chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; Shingles rash; neuralgia; lession in left axilla; Shingles rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) unknown for eosinophilic asthma.   Concurrent medical conditions included eosinophilic asthma. Concomitant products included valaciclovir hydrochloride (Valtrex).   In June 2018, the patient received the 1st dose of Shingrix. In October 2018, the patient received the 2nd dose of Shingrix. In February 2017, the patient started Nucala at an unknown dose and frequency. On an unknown date, less than a year after receiving Shingrix and Shingrix and an unknown time after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, neuralgia, skin lesion and varicella-like rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, neuralgia, skin lesion and varicella-like rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, neuralgia, skin lesion and varicella-like rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, neuralgia, skin lesion and varicella-like rash to be related to Nucala.  Additional details were provided as follows: The age at vaccination was not reported but it could be 79 or 80 years. The patient was diagnosed with eosinophilic asthma receiving Nucala every 4 weeks since February 2017, her last dose of Nucala was the 6th June 2018 and she did not have the batch number and expiration date but did provide the phone number for the infusion center.  The patient developed neuralgia before she broke out with Shingles rash, 4 or 5 days later she found a lesion in left axilla and went to an urgent care center where the physician confirmed her Shingles diagnosis.  The patient was currently has areas up and down left axilla area to wrist and was on day 6 of Valtrex. The reporter had consented to follow up. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and was not provided.
Extremely tired; A spontaneous report () was received from a consumer concerning a 18-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extremely tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the event of extremely tired. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, extremely tired was resolved on 21 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
pt noted swelling @ site of vax 1/2 day post vax;felt feverish;office visit 7x9cm erythematous, edematous induration;tx w/APAP, DPH & cooling measures;10/22/99 seen by PMD;
Coughing; Soreness; Felt tightness in chest that lasted for 45min-1hr; Lump on center of chest, that lasted for 45min-1hr; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), PAIN IN EXTREMITY (Soreness in arm), CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr), MASS (Lump on center of chest, that lasted for 45min-1hr) and PAIN (Soreness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm). On 03-Feb-2021, the patient experienced CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr) and MASS (Lump on center of chest, that lasted for 45min-1hr). On 04-Feb-2021, the patient experienced PAIN (Soreness). On 04-Feb-2021 at 6:00 AM, the patient experienced COUGH (Coughing). On 03-Feb-2021, PAIN IN EXTREMITY (Soreness in arm), CHEST DISCOMFORT (Felt tightness in chest that lasted for 45min-1hr) and MASS (Lump on center of chest, that lasted for 45min-1hr) had resolved. At the time of the report, COUGH (Coughing) had resolved and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient took ibuprofen to treat symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up TCR report received included no new information.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 240 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Fever, shaking chills , decreased O2 sats to 80's O2 initiated O2 sats improved
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 19-AUG-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Redness and swelling L arm began 2 days after injection (11/16/02).  presented to clinic 1/18/02 pm. Pt reports less redness swelling but remains and is warm to touch.
Cicada sounding/Hiss Noise on 4/15,4/16 then a pause and back on 4/19
Patient complained of numbness on left side of face and arms, tingling in fingers. Symptoms went away after a couple of hours.
patient checked yes to feeling sick today, when asked, he then stated " I was feeling bad three days ago, but I am not feeling bad now." supervisor was notified .  Pt stated he had an exposure 6 days ago, denied any s/sx.  vaccine was administered after pt denies any symptoms today.   Patient's right sleeve fell down over wheel, and he pulled his sleeve up to allow for bandaid placement. multiple bumps noted to right upper arm.  When questioned, he said yes i have some on my other arm, chest and back also.  Patient was asked why he denied any s/sx today.  Pt states " I thought this was an allergic reaction to grass."  Patient referred to adult health for testing.
Vaccines were administrated 24 hrs before onset of event. While playing at PE at school, pt felt weak, with some weakening of his legs which were shaky. Became pale and sweaty. Mother picked him up at school and brought him to the office. Exam revealed some pallor with low BP (82/56). Observe/push fluids & add salt to diet.
feet are swollen just a little; red rash on lower legs and feet; extreme fatigue; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (feet are swollen just a little), RASH ERYTHEMATOUS (red rash on lower legs and feet), FATIGUE (extreme fatigue), NAUSEA (nausea) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (feet are swollen just a little), RASH ERYTHEMATOUS (red rash on lower legs and feet), FATIGUE (extreme fatigue), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (feet are swollen just a little), RASH ERYTHEMATOUS (red rash on lower legs and feet), FATIGUE (extreme fatigue), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Added TCR: Spoke to the patient's sister, the patient still has swelling of the feet, but the rest ofthe events were resolved. Does not have email
Greater than 4 cm local erythematous reaction to Anthrax. Had other shot x 2 in 1991.
