chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INTERMITTENT HEART RACING; BODY ACHES; CHILLS; WEAKNESS; 101 TEMPERATURE; NAUSEA; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced intermittent heart racing. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced 101 temperature. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 101 temperature, chills, nausea, body aches, severe fatigue, weakness, and intermittent heart racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Chills, shivering, body aches, joint aches , treated with Motrin with improved symtpoms
pt recv vax MAY97 & in 1997 pt devel a sterile abscess w/ 2.5inches of swelling @ the four different inj site in the upper arm;tx w/DPH;pharmacist thought that it may have been an allerg rxn to aluminum phosphate;
This spontaneous report was received from a nurse and refers to a 4 month old male patient. The patient did not have pertinent medical history and drug reactions or allergies. The patient did not use any concomitant medications. On 16-JUL-2015, the patient was vaccinated with the first dose of ROTATEQ suspension single dose (1 DF) orally (lot number K023157 and expiry date 23-JUL-2016). On 10-SEP-2015, the patient was vaccinated with the second dose of ROTATEQ single dose (lot number L008031 and expiry date 03-AUG-2016). On 07-OCT-2015, the patient was diagnosed with intussusception. On 07-OCT-2015, the patient sought medical attention and was admitted to the hospital. On 08-OCT-2015, the patient had an unspecified laparoscopic surgical procedure. The outcome of the events was reported as recovering. The reporter did not provide the causality between the events and the suspect therapy. The reporter considered the events unspecified laparoscopic surgical procedure and intussusception as serious due hospitalization, disability and life threatening. Additional information has been requested.
redness, swelling, warm to the touch. treated with a compress, ibuprofen, and Benadryl. Arm still sore from the shot, arm is fully functional.
Information has been received from a physician concerning a female pt with seizures who in approx Oct 2006, about two months ago, was vaccinated IM with a first 0.5ml dose of HPV vaccine. Right after receiving the vaccination, the pt started to have seizures every day for about two weeks after receiving the vaccine. It was noted that the pt already has seizures but had them once or twice a week not everyday. Subsequently, the pt recovered. Upon internal review, seizures was considered to be an other important medical event (OMIC). Additional information has been requested.
Approximately 5-10 minutes after receiving the injection the patient had a fainting episode.  Which resulted in the patient hitting his head.
Initial and follow-up information has been received from a physician concerning a 65 year old female with hypertension and joint discomfort who in December 2003 was vaccinated with a first dose of PNEUMOVAX 23 (lot number, injection site and route not reported). On 29-OCT-2008 the patient was vaccinated intramuscularly with a second dose of PNEUMOVAX 23 (lot # 657525/0554U) in the right deltoid and a dose of FLUZONE (lot number U2805AA) in the left deltoid. Concomitant therapy also included TENORMIN, glaucoma drops, hydrochlorothiazide (manufacturer unknown) and LILPITOR. The physician reported that the patient's blood pressure had been checked once or twice a week and remained stable. Three or four weeks ago actually got a bit low into the 90s. Five days ago she started on 50 mg of INDOCIN a day for some joint discomfort and coincident with that her BP jumped up into the 155 range systolic with normal diastolics. On the same day, within about 4-5 hours after receiving the vaccine, the patient experienced pain, swelling and erythema which had gradually involved the upper arm on the right side. She had not other systemic symptoms. On 31-OCT-2008, the patient visited the doctor's office. Physical examination showed that BP: 154/80, pulse 70 and regular. Lungs: clear. From just distal to the shoulder to approximately the elbow of the right arm, there was mild generalized erythema, mild warmth and some mild swelling. The physician stated that this was all consistent with a reaction to the PNEUMOVAX 23. The patient had been using TYLENOL and was prescribed BENADRYL 50 mg every 4 hours as needed, along with moist warm compresses. As of the reporting time, the patient recovered from the events. This is one of several reports received from the same source. All these patients developed reactions after receiving PNEUMOVAX 23 (lot # 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the center and was released. Additional information is not expected.
