expiration date 29-OCT-2022; strength, dose and route were not reported) was vaccinated to another patient (another linked case) for prophylaxis, some were splashed onto this patient (the pharmacist) skin on his hand (Accidental exposure to product, Occupational exposure to product).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA008400: