chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a health care professional on 06 February 2012. A 23-month-old female patient had received a dose 1 intramuscular injection in the left thigh of DAPTACEL, sanofi pasteur Ltd. lot number C3944AA on 01 February 2012 and a dose 2 intramuscular injection in the right thigh of IPOL, sanofi pasteur SA lot number 94244-0 (not a valid sanofi pasteur lot number) on 01 February 2012 with a 5/8 inch needle. On 04 February 2012, the patient experienced a flat red rash at the injection site on the left thigh and "all down the thigh" with a temperature of 101, vomiting, pain and swelling at the injection site. The patient was seen in the physician's office on 06 February 2012 and no treatment was prescribed. The patient had no known allergies (NKA) and a medical history of kidney reflux. The patient was concomitantly taking BACTRIM. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 12 March 2012. The lot number of IPOL was reported as G1500. The patient's birth weight was 7 pounds 15 ounces and the patient had one brother or sister. The patient's outcome remained not recovered. Follow-up information was received on 21 May 2012: It was reported that the patient recovered on 18 Feb 2012. The patient had no illness at the time of vaccination.
Swelling at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included LEVOTHYROXINE, QUINAPRIL and OMEPRAZOLE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-023628 (Patient Link).
Itchy and irritating rash; Itchy and irritating rash; The rash is on my left forearm, left hand, right abdomen and right breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast). At the time of the report, RASH PRURITIC (Itchy and irritating rash), SKIN IRRITATION (Itchy and irritating rash) and RASH (The rash is on my left forearm, left hand, right abdomen and right breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Vomiting, given Zofran, then vomited again. Patient denies dizziness, abdominal pain, eye and lip swelling, and rash
Patient presenting with complaint of scratchy throat.  vital signs: BP: 130/80 Pulse:83 Respirations: 17 O2:98% Provider ordered Benadryl IM. Given at 10:48 And continue to monitor for 20 min  Assessed patient at 11:10 Scratchy throat improved no further complaints. Patient sent home advised to follow up with PCP or go to ER if any worsening reactions occur.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279742, 2018SA279744, 2018SA277209, 2018SA279741, 2018SA279740, 2018SA279745, 2018SA279746, 2018SA279747 and 2018SA279743 (same reporter). This case involves a 45 years old female patient who was vaccinated with vaccine FLUBLOK QIV (lot QFAA1829 and exp. Date 30 Jun 2019) via unknown route in the left deltoid on 02-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to shipping excursion for FLUBLOK QUADRIVALENT and was administered to patient. It was reported that shipment was sent to her clinic on 27-Sep-2018 and was received on 01-Oct-2018 and administered to 10 patients. No symptoms reported. No corrective treatment given. 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. List of documents held by sender: none.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included tested positive for COVID twice over six months and immunodeficiency. The concomitant medications included corticosteroids. The patient tested positive for COVID twice over six months and the second time was more than a month after two Pfizer vaccines. The patient do take corticosteroids so am immunocompromised. The outcome of the event was unknown..   Information on the lot/batch number has been requested.
Within 24 hours of receiving the flu shot - Frozen shoulder/limited mobility, extreme arm weakness, intense pain in the shoulder and deltoid muscle, aching and sometimes numbness. Issues with everyday activities and sleeping. I began physical therapy on 12/3/18, a little less than a month after the shot was administered. This was the recommendation from the Urgent Care that I visited 2.5 weeks after I got the shot. My shoulder/arm was not getting better, it was actually getting worse at this point. I have been to 12 physical therapy visits. I am still currently going. I was initially going twice a week and now am down to once a week because we are having issues getting the insurance to clear more visits. The physical therapy has worked very well to get most of my mobility back in my shoulder, but all the other symptoms listed are still an issue.
Patient is inmunocompromised and received 0.25ml of moderna vaccine instead of 0.5ml.
