chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a child patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The office reported that the patient who received FLUARIX vaccine resulted positive for influenza. This case was considered as suspected vaccination failure case since the time to onset were unknown at the time reporting. The reporter did not agree to follow up from GlaxoSmithKline. This case was linked with US2019GSK000801 and US2019GSK000802, reported by the same reporter. Lab Comments: On an unknown date, the patient did laboratory test.
Post vaccine varicella (04/11/2001 and 05/26/2004) 01/19/2005 presented with a rash in the groin area x 4 days.
Information has been received from a physician concerning a 19 year old female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL and experienced flu like symptoms after each dose. The vaccine administered at her gynecologist's office so no additional information was available at this time. No further information is available.
100 degree fever for 24 hours, lengthy (1 hour) mucous discharge from nose 10 hours after injection, pain in arm 3 days. Ibuprofen for pain/fever.
Swelling and warmth around injection site. Some itching. Patient seen 2 days later and treated with cool compresses, BENADRYL & PRELONE.
A report has been received from a Health Professional concerning a 10 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 09-Dec-2013. The Licensed Practical Nurse reported that they accidentally gave a patient a dose of expired FLUMIST on 09-Dec-2013. The patient had not experienced any adverse symptoms. The outcome of the event of gave patient a dose of expired FLUMIST is unknown. The report was considered to be non-serious.
Strong ache in the left shoulder around the site of injection (Tdap and flu shot) becoming stronger with time into the next day.  Arm was used in moderate to heavy exercise after being injected. Pain then into the neck and became more generalized throughout the body, though less intense.
Initial misuse report received from a healthcare professional on 01 October 2013. The patient had received PENTACEL. Nurse reported that gave DTAP / IPV portion to patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
This report is due to administration of expired vaccine. Patient was given a vaccine that had a BUD of 12/1/21. The vaccine itself expires on 1-29-22, but due to being in the refrigerator from 11/1/21, it expired on 12/1/21 and this was missed.
high fever; arm swollen; Initial information was received on 09-Jun-2021 regarding an unsolicited valid non-serious courtesy case from a physician.  This case involves a female patient (age not reported, elderly) who had high fever (pyrexia) and arm swollen (peripheral swelling) while receiving TETANUS TOXOID.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious high fever (pyrexia) and arm swollen (peripheral swelling) (unknown latency) following the administration of TETANUS TOXOID.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
-swelling, pain, redness at shot site -fatigue  -uncontrollable shivering  -extremely cold -extremely hot -fever -frequent urination -diarrhea  -muscle soreness, swelling, tenderness -inner ear pain, ringing  -temporary absence of sound -headache  -coughing  -throat congestion  -runny nose -restlessness  -brain fog -intense and frequent dreams -sleeplessness
Patient stated had fever night of but went away (she was counseled on flu like symptoms possible) but more concerned about tenderness/soreness  under left arm in lymph node area. Advised patient to ice area. Still tender 3 days later post imz(today)
Rash at the injection site, onset on day 7 after the first dose of COVID vaccine. The rash is raised, slightly itchy, and measure 8 cm in length, and 6 cm wide. No other signs or symptoms - I was just surprised at the reaction a week after the shot so I thought I should report it.
left neck swollen glands and feels like something in my throat -  symptoms were worse first two weeks after the vaccine received but are still ongoing
developed sx and tested positive for covid 1/22/2022 on binax rapid antigen test
Patient got the full dose (0.5mL) but they are not immunocompromised and should have only received 0.25mL. I realized my dose error while patient was still in the store. I notified the patient immediately.
continuous intestinal problems; raging diarrhea; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown) as single dose on 24Feb2021 for covid 19 immunization. It was reported that the patient received first dose of of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown) as single dose on 03Feb2021. Medical history and concomitant medication were not reported. The patient reported that after first shot on 03Feb2021, the patient developed raging diarrhea and again after the second shot on 24Feb 2021. A Since then, patient developed continuous intestinal problems. Patient did not feel that this should be a normal outcome and would like to know if there have been similar instances with others who received the Pfizer vaccines. The outcome of the event was unknown.  Follow up (08Apr2021): This is a follow up spontaneous report received from a contactable consumer in response to medical inquiry sent which included that: forwarded as an Adverse Event and Medical Inquiry on 9Apr2021 Reporter provided verification of contact address on 8Apr2021.
