chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per provider note of 11/17/2021 at 4:35 PM-- patient had non-cardiac chest discomfort/reproducible chest discomfort for nursing and pleuritic chest pain for the PA--- was given 25 mg of Benadryl and 600 mg of ibuprofen both orally-- vitals are stable RR14-16, cardiovascular regular without ectopy, lungs mildly diminished throughout, clear, no wheezes or rhonchi, abdomen soft, nontender, bowel sounds present times four, extremities unremarkable 1) noncardiac chest discomfort secondary to bronchospasm 2) mild non-cardiac chest discomfort from reproducible chest myalgia 3) mild bilateral pleuritic discomfort  all of the above occurred after receiving the Covid booster earlier today-- he denies any shortness of breath or chest tightness currently
This prospective pregnancy report has been received from a husband concerning his wife of unknown age. Information concerning medical history and concurrent condition was not reported. On 07-APR-2015, the patient was vaccinated with GARDASIL 9 or GARDASIL (the husband could not confirm which was vaccinated), when the patient was 35 weeks pregnant. No adverse effects were reported. The last menstrual period (LMP) date was estimated as 05-AUG-2014. The due date was estimated as 12-MAY-2015. The trimester of exposure was ranged at the third trimester (28-42 weeks). The pregnancy outcome was pending. Additional information has been requested.
Received 2nd MMR vaccine on Friday 10/4/19, hx of rash after getting vaccines per mother.  PCP encouraged her to come in if this happens again for complete and accurate documentation.  10/6/19- Rash/hives with associated symptoms of  headache and abdominal pain, denies vomiting. 10/7/19- Temperature of  99.0, headache which was more occipital, diarrhea and abdominal pain, no family with GI sx. 10/8/19- Home again from school with complaints of abdominal pain around the umbilicus), no vomiting, afebrile.   Reports feeling 88% herself today.  Abdominal pain intermittent today, BM do make this feel better.  Hx of stomach pain, seems to have gotten better since last year.  Likely related to anxiety but 5th grade seems to have improved this.   Previous reaction to immunization, Tdap, reported by mother.  Child was not seen for evaluation although mother does have pictures of this reaction.    Tetanus was given on 9/12/19, home on 13th with sore throat,  9/14/19- Atarted with URI symptoms. 9/15/19- Fever low grade 100 9/16/19- Hives started on arm and torso.  Reports this reaction as not as severe,  one large hive that began 2 days after receiving vaccine.    Had given benadryl 3 days prior for both vaccines, currently still taking for this reaction at night.  Hives went away in the middle of the night, This morning petechial rash present (5inches  x 3inches), No respiratory symptoms at any time during reactions.        .
wheals/hives/wheals and that "it's all over my legs; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (wheals/hives/wheals and that "it's all over my legs) in a 61-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 prophylaxis.     Concurrent medical conditions included Diabetes.    On 20-Dec-2022, 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 URTICARIA (wheals/hives/wheals and that "it's all over my legs). The patient was treated with PREDNISONE at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (wheals/hives/wheals and that "it's all over my legs) had not resolved.            No concomitant medications were reported.  The patient reported that, she had received a 3rd booster on 20-Dec-2022 and ended up breaking out with wheals or hives. She mentioned that she had been using prednisone, hydrocortisone cream and steroids shot but that she was still breaking out with wheals and that it all over her legs today. She did not know if that was normal reaction.   Reporter did not allow further contact
Left arm was swollen 2x normal size, redness and heat from site of shot to elbow.  Became nauseous and dizzy when rising at one point (6-7 hours post shot).  Took ibuprofen which reduced swelling slightly.  Stomach slightly nauseous throughout next day.  Arm is showing steady improvement but still not back to normal after 30 hours post shot.
Myalgia, Fever, inj site soreness, fever 100F Narrative:
no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 13-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 11-DEC-2019.  This case is one of 4 cases received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1912USA004231: US-009507513-2006USA005344: US-009507513-2006USA005346:
Seizure; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in upper arm right on 09Jul2021 14:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Patient's weight: 83.91 kg and Height: 174 cm. Medical history included ongoing visually disabled, scarred kidneys, one side of body shorter than other half and epilepsy. Concomitant medication included levetiracetam (KEPPRA) taken for epilepsy from an unspecified start date and ongoing. The patient experienced seizure on 10Jul2021 16:30 which did not require emergency room of physician's office visit. Someone in the background of the call could be heard sounded like stating patient gets a seizure when he gets sick. He just rested at home and took care of himself at home. He just treated the seizure like he would any other time and rested. He commented his seizure was due to visual disability. The patient had no previous immunization and no other vaccines administered within 4 weeks. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Body aches, chills, joint pain, 100 degree fever,sore injection site and swollen lymph node in right armpit.    Symptoms came on about 10 hours after injection with the swollen lymph node coming over 24hrs after injection.
The patient stated that she has " a lot of pain" in her bursa of the same shoulder she received the injection. She states that she has had shoulder pain previous to the injection but not as severe as it is now. The site of the pain is not where the injection was administered. She stated that she received the vaccine around noon on 6/9/20 and states that it really began to hurt around 6:00 pm that same day.
warmth and hotness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmth and hotness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     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 INJECTION SITE WARMTH (warmth and hotness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE WARMTH (warmth and hotness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not provided. The patient stated that he will call the vaccination provider in 24 hours if it does not resolve, but does not have a primary care provider since his normal provider retired six months ago.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
little bumps at shot the site/fist size red spot that is a litttle swollen and itchy; little bumps at shot the site/fist size red spot that is a litttle swollen and itchy; little bumps at shot the site/fist size red spot that is a litttle swollen and itchy; injections site was sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy), VACCINATION SITE PAIN (injections site was sore), VACCINATION SITE SWELLING (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy) and VACCINATION SITE PRURITUS (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (injections site was sore). On 16-Mar-2021, the patient experienced RASH MACULAR (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy), VACCINATION SITE SWELLING (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy) and VACCINATION SITE PRURITUS (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy). At the time of the report, RASH MACULAR (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy), VACCINATION SITE PAIN (injections site was sore), VACCINATION SITE SWELLING (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy) and VACCINATION SITE PRURITUS (little bumps at shot the site/fist size red spot that is a litttle swollen and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter. No treatment information was provided.
