chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2022 at 1:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.61.  Concomitant medication was not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM, 03 PM and temperature was 32, 32, 32, 35, 35 respectively. Total doses given for the day was 162 from 9 AM vial, condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. On 14-FEB-2021, no hourly temperature recordings available.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when temperature data logger registered 34 or 35 degree F.  Treatment information was not reported.
A non-serious spontaneous report of gave H1N1 LAIV to person >49 years old was received from a registered nurse/healthcare professional concerning a 64-year-old male. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
ITCHING; RASH ON ARMS, BACK AND LOWER TORSO; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced flu-like symptoms. On 11-APR-2021, the subject experienced itching. On 11-APR-2021, the subject experienced rash on arms, back and lower torso. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 08-APR-2021, and had not recovered from itching, and rash on arms, back and lower torso. This report was non-serious.
Pt recvd 1st dose of Engerix-B & 1 wk post vax exp a rash described by reporter as welts on abd transient size of thumbprint; pruritic;
Patient received vaccines that were in a refrigerator at the time of a power outage for unknown amt. of time.  Vaccines were deemed "spoiled" after patient's visit.
Chest pain, high BP, was told not heart attack.  Now I have leg pain that is more like growing pains that won't go away. I still have chest pain that comes and goes. I never had these problems before the vaccine.
Child's arm swelled up, became hot, and painful to touch.  Mother called regarding reaction on Saturday 2/4/06.  RN on call instructed mother to take the child to ER.   RN administering vaccine called mother on Monday, 2/6/06, regarding the ER findings.  Child was placed on Cephalexin and is to see his regular physician on Wednesday, 2/8/06.  Mother was giving the antibiotic, using hot packs, and Tylenol for comfort.
Experienced really bad injection site pain all trough the night; Information has been received from a male patient of unknown age, concerning himself. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). Subsequently, the patient experienced really bad injection site pain all through the night. The outcome of the injection site pain was unknown.  The causal relationship between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the injection site pain was not provided.
I had Measles; Nurse reported he developed psoriasis on an unspecified date.; Nurse reported he has a "negative titer for mumps".; This spontaneous report was received from a male nurse of unknown age, referring to himself. His concomitant therapies included (TREMFYA). The patient had no previous drug reactions or allergies.      On an unknown date,  when the patient was a child, he was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose number, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prophylaxis. Other suspect therapies included a sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not provided).   On an unknown date, the nurse reported that he had measles (medically significant) and developed psoriasis (also reported as "pertinent medical history", conflicting information). Also, he reported he had measles, mumps and rubella (MMR) titers on an unspecified date and was negative titer for mumps (mumps antibody test negative). The patient did not seek medical attention and there was not treatment given for the adverse events.      At the time of reporting, the outcome of measles was unknown and for the events of psoriasis and mumps antibody test negative, was reported as not recovered/not resolved. The causal relationship between the suspect drugs and the aforementioned events was not provided.  Upon internal review, the event of measles was considered medically significant.
Pfizer / BioNTech administration date=12Oct2021; COVID 19 Treatment start date=06May2022; Pfizer / BioNTech administration date=12Oct2021; COVID 19 Treatment start date=06May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech administration date=12Oct2021; COVID 19 Treatment start date=06May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; negative; positive. Therapeutic measures were taken as a result of drug ineffective. No other medication in 2 weeks. No known allergies. After taking Paxlovid for 5 days, symptoms resolved and tested negative 3 days in a row. On the 5th day after my treatment, patient had symptoms and testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning an 11 year old female who on an unspecified date, was vaccinated with a dose of MMR II. On 02-NOV-2009 the patient experienced mumps. On 01-DEC-2009, the patient was diagnosed and the patient was afebrile. The patient had parotitis. Parotitis count was 139. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a physician reported that on 09-NOV-2009 the patient experience mumps. On 11-NOV-2009 the patient was diagnosed. The patient had right parotitis. On the same day, the first blood work was performed and no result was provided. Additional information has been requested.
Client during TC, expressed through the telephone Interpreter, received the J & J COVID 19 vaccine, in left arm, on 3/14/2021. After receiving vaccine had slight soreness at site, and on 3/27/2021 started having left sided facial droopiness, difficulty swallowing, talking, fatigue, SOB and weakness, around 10:00 am. Per Client, children called EMS, and was transported to Hospital. Per Client, was treated at hospital and informed by medical personal, that she probably experienced a stroke. Client was not admitted to hospital, sent home the same day, and instructed to follow up with PCP. Per Client, on 3/29/2021 followed up with PCP, and on 5/12/2021 had a MRI procedure and due to for follow up on this Monday, 5/17/2021. Per Client already taking an anticoagulant for other chronic medical conditions. Per Client is starting to speak clearer and able to eat without difficulties. Suggested to Client, continue to follow up with PCP and to call EMS for medical emergency. Client verbalized understanding information provided.
