chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm for 24 hours.; Became achey the next evening and subsided a few hours later. No other information provided.; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 06Feb2021(at the age of 50-year-old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and not tested covid post vaccination. On an unspecified date, the patient experienced sore arm for 24 hours, became achey the next evening and subsided a few hours later. No other information provided. Patient did not receive treatment for events. The outcome of the events was recovered on an unspecified date in 2021.  Information on lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
the injection site is about the size of a 50 cent piece; injection site is itchy; got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (the injection site is about the size of a 50 cent piece), INJECTION SITE PRURITUS (injection site is itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021). On an unknown date, the patient experienced INJECTION SITE SWELLING (the injection site is about the size of a 50 cent piece) and INJECTION SITE PRURITUS (injection site is itchy). On 11-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 1st dose on 18Apr2021 and got 2nd dose on 11Aug2021) had resolved. At the time of the report, INJECTION SITE SWELLING (the injection site is about the size of a 50 cent piece) and INJECTION SITE PRURITUS (injection site is itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-364292, MOD-2021-367502 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, myalgia and fatigue. The patient was treated with TYLENOL and ibuprofen. On an unknown date, the outcome of the fever, myalgia and fatigue were recovered/resolved. The reporter considered the fever, myalgia and fatigue to be probably related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional did not had any other patient demographic details or vaccine information. The events got resolved within 3 days. The healthcare professional called regarding a different patient's adverse event and happened to causally mention this particular patient and what he was told the events experienced by the patient.
pt recv vax 30OCT98 & 1NOV98 began w/hives on body, spreading to abd on 3NOV98;pt reports no other discomfort or sx;has not taken any med instructed by clinic to contact PMD;
Pt's mother contacted office stating that the site is bright red, warm and raised. It is also, very tender.
pt recv vax & some OPV vax may have enter pt rt eye;when pt awoke from nap 7.5 hr later rt eye was swollen;seen by MD tx w/DPH;swelling had completely resolved 24hr later;
blood sugar spiked/blood sugar went up; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 03Apr2021 (at the age of 52-year-old), as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included heart surgery on unknown date of 2010, covid-19 on 24Apr2020, cardiac rheumatism, feel agitated on unknown date of Apr2020 and spent 15 days in the hospital from unknown date of Apr2020 to unknown date of May2020. The patient's concomitant medications were not reported. The patient past drug included Oxygen from unknown date of Apr2020 to unknown date of Apr2020. The patient experienced blood sugar spiked/blood sugar went up on an unspecified date. The patient stated that she received both doses of Pfizer Covid vaccine and after her first dose she noticed that her blood sugar spiked but she handled it with insulin. Stated that she had open heart surgery in 2010. Stated that she had Covid last year and feels the same now (feel agitated like when I had Covid). Stated that she came back negative. Stated that she had Covid on 24Apr2020 and she spent 15 days in the hospital and was left at home with oxygen for one month. Stated when she had Covid was 209 and she has lost 30 pounds. Clarified that she lost weight before the vaccine and she lost weight and was at 186. Stated that she had the first dose on 03Apr2021. Stated that she was at 111 before the first dose and at 287 at 9pm. Stated there was not that much discomfort with the first shot. The seriousness criteria of the event were reported as serious (medically significant) by the reporter. The patient underwent lab tests and procedures which included glucose test: I am fine and COVID test: negative on unspecified date. Therapeutic measures were taken as a result of blood sugar spiked/blood sugar went up (blood glucose increased). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sore Rt arm, chills, low grade temp, body aches, headache started 12 hours after injection for 36 hrs. Swelling under Rt eye began almost 24 hours after injection and continues to be swollen.
Received injection on the R arm. However, injection was administered very close to the shoulder instead of the deltoid muscle. Area is very swollen and it has not decreased in swelling in several days despite applying ice, taking ibuprorfen, and also applying heat. There is also a knot. I massaged the area to try to loosen the knot. However, I noticed it gets more swollen instead of getting better. The pain subsides momentarily. However, it returns. It is affecting my range of motion, I cannot lift my arm above my head as it causes extreme pain.
