chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE PATIENT RECEIVED MODERNA BOOSTER ON 2/11/22. 2 DAYS LATER, ON 2/13/22, THEY COMPLAINED OF A CLOGGING SENSATION OF THEIR LEFT EAR. IN ADDITION, THEY DEVELOPED A RED RASH THAT RADIATED FROM THE LEFT SIDE OF THEIR NECK TO THEIR MID CHEST REGION, HEADACHE & CHILLS. THEY DENIED PAIN, ITCHINESS OR BURNING SENSATION. THE PATIENT WAS SEEN BY THEIR PRIMARY CARE PROVIDER THAT THEN REFERRED THEM TO AN ENT. A COURSE OF STEROIDS & A MRI WERE PRESCRIBED. MRI NOT YET COMPLETED TO DATE. SIGNS & SYMPTOMS ARE REPORTED AS GETTING PROGRESSIVELY WORSE WITH HEARING LOSS & RINGING IN THE LEFT EAR IN ADDITION TO THE ORIGINALLY REPORTED CLOGGED FEELING.
Patient had two witnessed seizure like episodes with nystagmus and unresponsive each episode lasted less than 20 seconds. Patient had prodrome prior to both events but no memory or either event. Both event happened within 15 minutes of vaccine administration. Patient was transported to the emegency department for further testing and care.
presented with complaint of weakness, diarrhea, decreased appetite, mild shortness of breath, cough, fatigue  -- Found to be hypoxic upon arrival to the emergency department requiring O2  & positive for COVID-19 with diarrhea, weakness and hypoxia-all secondary to viral illness
Information regarding Flumist (2002-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from the mother of an 11 year old female who experienced runny nose, congestion, cough and sore throat.  At 11 years of age, the pt received a dose on 12/12/03.  The child had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  The mother reported that the child only received half of a Flumist dose in one nostril.  On 12/13/03, the child experienced runny nose (rhinorrhoea), congestion (nasal congestion), cough (cough) and sore throat (pharyngolaryngeal pain).  As of 12/17/03, her symptoms persisted.  No additional information was available at the time of this report.
patient states she called about 2 weeks ago, stating that site where injection was given was still quite sore and had a raised bump and mobility is lessed. her doctor claims that the shot was given higher than it hould have been--but I have never had this ever before--and been given even the old Zoster vaccine that came frozen
Large Itchy Swollen Rash with hives on injection site. I did some research online and it looked exactly like the examples of ?Covid Arm?. I took 2 Benadryl which was suggested in one of the articles.
Around 3 months after receiving my first dose of Moderna, I was experiencing extreme fatigue. When I had my routine labs drawn for my thyroid values were askew. They were four times higher than I was in when I was first diagnosed with thyroid disease. That's been an ongoing problem. I have to have my labs drawn every 2 to 3 months and my medication is constantly changing. Prior to receiving my vaccines, I had been on the same dosages for 9 years.
Dose 1: Johnson vaccine and Dose 2: Pfizer; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 01Jun2022 at 12:00 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 13Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE, start date: 01Jun2020; VALIUM, start date: 23Nov2022, stop date: 26Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1: Johnson vaccine and Dose 2: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Nov2022 to 26Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever of 103 Loss of appetite which led to weight loss (7lbs in 3 days) Chills  Severe fatigue Severe nausea  Vomiting  Diarrhea  Dehydration
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-NOV-2015 at time- 20:46, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Information has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. The patient received the first dose of VARIVAX (dose and route were unknown) in 2009, the second dose was administered on an unknown date in 2011. The primary reporter stated that post-vaccination titers were drawn to confirm evidence of immunity to varicella on an unknown date. The results of the serological testing determined that she was serological negative "negative titers" for varicella immunity on an unknown date. The outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Information has been received from a medical assistant concerning a 20 year old female patient, who on unspecified date was vaccinated with the first and second dose of GARDASIL (route and lot # no reported). The medical assistant stated that the patient who went on 20-AUG-2010 to the office for the third dose of GARDASIL changed her mind prior to vaccination stating that on an unspecified date following the second dose she experienced nausea. At the time of the report, the patient outcome was unknown. It was unknown if the patient sought medical attention. Follow-up information has been received from the medical assistant concerning a female student. The patient had received 2 prior doses at college. The GARDASIL was drawn up from a single dose vial and was taken into the patient's exam room. The patient then decided she didn't want the vaccine because the she became dizzy, lightheaded and nauseous nauseas after her second injection at college and this particular day she had not one to drive her home. So she declined the vaccine. The vaccine had already been drawn up but was not administered. On an unspecified date, the patient recovered. Additional information is not expected.
