chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not sure if the AE is associated with the vaccine or not but since I have been in Pharma for 36 years I thought I needed to report this to provide data to assess association of the injury I sustained to the vaccine. After receiving my final dose on 3/24/21 I continued to play soccer in a men's league. On May 16, 2021 while playing in a game I ruptured / tore my patellar tendon resulting in the need for a patellar tendon reconstructive knee surgery on May 21, 2021. Again, not sure of causation however in my long experience in Pharma, post marketing surveillance AE reporting reveals patterns and those patterns get reported and on occasion PI changes are made.
LIVER DAMAGE; PAIN IN LOWER RIGHT ABDOMINAL  AREA; This spontaneous report received from a patient concerned a 3 decade (in twenties)old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and other pre-existing medical conditions included patient had no history of drugs/prescription drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After vaccine, on an unspecified date, the patient was rushed to the emergency room. The doctors could not diagnose the pain in lower right abdominal area but found that the liver had been severely damaged (coded as liver damage) in a short period of time. Patient stated that his medical group would like him to undergo further testing and had scheduled him for the same since their concerns were whether the patient's liver would fail or cause immune system disorders in the future. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from liver damage, and the outcome of pain in lower right abdominal area was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210430986 - covid-19 vaccine ad26.cov2.s - liver damage. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Injection was given / in right arm  / had redness / at the injection site / have resolved; Injection was given / in right arm / swelling at the injection site / have resolved; administered injection / via subcutaneous route instead of intramuscular route / was given 28Jun2021 in right arm; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   On 28th June 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 28th June 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine in the right arm subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route. The patient called back to the office on 1st July 2021 to report she had redness and swelling at the injection site. The reporter granted permission for follow-up.
Pt devel sudden severe, mid sternal chest pain @ 5PM 20APR92; pain severe enough that hurt to breathe deeply; pain worse when supine; mom not observe  SOB, no duskiness, no cyanosis; mom did observe sl swelling in area above heart;
I had noticeable heart inflammation with heart palpitations for a few weeks. They would typically occur in the evening. I did not receive treatment for this the inflammation eventually went away on its own.
Rash started 2/10/17: numerous scattered red papules and a few vesicles with erythema; scattered throughout his body. Calamine lotion as needed, TYLENOL for fever.
noted cyanosis assoc w/shallow to minimal spontaneous breathing followed by 2 hrs of pallor & lethargy; episode required no tx x/manual stimulation;
This spontaneous report was received from a Nurse via a company representative, referring to an 11 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly for vaccination (strength, dose, frequency, lot number and expiration date were not reported). Afterwards, on an unknown date, the patient experienced a bad headache for an unknown period. At the time of the report, the outcome of bad headache and its causality with GARDASIL 9 were unknown.
heart arrhythmia; severe tachycardia; chest pain on the left side; shortness of breath; I have painful hard lumps behind my knee and down my calf; fevers; body aches/ painful hard lumps; now cannot walk up stairs or reasonable distances without my heart acting up; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 12:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "sulfa allergy" (unspecified if ongoing), notes: sulfa allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Past drug history included: Nitrofurantoin, reaction(s): "nitrofurantoin: Drug Allergy". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The following information was reported: ARRHYTHMIA (medically significant) with onset 05Dec2021 20:00, outcome "not recovered", described as "heart arrhythmia"; TACHYCARDIA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "severe tachycardia"; CHEST PAIN (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "chest pain on the left side"; DYSPNOEA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "shortness of breath"; MASS (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "I have painful hard lumps behind my knee and down my calf"; PYREXIA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "fevers"; PAIN (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "body aches/ painful hard lumps"; GAIT DISTURBANCE (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "now cannot walk up stairs or reasonable distances without my heart acting up". The events "heart arrhythmia", "severe tachycardia", "chest pain on the left side", "shortness of breath", "i have painful hard lumps behind my knee and down my calf", "fevers", "body aches/ painful hard lumps" and "now cannot walk up stairs or reasonable distances without my heart acting up" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arrhythmia, tachycardia, chest pain, dyspnoea, mass, pyrexia, pain, gait disturbance. The patient had fevers and body aches for four days so far. The events were reported as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tingly sensation at tips of fingers later became numb, next weaker than day before. But arm was getting worse .
2-5-12 Awakened with painful back of (lt) side of neck, fever, headache. Had 2" reddened, warm indurated area at site KINRIX inj. on (rt) thigh.
DTAP right delt. 24 hrs post injection.  Right delt. red/swollen/itchy 10x10cm, non-tender.  Treatment with Tylenol/Benadryl.
