chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the reporter thought that she and her husband received FLUZONE HD for this season, In error, the pharmacist gave them the fluzone low dose with no adverse event; Initial information regarding an unsolicited valid non-serious case from a patient was received on 26-Oct-2020.  This case involves an unknown age female patient it was reported that the reporter thought that she and her husband received  INFLUENZA VACCINE TRIVALENT [FLUZONE HD] for this season, in error, the pharmacist gave them the INFLUENZA VACCINE TRIVALENT [FLUZONE] (product dispensing error) (dose, route, anatomical location, expiry date and lot number unknown) for prophylactic vaccination on 20-Oct-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not provided.   This is a true medication error case due to product dispensing error (latency same day).   No laboratory data was provided.  At the time of this report, no adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information regarding batch number for the case.
Pt. was given 1ml of Engerix-B instead of 0.5ml pt did not have any adverse events
On January 24, 2021, Sunday, I received my first Covid-19 Vaccine. I had a shoulder/arm for the afternoon. Next day, all fine. I do not have a heart condition. However on Monday, February 1st I had  odd heart palpitation. It felt like my heart skipped a beat. This occurred off and on, not lasting no more than 2-5 seconds. I thought nothing of it since I experienced something like this when I was a grad student when I was under a lot of stress. So I called my insurance nurse line and explained my symptoms. Nurse recommended I stop drinking coffee and stop taking vitamin supplements.  Nurse advised to reach out to my doctor. I tried to make an appointment none was available within a month. I showed up on at the doctor's on Monday, February 8th. They gave me an EKG, it seemed normal. But I have a several tests scheduled for Monday, February 22, 2021. It just seemed odd that I have this palpitation off and on for a few seconds anywhere from 5-10 times in 24 hours.  I have not had this sensation since grad school back in 1984.
No addtional AE.; Nurse reporting PROQUAD was administered after expiration.; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 15-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, 0.5 milliliter (ml), administered for prophylaxis (lot number U006313, which was determined to be valid, with an expiration date on 24-AUG-2022) (expired product administered)(strength, route of administration, and anatomical site of injection were not reported).   No additional adverse events were reported in the patient.
The patient fell the day after receiving the Moderna COVID-19 vaccine. She broke her hip in this fall. During surgery to correct the broken hip, she went in to sudden and unexpected cardiac arrest. The anesthetist did not notice any ST changes or A fib; dysrhythmia was very unexpected. The patient had a DNR. She died at 13:00 on 02/07/2021.   Causes of death are listed as 1. Cardiac Arrest 2. Recent hip fracture with hip placement 3. History of Breast Cancer 4. Hypothyroid and 5. Dementia
after getting her 2nd dose of the Covid vaccine she has been bleeding a lot; wanting to know if there is an interaction between Depo Provera and the Covid vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunisation; medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. On an unspecified date the patient experienced after getting her 2nd dose of the covid vaccine she has been bleeding a lot, wanting to know if there is an interaction between depo provera and the covid vaccine. Reporter is on Depo Provera and noticed that after getting her 2nd dose of the Covid vaccine she has been bleeding a lot. She is wanting to know if there is an interaction between Depo Provera and the Covid vaccine. Action taken for medroxyprogesterone acetate (DEPO-PROVERA) was unknown. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sore arm; Fatigue; This is a spontaneous report from a Pfizer sponsored program . A contactable 63-years-old male consumer (patient) reported to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that first dose about 3 weeks ago, second dose due to 03Mar2021. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, fatigue. Patient requested information regarding antibodies testing or T-cells tests to assess for immunity/effectiveness after vaccination. Patient asked if he use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(Pain and) swelling with a knot where the clavicle meets the shoulder; The vaccine seems to have been injected subcutaneously; Raised, painful red area at the injection site; Raised, (painful) red area at the injection site; This is a spontaneous case, reported by pharmacist to Agency  (case ID: SEQ19-04690) and initially received on 15-Oct-2019 with aditional document (case ID: SEQ19-04688, beeing processed together), concernig a 70-year-old female patient.  The patients relevant medical history and concomitant medications were not provided.  On 13-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59 dose: 0.5 ml, anatomical location: deltoid, route of administration: subcutaneous, batch number: 261277, expiration date: 31-May-2020] explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis.  On the same day, after vaccine administration, the patient developed a pawn on his arm which is a raised, painful red area at the injection site. The reporter mentioned the patient received the injection quite high up in the arm (closer to shoulder) and not sure if it was injected in the muscle. The patient explained the dose seems to have been injected subcutaneously and experienced pain and swelling with a knot where the clavicle meets the shoulder.  The outcome of the events 'pain' and 'swelling' were not resolved and the outcome of the event 'red area at the injection site' was not reported.  The reporter assessed the case as non-serious and did not provide causality criteria.  This case is linked with companion case 201905268 due to the same reporter.  Non-significant follow-up reporter by other non health professional from Agency [reference number: SEQ19-05571] on 13-Nov-2019: Additional Agency reference number added. No changes in narrative.  Company Comment: The patient experienced vaccination site pain, injection site erythema, and vaccination site swelling after incorrect route of product administration with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Incorrect route of product administration is assessed as not related per company conventions. Considering all the above mentioned, causal relationship between the suspect product and all other events is assessed as related.; Reporter's Comments: The reporter assessed the case as non-serious.
