chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; whole body aches; feet burning; fast heart beat; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 10:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19, cholesterol, thalassemia and blood pressure high. Concomitant medications included lisinopril(MANUFACTURER UNKNOWN), omeprazole magnesium (OMEPRAZOLE), atorvastatin (MANUFACTURER UNKNOWN) and vitamins(MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 11:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  On 07Apr2021 at 20:00, the patient experienced chills, whole body aches, feet burning, fast heartbeat, headache  and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the occurred events. The clinical outcome of the event chills, whole body aches, feet burning, fast heartbeat, headache and fatigue was recovered on unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Dad states that they left the office after the vaccine, patient took a nap and then awoke with a nosebleed that lasted 2-3 minutes, he was able to stop it with slight pressure. Dad states that she has never had a nosebleed before. Denies other symptoms or treatments.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date (reported as after an unspecified period of time), the patient "developed a rash". The outcome of the event and the relatedness between the event and VARIVAX were not reported. Additional information is not expected since the physician's contact details were not provided.
Loss of taste and smell; Loss of taste and smell; sinus congestion; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EWO176, Expiration date: unknown), via unspecified route, administered in left arm on 08Jun2021 at 11:20 am (at the age of 21-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccine taken within in 4 weeks. On 08Jun2021, after the vaccination, the patient experienced fever and chills at night and headache in the afternoon. And later, 10Jun2021 patient experienced Loss of taste and smell and Sinus congestion in the evening. She explained she experienced some of the side effects, on her information sheet, but she is also experiencing sinus congestion along with taste and smell loss. She states that it has already been a week and, clarified her fever, chills and headache, only lasted a few days. She asks, why did she lose her taste and smell, in the first place and when will they return to normal and they were not side effects that were included on her information sheet and asked whether are they normal side effects to have. The outcome of the events pyrexia, chills and headache was recovered on 08Jun2021 and sinus congestion and loss of smell and taste was not recovered or resolved.  No follow-up attempts possible. No further information expected.
pain in injection site for days after; chills; nausea; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-OCT-2023, the patient received Shingrix. On 23-OCT-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain in injection site for days after), chills (Verbatim: chills) and nausea (Verbatim: nausea). The outcome of the injection site pain, chills and nausea were not resolved.   It was unknown if the reporter considered the injection site pain, chills and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, chills and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2023 This report was submitted via the online direct entry reporting system. The patient self-reported this case. The patient received Shingrix and had chills, nausea and pain in injection site for days after. The patient did not receive any other products. The reporter asked to specify to pharmacists on how to give this shot. The reporter read online that it made a difference on how it was administered, but he could not find out how it was supposed to be given because he was not a doctor. The symptoms were not treated. The follow-up would not possible as no contact details were available.
Back in Dec before my 1st shot 12/18/20, I donated blood, confirmed my blood was good and sent to the hospital. Then I got my second shot 1/8/21 and a little bit after that I donated blood again (02/05/2021), this time sent a letter that my blood tested positive for Trypanosoma Cruzi and that they can?t use my blood and that I should see my Doc. I went to see my Infectious Disease 4/8/21 Doctor and he did all the tests and they came back negative. He said I didn?t have anything and he thinks it was a reaction from the vaccine that caused the antibodies test to be positive.
01/13/2022: Event occurred after 2nd vaccine. 89-year-old female presented to emergency department with generalized weakness. The patient cannot provide any history of present illness secondary to her dementia. Per EMS, patient lives with someone who has COVID-19. She has gotten progressively weaker. When I discussed the patient with her daughter, she stated the patient's husband has COVID-19. 01/14/2022: Remains hospitalized.
Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid.  The information on the lot/batch number has been requested.  Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/4/2023 ASTHMA, UNSPECIFIED
Severe malaise, myalgias, light headedness, sinus pressure, chills and sweats for 16 hours.
Please see attached. Any questions, pls call individual. The provider identified the issue as a local reaction. Instructed patient to take BENADRYL and to seek a appointment with her personal physician. Call made to occupation health. The office initially stated that there were no available appts till Friday for occupation health. The provider refused to see the patient per someone in office. Pt requested to contact personal physician and to go if able to next available appointment.
A couple of hours post vax, the pt broke out in hives all over and this lasted for 1 week.
Late Tuesday stomach cramps, vomited, sweats along with vomiting. On 10/23/2001 Wednesday sipped water, tea, ate little in the evening and had no problems.
warm to the touch; headache; swelling at and around injection site; rash at and around injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site rash and headache. On 1st December 2022, the patient experienced feeling of warmth. On an unknown date, the outcome of the injection site swelling and injection site rash were recovered/resolved and the outcome of the headache and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site rash, headache and feeling of warmth to be related to Shingrix.     Additional Information: GSK receipt date: 01-DEC-2022 Reporters comment:  The patient received Shingrix vaccine a week prior to the reporting.  The patient experienced swelling and rash at and around the sight of injection and headache. After several days it went away.  Then on the day of reporting I woke, and the rash had returned and feels warm to the touch.  The patient had headache again.
