chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Severe coldness and shaking, lips, nose and arms turned purple and swollen.  Heavy breathing. Feet swollen. Went to ER and had elevated heart rate of bpm 120 and fever of 101.4.  Tachycardic.
Patient came in for office visit 8/29/16. It was decided by both patient and provider to receive flu shot and PNEUMOVAX. Patient was advised to have one injection in each arm. Patient repeatedly refused and insisted on both in left arm. Was seen on 9/1/16 for fever and arm edema. Given KEFLEX after phone call to nurse. Pt is fine now.
Pt started vomiting the within 18hrs and developed flat rash not itchy 24 hrs after vaccine. Rash went away within 48hrs after vaccine administration.
Patient came to pharmacy the day after receiving the vaccine with a complaints of a sore arm. He showed me the vaccine site, it was red, warm to the touch, and sore. He said he just wanted to make sure it was nothing to be concerned about.
7:00PM fatigued, burning up fever 100., ibuprofen/tylenol dose; Sunday afternoon nausea, loss control of body, anxious, feeling of fainting, unable to move-paralyzed, pressed button for medical help, ambulance arrived, pt transported to ER -- 102. temp ambulance, RN at hosp temp 98., pt was shaky, 8:30PM erratic heartbeat per admitting doctor - pt admitted. Pt PCP/Cardiologist contacted, kept on heart monitor, pt discharged Monday afternoon. 1/14/21 chest pain, nausea, 102. fever.  symptoms
At 12am on 1/12/21, I experienced extreme hot flashes and nausea while sleeping. I was unable to walk at first, but after standing up I fainted and became extreme cold.  This same exact feeling happened again at 7am on 1/12/21 without loss of consciousness.
Severe swelling of neck glands requiring emergency room visit.  Steroid and Toradol shot - swelling went down in 45 minutes
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received). On 22nd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was the caller's husband, he developed flu like symptoms after his second SHINGRIX dose. This case has been linked with case US2018136199, US2018136201 and US2018136203.
Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced BLOOD GLUCOSE INCREASED (Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.). At the time of the report, BLOOD GLUCOSE INCREASED (Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Blood glucose: glucose has gone up 15-30 points. Glucose has gone up 15-30 points.Patient's baseline was reported to be always under 100..     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Administration of vaccine past published expiry; The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   On 01-Apr-2022, the vial was initially stored in the refrigerator  and thawed on the day of use. Patients administered the vaccines on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022,01-Apr-2022 and 04-Apr-2022 No concomitant medication information provided. No treatment medication information provided.
Vaccine - 11/25/13. Sick - 12/1/13 (diag. pneumonia). 12/12 - admitted - Guillain Barre on vent., feeding tube and very little muscle movement.
Mom states patient woke up 10/14/15, the morning after vaccine administration, with itchy rash all body. Taken to PMD who believes allergic reaction to HPV since had been given previous dose of Hep A. Given steroid injection and skin cream. Advised not to continue HPV vaccine series.
Information has been received from a physician concerning a 21 year old female who on 29-JUN-2007 was vaccinated with a dose of Gardasil (lot # 653736/0014U) 0.5mL injection. There was no concomitant medication. ON 29-JUN-2007 the patient developed a 101.5 degrees fever for 2 days after being vaccinated with Gardasil. Medical attention was sought. On 30-JUN-2007 the patient recovered from the 101.5 degrees fever. No further information was provided. Additional information has been requested.
Breakthrough COVID-19 case.  8/20/21: Patient presents to the emergency room complaining of altered mental status.  Patient did not receive dialysis today due to AMS so dialysis center called 911.  Patient's last dialysis was Monday.  Patient's daughter reports decreased appetite, diarrhea, and weakness yesterday.  Admitted 8/20/21. Note: patient received Pfizer Covid-19 vaccines on 6/1/21 & 6/22/21. Covid test positive on 8/20/21,  but no respiratory symptoms or hypoxia during admission. Treated for hypertension, dialysis, hyperkalemia. Discharged 8/24/21.