sore arm/ pain that went down his arm; This is a spontaneous report from a contactable consumer.  A 71-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number X93809), at his 71 years old via an unspecified route of administration on 28Jun2019 at single dose for immunisation/prevention. There was no medical history or concomitant medications. The patient experienced sore arm three weeks after it was administered, the patient had to put ice packs as having pain that went down his arm.
This spontaneous report was received from a licensed vocational nurse refers to patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 17-JUL-2015, the patient was vaccinated with a dose of an improperly stored ZOSTAVAX, lot number L003216, expiration date 30-APR-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Child received Kinrix injection in R thigh on 4/27/2009.  On 4/28/09 - child seen by doctor diagnosed with (hives) reaction to Kinrix.  Given Benadryl.
Patient had nausea and vomitted 4 times she stated.  The day after she received her shot, she woke up the next morning and stood up to get out of bed and passed out.  She said that she did not know how long she was out for--she just woke up and she was on the floor.  She also had a temperature.  I advised her she may be dehydrated from the nausea and that may have resulted in her blood pressure lowering and her passing out.  I advised she did go see a doctor to be further assessed but she had no one to take her and did not feel comfortable driving.  I advised to focus on hydration is she was unable to get anywhere.  I called back that afternoon to check on her and she felt considerably better after pushing fluids and having some crackers.
Not long after my vaccine, I had one day of watery discharge and then it resolved itself. I went to the clinic and they did some test and that showed I was leaking amniotic fluid. I ended up getting a dose of magnesium, a dose of betamethasone, and antibiotics. They monitored me for 3 days and then discharged. My due date is 1/27/23, and everything up to this point has been normal. Everything seems to be normal now. His weight is 2 3/4 pounds at this time.
Odd shape rash appearance with hive at injection  location approximately 8 inches in size. Hot to touch,  and swelling.
Urticaria (Torso & Extremities) starting near injection site - No Hx of egg or latex allergy rash resolving.
That evening my hands became very weak.  Over the next 3-4 days I could barely stay awake, sleeping 20+ hours/day
15Feb91 crying, no fever, crying @ night, Sat. night crying all night, would not take bottle, child OK on 19Feb91
Chills; shaking really bad due to chills; Low grade 100.5F fever; A spontaneous report was received from a Healthcare Professional concerning a 82 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, chills, shaking really bad due to chills, and low grade 100.5f fever.  The patient's medical history was included bypass surgery. Concomitant medications reported were not provided for drug use for unknown indication.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events, chills. shaking really bad due to chills, low grade 100.5f fever,  term.  Treatment details included ibuprofen.  Action taken with mRNA-1273 in response to the events, chills, shaking really bad due to chills, and low grade 100.5f fever,  was not reported.   On an unknown date the outcome of events include, chills, shaking really bad due to chills, and low grade 100.5 f fever was not reported.; Reporter's Comments: This case concerns an 82 year old male patient, with history of bypass surgery, who experienced a non-serious unexpected event of tremor, and expected events of chills and pyrexia, 3 days after receiving second dose of mRNA- 1273 (Lot# Unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020) and NO ADVERSE EVENT (She did not experience any side effects) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020) and NO ADVERSE EVENT (She did not experience any side effects). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020) had resolved and NO ADVERSE EVENT (She did not experience any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains Reporter's information(Address1,phone number, email, state, postal code, city)updated. Patient details updated except initials. Event(no adverse effect)added.
