chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects; the patient was administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-MAR-2020, the patient received improperly stored vaccine doses. At 11:08, the patient received an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # S030093 (expiration date 24-MAR-2021), 0.5 mL subcutaneously (SC) on the right arm (RA) and at 11:10, an improperly stored dose of diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX) lot # PP9L5 (expiration date not reported), 0.5 mL intramuscularly (IM) on the RA. Both vaccines were administered for prophylaxis.   It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored between -14 Celsius degrees and -10 Celsius degrees (mainly at -11.2 Celsius degrees) for 3 hours and 42 minutes and a digital data logger was involved; for diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX), no information was reported. No adverse effects were reported.  This was one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2003USA002275: US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008889: US-009507513-2008USA008883: US-009507513-2008USA008890: US-009507513-2008USA008892: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
strong headache focused behind eyes, moderate body aches and chills and fatigue, minor dizziness and nausea, slight cough. All beginning at around 6 pm (9 hours after shot) and ending around 5 pm the next day. Fatigue continues.
It started with general pains and a slight headache. By later in the evening, I was having a really upset stomach. I had a lot of difficulty sleeping. And I really couldn't fall asleep until after 3am. I woke up around 5 in the morning and I had nausea. Even starting around 7pm the night before, I had diarrhea which stopped by 10/11 pm. I had that one bout of nausea, and I was basically just knocked out the rest of the day. I had kind of a sore throat and a little bit of coughing and that was very minimal. No appetite, no desire to eat until the afternoon. I was able to get a good night of sleep after on that Tuesday night. I think it was Tuesday during the day that I called my doctor and she wanted me to have a COVID test and they called back very quickly to come through the drive through. I did that Tuesday afternoon and had the results later in the afternoon which was negative. And I felt a bit better Tuesday night. And by Wednesday I wasn't 100%, but Thursday was better. Friends said there was a really bad stomach virus that was going around. It started off the first day with all the symptoms and it was bad. I hope it's not related to the vaccine but I think I just caught a stomach flu that was really really bad.
my right side Lymphnode is swollen. Also same side as shot; Dose 1 on 05Feb2021 and dose 2 on 31Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Lot number: ER8727) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Pfizer/BioNtech Covid-19 Vaccine details:Dose- 1, Date/Time- 05Feb2021,  Site and Route of injection- left arm, intramuscular, Batch/Lot number- EP9581), administration date: 05Feb2021, when the patient was 38 years old, for covid 19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "my right side Lymphnode is swollen. Also same side as shot". The event "my right side lymphnode is swollen. also same side as shot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information:Patient Age at Time of Vaccination: 38 Years(First dose), 39 Years(Second dose). No relevant medical history.  No follow-up attempts are possible. No further information is expected.
Patient was receiving second dose of moderna. Upon vaccination the nurse administering vaccine stated that the vaccine ?squirted? out of the hub of needle of vanishing point. Nurse stated that most of the vaccine did not get injected. Pharmacist aware and ok to redose per pharmacist Micah. Patient aware and ok.
On 11/27/2021 at approximately 3:43 PM, 66 year old female client arrives to vaccination site requesting Moderna Booster dose.  Client reports completing the 2-dose Moderna series and reports experiencing  "heat" at injection site one day after receiving  the second dose.  Client reports that heat subsided shortly after with rest.  Client denies experiencing itching or any other symptoms at injection site.  Elevated issue to Clinical Supervisor who approves proceeding of client to receive Moderna Booster.  Explained emergency precautions and measures to client who verbalizes understanding.  Moderna Booster administered intramuscularly in left arm at approximately 3:45 pm on 11/27/21 by RN.  Lot # 027H21B.  No symptoms noted or reported during observation period.