Pt received 1st pfizer covid vaccination. He was fine after I gave the immunization and then went to post immunization waiting area. Patient had family with but they went to cafe. I came back to pharmacy then patient fainted from chair and was caught by another patient sitting in the area. I came right outside as soon as this happened and pt was on ground. He felt clammy and looked pale. I asked him if he was awake and ok to assess situation if he was responsive and then he became alert and said he was ok. The pharmacy staff inside pharmacy was on phone with 911 but patient became alert and declined assistance from 911. we had him lay on floor for several minutes then got him into a chair and got him water. The family came back right after he fainted. Patient was ok after and store manager also filled out incident report for sams club. I advised before he left that he talk to his doctor before he would get the second dose of this vaccine to make sure they feel if he should receive second dose and to check if they want him to get this vaccine under dr supervision.
Sedation, Myalgia, Arthralgia, 8 HRS POST VACCINE FELT MODERATE FLU LIKE SYMPTOMS; CHILLS, FATIGUE, BODY ACHES AND WEAKNESS
28yo Male, presenting for 1st Pfizer vaccine, presented with fever and profound body aches, HA, and chills approx 10hrs after receiving 1st dose. Pt presented to medical clinic 24hrs later for eval and tx. No red flags on exam besides tachycardia and fever. Lung CTAB, and Heart/chest exam unremarkable. Pt treated with Tylenol after eval of sx. Pt would like this documented.
"Covid Arm"  circular patch  about 3 inches in diameter, red with itching and stinging  surrounding injection site. Reaction still  visible at 9 AM on 2/11/21
Diarrhea which started morning after injection and lasted 12 hours, Extremely soreness at injection site starting morning after administration which continued for 4 days, 2nd day post injection - 3.5" diameter red area which was swollen and warm to touch and continues through day 5 and now with intense itching at site.
Pt received vaccines on 3/24/00. On 3/26/00, the pt was seen with a 6-7 cm hard, indurated lesion on the right anterior thigh, erythematous. Treated with Duricef.
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 02-APR-2015 (improperly stored only) and 29-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
vaccine administered beyond 30 day use by date; The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022) and PRODUCT STORAGE ERROR (vaccine administered beyond 30 day use by date) in an 82-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine administered beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022) and PRODUCT STORAGE ERROR (vaccine administered beyond 30 day use by date) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The occupation of the reporter was reported as clinic manager.  No concomitant medications was provided by the reporter. The vial was initially stored in the refrigerator 31-May-2022 4PM, 30 day BUD out of the freezer and was administration of vaccine on 01-jul-2022 between  9am and 12noon.  The vial did not undergo any temperature excursions.  No treatment medications was provided by the reporter.
At night I have a racing heartrate, unable to fall asleep,  when I do fall asleep no longer than an hour.  I am sure that this will shorten my lifespan as when I do feel like I can sleep I have to be up to go to work tired.
patient on 56 days after first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient on 56 days after first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient on 56 days after first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient on 56 days after first shot) had resolved.        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 were provided. No treatment medications were provided.   Reporter did not allow further contact
Received the first dose of the Moderna COVID-19 vaccine on day one, and then received the second dose of the Moderna COVID-19 vaccine only 5 days later; A spontaneous report (United States) was received from a pharmacist concerning a patient, unknown age, who received the first dose Moderna's COVID-19 vaccine (mRNA-1273) and then received the second dose only 5 days later.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided). 5 days later, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 09 Feb 2021, a pharmacist reported a patient received the first dose of the Moderna COVID-19 vaccine on day one, and then received the second dose of the vaccine only 5 days later. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, Received the first dose of the Moderna COVID-19 vaccine on day one, and then received the second dose of the Moderna COVID-19 vaccine only 5 days later, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date (reported as "years ago"), the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose frequency and route not reported) that had been improperly stored "in another practice". The ZOSTAVAX that was administered had been exposed to warmer than 77 Fahrenheit temperature (F) during transport from the pharmacy to an unspecified physician's practice. No adverse effects reported. Additional information has been requested.