Given FLUZONE Quadrivalent at 9:30 am 11/6/14. By afternoon: c/o hoarseness, dry cough, HA, red eyes. By evening: increased fatigue, scratchy throat, runny/stuffy nose and eyes which got red and crusty. Felt better evening of 11/6/14. 11/7/14: resolved.
Pt recvd 2 doses of Engerix-B 7 approx 2 months ago p/1st dose pt exp nausea, jaundice, severe weakness, unable to eat due to nausea, h/a; dx by another MD as having chronic fatigue synd; 2nd MD did test for Epstein-Barr & found it was ele;
Information has been received 14-APR-2017 from a medical assistant regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 11-APR-2017 the patient was vaccinated with a dose of ROTATEQ lot # M038724 expiration 24-APR-2018, oral for prophylaxis which was improperly stored. No adverse effects were reported. The vaccine was stored between 32 degree Fahrenheit and 35 degree Fahrenheit for 1 hour.  There were no previous temperature excursions. The call was made due to a data logger. No additional information was provided.  Additional information has been requested.
About a week after receiving the second dose of the Moderna COVID-19 vaccine, I started to have pain in my heart that I have never felt before. It was like a stabbing pain right over my heart. The pain did not radiate. It would happen randomly throughout the day and usually last about 10 minutes. It started to get worse around June 2021, so I contacted my doctor. My doctor prescribed a non-steroid anti-inflammatory, Naproxen. After finishing 2 weeks on Naproxen, my symptoms were almost completely gone. Now, in September 2021, my symptoms are pretty much gone.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
1) acid reflux 2) ache joints 3) high cholesterol 4) depression 5) headaches 6)  ringing in the ears 7) insomnia 8) transoparietal subcortical infarct 9) anxiety
Information has been received from the authors in a published literature article, refers to a 18 month old boy who presented with herpes zoster. The authors described an atypical presentation of a common clinical entity. The patient presented to the emergency department with a rash on the left lower extremity. He was fully vaccinated, with routine vaccines at 12 months of age administered in the left thigh. On an unspecified date, the patient was vaccinated with VARIVAX in the left thigh (lot# and dosing details unspecified). He was also vaccinated with influenza vaccine, 1 week prior to the presentation in the left buttock, after which his parents noted a red patch near the site of vaccination. The patch became raised and spread down the left thigh over the course of several days. The rash did not bleed, ulcerate, weep, or appear itchy or painful, though the patient did seem uncomfortable when getting dressed. He had no known sick contacts at day care, exposure to herpes simplex virus, or exposure to new topical products or clothing. His pediatrician prescribed cephalexin and mupirocin for a presumed cutaneous bacterial infection. The eruption continued to spread down his left thigh over the next 2 days, at which point the pediatrician advised the family to go to the emergency department. On examination, the boy was afebrile and well-appearing. There were multiple discrete clusters of monomorphic pink to violaceous papulo-vesicles with surrounding erythema scattered across the left buttock, thigh, and upper calf, some with central punctate hemorrhagic crust. The lesions were non-tender. There were no skin lesions elsewhere. A test was performed. A diagnosis of herpes zoster was made. Because the patient's eruption was asymptomatic and improving by the time that test results were available, treatment with acyclovir was deferred. The grouped papulovesicles in a unilateral L3-L5 distribution involving the same extremity in which the VARIVAX was administered raised suspicion for herpes zoster in this patient. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter had a patient who had muscle pain since the SHINGRIX shot that started 3 to 4 weeks afterward and had gotten worse. The shot was only thing the patient had done differently.
Primarily exhaustion; Lack of energy; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8731) via an unspecified route of administration in the right arm on 16Apr2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Patient had medical history which was unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of taking COVID-19 vaccine, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8727) via an unspecified route of administration in the right arm on 25Mar2021 at 14:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced primarily exhaustion, lack of energy. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10May2021, the patient underwent SARS-CoV-2 PCR (Nasal Swab) and the result was Negative. The clinical outcome of the events primarily exhaustion, lack of energy was not recovered at the time of this report.
