chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has been sick since; freezing; temperature of 100°F; chills; muscle aches; joint pain; nauseous; headache; her feet are wobbly when walking; This is a spontaneous report from a contactable consumer (patient). A A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included poor immunization of her lungs and post covid syndrome. Lab test included COVID-19 in December 2020 and temperature of 100°F. The patient's concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine yesterday and she has been sick ever since she received the first vaccine dose and was wondering how long the symptoms would last. Patient stated that she felt as if she had COVID-19 all over again. Patient also stated that she has been freezing, temperature of 100°F with Tylenol, chills, muscle aches and joint pain, nauseous, headache and her feet were wobbly when walking. Patient would like to know if these are possible side effects from the vaccine and what should she do about them and since she is having these side effects with the first dose will she have the same side effects with the second dose. She received two doses of the convalescent antibodies and Remdesivir. She also had post-Covid syndrome so she was afraid of how the side effects with the first and second dose will affect her. She was instructed by her physician that she should receive a covid vaccine since she may have a lower response to the vaccine so she doesn't want to be enduring these symptoms for nothing. Patient would like to know if it is necessary for her to receive the second dose to which the response was "she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
swelling in brain; tinnitus; pressure in her right ear; feeling a burning sensation that traveled from the injection site to the back of her neck and then to the other side to her other arm in same location then down her spine and top of her head; feeling a burning sensation that traveled from the injection site to the back of her neck and then to the other side to her other arm in same location then down her spine and top of her head; This is spontaneous report from a contactable consumer (the patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 15Apr2021 as a single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller states she would like to know if the reactions she experienced with the first dose of the Pfizer COVID vaccine are considered an allergic reaction and if she should receive the second dose. Caller states she received the first dose on 15Apr2021 and her side effects persisted until 21Apr2021. Caller states within the first fifteen minutes after the vaccine she started feeling a burning sensation that traveled from the injection site to the back of her neck and then to the other side to her other arm in same location then down her spine and top of her head. Caller states she also experienced pressure with the burning. Caller states the burning sensation persisted mostly behind her neck and top of her head. Caller states she felt like she had some swelling in brain because she also had tinnitus and pressure in the right ear. Caller describes this as almost how you feel when you have an ear infection and it felt uncomfortable. On 21Apr2021, all the event was recovered. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Caller states the Medical Information line should be able to give medical advice regarding whether or not a reaction is considered an allergic reaction or not.  Information about lot/batch number has been requested.
Approx. 2-3 hours after vaccinated, pt complained of arm hurting and was given Tylenol and cold compresses applied to arm. In the morning, on 8/15/02, arm still painful and deltoid swollen to 2 X size of other arm.
No adverse effects have occurred.  Individual is currently in a skilled nursing facility.  He was admitted on 1/27/21 and received the first dose of the COVID-19 vaccine on 1/27/21.  An error occurred as staff administered a Mantoux injection on 2/9/21.  No adverse effects have been noted.
ONE WEEK AFTER VACCINATION, FEVER OF 103.4, NEXT DAY FEVER CONTINUED AT 102.7, THEN CHILLS BEGAN.  FEVER HAS CONTINUED ALONG WITH LISTNESSNESS, CHILLS, SHIVERING, HIVES, LACK OF RESPONSE TO STIMULATION, DIZZINESS, LOST COLOR IN FACE - LIPS TURNED BLUE/PURPLE.  WE HAVE BEEN IN AND OUT OF THE EMERGENCY ROOM FOR DAYS WITH EXTREME CHILLS, HIGH FEVERS,
Patients vaccine record from her home country was incorrectly read as far as how many vaccines she already had in this series. No signs or symptoms of a physiological or physical reaction noted
pt recv vax & pt exp undetectable antibody levels;MD noted that the vaccine was obtained in England & given in Egypt;
Felt short of breath, dizzy, weak, nauseated, profuse sweating, muscle pain, double vision that continued until 8/24/15. Vomited once on 8/24.  Noticed rash-like area around injection site that was red, swollen and warm to touch on 8/24 that disappeared in 2 hours.
