chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On an unspecified date in 2011, the patient received her first dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). The second dose of GARDASIL was given 13 months after the first dose on an unspecified date. The third dose of GARDASIL was administered 25 months after the first dose on unspecified date. No adverse effect was reported. Additional information has been requested.
I experienced Intermenstrual spotting for 12 days. My period is typically 3 to 4 days, so this is very unusual. Spotting went away yesterday (day 11), but is present again today (day 12). I will continue to monitor my period. There were no other problems with bleeding. I experienced mild abdominal cramps on day 7. I have no history of on/gyn concerns and I have never been pregnant. I am not on any birth control.
Initial information received on 20-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 17 years old female patient who was vaccinated with a 1.5 ml third dose of vaccine IPOL (lot P1A171M and Exp. Date 24-Apr-2020) via subcutaneous route in the left arm on 20 Feb 2019. The patient's medical history not reported and concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN); DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) 0.5 ml on 20 Feb 2019 for Immunization. It was an actual medication error case due to overdose. There were no side effects. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
felt feverous, but temp not elevated. dizzy with difficult time keeping balance when walking   Narrative:
Shortness of breath  Sp02 in high 80s  Chest pains  Severe pain everywhere  Exhusted  Inability to move with out shaking
symptoms- migraine, headaches for two weeks, soreness in entire body and joints. No treatment provided
Four days after receiving vaccines child was lethargic, did not want to play per mom. She did have some bursts of energy that were short lived. Early this morning she woke up complaining of leg pain. Mom noted that her left leg was warm to touch. Mom took her temperature with a forehead scanner and her temperature was 100. Her leg is not red or swollen and she is now complaining of her right leg as well. Child was recently diagnosed with Anisocoria, as has her sibling.
Narrative:  74y.o. MALE with frequent falls, hx of orthostatic hypotension on midodrine, recent subdural hematoma due to falls, osteopenia, vit D deficiency, folic acid deficiency, ischemic cardiomyopathy, CAD/MI, CVA, hypothyroidism, peripheral neuropathy, R carotid stenosis, enlarged prostate, PVD, HLD, HTN, CKD3a who was in home hospice care died on 8/8/2021. Pt had received covid 19 EUA vaccinations on 3/5/21 & 4/6/21. It appears covid vaccines were not related to pt's death.
Headache Headache, chills, facial flushing, lymphadenopathy Narrative:
Severe chills and shaking, fever, headache, thirst, muscle aches, nausea
light headed/dizzy; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed/dizzy) and FATIGUE (tired) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (light headed/dizzy) and FATIGUE (tired). On 27-Feb-2021, FATIGUE (tired) had resolved. At the time of the report, DIZZINESS (light headed/dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.
Headache, Myalgia, Arthralgia, pain & swelling injection site, fatigue Narrative:  Will see Rheumatologist  Other Relevant History:
Blood tests in July-21 form a yearly routine check up should reduced kidney function. Also noticed dark urine. Blood tests July, Aug , and Nov showed kidney function declining or in other words in the process of declining. Blood tests going back to 2015 showed no changes all of those years, in other words stable.
Immediately following vaccines, the pt stood up and then fainted a minute later. Before fainting, the  nurse observed the pt's eyes rolling up, arms twitched and a little foaming at the mouth. The child's color was good and the child was alert a few seconds afterwards and was sent to ER. BP 90/50, P22, R20.
Pt. c/o dizziness after 10 minutes of recieving vaccine. BP 188/89, HR-72, R-16, SO2 99. Recheck on  VS at 0916- BP150/73, HR/76, R-16. No longer dizzy and no further complaints.
Slight tightening of chest giving feeling of not being able to breathe normally and needing to cough to catch breath.
Vendor administered student Moderna vaccine 4/13/2021 unknown to clinic.  Contract nurse administered dose 2 of Moderna vaccine 5/12/2021 at 2:20pm based on EMR documentation of dose 1.  Medical staff contacted student, no adverse events from each incident.
I just saw a 12 year old in the office who has an odd rash that started the day after she got her first COVID vaccine (Pfizer). She started with the two on her right ankle the day following the vaccine, then the two on her left ankle started the next day, followed by one more on her distal left arm over each of the next three days. She says the burn slightly when she touches them but no itching, not otherwise painful. They look to me like burns or something similar. I wonder if they are self-inflicted but she denies causing them or anything new recently aside from the vaccine. She has been using neosporin occasionally since they were noted, no other treatments.  Other vaccine reaction noted: fatigue and slightly sore arm. She just completed a course of clinda for strep on 5/5. Otherwise just takes vitamin D daily. No recent open water swimming, etc.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 47 years, in left 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: "Known allergies: Nsaids" (unspecified if ongoing), notes: Nsaids. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Known allergies Aspirin", notes: known allergies Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 2 negative covid rapid tests; (unspecified date) Negative, notes: 2 negative covid rapid tests; (04Jun2022) Positive, notes: tested positive again on rapid tests on day 5 post paxlovid; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment, start date: 26May2022 and Stop date: 30May2022 Clinical course: Bad taste while taking Paxlovid; Rebound Covid symptoms started 3 days after Paxlovid (after 2 negative covid rapid tests) and tested positive again on rapid tests on day 5 post paxlovid. Patient was recovering from symptoms and did not take treatment. No other medication reported in 2weeks.   No follow-up attempts are possible. No further information is expected.
