chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Improperly stored of PROQUAD; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapy were not reported.   On 11-AUG-2023, the patient was vaccinated with the improperly stored (temperature excursion [TE]) measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection 0.5 mL (lot# W029555, expiration date: 14-MAR-2024; dose number, anatomical location and route of administration not reported) as prophylaxis (product storage error). No adverse effects were reported. There was no additional adverse event (no adverse event).  This is one of several reports received from the same reporter.
3/27/2021 pt reports to be dizzy, lightheaded all day 3/28/2021 pt reports rash to right arm - mostly resolved 3/29/2021
This case was reported by a consumer via Interactive Digital Media and described the occurrence of paralysis in a child female patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced paralysis (serious criteria GSK medically significant) and movement disorder. On an unknown date, the outcome of the paralysis and movement disorder were unknown. It was unknown if the reporter considered the paralysis and movement disorder to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that her daughter was paralyzed by the pertussis vaccine as a child. The reporter reported build your immune system instead of taking a chance. The reporter reported that the patient could move was her eyes only. The reporter reported that she was an anti Vac and tell everyone not to get GARDASIL shot for their kids too. Case correction was done on 03 December 2018: The first time the reporter mentioned the DPT vaccine was from the follow-up comments that were received by GSK on 26 November 2018. This is the time when the case was considered as valid.
Large wheal and flare with warmth and pruritus, BENADRYL 25 mg q6h and prednisone 20 mg QD x 3 doses, day after Tx pt. didn't notify till 10/24.
Lab work for annual physical showed elevated liver enzymes. Gallbladder ultrasound done. Gallstone and sludge found. Referred to gallbladder surgeon. She referred to liver specialist who referred for liver biopsy. This was done on February 9, 2023. Scarring was found in liver and bile ducts. Additionally, there were strictures and some thickening. Referred for ERCP scope. This was done on March 9, 2023. Two autoimmune diseases have been potentially identified: Primary Schlerosing Cholangitis and IgG4-related disease (liver).
This spontaneous consumer report (initial receipt: 09-Oct-2014) concerns a 79-year-old female patient. The patient had medical history of diabetes, atrial fibrillation and penicillin allergy. Her concomitant medications included warfarin sodium, rosuvastatin, metoprolol, metformin, losartan, digoxin, diltiazem, sulfamethoxazole/trimethoprim, fish oil and vitamins. On 29-Sep-2014, the patient received AFLURIA (batch number not reported) in the left arm and PNEUMOVAX 23 injection (batch number: H018608) in the right arm. On 29-Sep-2014, in the evening, the patient complained of soreness in the right arm. She had a restless night trying to sleep. On 30-Sep-2014, the patient's arm was red just below the injection site for about 6 inches down including the elbow which was swollen. The redness was about 3 inches wide. The next day, the redness turned purple. The patient was advised to go to the emergency room. Blood works were done for diabetes. The patient was diagnosed with cellulitis and was injected antibiotic. Other treatments included stool softener, pain pills and an antibiotic (all unspecified). The patient felt better. There was no problem in the left arm. The outcome was reported as recovering, however the arm was still red.
Within a day of the third dose, my mild tinnitus became noticeably worse, and by the following week it was significantly worse.  It has not improved at all since,
patient did not indicate she has medical conditions but checked the box further down that she is immunocompromised on consent form. RPH took her into the room and explained she had a Moderna dose 3 vaccine, half a dose.  the patient did not correct  let her inject 0.25 ml.  She returned 2 days later asking for the other 0.25 ml and we are researching how to handle the situation.
Myalgia, Fever, Diarrhea, NauseaVomiting, injection site reaction,  Narrative: Employee reports experiencing injection site pain/discomfort, swelling, redness, and itching, as well as fever, headache, body aches, nausea, vomiting, and diarrhea. No medications were reportedly taken per employee. Reports symptoms began approximately 12 hours after receiving second dose of vaccine. Reports has recovered as o f01/22/2021.
Hepatitis B given (1st ) dose. Employee called about 1 hour later. Eyes swelling and itching. Benadryl 50mg PO and Prednisone 50mg PO given.
VERY WEAK SENSE OF SMELL AND JUST THAT NIGHT COULD NOT SMELL ANYMORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 27-JUL-2021 13:30 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-JUL-2021, the subject experienced very weak sense of smell and just that night could not smell anymore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very weak sense of smell and just that night could not smell anymore was not reported. This report was non-serious.