H9PV (Gardasil) and Men B (Bexerso) administered IM without difficulty while patient was seated in chair.  After administration, patient fainted and fell from chair, hitting left side of head on floor. Patient immediately placed in Trendelenburg position with legs elevated.   Vital signs monitored x 30 minutes and remained WNL throughout.  Mother present during visit.  Patient returned to sitting position, vital signs remained stable, alert and oriented x 3, talking and sipped on soft drink.  Patient stated that he has a history of fainting after vaccine administration as small child while living in custody of grandparents.  Mother was unaware of that history.  Patient left clinic ambulatory with steady gait accompanied by mother and grandfather.  Phone call to mother this morning.  Patient had uneventful evening, no difficulty sleeping, eating, concentrating, and denies any pain. Patient sent to school this morning without issue.
Redness, itchy and scaling rash on face only. She took Allegra every day since the reaction and states that rash is getting better.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   In MAR-2023, the patient received Bexsero. In MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used 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 Information: GSK receipt date: 09-Mar-2023 The healthcare processional called to receive a fax with medical information about maladministration of Bexsero after the Expiration Date, however she mentioned that a patient received a Bexsero 7 days a week later after the expiration date of vaccine. The healthcare processional does not want to provide any DOB information.  The reporter stated that was calling and provided only her first name and fax number (information sent by email to Safety Team).  The reporter did not consent to follow up.  The permission for a follow up was not requested due she said that she was looking for information only and not reporting anything. The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Rash on lower legs, mostly in front on shins. Diagnosed by dermatologist as guttate psoriasis possibly due to the COVID vaccine
Patient received the MMR and Varicella vaccine too early as documentation of the MMRV given on 4/23/21 was not available from Office of previous vaccination at the time of the visit. No adverse event occurred.
Febrile seizure lasting 45 seconds. EMS activated and when arrived temp 103.1. CXR negative, Flu A/B negative, glucose 139.
Narrative: Patient with no known past medical history, received 1st dose of Pfizer Covid vaccine on 10/20/21 and awoke on 10/21/21 with acute RUE and RLE weakness and facial droop, MRI confirmed acute lacunar stroke.
3-12-12 dx with chickenpox. Vesicle lesion w/ crust and mostly already drying out.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 11-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
About 10 minutes after the vaccine was administered, patient complained of dizziness and not ?feeling good?. She was sitting in a chair. She was immediately helped to lay on the floor, made to lay down and feet kept elevated. Vitals were BP 142/85, Pulse 102, oxygen sat 99% RA. Accucheck was 137. Code was activated. She became unresponsive 2 times briefly and needed woken up, Patient moved to ER 20minutes after the vaccine was given.
Severe Chills and muscle aches and fever of 100.5 prior to taking ibuprofen, arm soreness.  Also took Tylenol.  Severe night sweats.  Woke with a 99 fever and some muscle aches, but not as severe.  5th year taking this shot and never had an adverse reaction in the past.
body aches; tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021 at 15:00, after 14.5 hours of vaccination, the patient experienced body aches and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events body aches and tiredness were recovered on an unknown date in Mar2021 at the time of this report.   No follow-up attempts are needed. No further information is expected
Systemic: Body Aches Generalized-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe
Pt recv vax on 6/24/98; on 6/26/98 pt exp high temperature of 104.7
Arm soreness, headache, fatigue, low grade fever on day one. On day two or three patient experienced nose bleed. Nose bleed occurred once, was stopped with tissue. No profuse bleeding or clots observed by patient. Endorses intermittent chest pain and cloudy vision since vaccination.
Chills, shaking, severe headache,  Next day - sore all over and diarrhea. 3rd day -still a little sore and ocassional diarrhea
sore arm; sleepy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (sleepy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (sleepy). On 29-Jan-2021, PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-022538 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Updated reporter and patient info. Dr listed in Initial SD is not primary reporter or husband; Sender's Comments:  MOD-2021-022538:cross linked to "patient 2" (husband)
This is a spontaneous report from a contactable physician via Pfizer Sales representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced felt weird on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Rash 9 days after vaccines. Had MMR, Varicella on 03.08.13.