Swelling/redness/itchiness at injection site 1week after dose #1 of Moderna vaccine
Broke out in itchy rash on 01/04/03; Came to physician office on 01/05/03 with rash spreading on body. Physician dx as varicella.
Patient was vaccinated at clinic at approx 4pm and showed no signs and symptons during required 15 minute observation period. She return to work but began feeling lightheadness, cold sweats. and shortness of breath at 530pm. EMS was contacted at work place and patient was transported to hospital.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) outcome was unknown.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided by the reporter. It was reported that Pharmacist called 25Aug2021 and stated that a vial at room temperature yesterday 25Aug2021 at 10:30AM was not salvaged correctly and was administered to 2 patients today around 12:45pm Pharmacist asking if doses needs to be repeated. Agent spoke from SRL information which pharmacist also requested in email. 2 doses given from 1 vial. Total amount of time vial exposed to room temperature range (8-25 C or 46-77 F): Room temperature for greater then 24 hours. Approximately 24Aug2021 10:30AM to 25Aug2021 12:45pm date and time of dose administration.No treatment medication provided by the reporter.
eye balls are sunken; face hurts; fallen down a few times; hurting all over; nausea; fever of 99 degrees Fahrenheit; dizziness; spine hurt; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spine hurt), DIZZINESS (dizziness), EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts) and FALL (fallen down a few times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SPINAL PAIN (spine hurt), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 25-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN (hurting all over), NAUSEA (nausea) and PYREXIA (fever of 99 degrees Fahrenheit). On 26-Mar-2021, the patient experienced EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts) and FALL (fallen down a few times). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SPINAL PAIN (spine hurt), DIZZINESS (dizziness), EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts), FALL (fallen down a few times), PAIN IN EXTREMITY (sore arm), PAIN (hurting all over), NAUSEA (nausea), PYREXIA (fever of 99 degrees Fahrenheit) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information includes iced arm.
hard, red, swelling (60mm diameter) @ site of inj lt deltoid, pain & tenderness @ site also itches;
Patient receive the original Pfizer vaccine instead of the bivalent vaccine. No adverse events were reported.
Severe pain at injection site for over 4 days. Severe  for the first two days. Took 400 mg Ibuprofen  on day4 morning.
Small itchy bump at injection site. Below injection, large red rash like patch. Warm to the touch and hard. Began today, 8 days after injection and has lasted from midday to then evening so far.
pt recv vax & exp PVC's for approx 48hr;also devel lyme disease;
mins post vaccination pt experienced vomiting.   Vitals: BP 70/40, HR 69, RR 22 -- > 109/72, 68, 22 -- > 107/77, 72 -- > 112/77, 70 After vaccination pt became nauseous.  Pt was taken to treatment area.  V/S obtained and pt placed in semi-fowler.  Pt experienced vomiting x2.  Pt then experienced chills.  PT was covered w/ blanket and given water.  After nausea ceased, pt then experienced abd and back cramps that "took her breath away".  Provider was wanted and advised pt to visit ER/ call emergency if symptoms persist, but if she feels ok, then she can leave.  Pt expressed understanding.  After 30mins pt states that she feels better and ambulated to car w/ steady gait.
Patient complain of feeling dizzy an d nauseous.  EMS on site came over and assess patient, took her vital signs.  B/P 118/77, P84, R 18, Oxygen 98% on room air.  Patient refused transport to the hospital.  EMS monitor patient for 15 minutes, then she stated she felt better and wanted to leave, she was instructed to wait in observation for another 15 minutes.
Body aches after first shot; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body aches after first shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced MYALGIA (Body aches after first shot). On 18-Sep-2021, MYALGIA (Body aches 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 information was reported. No treatment medications were provided.   This case was linked to MOD-2021-366238 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 30th January 2019, the patient received the 1st dose of SHINGRIX. On 30th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain, muscle pain, feeling cold, feeling hot, weakness and tiredness. On an unknown date, the outcome of the pain, muscle pain, feeling cold, feeling hot, weakness and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain, muscle pain, feeling cold, feeling hot, weakness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing achiness, minor muscle pain, weakness, tiredness and feeling cold and hot. The patient had these symptoms for the last 7 days. The reporter gave consent to follow up. The patient did not have physician (MD) information at the time of the call.
