chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rnning temperature below normal 95-97F.; she tested positive for COVID-19 on 20Nov2021; drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Rnning temperature below normal 95-97F.), COVID-19 (she tested positive for COVID-19 on 20Nov2021) and DRUG INEFFECTIVE (drug ineffective) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced BODY TEMPERATURE DECREASED (Rnning temperature below normal 95-97F.) and COVID-19 (she tested positive for COVID-19 on 20Nov2021). 20-Nov-2021, the patient experienced DRUG INEFFECTIVE (drug ineffective). On 20-Nov-2021, DRUG INEFFECTIVE (drug ineffective) had resolved. At the time of the report, BODY TEMPERATURE DECREASED (Rnning temperature below normal 95-97F.) and COVID-19 (she tested positive for COVID-19 on 20Nov2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 95-97 f (Low) running temperature below normal 95-97F.. On 20-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a 75-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of COVID-19. Drug ineffective was also captured as an event. Event of COVID-19 occurred approximately 12 days after receiving a booster dose of mRNA-1273. This was the third dose administered of mRNA-1273. The first two doses were administered in an appropriate schedule of vaccination, approximately 9 months and 12 days prior to the occurrence of the reported event. Patient has experienced cough, headache, and rhinorrhea. It is not mentioned if the patient received treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-266851 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of COVID-19. Drug ineffective was also captured as an event. Event of COVID-19 occurred approximately 12 days after receiving a booster dose of mRNA-1273. This was the third dose administered of mRNA-1273. The first two doses were administered in an appropriate schedule of vaccination, approximately 9 months and 12 days prior to the occurrence of the reported event. Patient has experienced cough, headache, and rhinorrhea. It is not mentioned if the patient received treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Arms ,legs, and back area  developed  small maculopapular rash approximately 5-6 days after administration of vaccines. Patient went to his PCP and received a steroid shot and steroid ointment to which the rash responded pretty well, but has not completly cleared.
Child received influenza vaccine at school clinic. When entering form in the registry, found that child had received his shots 2 days prior at his pediatrician's office. Spoke with child's mother and child is fine.
Within 30 secs to 1 minute following vaccination patient started to seize. He came out of the seizure quickly (approx 20-30 sec). EMS was called and on site in minutes. Patient was breathing on his own but breathing was rapid. He lost color in his face/lips. When EMS arrived they noted that he was hypotensive and bradycardic. He began to regain color while EMS was on site. They opted to take him in for further evaluation.   No history of seizures.
NO ADVERSE EVENT...PATIENT REPORTED HAVING HAD COVID-19 VACCINE 12/18/20 (PFIZER) AND HAD COVID-19 BEFORE RECEIVING 2ND DOSE.  WE GAVE A DOSE OF MODERNA ON 6/8/21 AND WERE TOLD BY HEALTH DEPT THAT PATIENT SHOULD BE CONSIDERED FULLY VACCINATED BUT NEEDED A VAERS REPORT DONE
03/04/21 Pain, itching, redness around injection site with redness at injection site. 03/04/21 Started Acetaminophen, ice for swelling.  Redness 1X2 inches 03/05/21 Continued treatment with Acetaminophen, and included Aller-Fex 24hr pill.  Increased redness and pain headache redness 2X3 inches 03/06/21  Continued treatment Redness now at 3X2.5 inches. 03/07/21  Continued treatment Redness now at 4X2.5 inches. 03/08/21 Continued treatment Redness subsiding, still hard center mild pain, and itching.  Under control.
4 yr old WF has erythematous, swollen, tender Lt deltoid area after receiving DTaP and IPV on 8/22/02. Treated with Cefzil.
04/04/2021 -  Assessed at start of shift. Family at bedside and aware of condition. Left after assessment. Unable to arouse. BP 97/64 P 71 R 30 and shallow 02 sat 80% with 02 per NC in place at 2 LPM. Afebrile at 97.7. MS given at this time. Upon entering room at 2245 Pulse faint and R very shallow at 4. Resp. and pulse ceased at 2300.
no adverse event; She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.) and NO ADVERSE EVENT (no adverse event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 22-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (She states that a patient was supposed to receive 0.5 ml, but only got 0.25 ml.).    No concomitant medications were reported.    The reporter stated that a patient was supposed to receive 0.5 ml as initial booster, but only got 0.25 ml. HCP asked if the recommendation was considered 24 hours or on the same day because the patient got the half dose yesterday 22-Feb2-023. HCP asked if she should give a full dose today 23-Feb-2023.   No treatment medications were reported.