Woke up with heart rate of 146, felt dizzy and faint. Also had fever of 103.5, but I know fevers are part of the anticipated side effects. Called doctor at home, they were worried I might get palpations so they suggested an ER visit for testing. By the time I got to the ER, heart rate had dropped slightly, temp was still high.
It was reported that a 5 year old male child received a dose of IPOL on 10/22/01. Sometime after vaccination (date not specified) the patient developed a local reaction of redness, hot and tender to touch. Mother of child called 10/24/01, local reaction is size of tennis ball. No other signs and symptoms.
Fever, Chills, Body aches Motrin and Tylenol uses alternately for 24hrs and symptoms improved
no additional AE; overdose; This spontaneous report was received from a practice supervisor concerning a patient of unknown age. No information about the patient's current condition, medical history or concomitant therapy was reported.    On 07-SEP-2021, the patient was vaccinated with two doses of varicella virus vaccine live (oka/merck)(VARIVAX) (at the dose of 1 ml, route was not reported) at the same time for prophylaxis (overdose). No additional adverse event was reported.
Medication Administration Error: In the midst of attempting to vaccinate several children in a family at an elementary school clinic, a 12yo patient received a pediatric Pfizer COVID-19 vaccine for his first dose in his COVID-19 vaccine series. The patient's mother was notified by the administering nurse of the error. The patient will be scheduled to receive the full adult 30 mcg = 0.3 mL for his second Pfizer dose. After the incident, leadership shared the event with the department and discussed the need for increased staffing to support the time needed for pre-administration review.
Chest and back pain, Shortness of breath, Feelings of having a fast-beating, fluttering, or pounding heart, tiredness, headache, muscle pain, chills,  joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, diarrhea, vomiting and eventually signs of pancreatitis, jaundice and death within 4 months of 2nd shot.  This is 5 in family and friend group taking Pfizer.
Case number PHEH2016US029267, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly following temperature excursion at 52 Fahrenheit for 1 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if the vaccine was frozen. Nurse did not which lot was given to which patient. No adverse event was reported following this administration error (incorrect product storage).
Headache; fatigue; tenderness at injection site; low-grade fever; sore throat; stuffy nose; achy muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 11:00 (Batch/Lot number: unknown) at the age of 50 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: Bnt162b2 (dose 1, single, Dose vaccine location: Left arm, lot/batch number, expiry date and route of administration unspecified), administration date: 20Mar2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (dose 2, single, Dose vaccine location: Right arm, lot/batch number, expiry date and route of administration unspecified), administration date: 10Apr2021, when the patient was 50 years old, for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "tenderness at injection site"; PYREXIA (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "low-grade fever"; OROPHARYNGEAL PAIN (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "stuffy nose"; MYALGIA (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "achy muscles". Therapeutic measures were not taken as a result of headache, fatigue, vaccination site pain, pyrexia, oropharyngeal pain, nasal congestion, myalgia.  Additional information: It was reported that the patient did not receive any other vaccine in four weeks. Reportedly the patient did not have covid prior vaccination and was not covid tested post vaccination. The patient also did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician regarding a 34-years-old female patient. The patient's pertinent medical history included depression. Her drug allergies included penicillin and her concomitant medications included bupropion hydrochloride. On an unknown date, a Papanicolaou came out positive for human papilloma virus .  On 13-APR-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose reported as 1, intramuscularly as routine immunization (lot number R028387 with expiration date on 27-JUL-2021) (anatomical location was not reported).  On an unknown date in April 2020, the patient experienced joint pain. The patient did not seek for attention and did not received treatment for the joint pain (arthralgia). On 11-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose reported as 1, intramuscularly as routine immunization (lot number R028387 with expiration date on 27-JUL-2021) (anatomical location was not reported), and her joint pain got progressively worse after this dose. The physician wondered if the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) should be administered. At the time of this report, the patient had not recovered from joint pain. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not discontinued.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and arthralgia was not provided. 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. deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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
abd pain, vomiting, p/vax & a/adm to hosp;4 days later IV hydration much improved-hosp for 2 days;