chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 27-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
I've been on Nexplanon for more than 2 years after my 3rd baby. I've been amenorrhea since then. I got my Moderna 1st shot in Feb and 2nd shot in March. Starting July, my period came back, heavier than normal and between cycles. There were some months I got periods every other weeks, heavily and stretched for 5 days, . The most current one was on Nov 1-Nov 5 I got my normal period. On Nov 13,  I started bleeding again,  very heavily and still having it today on Nov 15. I went to my PCP to do annual check up and raised my concern but she couldn't find anything abnormal in my lab
illness/I was sick; This is a spontaneous report from contactable consumer. This consumer (patient) reported.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date in Feb2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was ill. The patient received Pfizer first vaccine in February but due to illness not able to received second shot. The reporter wanted to know can I receive second. will it be starting all over again because it's been quite a while since February and now we already into June." There was something, nothing to do with this covid or anything. Patient also wants to know can receive second shot. Will it be starting all over again because it's been quite a while since February and now already into June. The patient was referred Pfizer Medical Information for further guidance. The outcome of the event was unknown.
Pain, swelling, and redness at injection site. Patient was unable to move arm the day after injecton, 2 days post injection, patient is able to move arm slightly more.
In June of 2022, I did an at home test and tested positive for COVID-19. It was either the day of or after, I went to a local clinic and was prescribe Paxlovid.  I took the Paxlovid for five days. I felt better after a day or two of taking the Paxlovid.
Redness and swelling at site of vaccines. Parents used cold compress and Ibuprofen. Redness and swelling improved over 3 days. Area of redness after resolution reported to be about 2 inches.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Severe, Additional Details: patient developed dizziness and nausea while waiting in observation area post vaccination. staff checked patient's blood pressure and heart rate which were both within normal limits. patient instructed to lie down with head resting. after 30 minutes, symptoms subsided and no emergency services necessary.
Adult dose of Engerix-B to a 18 y/o; Adult dose of Engerix-B to a 18 y/o; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 39PZ2, expiry date 7th September 2023) and (batch number L9Y4G, expiry date 5th April 2024) for prophylaxis.   On 13th June 2022, the patient received Engerix B adult. On an unknown date, the dose was an unknown dose. On 13th June 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter reported that, administration of an adult dose of Engerix-B to a 18 y/o patient and a paediatric dose on 26th July 2022.  The patient had not experienced any adverse effects. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, administration of an adult dose of Engerix-B to a 18 y/o patient, which led to overdose and inappropriate age of vaccine administration. There were 2 batch numbers were reported for suspect, so it was not clear if it was given for 1st and 2nd dose, conservatively captured for suspect.
Information has been received from a father regarding his 13 year old daughter who on an unspecified date was vaccinated with a first dose of GARDASIL (dose, route and lot # not reported). The patient's father stated that his daughter had a seizure in the car that lasted for seven or eight seconds. There was no treatment given for the events. There were no laboratories performed. The patient did no seek medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
A day after shot I noticed swelling. Within two days the shot area had sunken in & was painful. I went to my dr. a few days later & he said I had an reaction to a strain in the shot. It destroyed the tissue in my arm & I am in constant pain.
came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; This is a spontaneous report from a contactable pharmacist.     A 69-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation. The patient medical history and concomitant was not reported. Patient previously took Moderna dose 1 and dose 2 for covid 19 immunization. It was Reported that, Caller is a pharmacist who reports a patient (69 years old, female) came in to receive the Pfizer Covid-19 booster dose. Caller reported that the patient received Moderna for the original 2-dose series and is inquiring about additional information regarding this scenario. Pfizer has no information regarding the interchangeability of Covid-19 vaccines, however the CDC released interim considerations regarding interchangeability. Refer to the attached document and states "The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses. Pfizer is independent of these recommendations the patient experienced came in to receive the pfizer covid-19 booster dose/patient received moderna for the original 2-dose series on an, came in to receive the pfizer covid-19 booster dose/patient received moderna for the original 2-dose series on an unspecified date with outcome of unknown.   Follow-up (07Sep2021): This is a follow-up spontaneous report from a pharmacist reported information included.  Follow-up (07Sep2021):This is a follow-up spontaneous report from a pharmacist reported information included
Findings suggestive of multifocal pneumonia/parenchymal disease and/or pulmonary edema, started on IV cefepime and vancomycin. Continued treatment and then discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient came in for the shingles vaccination around 2.30pm, I gave the vaccine around 2.37pm. After the shot was done she went to pick up her medications. she started to feel dizzy after that and sat in the chair. I saw her holding her head, and I rushed to be with her and her body started to tremble a little. I held her upper body and supported her and  asked if she can breath and if she is feeling okay. She could not respond clearly when I told the technicians to call EMS. Meanwhile, patient body started to go limp, there was another customer standing there who helped me hold half of her weight. One of the front store staff helped us moved her body on the floor. She had a seizure for about a minute. We moved her to her side and she vomited twice. She also called patient niece from her cellphone. After her seizure and vomiting, patient became aware of her surrounding after couple of minutes of vomiting. she was breathing heavily, she also had a pulse. she started to respond to our questions and said she is little better. Emergency services teams arrived around 5 minutes after that. they took her blood pressure, pulse and blood glucose levels. They tried to sit her up and she was little dizzy and her blood pressure dropped.  They laid her down on the ground again until the emergency staff brought the stretcher to take her to ER.