Information has been received from a licensed practical nurse, for the Pregnancy Registry of GARDASIL, concerning a 21 year old female with factor V Leiden and a tobacco user with a history of 2 pregnancies and 1 live birth (one full-term delivery with deep venous thrombosis post delivery; and a tubal pregnancy with a miscarriage and oophorectomy) who on 19-NOV-2007 was vaccinated intramuscularly with 0.5 ml of GARDASIL.  Concomitant therapy included prenatal vitamins with folate  (manufacturer unspecified) and aspirin 81 mg daily for factor V Leiden.  After the vaccination on the same office visit, a pregnancy test was performed and the result was positive.  No other symptoms reported.  On 21-NOV-2007, and ultrasound was performed and confirmed a yolk sac was present.  The date of last menstrual period was 17-OCT-2007 and the estimated delivery date was 24-JUL-2008.  During the pregnancy, the other medications included LOVENOX 40 mg daily from 26-FEB-2008 until delivery for factor V Leiden and WELLBUTRIN XL 300mg daily from 14-JAN-2008 until delivery for depression.  On 04-FEB-2008, serum alpha-fetoprotein test (MSAFP) was performed and the result was negative.  On 18-FEB-2008, an ultrasound was done with the normal result.  On 22-JUL-2008, at 40 weeks the patient delivered a normal, healthy female baby weighting 7 pounds 7 ounces.  The apgar scores were 8/8.  There were no congenital anomalies and no other complications/abnormalities.  Additional information is not expected.
Information has been received from a medical assistant(also reported as office manager) referring to a 19 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 02-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1704USA014784:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 20-SEP-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M017983, expiry date 20-MAY-2018 (exact dose and route of administration were not reported) for prophylaxis. The dose of vaccine was stored in temperature -17 degrees Celsius (C) for 1 hour. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported.
Pt stated she began to feel achy at about 4pm the day she received the injection of Pneumococcal Vaccine 23. She developed a fever as high as 102 which resolved by the next morning. Pt complained of severe pain at the site of the injection to the extent she could not use her arm for 12 hours. Pt denied swelling or redness at the injection site. Patient emailed the Immunization Assistance Program Coordinator and reported the vaccine reaction. Coordinator phone patient and again later in the day. She is feeling much better and is able to use her arm.
Extreme fatigue  for 3-4 weeks; hot, itchy at injection site; hard mass at injection site; sinus infection; burning soles of feet.
On the second day I felt like flu symptoms. I stayed in bed for a couple days. The heart issues start to develop later than week, and I went to the ER at the hospital and was in Jun 15-July 3rd 2021. I was in the hospital. I went to Cardiologist for a follow up and they gave me medicine.
A report was received from a health professional on 11/02/2001, concerning a 29 year old female patient who experienced a headache and blurred vision, 1 day after receiving a Fluvirin vaccine on 10/21/2001. On 11/01/2001 , the patient experienced a temporal headache on the right side and blurring of vision in the left eye, 1 day after receiving a Fluvirin vaccine. The patient had previous vaccinations without adverse reactions. At the time of report, the patient had not recovered. There was insufficient information to determine the reporter's causality assessment.
Covid19 breakthrough.  1st vaccince on 01/20/2021.  89 y/o female with PMHx CAD with stents, Afib, Pacemaker, HTN, HLD, Anxiety presents with c/o 3 day history of worsening SOB, productive cough, poor appetite, chest pain, nausea, vomiting and headache. CXR with no acute process, Room air sat 98% and afebrile.  D-Dimer elevated but CTA chest with no pulmonary emboli.  Covid severity score=0 per MD.  No treatment presently.
5/21/08 child presented with redness, swelling and warm to the touch at injection site of varicella in right upper arm.  Instructed parent to call pediatrician for possible treatment.  5/22/08 parent of patient reports right arm no longer warm to the touch, redness and swelling almost gone.  Called peds and put cold packs on arm and gave child Ibuprophen as instructed by pediatrician.
First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated with numbness and weakness of the Left Arm, Left Leg, Left side of the face.
Local injection site reaction: erythema, swelling, and induration occurred approx. 6-8 hours following administration of PNEUMOVAX.
swollen arm; nausea/vomiting; nausea/vomiting; shaking; chills; dizziness; pain; insomnia; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and chronic sinusitis. Previously administered products included Shingrix with an associated reaction of peripheral swelling (1st dose was received in February 2020. please refer the case US2020AMR136096).   On 16th July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 17th July 2020, 1 days after receiving Shingrix, the patient experienced swelling arm, nausea, vomiting, tremor, chills, dizziness, pain, insomnia and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm and injection site pain were not recovered/not resolved and the outcome of the nausea, vomiting, tremor, chills, dizziness, pain and insomnia were recovered/resolved.   It was unknown if the reporter considered the swelling arm, nausea, vomiting, tremor, chills, dizziness, pain, insomnia and injection site pain to be related to Shingrix.  Additional case details were reported as follows: Lot and expiration date unavailable. The patient experienced vomiting, shaking, chills, dizziness, pain, swollen arm and insomnia, all have resolved except the swollen arm with soreness at injection site.  The patient reported testing her temperature, and stated no fever. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR136096:same reporter.