Cold sores in and around mouth developed.  Extreme fatigue.  Felt feverish on 1st day.  Complained that could not drink or eat, could not pass urine.  Felt pain in kidney area.  Also other cold like symptoms such as runny nose. Starting to feel better on 1/31/20.
Information has been received from a Nurse Practitioner (N.P) concerning an approximately 21 year old female patient with history of eczema who on 10-JUL-2009 was vaccinated with the first 0.5 mL dose of GARDASIL. Concomitant therapy "started around the same time" included NUVARING. It was reported that "a week and a half after getting GARDASIL" the patient started experiencing rash around her waist area that later spread to the whole body. It was reported that the patient did go to the primary physician and was administered a shot for the rash (unspecified what kind). There were no laboratory diagnostic tests performed. It was reported that eventually NUVARING was removed and the patient was recovered three days later. Follow up information has been from a Nurse Practitioner concerning a 22 year old female patient with illness at the time of vaccination reported as none, adverse events following prior vaccination reported as none, no known drug allergies and history of eczema who on 13-MAY-2009 was vaccinated with a first dose of GARDASIL (lot # 661846/1312X) intramuscularly into left upper arm at 10:30 AM. In June 2009 she experienced rash over arms and legs only. Unsure if reaction was due to vaccine because the patient also started NUVARING at the same time. On an unspecified date the patient recovered from rash over arms and legs. Additional information is not expected.
4/11 vaccination That evening, I had muscle cramping and soreness at injection site and arm. Mild HA, sore arm.  4/13 Evening, I ended up with a bruise on my leg. Was a quarter size. The next day it was very purple.  4/14 PCM ordered blood work, doubled size. PCM ordered blood work and tests to r/out clotting.  4/17 bruise was gone, HA was gone.
After the vaccination in November, I started having bad pain in my left hip that lasted about two weeks. After the hip pain subsided, the pain moved to my left wrist. It was swollen and sore. I couldn't even touch it. The wrist pain lasted about three weeks. After that, the same thing happened to my right wrist. The pain in my right wrist lasted about three weeks. Then, it moved to the muscle between my neck and shoulder blade on the right side. The pain there lasted about a week and a half. The pain moved to my right bicep. It was sore to the touch and lasted about two weeks. All these episodes happened consecutively. I also tested positive for COVID-19 on January 26, 2023. I was prescribed Paxlovid. I took it for five days. The symptoms went away, and I tested negative for COVID-19 on January 31, 2023. On February 5, 2023, I rebounded and tested positive for COVID-19 again. As of today, I am still testing positive for COVID-19. My COVOD-19 symptoms included congestion, sore throat, fever between 99.7-degrees and 101-degrees, nausea, a slight cough, headache, and dizziness.
Patient received his 2nd dose of the Pfizer vaccine and fainted approximately  minute after the dose was given. The patient's eyes rolled back as he fell to the floor where it appears that he had a mini seizure. We called for a code white and immediately began emergency procedures. I held the patient while he was sitting upright and kept speaking to him until he regain consciousness approximately 1 minute after he had syncope.  The patient seemed very confused because he had asked the question "where am I," as he opened his eyes. He slowly became more alert as time passed by and was aware of his surroundings within the next 2 minutes.  He then stated that he was hot and hungry and was given water (from me) and Gatorade from his mother at his request. It was not long after that that the patient fully recovered and was back to normal. I had them stay and observed him for at least 40 minutes just to make sure that he was ok. Statements were taken from a salaried member of management during this time.  There was no medication needed and none given during this incident. Plans were made with patient's mother for a follow up and our contact information was given incase they needed to contact us for anything at all. I will reach out to them in the next 1-2 days to see how the patient is progressing.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored PNEUMOVAX 23 lot # L019835/Expiration Date- 23-MAR-2017, lot # L049744/Expiration Date- 12-OCT-2017, lot # M020521/Expiration Date- 17-NOV-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was due to receive DtaP #2 and separate IPV #2, instead the combined DTaP/IPV (Quadracel) was given
Information was received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB (lot# L04048, expired on 04-FEB-2018; lot# M010212, expired on 21-JAN-2019) (dose and route unknown). The vaccines were exposed under 48 Fahrenheit degree (F) for underdetermined time frame and was back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.