Patient entered birthdate of 2002 at first vaccination, which would have made him 18 years old. When presenting for the 2nd vaccination, he told us his birth year was 2003, which makes him 17 years, and not eligible for Moderna. We completed the series since we started it.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N030175 and expiration date 16-JUN-2019) orally for prophylaxis. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
None: given after expiration date.  Expired 12/20/2022, given 3/21/2023
got the shingles after second shingles vaccine/Suspected vaccination failure; shingles/ It spread on the inside of right arm; it blistered; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 7 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got the shingles 7 months after the he/she got the 2nd shingles vaccine. The patient had no pain at all, no itching. The patient stated that it just blistered and spread on the inside of right arm. The patient stated that dermatologist said it was shingles and prescribed medication. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles were not provided. The follow up would not possible as contact information was not available.
12/16/20 awakened to an unusual headache and feeling more sluggish. Checked temp and it was 100.4. Supervisor notified and advised to get COVID testing. Throughout the day 12/16/20 temp stayed 100 and I developed body aches, arm was very tender at injection site. 12/17/20 afebrile and HA nearly resolved.
EXPIRED VACCINE ADMINISTERED (3 DAYS PAST EXPIRATION DATE); This spontaneous report received from a consumer concerned a 44 year old of unspecified 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, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered (3 days past expiration date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (3 days past expiration date) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132362, 20211132383, 20211132415 and 20211121650.
Patient experienced difficulty speaking and drooping on right side of face. Patient did not contact anyone that day, but waited until the morning after and then went to the ER and was diagnosed with Bell's Palsy.
Bells palsy (R) face appeared 9/29/21 slowly improving, appears to be possible related to obtaining flu shot shortly after Covid vaccine.
Within a minute of second shot,  immediately felt flush and faint and alerted staff i may pass out.  That feeling never went away and increased intensity.   Had extreme mental fog and felt like did not exist or was in a dream.    Felt like i could faint at any given moment.   After a week seeked care from urgent care at which time was sent to ER by staff.   Blood pressure was 166/133 and i felt like i was going to faint and could feel buzzing/vibrating pressure throughout body.   Got on a blood pressure medication and since it has been great.  I continued to feel same way for the past 4-5 months and still do mildly now.  About 6 weeks after vaccine my legs started giving out occasionally.   Then it started happening more frequently.   Soon it was every step could barely stand up.   Legs were very weak.   Ended up in ER in mid June   after experiencing a bout of paralysis for an hour or so.   After which both legs were so weak and my fainting feeling and extreme brain fog kicked in severely for days.   Have had MRIs on head, spine, ct scan on head,  chest xrays, ekg, nerve conduction tests,  extensive blood work all or which showed im heathy and could not explain the issues.  Did physical therapy to strengthen leg (primarily left) and walk with a cane.  Took almost 2 months of work.   Getting much better now 5 months in.  Still leg weakness and still the faint/brain fog feeling however it is much less severe and livable.   Feel like now finally on path back to normalcy.  About 80% now.
Patient reports having flu-like symptoms (myalgia & lethargy) for approximately 5-6 days following vaccination. Patient received booster dose on 4/22/19 at same facility.
vaccines administered after being exposed to freezing temperatures.; This case was reported by a physician via call center representative and described the occurrence of incorrect product storage in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Engerix B, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patients were administered doses of vaccines after being exposed to freezing temperatures, which led to incorrect product storage. The vaccines affected were Bexsero, Engerix-B, Menveo, Boostrix and Flulaval QIV. The reporter contacted first via phone to receive stability data, than contacted via chat to ask for revaccination information. She did not have details of how many patients were affected at time of chat or who the patients were. She was good to follow up with via the email above to provide details once she had them. The reporter consented to follow up. GSK Note- the formulations for Engerix B, Boostrix, Flulaval tetra was not confirmed and therefore captured as per source document.
Sore arm first 24-48hrs. Soreness now resolved.  Now reports very red, itchy,hard, size of 2 quarters, oval shaped, states it appears to be cellulitis.  Stomach upset-nausea, denies diarrhea  Taken antihistamine and antibacterial ointment for since 2/2/21with minimal relief.
rash got worsen; Rash on both arms/Rash spread to chest, back and legs; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (rash got worsen) and RASH (Rash on both arms/Rash spread to chest, back and legs) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (rash got worsen) and RASH (Rash on both arms/Rash spread to chest, back and legs). At the time of the report, CONDITION AGGRAVATED (rash got worsen) and RASH (Rash on both arms/Rash spread to chest, back and legs) outcome was unknown.            No concomitant medications were provided. Treatment medications was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Patient developed genital herpes primary episode 12/16/08. Treated with hydrontisone prior to culture result. Resolved on own. Pt and her mother reported patient had never been sexually active or nude with a partner. Brother has hx cold sores.
Chills followed by sweats have continued off and on for over a week. Very tired headache very thirsty body aches