Cannot sleep on left shoulder; constant left shoulder pain / cannot sleep on left shoulder; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cannot sleep on left shoulder), ARTHRALGIA (constant left shoulder pain / cannot sleep on left shoulder) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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 INSOMNIA (Cannot sleep on left shoulder), ARTHRALGIA (constant left shoulder pain / cannot sleep on left shoulder) and NAUSEA (Nausea). At the time of the report, INSOMNIA (Cannot sleep on left shoulder) and ARTHRALGIA (constant left shoulder pain / cannot sleep on left shoulder) had not resolved and NAUSEA (Nausea) had resolved.            Patient stated within two months of second dose patient experienced constant pain. Patient stated that he cannot sleep on left shoulder till the time of report.  No concomitant medications were reported. No treatment medications were reported.
Felt like a had the flu for about 24 hours.  Shivers, cold but hot at the same time, headache, body aches
So dizzy; Just don't feel good; just don't feel good.; high temperature, sa high as 101.5; chill; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.), PYREXIA (high temperature, sa high as 101.5) and CHILLS (chill) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.), PYREXIA (high temperature, sa high as 101.5) and CHILLS (chill). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.) and CHILLS (chill) outcome was unknown and PYREXIA (high temperature, sa high as 101.5) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2005, Body temperature: 101.5 (Inconclusive) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
Sore arm; Fever; Headache; very painful on whole left side side of his head; when he is walking, it hurts a lot; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced sore arm, fever, headache; very painful on whole left side of his head; when he is walking, it hurts a lot. Reported that he has his 2nd dose of vaccine on 30th like in afternoon and fever ended on Saturday. It was like Friday and Saturday he had a headache since he got the vaccine, he doesn't get normally headache, so it got worse last night, it feels very painful on whole left side of his head. The outcomes of events (sore arm, fever) were recovered on an unspecified date in 2021, the outcome of event (headache; very painful on whole left side of his head; when he is walking, it hurts a lot) was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Chills and body aches 12  hrs after injection, followed within a few hours by fever, nausea, fatigue, and an altered sense of taste.  Fever broke after 24 hours.  Fatigue lasted 3 days.  Sense of taste is still not normal - some foods (rice, cucumbers, and others) taste sour.
pediatric dose/to a male adult patient.; pediatric dose/to a male adult patient.; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 64-year-old male patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were 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 reported as follows: The age at vaccination was not reported. The reporter called to report that a medical assistant of the center where she works, applied a pediatric dose of Engerix-B vaccine to adult patient, which led to adult use of a child product and underdose. At the time of the reporting, the patient was doing well. No further details were reported. The reporter consented to follow up by email.
Arm soreness for 4 days Increased asthma  body fatigue 2-3 days
Booster vaccine given on 11/9. Patient had a STEMI on 11/10- stents placed x3 with a good outcome. Ongoing hospitalization.
Pt recvd vax 16JUN92 & was found to be pregnant; 16JUL92 MD stated that an ultrasound revealed that the baby's size was lower that expected; No further details were provided;
Received 3rd dose of vaccine; A spontaneous report was received from a pharmacist concerning an 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and administered 3rd dose of vaccine/extra dose administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037k20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch number: 011m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Mar 2021, the patient received third dose of mRNA-1273 (lot/batch number: 012a21a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The reporter was unaware of any side effects. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of event received 3rd dose of vaccine was considered resolved on 15 Mar 2021.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273, lot # 037k20a with no associated AEs.
dose was given from a vial that had had been punctured for 12 plus hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given from a vial that had had been punctured for 12 plus hours) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given from a vial that had had been punctured for 12 plus hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given from a vial that had had been punctured for 12 plus hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
this patient had both pfizer vaccine injections 1-28-21 and 2-25-21; he then went on to have covid
whole body hurt to touch, extreme stabbing joint pains in left elbow, left hip, left ankle, throbbing spine pain. extreme left sided quadrant pain. headache. symptoms lasted 24 hrs.
Hives on face and at injection site (right thigh) of MMR, Varicella and PCV.