Patient was vaccinated in LEFT arm. Shortly after vaccination, patient's RIGHT arm started to shake uncontrollably. Patient called me (immunizing pharmacist) around 6 PM and I recommended patient go to Emergency Room immediately.
She presents with pain in left upper arm which began 4 days ago, when she had 2nd Men B vaccine. Arm is increasingly painful with movement, as compared to soreness after first dose which resolved after 3 days. She was unable to drive herself home due to pain last night, and can't get comfortable. Associated symptoms include pain with moving arm, shoulder/neck pain, tingling sensation in hand, pain in lower arm. She did not have severe pain with injection, did not have significant bleeding from injection site. ROS negative for redness, swelling, bruising, increased warmth of arm. No lower extremity weakness, cough, difficulty breathing. ASSESSMENT: Postimmunization reaction. PLAN:  Hydrocodone for next 1-2 days only. Discussed in detail cannot take while taking Baclofen. Baclofen recently prescribed by neuro as adjunct to migraine treatment, and has not taken this medication at all. Rx discussed with MD. Alternate heat and ice. Elevate arm.
took COVID test and it came back positive; took COVID test and it came back positive; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EJ1685, Expiration Date was not reported), via an unspecified route of administration, administered in left arm like the shoulder on 03Mar2021 (at the age of 50-years-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EK5730, Expiration Date was not reported), via an unspecified route of administration, administered in left arm like the shoulder on 24Mar2021(at the age of 50-years-old) as dose 2, single for covid-19 immunisation at vaccination clinic. The patient medical history was none. There were no concomitant medications.  It was reported that, the patient had the vaccine in Mar. He was a little stuffy this week and had mild symptoms. Down the street has COVID test. He took COVID test and it came back positive. Patient clarified yesterday, 29Jul2021, he had rapid COVID test and it was positive. PCR test was also done, but he hasn't gotten the PCR results, that will take a couple of days. He took the test yesterday morning between 11:00AM or 11:30AM. His awareness date of testing COVID positive was yesterday, 29Jul2021. Patient states that he was stuffy, had a little cough, and didn't feel right on Sunday 25Jul2021. He went to a drive up testing site. He was feeling off and had a cough. The patient underwent lab tests and procedures which included PCR test: unknown results on 29Jul2021, Rapid COVID Test: positive on 29Jul2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Muscle pain; arm is not as sore and there is not as much redness and swelling; arm is not as sore and there is not as much redness and swelling, although it hurts; arm is not as sore and there is not as much redness and swelling; Shivers; Tiredness; Headaches; upset stomach; feels like she has a fever; feels like throwing up and is afraid that she can't stand up without vomiting; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain, swelling arm, pain in arm, erythema of extremities and shivers were not recovered/not resolved and the outcome of the tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing were unknown.   It was unknown if the reporter considered the muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after vaccination, the arm was not as sore and there was not as much redness and swelling, although it hurts. The patient stated that after vaccination, felt like had a fever but was not sure. the patient stated that felt like throwing up and was afraid that could not stand up without vomiting. For the tollerence of 1st dose refer case US2020032222.
Ankle swelling; Tingling in both feet; left leg is numb waist down; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Ankle swelling), PARAESTHESIA (Tingling in both feet) and HYPOAESTHESIA (left leg is numb waist down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced JOINT SWELLING (Ankle swelling), PARAESTHESIA (Tingling in both feet) and HYPOAESTHESIA (left leg is numb waist down). At the time of the report, JOINT SWELLING (Ankle swelling), PARAESTHESIA (Tingling in both feet) and HYPOAESTHESIA (left leg is numb waist down) outcome was unknown.            Concomitant information was not provided.  Treatment information was not provided.