shivering; vomiting; couldn't breathe properly it started hurting around her lungs and her head; couldn't breathe properly it started hurting around her lungs and her head; headache; muscle pain; stomach ache; diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO168), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL). The patient experienced stomachache, diarrhea, headache, muscle pain on 06Aug2021, vomiting, shivering, couldn't breathe properly it started hurting around her lungs and her head on an unspecified date. Her daughter went to doctor with patient, and she has received a Covid 19 test to rule out Covid 19 (Did not share data). Consumer did not share if COVID 19 test results are back during this call. The caller got the vaccine on 04Aug2021. On Friday the caller started not feeling well with a stomachache, headache, diarrhea, shivering, muscle pain, and every single side effect mentioned. This lasted for days and yesterday and today she barely started feeling better. Last night the caller couldn't breathe properly it started hurting around her lungs and her head. at the time of report patient went to her doctor and they gave her a urine test and it came back that everything was good. The reporter asked the doctor why she had a stomachache. The reporters doctor asked her if she had a covid test recently. The reporter got the vaccine on 04Aug2021 and started feeling bad after the vaccine. The reporter felt fine before the vaccine. If the reporter already had her vaccine, why are they asking her to take a covid test? If these are side effects from the vaccine, are they going to pass through or how do they work? The patient underwent lab tests and procedures which included urine analysis: negative on 11Aug2021. The reporter was scheduled for her second dose on 25Aug2021. The stomachache was getting better but the food was still not processed properly and the reporter doesn't have her appetite like she used to. The reporters diarrhea was better, she doesn't have it anymore. Description of Product Complaint: The caller's doctor asked her if she had a covid test recently. The caller got the vaccine on 04Aug2021 and started feeling bad after the vaccine. The caller felt fine before the vaccine. If the caller already had her vaccine why are they asking her to take a covid test? Lot EWO168, NDC and expiration date unknown. The outcome of the events stomachache, diarrhea, shivering, vomiting was recovering. The outcome of the events headache, muscle pain was not recovered.  The outcome of couldn't breathe properly it started hurting around her lungs and her head (Dyspnoea) was unknown.   (Follow-up 11Aug2021): This is a follow-up spontaneous report received from a contactable consumer.   Follow-up activities closed. Batch/lot number available.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J012384, exp. date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Heart enlargement causing dizzy and fainting daily. Treatments, rest and stay off get. Still active.
Swollen, redness, and pain of 1 day,  No SOB, No rash, no respiratory difficulty, no signs of distress
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-JAN-2018, 09-APR-2018 and 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported a similar event for two patients. This is the first of two reports. A 16 year-old female patient of an unspecified ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on 01Jun2016. The patient medical history and concomitant medications were not reported. The patient fainted 15 minutes after the vaccination on 01Jun2016. Outcome was unknown.
atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a spontaneous report from a contactable consumer(patient himself). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration, at Right Arm on 24Mar2021 12:30 (at age of 61 years old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Short of breath, atrial fib, fatigue, nausea, discolored, dizziness, unable to function, all on 24Mar2021 14:00. Adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Grandmother called clinic on 7-23-15 at 3 pm to report swelling in right arm and fever in child. Family decided to take child to MD today and was calling to ask what vaccines child received in right arm to inform MD.
A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.; Vial was first punctured and then stored in room temperature for greater than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.) and PRODUCT STORAGE ERROR (Vial was first punctured and then stored in room temperature for greater than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured and then stored in room temperature for greater than 12 hours). On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.) and PRODUCT STORAGE ERROR (Vial was first punctured and then stored in room temperature for greater than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. It was reported that the dose was given past 12 hours post punctured. Number of doses/vials was 1 dose. Vial was initially stored in the refrigerator on 06-Jul-2022 Vial was first punctured on 14-Jul-2022 Vial was stored in the Room temperature post punctured. Vial did not undergo any temperature excursions. Vial was not exposed to room temperature more than 24 hours.
Received TDAP (ADACEL) vaccine 6/24/10 8:30AM. C/O tenderness in left arm & left neck gland that started this morning. Patient also c/o general malaise. Phone call 6/28/10. Patient feeling better. Did not have to go to MD.
Seizure about 7 hours afater vaccine received. Hospital admit, MRI, EEG. No seizure meds at D/C.
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 administered dose of GARDASIL on 13-SEP-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information has been requested.
March 2021 Pain in shoulder (rotator cuff) neck and large muscle in arm swollen and painful; April 2021 Pain in leg and knee - unable to walk
Information has been received from a physician concerning an infant patient, who on an unspecified date was accidentally vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) which was not indicated for patients under two years of age when they were supposed to give PREVNAR 13. Follow up information has been received from the physician concerning a 24 week old (gender unknown) patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). There were no adverse reactions. This is one of several reports received from the same source. Additional information has been requested.
redness on arm from shoulder to elbow initially, then decreasing. Itching started on both arms and chest/face started a few days ago (on date indicated). Rash is not highly visible, but she notices.
Extreme Nausea, Fatigue, Bad taste in mouth and fever chills for 4 full days post vaccine; Extreme Nausea, Fatigue, Bad taste in mouth and fever chills for 4 full days post vaccine; Extreme Nausea, Fatigue, Bad taste in mouth and fever chills for 4 full days post vaccine; Extreme Nausea, Fatigue, Bad taste in mouth and fever chills for 4 full days post vaccine; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 11Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the 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 12Apr2021, the patient experienced extreme nausea, fatigue, bad taste in mouth and fever chills for four full days post vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme nausea, fatigue, bad taste in mouth and fever chills for four full days post vaccine was not  resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
(R) thigh was given MMR and Varicella SQ and after receiving the vaccines, broke out in hives. 11:16 AM. Placed ice to thigh with some relief. Also gave BENADRYL.
Dizziness, high blood pressure 150/80.(usually 110 over 70)