Patient is a 72-year-old female presenting with fever and altered mental status.  History is obtained for the patient and her husband.  She got her second dose of Pfizer vaccine for Covid on 3/6/21.  On 3/7/21, she woke with fever and urinary symptoms.  She have an episode of incontinence and urinary frequency and urgency today.  She was too weak to get up out of the recliner at home.  She did have a fever this morning, which resolved with Tylenol.  She also has been confused much lower mentally than normal.  She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT.  She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin,  IV fluids, and tylenol.
Breakthrough COVID case even though he was vaccinated/got COVID yesterday; Breakthrough COVID case even though he was vaccinated/got COVID yesterday; This is a spontaneous report received from non-contactable reporter(s) (Nurse).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2023 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), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Breakthrough COVID case even though he was vaccinated/got COVID yesterday". Clinical course: Reporter stated that she wanted to informed that, her husband who had his vaccination got COVID yesterday, last night she calling to report that he had a breakthrough COVID case even though he was vaccinated. The last one he had was the COVID Pfizer Bivalent in Sep. Reporter felt like it was her husband's best decision so she could gave his contact information but that was as far as she wanted to go and he could talk when he was not ill."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are  related to bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5)  cannot be excluded.  This case will be reassessed should additional information become available.
pt called the clinic today stating that devel sx of dizziness, h/a, & nausea the same day the flu vax was administered & continues to have these sx; 2NOV92 seen by clinic- rxn to flu vax vs episode of viral gastroenteritis; systolic hyperte
On the day of these vaccines, patient stopped making all vocal sounds except crying for 2 months.  Also, she had decreased eye contact which was most severe for 2-3 months after her 4-month vaccinations, but which continues today.  Previously, she had been a normal, alert, babbling baby.  She currently has persistent motor and social difficulties and some ADHD symptoms consistent with PDD/high-level Autistic Spectrum Disorder.  Parents, unaware these symptoms indicated an adverse vaccine reaction, did not report reaction to physician immediately after it occurred. 60 day follow up 4/5/04: She has a variety of symptoms her doctors feel are related to this event which are causing difficulty for her at school--motor planning deficit, sensory integration deficit, social difficulties and trouble focusing on challenging tasks. She has poor eye contact and problems with listening. We, her parents, have a great difficulty finding the appropriate physician to study or treat her condition. One physician told us her symptoms most closely follow mercury poisoning, but we have been unable to confirm this. Because she does not have a clear diagnosis or recognized disability, we have been unable to get some therapy her doctors have recommended from her school or from private providers. We really wish there was more assistance providedfrom VAERS or the vaccine manufacturer to the families/physician caring for children like our daughter to help them diagnose, treat, study and prevent.
I awoke with a bad cough and headache. I was taking THERAFLU, it did nothing for me, I was not eating or drinking anything. The next day I felt worse and my fever for up to 102F, the cough and headache got worse and then I started to dry heave. I took a home COVID-19 test that came back positive. On December 24, I went to the local corner emergency center, they tested me for COVID-19, influenza A/B, pneumonia. I tested positive for all three and gave me antibiotic medication and sent me home. The medication did nothing as I could not hold anything down. I ended up back at local emergency center. I was very dehydrated; they gave me IV fluids with antibiotics in it. They ran a CT scan and saw a concerning blockage. They called to have me transported to the hospital where I was admitted and had emergency surgery for the possible blockage. They discovered that it was not a blockage but fluid that was built up on the left side of my left abdominal cavity. After spending 8 days in the hospital, I was released I have recovered I am getting stronger, still a bit tired.
Priapism approx. 12 hours after receiving Moderna COVID vaccine. Evaluated in emergency department,  priapism resolved with penile aspiration.
pt recv vax AUG95 & lab eval in JAN97 revealed that the pt failed to seroconvert (varicella antibody titer 0.64 negative);
rash; itchy; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID:   A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "itchy". Additional information: The patient got both flu vaccine and Pfizer covid-19 vaccine and got rash and itchy reaction. Caller wanted to check the ingredients that caused the reaction and if there was any way to get the list of the ingredients of the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
the caller noticed her thumb and pinky fingers felt tingly and numb; she felt tingling in her fingers/it is still in her thumb and is still tingling; ear infection; super sick; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 56-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in arm on an unspecified date in May2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. No reactions were reported with the first dose. Patient had the second covid shot she has a question about a experience she had been having. It was reported that on an unspecified date in May2021 after administration of second dose on the way home from receiving the vaccine in her arm, her upper arm, the patient noticed her thumb and pinky fingers felt tingly/tingling and numb, so she just shook it out. That night she reported she felt like she slept on that arm and thought it fell asleep. She would like to know if it was possible they hit a nerve and would like information on the tingling. She further stated that she was super sick with an ear infection and forgot about the numbness/tingling. She said that she was very skinny. She said that she had been dealing with medical issues currently, and put the tingling on the back burner, but realized this week it was still in her thumb and was still tingling. She said that she had a lot of flu shots in the past but has never had the tingling. Now 3 months later she was recovering at home and noticed that her thumb was still numb and tingling sometimes but not in pain. She was very petite and wondered if the vaccination provider administered the vaccine in a nerve to cause this side effect. It was very concerning. The outcome of the events was recovering.  The lot number for the vaccine, [Pfizer/BioNTech Covid-19 Vaccine], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Had something in her arm after the first booster but didn't experience the same with the rest of the doses; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Had something in her arm after the first booster but didn't experience the same with the rest of the doses) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048c21a, 031m20a and 036a21a) for COVID-19 prophylaxis.     No medical history was provided by the reporter. Patient had never tested positive or diagnosed for COVID-19.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Had something in her arm after the first booster but didn't experience the same with the rest of the doses). At the time of the report, LIMB DISCOMFORT (Had something in her arm after the first booster but didn't experience the same with the rest of the doses) outcome was unknown.            Concomitant medication reported included Statin.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-614403 (Patient Link).