Within one hour of vaccination, my arm  begin to swell around injection site and very painful. Ran a fever that night over 102f, next day swelling was even worse, treated with ice packs and Advil. The area started itching and treated with topical hydrocortisone. By third day swelling turned to a hard knot under injection site with extreme redness and tenderness. Continue to run fever off and on with extreme itching and continuing to treat with cold packs and Tylenol for fevers.  Have felt very weak through this and had nausea but no vomiting.  Still have the redness, itching, hard knot/nodule , weak feeling and  had low grade fever this morning.
Chills, fever 102., nauseous, aches, dehydrated, exhausted, very sore arm.
16 year old patient was administered Moderna Covid-19 vaccine which is below age authorized by Emergency Use Authorization
no adverse event; For doses administered past the expiration/beyond-use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (For doses administered past the expiration/beyond-use date).    No concomitant medications was reported. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712878 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712878:Same reporter US-MODERNATX, INC.-MOD-2023-712882:Same reporter
pt recvd vax 15MAR95 & 27MAR95 fever 103.9, eye white red, yellow & mattered eye;same MD did not improve w/ATB;adm to hosp fever went down a/admission to hosp put on IV ATB-Ceftin;mom states dx preseptal periorbital cellulitis d/t immun
Headache; Fatigue; Fever 101.5°F; Fever 99.7°F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever 101.5°F) and PYREXIA (Fever 99.7°F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MLS319813) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever 101.5°F) and PYREXIA (Fever 99.7°F). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever 101.5°F) and PYREXIA (Fever 99.7°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Pyrexia: 101.5 (abnormal) 98.7° F to 101.5°Fand back to 99.7°F..         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-229294 (Patient Link).
I was informed that a child age 13 was given a pediatric dose. The child was screened prior to reaching me. The screener informed me that the child met criteria for pediatric dose.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (lot numbers: M004542, Expiry date: 18-OCT-2017; lot numbers: M004726, Expiry date: 19-OCT-2017; lot numbers: L033545, Expiry date: 30-MAY-2017; lot numbers: L039141, Expiry date: 16-AUG-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. This case is linked to case number 1610USA010371, 1610USA012625, 1610USA012626 and 1610USA012627 via same reporter link. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 08-MAY-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at medical department for a blistering vesicular outbreak which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
5-10 minutes after the vaccine was given, pt became lightheaded and had severe spasms in her back and radiating down legs. She needed support to walk. Spasms were gone within 15 minutes but pt's blood pressure was elevated. Pt went to her primary care physician who believes the spasms were a result of being nervous. She will be rechecked for blood pressure elevation in 5 days.
I was extra tired; I was woken up and violently throwing up; This is a spontaneous report from a contactable other HCP (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 intramuscular, administered in arm left on 15Jan2021 at 12:00 as 1st dose, single for COVID-19 immunization. Medical history included allergic to sulfa. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included sertraline 10 mg received within 2 weeks of COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not undergo COVID test post vaccination. On 15Jan2021, the patient was vaccinated at noon and was fine the rest of the day into 16Jan2021. On 16Jan2021, late night/17Jan2021 early morning at 01:00 approximately, the patient woken up and violently throwing up. It lasted about 20 minutes and then it was over. The next day, the patient was extra tired. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was recovered.  Information on the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient called on 9/2 to state he had a red patch on his chest develop around the front and to the back under the arm that received the shot, no itching, hives or pain. He stated as of 1pm it seemed to get better.
This case was reported by a healthcare professional and described the occurrence of burning sensation injection site in an adult female subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. The subject's medical history included seasonal allergy. Concurrent medications included Depo provera. On an unspecified date before 03 May 2006, the subject received a dose of Engerix-B in the left arm (dose number and lot number not provided). Less than one day after vaccination with Engerix-B, the subject experienced burning sensation injection site. The event resolved after "about one minute." The healthcare professional considered the event was probably related to vaccination with Engerix-B.
Papular rash after PCV 13 on arms legs in clusters. No other etiology - lasted 2 days - pruritis.