COVID vaccine seemed to make Crohn's disease worsening; MARKETING PROGRAM NAME NOT AVAILBALE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4510259-00.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "COVID vaccine seemed to make Crohn's disease worsening". The action taken for adalimumab was unknown.  The reporter considered "covid vaccine seemed to make crohn's disease worsening" related to BNT162b2. Causality for Humira (Adalimumab)The reporter causality for the event(s) of COVID vaccine seemed to make Crohn's disease worsening was not provided.  Clinical Course: Describe reaction (include relevant test/lab data): Crohn's disease aggravated (Crohn's disease): Not recovered/not resolved. Solicited report by a consumer of an adult female with an event of non-serious COVID vaccine seemed to make Crohn's disease worsening with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced COVID vaccine seemed to make Crohn's disease worsening. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. Did event abate after stopping drug was NA. Concomitant drugs and dates of administration: Not reported, Other relevant history: Not reported. Study No: Facilitated collect. Report source: study Causality: Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB)                     Causality: Crohn's disease aggravated (Crohn's disease)                     Causality as per reporter (Drug/Vaccine): Not Reported                 Drug: Pfizer BioNTech COVID-19 vaccine (Tozinameran), unknown, unknown, unknown                     Causality: Crohn's disease aggravated (Crohn's disease)                     Causality as per reporter (Drug/Vaccine): Probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  crohn's disease worsening cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient fainted, then developed abdominal pain and diarrhea. Patient also on menstrual cycle at visit.
Sat after Tdap, 5 minutes later fainted-slid to floor from sitting position. Responded to verbal directions immediately-opened eyes. To Left lying position for 10 minutes. BP 112/66 pulse 64. To sitting position-tolerated water and crackers - BP 104/61, pulse 75 oxygen saturation 100%. MD evaluated patient and spoke to Mom. To standing position - tolerated well - to home within 30 minutes.
Elevated resting heart rate while awake and while sleeping, and accelerating to a higher rate in less time than usual during workouts. Resting heart rate average from January 2021 through December 2021 has been 56 bpm as tracked by watch. Since vaccine, heart rate averaged 69 bpm including during sleep. It has also elevated to higher levels much more quickly during exercise, with minimal effort. Typically it is difficult for my HR to go up into higher zones even during intense spin bike workouts, which I do daily. During last night's workout, heart rate went up to 135 with minimal effort and very little time exercising. I did not feel sick or lightheaded, however.
Sore arm; Arm was hurting, felt pain down to the arm going to the wrist and fingers; Can't move because of the pain; Solid deep pain with moments of shooting pain; Headache; had bad chills with no fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (Pre-existing type 2 diabetes for 40 years.) and Neuropathy peripheral.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain), HEADACHE (Headache) and CHILLS (had bad chills with no fever). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Prophylaxis, at a dose of 2 Tab and TRAMADOL (oral) for Prophylaxis, at a dose of 1 Tab. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (Arm was hurting, felt pain down to the arm going to the wrist and fingers), MOBILITY DECREASED (Can't move because of the pain), PAIN (Solid deep pain with moments of shooting pain), HEADACHE (Headache) and CHILLS (had bad chills with no fever) outcome was unknown.            Treatment for the event included Tylenol extra strength two tablets and Tramadol 1 tablet. No Concomitant medications were provided
headache; scratchy throat; extremely tired; felt bad; This is a spontaneous report from a Pfizer Sponsored Program  Support via a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in unspecified anatomical location on 03Mar2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, scratchy throat and was extremely tired. The patient stated that she felt bad for a day and a half. The patient asked if she could continue to take the second dose. The case was assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
still got COVID; still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "still got COVID". Clinical course: Patient received all shots, never went out without a mask but still got COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
i have had 3 menstruation cycles  in the month following my vaccination. I had my first one from 09-16-21 to 09-21-21. I stopped bleeding and then began a second period from the 10-02-21 through 10-09-21. Unusually long and dark almost black in color and painful. Then I stopped again on the 9th only to start another cycle 5 days later on the 10/13/21. This is so frustrating, wrong, and terrifying.  I dont know why I am bleeding every other week. i am not on birth control, contraceptives, and it's impossible that I am pregnant. I have no STDs/STis. I had a pap swear and ultrasound done last year and there were no abnormalities in my reproductive organs.  I have never experienced anything like this. I have not received  medical care for this due to the fact no doctors have any research on this issue and everyone claims the vaccine is safe.
Patient was fine with no side effects of the vaccine. On Saturday, July 30, she was exposed during a 30-minute outside swim lesson. We were notified on Sunday the 31st that the instructor tested positive Sunday morning. Monday late afternoon patient looked tired and was very fussy. I took her temperature with an electronic ear thermometer and it read 101.4. I gave her some ibuprofen to make her more comfortable at 3:50 and by 4:25 she was acting normal and seemed to feel fine. At 7:30 that night we performed a home rapid antigen test.  The positive line showed up immediately and remained well past the 15-minute wait time. At that time we put patient to bed and she slept all night with no complaints. No further medicine has been given to her. Tuesday morning I took her temperature again and she tested at 100.3. She as acting normal and remained in her normal 3-year old state for the rest of the day. Wednesday morning I took her temperature again and she was at 99.5 and feeling fine.
A report has been received from a Health Professional concerning a 14 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 21-Jan-2014. The patient was inadvertently administered expired FLUMIST QUADRIVALENT. No adverse experiences have been reported. The patient experienced gave expired FLUMIST QUADRIVALENT which started on 21-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter. Corrected report 05-Feb-2014: Case medically confirmed box ticked.