Got covid-19 on 08/30/2022 Diarrhea,  stuffy nose, tiredness  I was given Paxlovid  3tablets twice a day for 5 days.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR with update on outcome, Reporter denied further Follow-up
Had vaccine on 2/15 , then on 2/16 evening had stroke like symptoms trying to turn the TV channel and could not find numbers on remote. then her friend called and could not formulate words to her on the phone and could not say the words that she was thinking. Then she called her brother who is a doctor and he told her to go to Cardiologist and get in. She was talking normal by the time she talked to him.  Adverse reaction was TIA.    TIA symptoms lasted 5-10 minutes max per patient.
Patient was sitting in observation area 5 minutes post vaccination, scheduled to be observed for 30 minutes total due to history of anaphylaxis. She was seated in the recliner She reported to have itchy watery eyes, chest tightness.  Breath sounds were clear, with good air movement bilaterally, no wheezing or crackles, no accessory muscle use, normal speech. Patient's boyfriend noted her tongue and eyelids to appear slightly swollen compared to baseline. Patient denied dizziness, chest pain, shortness of breath, body rash or itching. Patient maintained normal speech and normal unlabored respirations.  BP was checked and noted to be normal. O2 sat 99%. Patient received  benadryl 50mg PO. She was observed for about 10 minutes before her tongue appeared more swollen and she complained of difficulty breathing. At this point, the patient appeared pale, 911 was activated. EPI-pen was administered via autoinjector in the left lateral thigh. O2 sat was 99%. Patient has increased chest tightness and new onset shortness of breath for which she was given an Albuterol nebulizer. Breath sounds were clear, no wheezing. O2 sat reassessed which decreased to 73%, she had bilateral cramping of hands and digits. Non-rebreather was applied, oxygen saturation improved and hand cramps resolved. 911 was called for a second time to report rapid desaturation. Patient's O2 saturation and HR fluctuated, BP remained stable throughout. EMS arrived. A right AC IV was placed, Solumedrol 125mg IVP was administered by EMS. Patient was transferred onto EMS stretcher, still requiring nonrebreather. Patient was escorted to ED for further management of anaphylxis post Moderna vaccine.
Smallpox given on 11/3/07, Flumist given on 11/15/07
A couple of days after receiving my vaccination on 12/15/2021, I had a 104 F fever that lasted for about 12 hours. On 12/21/2021, I had another fever, vomiting, headache pains, and ended up going to the emergency room at Hospital. They found out I was septic, and ran numerous tests including blood culture, stool culture, CAT scans, AVISE blood test, thyroid and other tests. They were never able to determine what infection caused the sepsis. They gave me antibiotics and helped my bloodwork to return to normal and discharged me 3 days later after admission. Since then, I've had 8 high-grade fevers and been to several specialists and doctors who can't seem to diagnosis what's causing my sepsis occurrences. Every 7-14 days, I have nausea, painful headaches, muscle and joint aches, and fever since receiving my booster shot.
The pt developed tingling and numbness in hands and feet on 05/30/2001. On 06/01/2001, itching all over the body. On 06/02/2001, more tingling and numbness. on 06/03/2001, tingling in lips, tongue added. Numbness in all described plus loss of balance, weakness in knees and legs, and was unable to walk. The pt was hospitalized. On 06/07/2001, the pt became totaly paralyzed. Pt was diagnosed with Guillain-Barré syndrome. On 06/28/2001, the pt was discharged to home.