expired dose of YF-VAX was administered with no adverse event reported; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via Media information (under the reference: 00826503).  This case involves a 32-year-old male patient receiving expired dose of YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  On an unknown date, the patient received a 0.5mL dosage form total dose of suspect YELLOW FEVER VACCINE - US [Frequency: once, strength: standard, lot U6428AA,Expiration Date :30-Sep-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine use. (latency: same day)  It was reported  "expired YF-VAX administered to 5 patients."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  US-SA-2021SA356701: US-SA-2021SA354618: US-SA-2021SA355405: US-SA-2021SA357534: US-SA-2021SA356051: US-SA-2021SA354618: US-SA-2021SA354616:
PCR positive; PCR positive; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: F63527), in left arm, as dose 2, single (Lot number: EL9262), in right arm and as dose 3 (booster), single (Lot number: EL1284), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 06Jun2022 (unspecified if ongoing), notes: Hysterectomy 06Jun2022 complicated by, infection; "infection", start date: 06Jun2022 (unspecified if ongoing), notes: Hysterectomy 06Jun2022 complicated by, infection. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "PCR positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Results unknown; (01Jan2022) Positive, notes: Nasal Swab.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. covid test post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. facility type vaccine: Pharmacy or Drug Store; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201358671 same patient different dose/drug/event;US-PFIZER INC-202201358672 same patient different dose/drug/event;US-PFIZER INC-202201345760 same patient different dose/drug/event;
numb sensation in fingers; tingling sensation in fingers; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numb sensation in fingers) and PARAESTHESIA (tingling sensation in fingers) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced HYPOAESTHESIA (numb sensation in fingers) and PARAESTHESIA (tingling sensation in fingers). At the time of the report, HYPOAESTHESIA (numb sensation in fingers) and PARAESTHESIA (tingling sensation in fingers) 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.
After receiving vaccine patient started experiencing dizziness and blurred vision. I had him to sit down and I went out to check his blood pressure was 93/47.  He began to sweat and stated that his arms and legs were tingling  and he was nauseated. We called 911, placed a cold pack on his neck and checked his blood pressure again. It was 111/73. His hands and fingers started getting stiff. He did not experience any trouble breathing and no rash or itching.  When the fire department arrived, they checked his blood glucose (115) BP (110/82) heart rate (69) O2 (99).  His hands started to get better.  When the EMT arrived they checked his BP sitting and standing and it was normal.  He declined to go with them but his stepdad took him to the ER
Pt described an injection - site rash, red, blistering. Two physicians diagnosed it as a local Shingles reaction, according to the patient. Rash occurred 3 days after the injection. 10 days later, the rash is now the same size, still red but not blistering. No soreness/pain reported.
Localized rash that spread over the course of a few days to hives extending from knees to neck
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses 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 (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 58-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
pt recv vax&fainted;pt had been instructed to wait 20min p/inj but had left waiting area p/5min&apparently fainted in the hall;pt was lying on the floor conscious but confused;pt had cut lt chin,lt lower lip,lt tooth was broke,abrasio
Patient noticed a vivid pink "cuff" midway down upper arm below injection site. It was slightly swollen and sore.
Symptomatic palpitation, shortness of breath, passing out at 5:05 am in the morning. Heart continues to race and then slowdown all today, current time is 6:05 pm.
Information has been received from a medical assistant concerning an 18 year old female patient who on 29-MAY-2007 at 11:00 AM, was vaccinated into the left arm with a first dose of Gardasil. Suspect therapy included MENACTRA and VAQTA (manufacturer unknown). After administration of the vaccine's the patient experienced a vasovagal reaction. The patient was "O.K." after 10 to 20 minutes. Additional information is not expected.
The day after receiving the vaccine, I had fatigue, vomiting, low grade fever,  headache, chills and my arm was hurting like heck. The next day I felt better besides just feeling tired. I am feeling a lot better today but still feeling tired.   Around the 23 of November 2020 I had COVID-19