Had a sore arm immediately after the shot.  didn't think much of it, of course, I just had a shot.  I was already on some prednisone for Gout from the first shot, After this shot, the Gout really kicked up even higher, so my Dr. increased the steroid, pain in arm/shoulder was there, but again, just thought was normal shot kind of thing.  (saw dr. a week after shot for Gout pain increase). Pain in arm stayed steady, now pain is just worse and worse each day, and it's been well over a month, so I know this is NOT normal.  I went to Dr. on 4/26.  He was unfamiliar with SIRVA.  He said see how it goes, and we can do a shot in the arm (I'm AFRAID Of a SHOT in the ARM) , an MRI, to see what is happening.  We decided to give another week.  Well, this week was HORRIBLE!  I cannot sleep, the pain at night is unbearable, and taking aleve, tylenol, etc do nothing.  The pain during the day is getting more each day, I've been doing  exercises I've found online with no relief.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Medium
Fast heart beat; lightheadedness; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (Fast heart beat) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent insertion NOS (Patient had a stent inserted in him 9 months ago.) in May 2020. Concomitant products included TICAGRELOR (BRILINTA) from 12-May-2020 to an unknown date and ACETYLSALICYLIC ACID (ASPRIN) from 12-May-2020 to an unknown date for Anticoagulant therapy, PRAVASTATIN from 12-Sep-2014 to an unknown date for Cholesterol, METFORMIN from 12-Jan-2008 to an unknown date for Diabetes, ALLOPURINOL from 12-Mar-1999 to an unknown date for Gout.   On 30-Dec-2020 at 5:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced DIZZINESS (lightheadedness) and DYSPNOEA (Shortness of breath). On 04-Jan-2021 at 5:00 PM, the patient experienced ARRHYTHMIA (Fast heart beat) (seriousness criterion medically significant). On 05-Jan-2021, ARRHYTHMIA (Fast heart beat) had resolved. At the time of the report, DIZZINESS (lightheadedness) and DYSPNOEA (Shortness of breath) outcome was unknown.            On 02/25/21, patient visited his cardiologist who suggested that he should have a LINQ monitor (ILR) implant proceedure performed to record his heart beat function to mitigate a stroke risk. On 03/23/21 his cardiologist performed his LINQ monitor implant.  Patient have had only two episodes. Both occurred in a similar period after each Moderna covid vaccine. Patient have not had such physical experience before the vaccines and since. In the absence of any other circumstances (mitigating or otherwise) he believe that those two episodes were most likely a reaction to the vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-025272.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Upgrading from NS to Serious. Dizziness and shortness of breadth, events were added. Event Tachycardia coding was changed too Arrhythmia. On 30-Apr-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field. On 02-Jun-2021: Reporter needs clarification on having two cases for two doses, believes they are duplicates On 02-Jun-2021: Non Significant Follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a medical assistant concerning a 15 years old female who on 10-JUN-2009 was vaccinated intramuscular administration in arm with the first dose of GARDASIL (661952/1129X). Concomitant therapy included (VARIVAX) and unspecified hepatitis A virus vaccine. On 10-JUN-2009 the patient fainted and experiencing jerking movements after receiving her first dose of GARDASIL. The patient had sought unspecified medical attention. At the time of the report, the patient had recovered on 10-JUN-2009. Additional information has been requested.
Information has been received from a nurse concerning a 53 year old female who on 08-DEC-2000 was vaccinated with a 0.5 ml first dose of PNEUMOVAX 23. On 08-DEC-2000 the patient experienced anaphylactic reaction immediately after receiving PNEUMOVAX 23. She was admitted to the hospital and hospitalized for two days on 08-DEC-2000 and 09-DEC-2000. Subsequently, the patient recovered from the anaphylactic reaction. The reporting nurse considered anaphylactic reaction to be immediately life-threatening. Additional information has been requested.
