chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delayed arm swelling; delayed itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (delayed itchy arm) and VACCINATION SITE SWELLING (Delayed arm swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (delayed itchy arm). On 20-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Delayed arm swelling). At the time of the report, VACCINATION SITE PRURITUS (delayed itchy arm) and VACCINATION SITE SWELLING (Delayed arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up was received on 27 Apr 2021 included,no new information
Anthrax dose 5 was given; subsequently pt dvlped 37 cm edema mid arm to forearm, erythema, hot & tender and 2 cm induration at injection site.
Severe chills to the point of being convulsions.  They were so powerful i could not call to my wife to come help.   Once I was able to get under the covers, they started subsiding.
5/3/16 evening, c/o hint of redness, itching swelling to injection site. From shoulder to elbow. Seen after 2 office calls 5/4/16. MOTRIN given Q6 hours - dosed by wt and encouraged BENADRYL by provider.
they've also experienced teeth sensitivity to hot and cold temperatures; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), administration date 27Nov2021 (Batch/Lot number: unknown) as dose 1 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "they've also experienced teeth sensitivity to hot and cold temperatures".  Additional information: Caller asked any information on menstrual irregularities following vaccination with the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) Caller states: She was a premenopausal 53 year old woman, very healthy, active, not a smoker, don't drink alcohol and  exercise regularly. On 01Dec2021 had COVID-19 infection that lasted from 6 to 7 weeks, within weeks  ended up getting a cycle again and experienced 1 or 2 cycles,  had all the premenstrual symptoms: she broke out [pimples], she was irritable, experienced nausea, felt bloated, experienced premenstrual cramps and overall felt miserable . On 27Nov2021 she received first dose on the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) and since the she has not felt right since then: her teeth hurt, they are extremely sensitive to temperature (hot or cold). She even have tooth pain in a tooth that does not even have a root anymore, she did not change paste or any other factors that may be causing this situation. She had chills, cough and feel fatigued, she had experienced fever as well, had a bullseye headache that has not gone away since then and sinus pressure since  got the vaccine. Some hours are worse than others. She has not had a menstrual cycle for over a year now (since my COVID-19 infection), but experiencing all the premenstrual symptoms she asked if any information on teeth pain reports after receiving the first dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767836 ame reporter/drug, different patients.;US-PFIZER INC-202101771852 Same reporter/drug, different patients.
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
chest pain; Resting HR increase from my normal low 50s to 67 according to my watch the day after second dose; kidney pain bilaterally; GI distress; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone", notes: prednisone. And to expand on above., I have had over 70 negative rapid, tests and 1 negative antibody. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Oct2021, for Covid-19 immunization, reaction(s): "Extreme fatigue". The following information was reported: CHEST PAIN (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "chest pain"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Resting HR increase from my normal low 50s to 67 according to my watch the day after second dose"; RENAL PAIN (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "kidney pain bilaterally"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "GI distress"; FATIGUE (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "extreme fatigue". The events "chest pain", "resting hr increase from my normal low 50s to 67 according to my watch the day after second dose", "kidney pain bilaterally", "gi distress" and "extreme fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, heart rate increased, abdominal discomfort, fatigue.  Additional Information: Patient took other medications in two weeks: Multivitamin. Patient received treatment for AEs was probiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & 1 1/2 hrs later had a near miss SIDS-apneic event; position may have contributed-on belly flat on soft bedding in stroller;
This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX. Concomitant products included Metformin, PREVACID, simvastatin, VENTOLIN, TRADJENTA and TRAVATAN. On 28th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th May 2018, 1 days after receiving SHINGRIX, the patient experienced fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising. On an unknown date, the outcome of the fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising were not recovered/not resolved. The reporter considered the fever, breathing rate increased, influenza-like symptoms, injection site erythema, injection site swelling and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced fever of 100 degree F, breathing faster than normal, and flu like syndrome. The patient was unable to provide full demographics for the pharmacy or his prescriber. The contact details of the physician was provided.
Mild to moderate swelling of the uvula, beginning three hours after the vaccine was received, reducing after a day or two.
Rt. arm sore (heavy sensation under arm) breathing difficulty for 2 hr. Coughing all night, then rash on face and dry bumpy skin, then mild rash more on Rt side than left. Slight heat sensations. No soreness in joints.