Tachycardia at rest >120 BPM, fever 99 Fahrenheit, SPO2 92%.  Relieved without medication after 8 hours.
On July 8th it began with a deep cough in my chest.  The second day I got terrible body pain including the bottom of my feet.  On Saturday the 9th I began to get a fever.  I took home test, negative.  The highest I recorded was 101.  I tested 10th, negative.  The pain began to subside by July 11th.  Drive up test, positive.  I got headaches, chills, severe sore throat.  It then moved into a weird ear ache and congestion in my ears.  Classic cold symptoms with congestion in my nose.  Shortness of breath as well.  All of this dissipated by July 15th.  As of today, July 18th, I have tested negative.  Paxlovid for 5 days.
I am a nurse practitioner here at the facility. I received the vaccine on 12/18/2020 at  noon. On Monday evening 12/21/2020 I developed floaters and flashes of light in my right eye. I awoke on 12/22/2020 with continued worsening symptoms. I went to my optometrist. I was diagnosed with Vitreous detachment of the right eye. The optometrist did not feel it was related to vaccine but our health nurse advised reporting.
14OCT collapsed, disorientated, combative, uncooperative, diaphoretic, very sensitive to touch, intubated, dec paralyzed for CT, IV, haldol, LP, FC;extubated confusion cont on 15OCT;dx likely allergic rxn to f/u shot r/o encephalitis mening
Sometime after the vaccination the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Diffuse induration from hip to knee on left. Treated with antibiotics and ice. Gradually resolved. Hospital d/c summary diagnosis was local reaction to pediatric immunization L thigh.
Tested positive for Covid virus after being fully vaccinated with Pfizer vaccine on 3/10/21 and 4/01/21; Tested positive for Covid virus after being fully vaccinated with Pfizer vaccine on 3/10/21 and 4/01/21; This is a spontaneous report from a contactable other hcp (patient).     A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE 2, SINGLE and first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid virus after being fully vaccinated with Pfizer vaccine on an unspecified date in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and a close  association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of COVID-19 and drug ineffective.
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency. A response from Moderna is expected to be received between 8-10 business days. Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed in system is 12/31/2069. To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA). Patient contacted on 12/4/2021 and no adverse effects reported.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 19-MAR-2015 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), 0.5 ml, subcutaneously (dose series, batch/lot # and expiration date not reported). No adverse effects were reported. Additional information has been requested.
My Doctor ordered an Electrocardiogram for me and I found out that I have Mitral Valve Prolapse. I was having chest pains and heart palpitations prior to my Doctor ordering the testing.
fatigue; fever of 101 F; extreme thirst; headache; This is a spontaneous report from a contactable consumer. This consumer reported for a 28-year-old male patient that received second dose of bnt162b2 (BNT162B2, COVID 19), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Other vaccine in four weeks was unknown. Manufacturer contractor reporting on behalf of so media post observed from a medical student who received second round of vaccine. Per post, 12 hours after vaccination, patient woke up with fever of 101 F, extreme thirst, headache, and fatigue. Patient posted follow-up saying that 26 hours after the vaccination, symptoms have resolved and he has returned to "feeling like himself." The events started from 12Jan2021. The outcome of the events was recovered in Jan2021. Treatment was received included Per media post, patient self treated with OTC Tylenol. Covid prior vaccination was unknown. Covid tested post vaccination was unknown  Information of lot/batch number has been requested.
Patient claims her arm started getting very red, swollen and warm and somewhat painful. It has been 7 days and her arm continues to be red and swollen.
Patient was in severe pain at sight worsened overnight, patient went to hospital and was given a shot for pain.