High fever 101-103 degrees, 2 days. Nausea, redness in local area about 2 inches around. Pain in arm (burning), numbness in fingers. Motrin 600, Benadryl.
patient said unable to lift her left arm from her side after the day after the vaccination.  She contacted her doctor on  10/2 and was prescribed cyclobenzaprine on 10/4.     she still has trouble lifting her arm with light weight.
Kidney stone; Pinched nerve; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant), NERVE COMPRESSION (Pinched nerve) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, NEPHROLITHIASIS (Kidney stone) and NERVE COMPRESSION (Pinched nerve) had resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medications were reported.  Patient received Humira.  No treatment medications were reported.  The reporter did not provide any causality assessment for the event of vaccination site pain with Humira and assessed rest of the events as not reasonably possible to Humira.  The reporter assessed vaccination site pain as related to Moderna vaccine and did not provide any causality assessment for rest of the events with Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Nephrolithiasis, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Nephrolithiasis, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
itchy rash to left arm around injection site, started 1/30/21 and continues as of 2/1/21
Very nervous about getting vaccine. Preceded by smaller step-adopted brother. Received vaccine w/o any resistance. Walked down hall and into waiting room-sat in chair and almost passed out-Instructed to put head down and give cool cloth for back of neck and forehead.
Pt experienced hemolytic anemia,a stroke,and a seizure. Pt is still hospitalized.
Patient has 22-25 discrete vesicular, small itchy lesions developed over scalp, face, torso and legs. Most spots are dried now, they began on 02/11/05 until today 02/16/05.
Approx 30 minutes after my 1st Moderna vaccination,  I noticed that I was having difficulty swallowing water.  I soon began to not feel very well.  Sort of light headed.  My heart was racing.  When I looked at my watch it recorded my heart rate at 160 beats per minute!!  I started taking deep breaths and a technique called EFT tapping to calm me down.  Eventually it worked, but I felt extreme tiredness after that.  When I woke up in the morning my entire face was swollen.  I also noticed on the 2nd day after vaccine shot I had dark purple circles under my eyes.  None of those things have ever happened to me before in my life.
Resident presented to Clinic with rt side jaw swelling.  Resident received Covid vaccine at pharmacy but no lot number was able to be find when resident was looked up in system.
pt recv vax 11SEP98 & 23SEp98 pt exp fever, rash & aches;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority sponsored program (159558). The reporter is the patient. A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: FH8028) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "anxiety" (ongoing), notes: medical Anxiety. Concomitant medication(s) included: RISPERDAL taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Lot: EL9261, Expiry: Unknown), administration date: 27Jan2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, Lot: EN5318, Expiry: Unknown), administration date: 17Feb2021, when the patient was 35 years old, for Covid-19 immunization; Tetanus, administration date: May2021. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "booster dose"; FATIGUE (non-serious) with onset 24Nov2021, outcome "unknown", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "unknown", described as "swollen lymph nodes"; NIGHT SWEATS (non-serious) with onset 23Nov2021, outcome "unknown", described as "night sweats"; ABDOMINAL DISCOMFORT (non-serious) with onset 24Nov2021, outcome "unknown", described as "stomach is queasy and unsettled"; PYREXIA (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "body aches"; DIZZINESS (non-serious) with onset 24Nov2021, outcome "unknown", described as "dizziness"; FEELING COLD (non-serious) with onset 25Nov2021, outcome "unknown", described as "very cold at times"; NERVOUSNESS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shaky"; CHILLS (non-serious) with onset 25Nov2021, outcome "unknown", described as "shivers"; DECREASED APPETITE (non-serious) with onset 24Nov2021, outcome "unknown", described as "lack of appetite"; NAUSEA (non-serious) with onset 30Nov2021, outcome "unknown", described as "pretty nauseous". The event "swollen lymph nodes" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: pyrexia: (22Nov2021) 99.7 degrees. Follow-up attempts are completed. No further information is expected.
Site of vaccination/L shoulder remains painful when sleeping on (L) shoulder or actively using (L) shoulder 2 mo after date of vaccination.