On 1/23/2022 at about 6 PM, I had a sore throat and felt tired. On 1/24/2022-1/31/2022, I had intermittent fever, chills, and lethargy. On 1/24/2022, I took a PCR test, and the result was positive; I had a breakthrough case. I had ongoing tiredness for 2 full weeks, and this was my main symptom.
Nurse administered 2 shots in left arm ( flu and HepA), then 1 shot in right arm (HepB).  Patient jumped up and said "I feel hot." Nurse assisted patient back to chair where patient was sweaty, pale and complained of "feeling faint".  Stated he had not eaten lunch.  Given Coca-cola and cool cloth.  Was monitored for 25 minutes.  Friend drove patient home.
First dose was just cathartic roughly three hours after shot. Second shot starting again 3-4 hours after injection developed itchy hives purple in color on face and around injection site. Fever of 99.8 degrees Farhat and flu like symptoms that lasted for four days.
Initial and follow up information has been received for the Pregnancy Registry for Gardasil from a Registered Nurse (R.N.) concerning a 25 year old female patient with high Human Papilloma Virus (HPV) who on 23-MAR-2007 was vaccinated IM in to right deltoid a dose of with  GARDASIL lot #655618/0186U.  The nurse reported that now she was pregnant after receiving the injection.  Routine prenatal labs were done.  Patient was 19 weeks of gestation at the time of this report.  The patient sought unspecified medical attention.  In follow up information the nurse reported that the patient had Urinary tract infection (UTI) for which she was treated with MACROBID twice a day from 21-MAY-2007 till 31-MAY-2007.  On 18-JUL-2007 she had an ultrasound done which had normal result.  She also had maternal serum alpha-fetoprotein test (MSAFP) with a normal result.  The outcome was unknown.  This is one of the two patient from the same office.  Additional information has been requested.This is in follow-up to report (s) previously submitted on 10/08/2007, 7/8/2008. In follow up telephone call to the physician's office the nurse reported that on 14-DEC-2007 at 39 1/2 weeks gestation, the patient delivered a normal baby boy with no congenital anomalies by repeat cesarean section. His birth weight was 6 pounds 15 ounces, and he was 18.5 inches. The infant's apgar score was 8/9. Other medications taken during prenancy were vitimans (unspecified) and iron (unspecified) 325 mg by mouth three times a day. It was reported that there were no complications for the mother or the baby. This is one of the two patient from the same office. Additional information is not expected. Additional information is not expected.
Information of this prospective pregnancy report has been received from a physician referring to a female patient of unknown age. The patient became pregnant on an unknown date (date of last menstrual period not provided). On an unknown date the pregnant patient was inadvertently administered VARIVAX (Merck) (lot#, expired date, dose, frequency and route were unknown) (vaccine exposure during pregnancy). The estimated date of delivery and the due date were not provided. The patient had sought unknown type of medical attention. There were no product quality complaints (PQC) involved. Additional information has been requested.
Narrative: 64 YOM with history of advanced COPD, chronic hypoxic respiratory failure on home 02 @2L/min, Lung CA with mets s/p resection and chemotherapy and Lymphoma, now in remission. He also has malignant rt pleural effusion s/p thoracentesis 5/26/21 with 1.8L of exudative fluid removed. He comes tonight with SOB worse over several days and pain the Rt lumbar area. No fever or chills, no nausea or vomiting. Say he has been doing better since ED discharge until last PM when SOB worsened, started to use increasing amount of 02 supplement without improvement. He also admits he has been having worsening cough productive of greenish yellow sputum. Was in the ED on 6/9/21 and discharged with tapering dose prednisone. He became hypoxic to 80's in ED and CTA chest was done but negative for PE and stable with his chronic issues including mets and Rt sided effusion (Less). He improved with SVN treatment, IV Decadron. COVID-19 testing is positive and admission requested but did complete his Pfizer vaccine with second dose on 2/26/2021. Admitted to hospital with COPS exacerbation, acute on chronic hypoxic respiratory failure. Acute bacterial bronchitis. Patient's symptoms improved after treatment with corticosteroids, antibiotics, and other supportive therapy.