My daughter was given the Pfizer vaccine on May 17, 2021 and started her period early on May 21, 2021. Her period came on super heavy on the 21st, bleeding through everything to the point where I went to the store to get her DEPENDS to wear at night because she was bleeding through everything. We ended up at the urgent care on Sunday May 23, 2021 and she saw her own primary care doctor who thought it might just be her body trying to regulate her cycles so she put her on birth control pills. She started  them immediately. She told us the pill would help lighten up her bleeding. It DID NOT!  She continued to bleed heavily all week. A week later we were back on a call with a different doctor on Sunday, May 30, 2021. She just told us the same thing that it's probably her body just regulating her cycle. The concern I have is that both doctor's use of the word "PROBABLY". It has not set well with myself or my husband. When all was said and done, the doctor upped her a regime of 3 birth control pills a day with a gradual move to 2 a day and then a hope to going back to 1 a day. THIS DID NOT WORK EITHER!!  My daughter bled a total of 50 DAYS  from May 21, 2021 - July 16, 2021, with a few days here and there when the bleeding stopped and then came back with a vengeance.
Case number PHEH2014US024977, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 63-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 17 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion.
Headache and slight dizziness within the first 15 minutes. Around 7pm started feeling nauseated while still feeling dizzy and having a headache. Next day felt extremely tired and worn out all day. Saturday-woke up feeling fine but around 1pm started getting a headache and dizziness again that lasted through the night. Sunday-woke up feeling a little tired and about 2pm started feeling nauseated  and dizzy again. Slight headache around 4.
Late January or early February the patient received a chemical burn to her hair. She saw her physician, who gave her a tetanus and varicella vaccine, plus two antibiotics. Four weeks later the patient developed shingles on her scalp. The patient presently has a hair follicle infection and has not recovered.
Rash; Severe reaction of Erythema Multiforme; This is a spontaneous report from a contactable physician. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was in urgent care, had a severe reaction of Erythema Multiforme on Mar2021 from the Pfizer covid vaccine, after the first dose. Patient was negative for covid infection, reporter believes his reaction is due to covid vaccine. Patient visited urgent care on 12Mar2021 with a rash. He was prescribed Prednisone. He returned the following day with was described as erythema multiforme, which doctor believes was due to the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded assuming a plausible temporal association . The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Hives and a rash on my arms, legs, feet, torso, and face. Very itchy.  Rash still present 3 days after onset but is helped by antihistamine medication.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 9:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 9:28 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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.   Age of patient was reported as 20.50 for dose administered on 22-Jun-2021.  No concomitant medications were reported.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 22-Jun-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period 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 using a  traceable temperature monitor at every hour.  No treatment medications were reported.
Swelling of left upper arm, redness of skin 7 cm in diameter , some itchy of skin. No difficulty breathing or swallowing. No swelling of face , mouth or tongue. Also has red ears and throat. Gave pediazole , ibupofen and benadryl
woke up with Mild chills; body aches for 12 hours; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  lot number: EH9899, via intramuscular on 06Jan2021 at 07:30 (at the age of 54 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included enlarged prostate from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tamsulosin, Vitamin D-3, Vitamin C, and montelukast sodium (SINGULAIR), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2 with lot number: EH9899 on 16Dec2020 at 16:30, intramuscular in left arm. The vaccine was given at a hospital. On 07Jan2021 at 06:00, the patient woke up with mild chills, and body aches for 12 hours. The patient did not receive treatment for the events. The clinical outcome of mild chills, and body aches for 12 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pt was seen at ER approximately 48 hrs after getting vaccines with fever 103.4. Parents also noticed infant "shaking." Was hospitalized at hospital. Medical Records received on 10/09/2003 states bacteremia and vaccine reaction.
A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.).    No concomitant medications were provided. No treatment medications were provided.
Headache; site soreness; site swelling; nausea; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: eR8727) via an unspecified route of administration in the arm right on 30Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, site soreness, site swelling, nausea and tiredness. The patient did not receive any treatment for the events. The clinical outcome of the events headache, vaccination site pain, vaccination site swelling, nausea and fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.