On the 27th in the evening at home-I was resting and I started having chest pain. My chest hurt, my left arm went numb, my jaw was tight, my whole body was fatigued and I could not move and it was hard to breath. After getting to the ER we did tests and it showed in my Triphoton levels showed I was having a cardiac event. We did the EKG and Cath and ruled out any blockages. We found that my heart was not working correctly and it was a stress induced cardiomyopathy.
pressure behind ears; Jaw pain; sore throat; fatigue; lightheaded; headache; clammy feeling.; syncopal; This is a spontaneous report from a contactable Nurse. The nurse reported that a 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiration date were UNKNOWN), first dose via an intramuscular route of administration in the right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history includes artificial heart valve, transcatheter aortic valve replacement and penicillin allergy. Concomitant medications included ramipril, carvedilol and acetylsalicylic acid (ASPIRIN). Patient not received other vaccine in four weeks. Other medications in two weeks: ramipril, carvedilol, aspirin. Immediately following the injection. On 26Feb2021 patient had pressure behind ears, jaw pain, sore throat, fatigue, lightheaded, headache, and clammy feeling. Not received any treatment. Patient not had covid prior vaccination; covid not tested post vaccination. patient had the first vaccine and had syncopal in 2021, dizzy, episodes that lasted for 5 weeks. persistent dizziness, almost immediately, and it has lasted for multiple weeks. she did not have throat tightness, cough or shortness of breath. The outcome of the event syncopal was recovered in 2021. For other events outcome was resolved with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect drug.  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.
Patient was hospitalized four days after his vaccination. He is presently still admitted. Treatment is ongoing.
patient came in for a Influenza vaccine and I was told by another CMA was ok to use private stock. Vaccine was a Fluarix for 6months and older. Patient had no reaction did well with vaccine.
No symptoms and no asthma/ findings on exam. Plan to f/u in 7 days/ MOC was advise to call or go to ED if fever, rash or any reactions.
most severe: -headache-sharp and painful off and on -very red hot face along with cold hands -sever joint pain in hips and knees  -loss of feeling in my legs, tried to walk to the bathroom and had a hard time, looked down and my legs were not working right and they were crossed and i was loosing control of them -fever, chills -sharp chest pains -pressure in the chest -shoulder and across the back pain -exhaustion -trouble breathing -nausea -foggy thinking -swollen glands
Mayor constipation; hernia; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Mayor constipation) and HERNIA (hernia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Mayor constipation) and HERNIA (hernia). At the time of the report, CONSTIPATION (Mayor constipation) and HERNIA (hernia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient underwent surgical repair and have catheter.   This case was linked to MOD-2021-032096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 Apr 2021 reported event hernia, surgical repair and having catheter. Added patient email.
J96.00 ACUTE RESPIRATORY FAILURE 4/7/2023 HX OF MENINGIOMA J96.00 ACUTE RESPIRATORY FAILURE 4/7/2023 EPILEPSY, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 4/7/2023 HX OF MENINGIOMA
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 54.69. No concomitant medication was reported by reporter. Batch number 030B21A underwent temperature excursion on 03-Apr-2021with temperature 34 degrees Fahrenheit at 9:00 AM . This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Minor received 1st Moderna vaccinations 2 months before her 18th birthday.  Guardian did not consent to the vaccination.  Department of Health verified with statistical records that the patients DOB which made the vaccine a contraindication.  1st Moderna vaccine given: 01/27/2021   No known adverse reactions noted.
Patient developed a bloody nose within 20-25 minutes of receiving her vaccination. It gradually subsided. We called her pediatrician, who did not advise urgent care or similar. She has never had a bloody nose before to my knowledge.
felt sick; FATIGUE; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (felt sick) and FATIGUE (FATIGUE) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (felt sick) and FATIGUE (FATIGUE). At the time of the report, ILLNESS (felt sick) and FATIGUE (FATIGUE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter  Patient had covid in month of july and December 2020   This case was linked to US-MODERNATX, INC.-MOD-2021-071237 (E2B Linked Report). This case was linked to MOD-2021-071237 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071237:CROSS LINKED TO DOSE 2
Information has been received from a nurse concerning a 13 year old female patient with no pertinent medical history and no known allergies who on 21-MAY-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 661952/1129X). On 27-JUL-2009 the patient was vaccinated with the second dose of GARDASIL (lot number 659054/0315Y). There was no concomitant medication. Subsequently the patient saw white spots and felt dizzy during her softball practice after received the second dose of GARDASIL. The patient called the office. There were no lab studies performed. The patient recovered on 27-JUL-2009. Additional information has been requested.