On 9-26-2017 during my regular medical checking at 2:15 P.M. I received one FLUZONE HIGH DOSE flu shot which I receive annually. For the first time by 5 PM I began feeling so weak and tired that I decided to go to bed. Before going to bed I went to the bathroom to urinate. My normal urine is nearly colorless to light yellow. This time my urine was dark brown like strong iced tea in color and smelled musty and spicy. I immediately stopped drinking all other beverages and drank exclusively water until the urine returned to normal. I remained in bed 2 1/2 days. Having an open lab app't. I went to the lab and had blood and urine samples taken. Results were all normal for me except the creatinine in the urinalysis which was 161.7 mg/dl. Norms for this test range from 47-110 mg/dl. I remained in bed for a total of 5 days before I felt strong enough to resume normal living patterns. The urine color did not return to my normal color for a full 2 weeks. On Friday, December 29, 2017 I came down with a flu virus and remained bedridden for 10 days before I felt well enough to get up. I remained weak and run down for another 5-6 weeks. Regarding the September flu vaccine reaction, I contacted my Dr's office twice, once about the weakness and urine odor and color change, and once about the urine creatine high reading. In both instances after discussion, the resulting decision was to wait and watch. No other symptoms related to this incident were observed.
Truly don?t think this is an effect of vaccine but prob seasonal allergies.  Congested productive cough with sore throat.  No temp but cough held on for 3 weeks.  Still have occasional productive cough in the a.m. but nothing like it was.  Teladoc prescribed nasal spray, inhaler and cough pill.
Patient received her Janssen COVID vaccine and was sitting in a chair in the conference room when she slumped over in her chair and became unresponsive. Patient had just received her one dose Janssen vaccine and was sitting in a chair approximately 3-5 minutes after receiving the vaccine.  She began to slump over in her chair and was unresponsive. Two RNs responded to assess the patient. Patients feet were elevated and ice packs applied to her neck and axillary areas. Patient was breathing and had a pulse. Patient responded to her name once and then passed out again. Patient was unable to respond after this.  Her eyes were open.  Patient was lifted into a wheelchair by three nurses and brought to a private area.  Patient was warm and sweat was running down her face.  Her sweater was removed and ice packs again were applied to her neck and axillary area.  Patient continued to have a pulse and was breathing.  EMS was called.  Patient slowly began to come around and could answer questions after about 5 minutes of being unresponsive. She was confused and had no memory of what had occurred. She reported feeling light headed and seeing spots in her vision.  She continued to feel light headed. EMS assessed patient.  Vitals were stable and blood sugar was WDL.  Patient reported feeling much better. She denied feeling light headed or dizzy any longer.  She was able to answer all questions asked.  Patient did not want to go to the hospital and refused transport to the hospital via ambulance. She was observed for an additional 20-30 minutes at which time her boss arrived to pick her up. She was educated on calling 911 if she began to feel light headed or dizzy again. Patient verbalized understanding. She was walked to the car by an RN.
PT STATES HE HAS SOME TIGHTNESS IN HER THROAT.  SHE DENIES CHEST PAIN OR THE PAIN WORSENING.  SHE ARRIVES AT THE MED OBS 1 VIA WHEELCHAIR AT 1502.  SHE DID NOT WANT TO GET OUT OF THE WHEELCHAIR AND SHE DID NOT WANT VITALS TAKEN.  HER FRIEND WITH HER STATED  SHE IS VERY ANXIOUS AND NEEDS HER NERVE PILL.  AT 3:08 HER PULSE WAS 65 OXYFEN SATS 99% ROOM AIR.  SHE DENIES WANT FOR WATER OR SNACKS.  1521 PATIENT WAS TAKEN TO THE EXIT VIA WHEELCHAIR, HER FRIEND, AND STAFF