1st dose: 02Feb2021 ,  2nd dose: 22Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 02Feb2021 ,  2nd dose: 22Mar2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076621A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for Blood pressure high, CARVEDILOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE, PANTOPRAZOLE and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 02Feb2021 ,  2nd dose: 22Mar2021). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 02Feb2021 ,  2nd dose: 22Mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided   This case was linked to MOD-2022-474595 (Patient Link).
Enlarged lymph nodes in left armpit area (2) and in base of neck on left side (1)
Sequence of events: March 29 - patient given Covid vaccine , by reports the patient started to experience progressive weakness after the vaccine April 9 - patient admitted to the hospital with Covid infection April 20 - patient still very ill with Covid April 23 - admitted again due to altered mental status, acute respiratory failure with hypoxia May 13 - Admitted for acute CHF June 12 - Admitted for altered mental status and acute respiratory failure June 21 - Admitted for altered mental status and acute respiratory failure July 8 - Admitted for altered mental status and acute respiratory failure August 6 - admitted with Guillan Barre Syndrome Currently - patient still having significant weakness, falls, etc
Within approximately 48 hours, I started breaking out in hives on the back of my head and then within 2 more days, it spread to my backside, buttocks and upper back.  I did not exhibit any signs of anaphylaxis; only hives.   Seven days after the vaccine, I went to an urgent treatment care center as the hives were continuing to spread . I requested an injection of 10 mg dexamethasone instead of a prednisone dose pack because of prior experiences (minor side effects).  The hives were mostly resolved when I woke up 12 hours later but returned 2 days later, even with taking my Zyrtec BID instead of once daily as recommended by Physician.  Today, April 9th, I started a prednisone 4mg dose pack after notifying my Physician's office again yesterday.
After receiving a covid-10 vaccine, they suffered heart palpitations that required going to the hospital.; On 02-MAR-2023, this serious initial non-interventional study safety report was received from a consumer and was received by Novavax on 02-MAR-2023.   A female of an unspecified age was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 2 on an unspecified date.  The following medical history was reported: Palpitations.  No concomitant medications were reported.  On an unspecified date, after second vaccination, the individual suffered heart palpitations that required going to the hospital (PT: Palpitations) (Serious: Hospitalization).  At the time of reporting, the event outcome of Palpitations was recovered/resolved.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This female of an unspecified age experienced: Palpitations after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Palpitations was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Palpitations was assessed as unknown.
Information has been received from a consumer concerning her 15 years old daughter with no drug reactions or allergies and no pertinent medical history who received first, second and third doses of GARDASIL (Lot number unknown), on August-2009, October 2009 and May-2010 respectively. There was no concomitant medication. The consumer reported that her daughter noticed she was beginning to lose hair after the second shot of GARDASIL and had progressively gotten worse ever since. There were no laboratory tests performed. The patient did not seek medical attention. At the time of this report, the patient had not recovered from "lose hair". No further information is available.
No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment
Around 0951, patient complained of "not feeling good. Numb all over and light headed". No SOB, no rash. Felt clammy, slightly pale.  Laid back the seat in the car and elevated patient's feet. Patient c/o feeling nauseated. 0955 50mg PO Benadryl given. 1000 BP 112/62 Pulse 56. 1003 BP 102/80. 1009 blood sugar 137. Patient was given a banana, water, and juice right before we gave her the vaccine. Patient stated she was super anxious, history of panic attacks, "but not like this. My whole body feels numb".  Patient yelled at her husband that she regretted getting the vaccine and her kids won't get it. She sat up and screamed, "I don't feel good". Continued nausea. 1010  - 911 called. 1013  BP 118/62.  1016 - ambulance arrived.
After administering the Pfizer Adult covid 19 vaccine Dose # 2 of the primary series, patient immediately stated he was claustrophobic,asked for me to open the side of the cubicle. I did and backed away from him. He immediately jumped up then stood by the cubicle entrance holding onto the cubicle side. Within seconds as I was counseling, he fainted . He fell directly backwards, hitting primarily his upper back and his head also but not as forceful. He was out for about 10-15 seconds, breathing ok, then slowly came to . laid for a few minutes, then sitting on the floor asking for water, then I got him the chair and pulled it out of the cubicle where he sat drinking the water until he felt ok to leave.Store management gathered information
This consumer report (initial receipt 11 Dec 2014) concerns an unknown demographics patient who had an egg allergy. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, following the influenza A vaccine, the patient experienced an unspecified allergic reaction. Reporter comments: The reporter (patient's daughter) could not confirm if the patient received AFLURIA.