Drug ineffective; caught covid19; broke out with bumps in between his knees/looked like hives; got into a car accident; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "caught covid19"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "broke out with bumps in between his knees/looked like hives"; ROAD TRAFFIC ACCIDENT (non-serious) with onset 2021, outcome "unknown", described as "got into a car accident". Clinical course: When patient got the first shot he broke out with bumps in between his knees and it was a whole bunch and looked like hives and then he got the 2nd shot of the Pfizer vaccine; states he had the 1st shot on 17Sep2021 and then 21 days later he was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days and some other stuff happened where he got into a car accident. He took the 2nd Pfizer shot and had to wait 24 or 30 days after he got covid to get the next dose and bot the next dose the other day of last week and on Friday or Thursday his whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms. Patient wanted to know what he should do about the hives, does he go to his regular doctor or what. Patient is just not feeling well now and just got off the phone with friends.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swollen lymph nodes on side of injection (left side). Swollen and very painful lymph node on left collarbone the size of large grape or pecan shell, swollen/tender lymph nodes on base of neck size of large blueberries. The entire area including under my left arm into armpit was tender, painful to touch and achy. Could not put any pressure on area. Area is still swollen but less painful on this date (2/27) 4 days later.
Fever, body aches, then the following morning intense chest pain lasting 4 hours.  Dosed with 2 aspirin, and  IBU
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a 64 year old female patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-JUL-2014, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a physician's office. On or about 21-JAN-2016, 04-APR-2016 and 23-FEB-2017, the patient was treated by a healthcare provider at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose and route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 16 hours with the highest recorded temperature of 48 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient HAD A VERY BAD COLD IMMEDIATELY AFTER GETTING THOSE VACCINATIONS.  FURTHER, A FEW WEEKS LATER SHE SUFFERED A FEBRILE SEIZURE WHICH LED TO HER HOSPITALIZATION FOR 4 DAYS. Patient HAD ALREADY BEEN TALKING AT THE TIME OF THE SEIZURE.  HOWEVER, ALL SPEECH WAS LOST, BEHAVIOR CHANGED, AND SHE HAS BEEN DIAGNOSED WITH AUTISM AND HAVE BEEN UNDER THE CARE OF A NEUROLOGIST, OCCUPATIONAL THERAPIST AND SPEECH THERAPIST FROM THAT TIME ON.    10/30/07 Reviewed pcp medical records which included vax records.  F/u visit of 9/30/05 reveals patient in hospital for seizure 9/25/05.  EEG to be repeated. By visit of 2/23/06, concerned for autism due to no eye contact, lack of speech, developmental delays & dare devil behaviors.  Referred to developmental pediatrics for early intervention.  Referred for hearing eval.  1/25/08 Reviewed ER medical records of 9/25/2005 which reveal patient experienced shaking & eyes rolling.  Tx w/antiseizure meds & transferred to higher level of care.   FINAL ER DX: convulsions. 3/5/08 Reviewed hospital medical records. FINAL DX: new onset seizures.  Admit of 9/25-9/27/2005 reveals patient experienced tonic-clonic seizure x 1-2 min followed by unresponsiveness.  Seen in outlying ER & transferred here.  Neuro consult done.  Tx w/Pb.  No further seizures during hospital stay.  D/C to f/u w/pcp.
patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLU (The patient also received a Flu shot today.). Past adverse reactions to the above products included No adverse event with FLU. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 22-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a booster dose today, 22DEC2022,from a vial with a Purple label that states booster only).    The ID was reported as 80777-275-99.  No treatment medications were reported.
Information has been received from a health professional described herself as a sensitive individual who can only take penicillin with no medical history or history of immunocompromise who on 14-NOV-2006 was splashed in both eyes with Rotateq. There was no concomitant medication. She said it felt like "ground glass" in her eyes. She immediately irrigated both eyes with water. The eye wash "did not help much". It was reported that she began coughing for approximately 2 minutes. At the time of the report she had a frontal headache and her eyes felt "30%" better. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested. Followup information from the rigistered nurse indicated that her eyes bothered her for two week and "even now" they remained slightly sensitive. Additional information has been requested.