02/13/22 presents to ED for "Rapid Heart Rate" "chest pain". PMHx of "HTN, DM II, HLD, Von Wilbrand disease, peripheral neuropathy"
Information has been received from a nurse practitioner concerning a 7 year old female with no medical history who on 6/18/1999, at one year of age, was vaccianted SC in the left arm with the first dose of varicella virus vaccine live (lot 629141/1836H). There was no illness at the time of vaccination. It was also noted that on 6/30/1999, the patient was vaccinated SC in the right arm with the first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 628894/1546H). The NP reported that on 6/3/2005, the patient developed a mild case of breakthrough varicella characterized by less than 25 lesions. ON 6/6/2005, a culture of a trunk lesion was positive for varicella Zoster virus DNA. Otherwise, the patient was not noted to be ill. Unspecified medical attention was sought, but no treatment was required. In June 2005, the patient subsequently recovered from the breakthrough varicella. Additional information is not expected.
redness at injection site of 3-4 inches; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness at injection site of 3-4 inches. The reporter wanted to know if there were any recommendations on how to treat this side effect. The outcome of the event was unknown.  Information about lot/batch number has been requested.
I am having hot flashes/episodes at least 10 times a day (including in the middle of the night), lasting 5 - 10 minutes each.  Nothing severe or debilitating, but unpleasant now that we has entered summer.  Just unusual, since I am 75.  Not getting worse, not getting better.  Been going on 5 - 6 weeks.  I'm guessing May 10 as the starting date, tho' it could have been sooner.  I did have the usual 100+ temp the next day after the second shot.
About 90 seconds after my technician gave the COVID19 second dose the patient felt dizzy and sat down in the lobby immediately. He began to drip sweat and his hands looked clammy. Patient said his hands were numb. He seemed to be breathing fine and when I asked if he felt tightness in his airway or chest he said no. I observed the patient and called down the street to urgent care to see if they could see him. I did no suspect an allergy so I did not use the epi pen, but I thought it could be an adverse reaction. The patient returned after urgent care and said since it was less then a minutes when it happened the provider thought it was actually a panic attack and not an adverse reaction, but I thought it deserved a report just in case.
After the 2nd injection, within 2 1/2 hours extreme itching at the site of injection and my arm had a red area around the injection  site and slight swelling.   After about 12 hours of receiving the injection I began to experience fever and chills.  I started taking tylenol at that time.  My fever got up to 100.6 the following day even with taking tylenol regularly.  For the next 24 hours I experienced fever, chills, fatigue and a sore arm.  The 2nd day everything  but the sore arm was back to normal and I was able to return to work.    The soreness in my arm lasted for about 5 days gradually getting less and less sore as those days went on.  I had only a mild soreness in my arm after the first dose of vaccine.
This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006040: US-009507513-1709USA006041: US-009507513-1709USA006042: US-009507513-1709USA006043: US-009507513-1709USA006044: US-009507513-1709USA006045: US-009507513-1709USA006057: US-009507513-1709USA006047: US-009507513-1709USA006048: US-009507513-1709USA006049: US-009507513-1709USA006050: US-009507513-1709USA006051: US-009507513-1709USA006052: US-009507513-1709USA006053: US-009507513-1709USA006054: US-009507513-1709USA006055: US-009507513-1709USA006056: US-009507513-1709USA006039: US-009507513-1709USA006038: US-009507513-1709USA006046.
Chest pain, SOB Treated with nitroglycerin, heart catherization, echocardiogram, EKG, anti-inflammatories , Atorvastin and Metoprolol.   Spent night in hospital under observation.  High Troponin levels of 11.01 which decreased over 24 hours .  Patient d/c and will see cardiologist next week.