Red rash on arm that received injection. Rash is itchy, swollen, and warm to touch. One day after shot it was roughly two inches in size. 48-72 hours later it grew to seven inches in size.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for a brief moment after he received the COVID vaccine. Called 911 to have him checked out.
-No symptoms after 1st shot -Symptoms appeared after 2nd shot about 6-8 hours after the injection -chills, fever (99.6), body aches, sharp shooting headache- symptoms subsided after about 2 days - arm showed redness, painful  and was warm to touch - discoloration of my arm still apparent 2 Weeks later***
Rash in the face that is itchy symmetric and bilateral; Rash in the face that is itchy symmetric and bilateral; This is a spontaneous report from a contactable physician (patient).  A 68-years-old male patient received first dose bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK5730) in Left arm, intramuscular on 06Jan2021 around 11:00 at SINGLE DOSE to prevent COVID, famotidine, oral from an unspecified date and ongoing at 40 mg, 2x/day for gastritis .  Medical history included gastritis, ongoing diabetes (diagnosed 3 years ago), ongoing hyperparathyroidism (diagnosed many, many years ago), ongoing sjogren's syndrome (diagnosed recently this year), gout from 2010 and ongoing , coronary atherosclerosis from Nov2020 and ongoing, ongoing chronic obstructive pulmonary disease (diagnosed many years ago), asthma from 2020 and ongoing , sleep apnoea from 2019 and ongoing, crohn's disease from 1981 and ongoing, and abdominal pain. The patient's concomitant medications included ongoing ASPIRIN [ACETYLSALICYLIC ACID] (reported he takes aspirin everyday and the aspirin causes him to have some abdominal pain).   The patient was administered with the first dose of the vaccine on 06Jan2021 and after that he developed a rash in the face that was itchy symmetric and bilateral on 08Jan2021. The rash was bilateral and symmetrical. The event was reported serious due to medically significant. Upon transfer, the caller clarifies he did not take steroids for the rash. A few days prior to receiving the COVID-19 vaccine, he started taking a new oral medication. So, he doesn't know if the rash is from the new medication or the vaccine, but he decided to call and report this event just in case. He clarifies the name of the new medication was famotidine. Today (12Jan2021) was the first day it was much better. Caller confirmed he did not take any steroids, the only medication he took was an antihistamine for the management of the symptoms. The outcome of the events was recovering.; Sender's Comments: The reported rash in the face that was itchy symmetric and bilateral occurred two days after the first dose of COVID 19 Vaccine, BNT162B2.  Based on the plausible temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Dizzy; Flu-like symptoms; Didn't felt like eating; aches and pain; Fatigue; 101 temperature; Fully blown aches and pain; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DECREASED APPETITE (Didn't felt like eating), PAIN IN EXTREMITY (aches and pain) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRAMADOL for COVID-19 vaccination, PENTOSAN POLYSULFATE SODIUM (ELMIRON), EZETIMIBE (ZETIA), SIMVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DECREASED APPETITE (Didn't felt like eating), PAIN IN EXTREMITY (aches and pain), FATIGUE (Fatigue), PYREXIA (101 temperature), MYALGIA (Fully blown aches and pain), NAUSEA (Nausea) and HEADACHE (Headache). On 04-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (aches and pain), FATIGUE (Fatigue), PYREXIA (101 temperature) and MYALGIA (Fully blown aches and pain) had resolved. At the time of the report, DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            Patient took Tylenol for the fever.
Received phone call from Mother stating that child woke up this morning with rash on both arms and legs. Described by Mom as "heat rash". Denies any itching or swelling, no discharge.