Myalgia, Arthralgia, pain, soreness to right arm into shoulder, no erythema, warmth or induration per employee Narrative:  Other Relevant History:
Patient had Moderna vaccine for doses 1, 2 and first booster. Got Pfizer vaccine for second booseter. Developed Hives Late Monday night after bosoter was given Had Pfizer the booster on Monday AM  Developed hives on Monday night  Lasted about 12 hours  Resolved  Felt crummy yesterday with body aches  Hives returned again last night even worse Arms, back, abdomen  No difficulty breathing  Swallowing WNL  Site WNL  Took Clairitin with relief  All 3 doses were Moderna and booster was Pfizer  No other changes in lifestyle/diet/laundry detergent/soaps
Left eye developed stye on lower lid, which lasted 2 weeks.  currently not an issue
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL (dose and route unknown) on 23-AUG-2013, lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
pt recv vax & devel vulvitis & poss hypersensitivity synd of serum sickness; No further details were provided;
Gradually fatigued from time of injection to about 7:30pm. By 8pm, I immediately felt the urge to vomit and I had developed a headache and fever. Staying as hydrated as possible, I took Tylenol and went to lay in bed around 9pm. I was insanely cold with a fever of 104. Through the next 10 hours my fever fluctuated between 102-104 degrees, but never broke and I was miserable. By about 10am it began to drop to 101 and further on as the day went on but it did take another 12 hours for it to be in the normal range.
Patient received vaccine 9-19-15 approx 215 PM. Patient noted red welt at admin site 9-20-15 evening and marked with pen at outline. On 9-21-15 contacted pharmacy with 3"x3" egg sized welt worse than   night before. Patient went to urgent care and was diagnosed with cellulitis and prescribed antibiotics.
Initial unsolicited report received from a consumer on 04 November 2015. This case involves a 90-years-old female patient who was vaccinated with an intramuscular dose of Fluzone HD (batch number, expiration date, dose, dose in series were not reported) and dose of PREVNAR 13 (batch number, expiration date, dose, dose in series, route were not reported) both in left arm on 29 October 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were denied. Concomitant medications were not reported. On 31 October 2015, two days following the vaccination, the patient developed muscle aches, sore bones, unstable gait and left arm soreness. Lab data was not reported. The patient received corrective treatment with aspirin. It was reported that patient was not evaluated and treated by physician. patient was self-medicated with aspirin. Outcome of events was reported as unknown. List of documents held by sender: none.
Initial report received on 01-Oct-2013 from pharmacist. A three patients of unknown age and unknown gender received FLUZONE HD (lot number, expiration date and route unknown). Patients had chills from, teeth chattering. Reporter stated that 3 people had chills, feeling cold and it began about 3 hours after vaccine administration and lasted about a day (24 hours). Outcome of the events was unknown at the time of this report. List of documents held by sender: none
Got severe case of varicella with fever to 104F-105F which started 7 days, post vax. He is recovering.
extremely painful arm and shoulder, very limited range of motion.  this started within a few hours of injection and continues to date. unable to raise arm in front or to the side.  cannot reach forward such as to remove dish from cupboard.  Cannot brush hair, Cannot lift more than a few ounces.  Need to keep arm very close to side of body in order to use.
Tinnitus in left ear. Persistent low ringing that is continuous from wake up to sleep. Started on 4/11 and has continued through 4/16. Symptoms continue at time of this reporting
Had fevers/chills, generalized fatigue, nausea (no vomiting), abdominal upset, cellulitis.
Large Left DVT and PE; Large Left DVT and PE; This is a spontaneous report from a contactable Physician reporting for a patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 28Aug2021 (Lot Number: FC3183), at the age of 62-year-old, as dose 2, single for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. Medical history included diabetes mellitus type2, asthma, hypertension, hyperlipidemia. The patient did not have COVID prior to vaccination. Concomitant medications included salbutamol (PROVENTIL); allopurinol (ZYLOPRIM); atorvastatin calcium (LIPITOR); colecalciferol (VIT D); metformin (METFORMIN); lisinopril (LISINOPRIL).  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Aug2021 05:00 PM (Lot Number: EW0179), at the age of 62-year-old, as dose 1, single for COVID-19 immunisation. The patient has known allergies to sulfamethoxazole-trimethoprim sulfamethoxazole.  On 16Oct2021 the patient experienced Large Left deep vein thrombosis (DVT) and pulmonary embolism (PE). The events resulted in emergency room/department or urgent care and treatments included Direct-Acting Oral Anticoagulant (DOAC). On 16Oct2021 the patient was tested for COVID-19 Nasal Swab Hospital Respiratory Panel and result was negative. The events were resolving.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Deep vein thrombosis and Pulmonary embolism cannot be ruled out. 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.