Pain in my left arm upon waking up in the morning. At times it goes down my entire arm. It is muscular in nature.
This spontaneous report was received from a licensed vocational nurse practitioner concerning a female patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. In January and February 2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, doses, expiration dates, anatomical locations and routes were unspecified). Concomitant therapy was not reported. It was reported that the doses were at least 4 weeks apart. On 24-AUG-2015 (1 week ago), the patient had serology test completed 1 week ago, on 24-AUG-2015 and the result of the test showed no immunity to chicken pox (negative serologic testing, Varicella virus test negative). The outcome of Varicella virus test negative was unknown. The relatedness between the event and suspect therapy was not provided. Additional information is not expected, as there was no consent to contact the physician.
Crying a lot, fussy, not eating well, diaper rash. Rigidity and posturing, eye movement irregularities.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In April 2014, the patients were vaccinated with doses of M-M-R II (Lot # K002528 exp date 18-FEB-2016) (doses not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that PEDVAXHIB dose 0.5 ml, route intramuscular that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the cases 1405USA007203, 1405USA007978, 1405USA007982, 1405USA007990 via same reporter link. Additional information has been requested.
I woke up with a sore throat and lasted the next day. Nasal congestion started on June 5, 2022. I also have a bad cough that started on June 5, 2022. I was at the cruise when this happened. My vitals on June 7, 2022, I self-tested with a rapid antigen. The first two tests were negative and the third was positive. I did a PCR test at the medical center  on July 7, 2022, which was positive.  They took my vitals which was 107/71 blood pressure and my temperature was 97.6.
Blister inside/back of mouth on the roof of mourth; Booster; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 14:30 (Lot number: FH8030) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: DO8B21A, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 52 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 029A21S, Location of injection: Arm Right), administration date: 05Mar2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 08Dec2021, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna"; ORAL MUCOSAL BLISTERING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Blister inside/back of mouth on the roof of mourth". Therapeutic measures were not taken as a result of oral mucosal blistering.  Additional information: Prior vaccination, the patient was not diagnosed with Covid-19. Post vaccination the patient had not been tested positive for Covid-19.  No follow-up attempts are possible. No further information is expected.
Loss of appetite, general malaise for 2 days, some loss of balance, stuffed nose
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRENA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Rebound covid infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported as treatment Paxlovid for COVID 19 Treatment, treatment start date: 14Oct2022 and treatment stop date: 19Oct2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse and described the occurrence of interval too short in a 17-year-old female patient who received HAVRIX (batch number A7HC5, expiry date 13th August 2016). Concomitant products included HAVRIX. On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced interval too short. On an unknown date, the outcome of the interval too short was unknown. It was unknown if the reporter considered the interval too short to be related to HAVRIX. Additional details: The booster dose of HAVRIX was administered inadvertently at 3 months after the first dose of HAVRIX.
pt recv vax & devel parotitis 2wk p/vax;pt was treated w/several courses of steroids, p/which parotitis reoccurred;pt had a very hard parotid gland, gen lymphadenopathy, devel fever & had joint involvement;pt hosp
Fingers and toes turning white and cold. Resolved after 3-4 hours. Fever and aches lasting 24+ hours.
Once documenting to records noticed that vaccine was expired. Patient kept in clinic for monitoring for adverse effects. Patient verbally stated feeling well. Advised mother to bring child if any s/s of adverse effect present. We will keep mother updated if revaccination of TD vaccine is need.   TD Tenivac Lot C5779AA EXP 10/2/2022
none, patient received a second dose of the flu vaccine after recieving FLUAD on 09/19/2023
9 days after vaccine  redness, swelling and itchiness  in the injection sight .  On the 11th dayt I saw my PCP Dr. he prescribed Cefprozil 500mg. twice a day for 10 days and Prednisone 10 mg for twice a day for 5 days..