I have a sore throat, fever and chills. I also have sinus congestive, sneezing and coughing. I am also having fatigue as well.  These symptoms are still ongoing. I have them for about 3 days now. I went on Jan 19th and was tested positive for Covid-19.
Pt Mom reports he developed an itchy rash on his stomach, arms and back by morning after received the second dose of Bexsero.  It lasted 2-3 days and "was worse at night".  Also reported he was "sick" with chills (unknown fever) for 2-3 days after the 1st dose.  He received no other vaccines or medication with the Bexsero vaccine.
Swelling and pain in (R) knee (L) elbow. Increased osteoarthritic pain in all joints. Slight sore throat, continuing on 12/18/13.
Received flu vaccine, headache, vomiting, pale, sweaty, shaky BP 62/20, 88 -> 64/26, 64 -> EMS called. EMS BP 104/42 P = 82, 100% o2 sat Bld sugar 111. EMS reporting irregular hrt rhythm. Dad not having EMS transport to hospital as suggested.
around the vaccine area there was swelling/Vaccination area was swollen; swelling has come down and now its puffy; They prescribed antibiotics because its infected. Very infected/Vaccination area was swollen for a month and after became infected; This is a spontaneous report from a contactable consumer. This male consumer (patient himself), a 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number was EM9810), via an unspecified route on 21May2021 (age at vaccination was 36-year-old), as single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number was not reported), dose 1 via an unspecified route on an unspecified date, as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19. Prior to vaccination and Since the vaccination, the patient was not been tested for COVID-19. On 21May2021 the patient experienced around the vaccine area there was swelling/vaccination area was swollen, swelling has come down and now its puffy and They prescribed antibiotics because its infected. Very infected/vaccination area was swollen for a month and after became infected. The patient treatment received for the adverse event as antibiotics. The outcome of all events was not recovered.  No follow up attempts are possible. No further information is expected.
This patient had a fever of 102, dizziness, muscle aches. Treating symptoms with Motrin.
Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL, concerning a 23 year old female with a history of 2 previous pregnancies and 2 elective terminations, who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 660553/0070X) and is pregnant. On 22-JUL-2008, the patient was seen in the office and was 8 weeks 6 days gestation. On an unknown date, an unspecified blood test was performed (results not provided). The patient sought medical attention at the physician's office. On 22-JUL-2008, an ultrasound was performed for confirm dates and was found within normal limits. The date of the last menstrual period was 21-MAY-2008 and the estimated date of delivery is 25-FEB-2008. Follow-up information has been received from a questionnaire completed by a health professional. It was reported that she was a patient with asthma and with a history of 2 pregnancies and 0 live births, terminations of pregnancy - elective; who 17-JUN-2008, was vaccinated with the second dose of GARDASIL (previously reported as the first dose). On 01-AUG-2008, the patient presented sinus infection and was treated with ZITHROMAX (2 tabs a day/1 tab x 3 days). In November 2008, the patient presented a toe nail infection and was treated with clotrimazole. Subsequently, the patient developed anemia and was prescribed with SLOW FE. In January 2009, the patient developed heartburn and was treated with ranitidine, TUMS (Q4-6H) (most often used), MYLANTA (before or after meals) and ZANTAC 75. During pregnancy, a MSAFP test was performed and results were within normal limits. On 14-FEB-2009, the patient delivered a normal, healthy female baby weighing 7 pounds 7 ounces and 19 inches in height. Apgar score was 8/9. On approximately 14-FEB-2009, the patient experienced pre eclampsia post partum. Outcome not reported. No further information is available.
Patient felt like a belt was tight around her chest from 40 minutes after vaccine and symptoms lasted for 4 hours.  Patient did not feel short of breath or pain,  just chest tightness to the point of irritation