Initial and follow up information has been received from a physician concerning an 8 year old patient who on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot Number 656077/1491F). Subsequently, within two to three days post vaccination, the patient developed a 10 cm area of redness and / or 6 X 6 cm area with a circular pattern with redness, warm to touch and pain. The reaction lasted approximately 1 week. Unspecified medical attention was sought; no treatment was required. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
My father received his second dose of the moderna vaccine on 3/27/2021.  Around 5PM he started to feel unwell and went to lay down.  My mom found him unresponsive at 10PM and called an ambulance.  She was told at the hospital that he had a massive brain bleed.  He passed away the following morning around 10AM.
knee flexibility was back to almost nothing; This is a spontaneous report from a contactable consumer.  A 46-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration the left arm on 24Mar2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history included Lyme disease. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient had not received other medications in the past two weeks. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 14:00, the patient experienced knee flexibility was back to almost nothing. Patient had just recovered from Lyme and took antibiotics in February. Lyme disease had impacted his knee joint, and he was fully flexible on the knee. Within 24 hours of the vaccine dose, his knee flexibility was back to almost nothing. Patient had another Lyme test that came back negative. The patient underwent lab tests and procedures which included laboratory test: negative. No treatment was given for knee flexibility was back to almost nothing. Clinical outcome of the event knee flexibility was back to almost nothing was not recovered.  Information on the lot/batch number has been requested.
Client did not know she was 12 weeks pregnant at the time she received first dose of HPV4 and TDaP.  Client is now 31 weeks gestation and ultra sound shows "large head with water around it".
Extreme fatigue initially, then awake most of the night with severe body aches (joints, tendons, muscles, bones) that made movement painful. Sharp stabbing pain in knees, abdomen. Severe headache, nausea, shivering/chills. Felt substantially better by 12 noon following day but still weak, tired, body aches.
Left sided chest pain- squeezing sensation, radiating to neck and down left arm, tingling left arm, with shortness of breath on exertion x several days
I became weak and faint approximately 1 to 1 1/2 hours after receiving flu shot.
TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2794) was received from a pharmacist on 12-Nov-2019. It described an adult female consumer who "took unrefrigerated Vivotif" (PT: Product storage error). She was receiving Vivotif for an unknown indication.  Case report: The consumer did not refrigerate Vivotif since picking it up on 06-Nov-2019 and had taken the first dose on the same day. It was reported that he did not know how many unrefrigerated doses she took.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.
Glucose numbers increased to 569; This is Spontaneous report from a contactable consumer (patient).   A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: BN6206) via unspecified route of administration in the right arm, on 16Mar2021 at 06:30 PM, as 1st dose single for COVID-19 Immunisation. Medical history included diabetes mellitus and was allergic to pork. Concomitant medications included Reported as: Insulin Triseba (coded to: INSULIN DEGLUDEC). The patient was 46-year-old and was not pregnant at the time of vaccination. On 17Mar2021, the patient's glucose numbers was increased to 569. It was reported that location of injection information was available for all vaccines received on the same date. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not received treatment for adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.   Additional information has been requested.
Patient and his mother filled out form. They put his birthday down wrong. They put his age as 18. While putting form later into Database found patient with correct address and info but DOB makes him 15. Mother contacted. She states they lied to get his shots and booster. She states he is "really big, like 6 foot and 300 lb and he really needed a vaccine".  Vaccine given 12/9/21 called 12/13/21. She states he is great; not having any trouble.
MD was called to the room after child appeared to have fainted following administration of 11 year old shots (Tdap, Menactra, HPV, and Flu). I was in the room within seconds and patient was lying down on exam table in no distress. She was immediately responsive to verbal command and made eye contact with me. She appeared very pale. (MA stated that she thought she might have jerked 1-2x but wasn't sure if the movement was her falling back). Child had good peripheral pulses, PERLA, RRR, and CTAB. Within 1-2 minutes she regained her color and was taking sips of water. She denied any difficulty breathing. No post-ictal event. It appears that she had a syncopal/vasovagal rx, most likely due to stressful trigger of vaccine administration. She was monitored with continuous pulse ox for 1 hour and was sitting up talking about halloween. Normal vital signs throughout. I explained to father and aunt that she would need to be monitored for the rest of the day and if any changes occurred she would need to be evaluated in the ER immediately. However, I did not believe that she had a seizure. Father was comfortable with assuming care and demonstrated understanding of instructions. I completed another full exam which included complete neuro examination and was completely normal. Child left clinic in no distress.
Patient felt weak and dizzy, which started after receiving the shot and persisted a few weeks. Pt also reported pain swallowing or could not swallow. Patients have reached out to her provider.
patient asymptomatic but was given Pfizer 2nd booster dose one month early.