AFTER GETTING OVER COVID SYMPTOMS THAT STARTED WITHIN 60 MINUTES OF THE INJECTION, i HAVE BEEN LEFT WITH A SMALL KNOW AND TENDERNESS (ON GOOD DAYS) AND A CONSTANT USE MY ARM, SLEEP ON IT, OR JUST ACHES AND I CAN'T GET AWAY FROM THE ACHING.
This dose was not as painful at time of injection as the first but as the night progressed the pain began to radiate down my arm to wrist, over my shoulder, into my scapula and lymph nodes in L Axilla and Cephalic areas. The wrist and back resolved but the nodes are still very tender, site is bruised, reddened and axilla has bruising. By 10pm I began to have nausea, diarrhea, fever and chills. The following two days these persisted, with very unusual and frequent diarrhea. Maybe I just picked up a virus at the wrong time but it seemed odd to me.
Patient was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml  which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient
Client came in for vaccination for job assignment. Client received the following vaccines Tdap, HepA  and Typhoid. Client stated I get nervous when I get shots. After shots client looked paled and cold to touch. Reported feeling a little dizzy applied cold compress to neck. Taken to exam room monitored vital signs 3:50 106/71 P49 O2 sat 99, 4:00 112/72 P 48, 4:05 113/78 64 02 sat 98. Client also reported had only eaten a piece of cake. Client was given cracker and a bottle of water. Later reported feeling better. Client appeared stable dismissed at 4:15.
dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; turn off the lights in the office/has to have the lights low, still sensitive; arm hurt worse with second dose; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EK9231, expiry date Apr2021), via an unspecified route of administration on 19Jan2021 at a single dose, administered left arm at 4:10-4:15pm, as a coworker came down with Covid (COVID-19 immunization).  The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm hurt with first dose of bnt162b2 given intramuscularly in the left arm (Lot number EL1284) on 29Dec2020 for COVID-19 immunization. Patient had her second Covid vaccine last Tuesday, 19Jan2021. She had a really bad migraine Friday, 22Jan2021 and had to turn off the lights in the office. On Saturday, 23Jan2021, her head was sensitive, but on Sunday, 24Jan2021, later in the evening she had this dull achiness on the right side of temple area that went down behind the right eye down to the temple. The dull and achiness was just enough to where she couldn't function and been like that ever since. She was prone to headaches and migraines, this was just different and so she took Tylenol and Aleve (both with believed dose was 200mg, 2 tablets by mouth since Jan2021), and another medication for migraines, Ubrelvy (lot number: 1084537, expiry Jan2022, dosage text: 100mg, 1 by mouth at first sign of headache, started in Jan2021). She took the Tylenol and it maybe of help, but the migraines/headaches are almost constant all day long. She took the Tylenol early Friday and when the migraine got really bad that was when she took the Ubrevly. She took the Aleve only yesterday, but she still has to have the lights low, still sensitive. Patient knew that the headaches are a sign of Covid, but when she had her first dose her arm hurt. This second arm hurt worse, arm hurt worse with second dose (Jan2021), and she did fine the first few days and Friday was when all of a sudden she had the migraine and had to turn off the lights in the office. She sits at a computer. The events did not require emergency room or physician office visits. Therapeutic measures were taken as a result of really bad migraine, "turn off the lights in the office/has to have the lights low, still sensitive", and "dull achiness on the right side of temple area/headaches". The patient had not recovered from really bad migraine, head was sensitive, and "dull achiness on the right side of temple area/headaches". The outcome of the events "turn off the lights in the office/has to have the lights low, still sensitive" and arm hurt worse with second dose was unknown.
patient's arm ached, experienced joint pain, and fatigue.   Then she developed a rash that was hot to touch and swollen and sore
Beginning Tuesday afternoon she because having severe pain in her arm, she couldn't raise her arm above her shoulder. She had a horrible headache, was very nauseous, could not even lie on her back to sleep. She had chills and flu like symptoms in addition.
No ADR Nurse gave dose to the wrong resident. This resident had already received a bivalent booster dose.
Erythema, swelling and heat surrounding injection site of DTaP approximately 2 inches across. Full range of motion of arm.
Tenderness in injection site that night and worse the next morning with development of redness and swelling. Exquisite tenderness and swelling in the right Axilla. General myalgia and fatigue.