Both ankles swelled and hurts. Comes and goes; Both ankles swelled and hurts. Comes and goes; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A non-pregnant female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 11Mar2021 12:30 as dose 1, single for COVID-19 immunization (Pharmacy or Drug Store). Medical history included hypertension, cardiac murmur, blood cholesterol increased, hepatic steatosis and covid-19. The patient had Covid prior to vaccination, and not tested for covid post vaccination. The patient had not received other vaccines within 4 weeks and patient had received medications in two weeks prior to the vaccination. On 12Mar2021 07:00, the patient experienced both ankles swelled and hurts. comes and goes. The patient had not received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient presented to the pharmacy for 2 immunizations (BOOSTRIX and Flu shot). They were asked if they wanted 1 shot in either arm and they stated that they wanted them in both arms.  They were advised of the side effects and still wanted both shots in the same arm.  The patient called the pharmacy on 2/3/19 and stated that on 1/2/19 they experienced pain, hotness, and redness at the injection site.  They went to see a doctor and were prescribed and antibiotic and pain medicine.
pt recvd vax;t 105.3 R eve of vax;grunting,pallor,cyanosis,unresponsive,shaking of limbs (not jerking);d;acute episode of shaking x 5 mins;
At 10 minutes after administration, patient complains of dizziness and lightheadedness. RN  walked patient to private holding room, laid in gurnee with HOB at 45 degrees. Given glass of water.   AT 15:22, BP 124/86, 99% Pulse ox, Heart rate 88 beats per min, Temp 99.1 oral, Respirations 18 breaths per min. Dizziness 8/10.    15:38, Blood pressure 129/86, Pulse ox 99%, heart rate 94 bpm, Oral temperature 98.1  Dizziness reported 7/10 severity.  15:53, B/P 120/86. pulse ox 100%, Heart rate 84, Oral temp 98.3. Dizziness 4/10.  Pt sat up, at edge of the bed, without dizziness. Stood on feet comfortable. Ambulated around room, then ambulated down hallway and back without incident. Then reported dizziness to 1 out of 10, and stated feeling comfortable to go home, would have co-worker assist if needed.
A nurse reported that an employee received a dose of Flu Shield (2001-2002 formula) on 04-Dec-2001. Two days later, the patient developed an injection site reaction characterized as "silver dollar" size, dark, red and warm. Manufacturer's comment The reporter indicated that 15 out of 16 employees experienced this reaction following receipt of Flu shield (2001-2002 Formula) lot 4018032; however, the other employees are not presently identifiable. Additional  reports will be generated when identifying information is received.
Very painful initial shot followed by continued pain in the arm/shoulder for 3 weeks at the current time ... pain is less now, but still ongoing.
c/o pain R inner arm, tingling R hand, swelling, to R shoulder-neck. c/o 5-10 min after. MMR given L arm. Tdap in R deltoid. Blood draw R antecub. Sent to urgent care. Sling to R arm, IBP 800 mg.
her husband received / first dose / September 2020. He has yet to receive the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in Spetmber 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not applicable for this report. The patient was not notified that 2nd dose was required. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, they referred to Food and Drug Administration, The centers for Disease Control and Prevention and Health Care Professional and provided content regarding not restarting vaccine series. No other information was provided.  The reporter did not consent to follow up.
G3P2002 now G3P2012 - Pregnancy, confirmed by UPT at 4 weeks gestation.  Spontaneous miscarriage at 6 weeks 5 days.    Of note, first covid vaccine was with Pfizer  in late April