7 days after receiving the vaccine, my arm became very itchy at the site of the injection.  That evening, I noticed a golf ball size red swollen area around the injection site.  The next morning, the reddened area had increased to the size of a baseball.  It remained itchy, red, swollen, and warm.  By that evening, the area had increased to the size of a canteloupe.  I presented to the local Urgent Care.  I was diagnosed with "cellulitis" and prescribed an antibiotic.  I did not take the antibiotic, as by the time I picked it up from the pharmacy the next morning, the redness and swelling had already started to decrease.  At this time, (10 days after vaccine), the redness and swelling are gone, and my arm just remains a little itchy.
Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Soreness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Soreness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.
This is a spontaneous case, initially received from other health professional on 09-Nov-2018, concerning a 02-year-old, female child. The patient had no medical history and did not take any other vaccine or medication at the time of vaccination. On 04-Oct-2018, the patient (under the age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, batch number: 252235, expiry date: 30-Jun-2019). At the time of this report, no adverse event was reported, but the patient was being monitored. This case is linked to case: 201805300 (same reporter). The reporter assessed the case as non-serious.
On 7-3-09 came to work at 7am with temp over the next three hours of 99.8 to 99.9. At 11am fever became 100.2 and employee was sent home from work. Had pain at site at that time. On Saturday pain was in arm from site to hand and fever to 100.2 continued. On Sunday numbness and tingling from shoulder to hand began and has continued through today. Deltoid and anterior chest muscles at axilla remain achey and sore today but have been painful on Sunday and Monday. Lymph nodes from axilla toward elbow are swollen and very tender to the touch.
No additional adverse symptoms reported; the patient was inadvertently administered one dose of improperly stored VAQTA (lot number 025993, expiration date 10/1712020) on 6/5/2020.; This spontaneous report was received from a health care worker referring to a 4 years old male patient. The patient's medical history, concomitant therapies, concurrent condition and drug allergies were not provided.  On 05-JUN-2020, the patient was inadvertently administered one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot# reported as 025993, which was evaluated and changed to the valid lot# S025993, expiration date 17-OCT-2020; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion was above 47 Fahrenheit degree (49.6 Fahrenheit degree) for 11 hours and 40 minutes. There was no previously temperature excursion. There was a data logger involved. No adverse symptoms were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received TIV on 10/11/10 (L) arm about 3:30 p.m. 2 hrs post vaccine - cough, eye itched, red, pus low grade fever 100.4, diaphoretic, achy. Symptoms lasted about 12-14 hours.
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA182241, 2018SA182252, 2018SA182253, 2018SA182255 and 2018SA182256 (same reporter). This case involves patient (age and gender not reported), who received a vaccine, which on 01-Jun-2018 reached to 52.8-degree F for 43 minutes and on 04-Jun-2018 product reached 48.2-degree F for more than 30 minutes, before patient received 0.5 ml dose of vaccine IPOL lot N1K931M via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported if the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
First weird taste in mouth 2-5 minutes after shot.  Then numbness in face & head?mostly on left side?that started 15-20 minutes after shot. Not the zero-sensation numbness of dental work or surgery, but more of an internal numbness. Over the course of 4 hours it slowly spread and then dissipated. Spread route: chin, mouth, jaw, ?sinus area? across cheeks & nose, eyes became a bit blurry, wrapped around to ear, side of head & back of head. No drooping, weakness or paralysis noticed.
45 minutes after vaccine administered, patient reports feeling throat swelling. Patient is crying and appears anxious. Patient reports feeling nervous prior to receiving vaccine. Patient able to speak clearly, follow commands, swallow Certirizine and drink water. HR 66 BP 134/76 at 2:40pm. Approximately 15 minutes later, patient reports feeling sore throat and throat swelling resolved. Patient experiencing mild headache also.  HR 67 BP 128/78 at 3:04pm. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 with symptoms worsen or respiratory distress. Patient declined transportation to hospital for further evaluation. Patient taking Uber home.
I have problems with my ears, heavy thinking, and brain fog. I went to my doctor and they ran some test. They said I have short term memory loss and my eardrums were blocked. The EMT said I had Keratosis Obturans. He removed the keratin. Things has gotten better since he has removed it. There is no known cause as to why it develops.