right arm is sore; Fever; tired; This is a spontaneous report from a contactable Nurse (patient).  An 89-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EM9809, Exp date 30Jun2021) intramuscular at single dose in right upper arm on 11Feb2021 16:24 for Covid-19 immunisation, administered at hospital.  Medical history included ongoing chronic obstructive pulmonary disease (COPD) and ongoing arthritis both diagnosed about 5 or 6 years before, covid-19 and pneumonia in Nov2020 and she was in the hospital from 04Nov2020 to 09Nov2020, she was hard of hearing. There were no concomitant medications. The patient received no prior vaccinations (within 4 weeks), aside the 1st dose of bnt162b2 (BNT162B2, Lot: EL9261, Exp date 31May2021) intramuscular at single dose in right upper arm on 21Jan2021 16:24 for Covid-19 immunisation. No additional vaccines administered on same date of BNT162B2. No events occurred following prior vaccinations. The patient experienced right arm is sore, fever, tired on 12Feb2021. The events were considered medically significant. No event required a visit to Emergency Room or physician. No relevant test done. Course of events as follows: Her arm was sore. Sore arm started on 12Feb2021 morning. She has arthritis and stated maybe this had something to with the soreness in upper right arm, near shoulder, where the vaccine was administered about an inch below her shoulder. Soreness was just there, it hurt. She was very tired and running a temperature of 100.4. She noticed the fever when she got up on 12Feb2021 morning, it was only 99.3 or 99 something, in afternoon it was 100.4. She did not like the fever. She took of paracetamol (TYLENOL 500mg, Lot: 9HV1619, Expiration date May2021) 1000mg twice and it did not really take her fever down. The outcome of events was not recovered.  The reporter considered there was a reasonable possibility that the events right arm is sore, fever, tired were related to the BNT162B2.; Sender's Comments: Based on information available, a acausal relationship between events right arm is sore, fever and tiredness and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
SEIZURE at day service lasting 2-3 minutes, ambulance ride to hospital, much testing, sent home with directions to follow up with neurologist
The patient developed a sore arm in the arm that received the vaccination,  as could be expected,  in the early morning the day following her injection. The symptoms progressed to include a knot at the injection site with intensifying pain in the area. By day 8, she had lost mobility in the affected arm to the point of not being able to lift the arm or perform regular daily activities. When visiting the pharmacy seven weeks after the injection, she asked to talk me concerning her adverse reactions. I questioned her about where the injection was given by the vaccinator and confirmed that it was given in the center area of the left deltoid muscle. I suggested that I felt like she was coincidentally having symptoms from a shoulder injury.  She saw her primary care provider  who suggested she alternate cold and heat to the area with no relief. She then saw an orthopedist on 4/8/21 who performed an exam and performed an X-ray. He told the patient that there had been severe bruising and bleeding in the muscle that had developed a calcification. He referred her back to her primary care provider for further treatment.  After discussing this finding  with the patient, I surmised that the unusual amount of injury and bleeding to the area was due to her taking Eliquis 5 mg  twice daily.
9/18/2020 at 11:15 am Client stated she became nauseated and dizzy. Client reported this to her supervisor. Client went on 9/18/2020 for COVID Testing which was negative. Client stated on 9/20/2020 she went to urgent care because she began  vomiting and had severe vertigo and was given a CT scan and prescribed Meclizine and Zofran. Client had little improvement and visited her doctor 9/23/2020 as she could not return to work. Her doctor prescribed more Zofran and started her on antibiotics which the client noticed she began to notice improvements. Client returned to work on 9/29/2020 still having episodes of dizziness but less than before.
sudden onset over 1-2 days of progressive joint pains-none in shoulders; rx w/NSAID
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M033337 with expiration date of 13-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013210: US-009507513-1703USA014484: US-009507513-1703USA014485: US-009507513-1703USA014486:
child received an expired dose of Daptacel/no AE; 24 months old male patient received a first dose of Daptacel, no AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 24 months old male patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  On 12-Feb-2020, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5366AA, expiry date: 07-Feb-2020) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medical error due to expired vaccine used and inappropriate schedule of vaccine administered as a 24 months old male patient received a first dose (expired dose) of Daptacel.  At the time of this report, no adverse event was reported.   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.
Slight fever, Injection site soreness, moderate bouts of nausea, extreme muscle fatigue, hot/cold flashes, all ended within 24 hours
Started having sever chest pains, numerous trips to doctor and urgent care. Treatmnet and outcome unknown at this time testing in progress.
Patient had the shots on 7/13/05.  On or around July 27, we began to notice bumps appearing on his right knee.  They then began to spread to the other knee.  The next week they were on the back of both knees.  The bumps (or rash) were red and somewhat swollen.  The next week the rash had spread to his arms.  We took him to his pediatrician  on 8/15/05.  She thought it might be eczema and prescribed a hydrocortisone cream.  After a week of treating the areas 2-3 times a day with the cream, the bumps/rash were still there.  I called his doctor again to tell her that they were getting better, but still there.  She then told me that he probably had GIANOTTI CROSTI.  After doing research on the Internet on this infection, I learned that it can occur as a result from MMR vaccines, which he had received approximately 2 weeks before the first symptoms.  I want this information passed on to other parents who might be in the same situation.  This has been a difficult time for us because we did not know if something very serious was happening to him.  This reaction should be added to the informational guides that are handed out to patients/parents before (or after) receiving the vaccines.