On 2/17 woke up with 102.3 fever, tongue, lips, eyes swollen, inside mouth/throat irritated, injection site red and swollen, tingling down left arm extreme fatigue. Increased Blood Pressure and Heart rate
Child was given KINRIX, MMR and varicella. Child was still in one room and rash was noted on face and chest with itching. Resolved after BENADRYL was given.
Prior to the covid vaccine, my menstrual cycle was very regular occurring every 28-30 days, and lasting 4 days.  After the vaccine,I  missed a cycle in April.  May menstrual cycle lasted 14 days and was very heavy.  June menstrual cycle lasted 14 days and was very heavy,   July menstrual cycle started very early 9 days after June cycle finished and was very very heavy, it lasted 5 days.     Between June 20 and July 17, I heavily menstruated 19 days of a total of 28 days.  I have never had irregular menstrual cycles, or cycles lasting more than 5 days until I received the covid vaccine.
COVID-19 pneumonia; ARDS; COVID-19 pneumonia; This is a literature report for a Pfizer sponsored program.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "heart failure with reduced ejection fraction" (unspecified if ongoing); "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ocrelizumab, notes: received last dose four months prior. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19 pneumonia"; ACUTE RESPIRATORY DISTRESS SYNDROME (hospitalization, medically significant), outcome "unknown", described as "ARDS". The patient underwent the following laboratory tests and procedures: antibody test: negative result for sars-cov-2 igm spike and cov-2, notes: lgG nucleocapsid. Therapeutic measures were taken as a result of covid-19 pneumonia, acute respiratory distress syndrome.; Sender's Comments: As there is limited information in the case provided, the causal association between the events acute respiratory distress syndrome, vaccination failure and covid-19 pneumonia with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : PFIZER_INC-202200011017 same article/reporter, different patient; PFIZER_INC-202200011018 same article/reporter, different patient
Vasovagal syncope 5 minutes following administration.  Patient blood pressure dropped to 140/44, very pale.  After a few minutes, returned to 140/100.  Normal color returned.  Stated this happened following a tattoo once.
Immunization related shingles dx 12/16/08. Facial shingles Tx : ACYCLOVIR. No prior hx of cpox.
Pt recvd 1st dose of vax w/no noted problem; Pt recvd 2nd dose of vax on 18AUG92 w/in an hr following vax pt exp a sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
Information has been received from a physician concerning a 47 year old male firefighter who in June 2005, August 2005, and December 2005 was vaccinated with the first, second, and third 0.5ml IM doses respectively of Recombivax HB.  Lab titers confirmed that he had not seroconverted and a second series of Recombivax HB on June 2006, July 2006, and December 2006 was initiated.  In May 2007 titers showed he had not seroconverted.  Unspecified medication attention was sought and the patient's recovery status was not recovered.  No product quality complaint reported.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with GARDASIL, intramuscular (lot and dose not reported). Concomitant medication was not reported. On an unknown date, the unspecified patients experienced pain and fainting, when receiving GARDASIL injections. It was also reported that the patients complained that the GARDASIL injection "really hurts" and that less than 1% of the reporter patients experienced fainting, after receiving GARDASIL. No treatment was given. No patients were hospitalized. At the time of the report, action taken regarding therapy with GARDASIL and the outcome of the events was not reported. This is one of two reports from the same source. Additional information has been requested.
Immunizations given 5/24/05. Erythema noticed 5/25/05. Brought to office 5/26 with erythema, swelling and warmth. Started on Augmentin to rule out cellulitis.