Lots of bruises on my left thigh; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Lots of bruises on my left thigh) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Lots of bruises on my left thigh). At the time of the report, CONTUSION (Lots of bruises on my left thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Oct-2020 and the estimated date of delivery was date. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Ultrasound abdomen: normal 11 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
PATIENT DEVELOPED LUE CELLULITIS 13 DAYS AFTER BEING ADMINSITERED THE PNEUMOCOCCAL VACCINE.  PATIENT GIVEN CEPHALEXIN 500MG TID FOR CELLULITIS.
Patient reports he had chills and headaches the day after his vaccine. He is reporting SOB at rest that worsens on exertion since having had his vaccine. Pt also reports back pain and chest pressure since the day he got his vaccine
This spontaneous report was received from a physician regarding an unspecified number of patients. The patients demographics were unknown. There were no pertinent medical history and drug reaction or allergies of the patients reported. The physician reported that on an unknown date, an unspecified number of patients were vaccinated with second dose of GARDASIL (dose, route, product lot and expiry date was not reported). The second dose in the GARDASIL series were administered seven to eight months after the first dose in the series. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Patient was accidentally stuck with a needle that was used to inject flu vaccine for her father. Patient has reported NO adverse events.
Pt tested COVID positive on 2-5-21, Hospitalized on 2/18/21
Blood count abnormalities. Elevated RBC, hemoglobin, and hematocrit. Bandemia. Repeated twice with similar results.
right eye continues to jump/jerk, sticks when I blink.; runny nose; sneezing; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 at 16:15 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure, obesity, arthritis. Patient had no known allergies. Other vaccine in four weeks was none. Concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT); potassium; simvastatin; metoprolol. Historical Vaccine included BNT162B2 (Lot number: ER8731) on 16Apr2021 at 06:15 pm as dose 1 for COVID-19 immunization and experienced discoloration at injection site. On 09May2021 at 07:30, the patient experienced "right eye continues to jump/jerk, sticks when i blink", runny nose and sneezing. Patient was not covid prior vaccination and not tested for covid post vaccination. Discoloration at injection site after first dose of vaccine that is still there after 3 weeks. No treatment was given for the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Patient reports near syncopal episode post vaccination.  This occurs each time she is vaccinated as she does not enjoy needles or vaccination.  Patient without other issues and signed refusal.
Numbness and prickly feeling throughout arm and hand (Rt) weakness in affected arm and hand. Mild rash around site and on abdomen.
Patient said she took two vaccines and two boosters all from Pfizer and for one of them, she passed out (blanked out); she was scared as it was pretty bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol; LOSARTAN taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Flu shot. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Patient said she took two vaccines and two boosters all from Pfizer and for one of them, she passed out (blanked out)"; NERVOUSNESS (non-serious), outcome "unknown", described as "she was scared as it was pretty bad". Clinical course: Patient said she took two vaccines and two boosters all from Pfizer and for one of them, she passed out (blanked out). About the new Booster shot (Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)), she wanted to know if she will experience passing out again. Patient stated she was scared as it was pretty bad and she did not know if she should get the new Covid booster. She would like to get it as she thought it can help her to avoid hospitalization, but she was scared. She got the flu shot but did not get the new Covid shot (She said she now got the Flu shot but did not get the new booster.). About height and weight: consumer stated, "It is about 5'8 and weight is about 200 pounds. I am trying to reduce."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received vaccine 11-29-13 about 1030 am. About 4 pm (same day) pt had "pain" in right arm and arm felt like it was paralyzed. "Pt applied ice and took two ALEVE. About 4 am (11-30-13) pt felt "a lot better" 11-30-13 Ppt reported adverse reaction. Instructed ice and ALEVE.
This spontaneous report as received from a pharmacy technician refers to a 11 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Woke up 12/6 at 1am. Intense ABD pain. Got ready for work 5am. Intense body aches, ABD pain, nausea. Called off of work. Every day since 12/6, I have had extreme fatigue,  body aches, and bilateral knee pain. I have NEVER had pain in my knees.
I tested positive on June 17th. I had extreme fatigue. I was having kind of flu symptoms which were extreme fatigue, congestion, and cough. I sent my doctor a note online to see if she wanted me to be on PAXLOVID. She did order that right away. I was home for 11 work days not including symptoms. That is because although my other symptoms had gone, I was having extreme fatigue, hot flashes, and nausea. This is my second time with COVID-19. This infection has increased or reactivated my long COVID-19 symptoms.
Initial unsolicited report received from a non-healthcare professional on 24 September 2015. This case involves an elderly male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number U5310CA, expiration date 30 June 2016, dose, route and site of administration was not reported) on 16 September 2015. The patient did not have any known allergies. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced burning rash over stomach and side areas. Lab data and corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none.
just soreness in area of injection for a few days. and very tired for a few days.  on 02/16/21.  Then on 02/16/21  I vomited x2 and experienced back and epigastric discomfort.  i had an ultrasound to r/o gallbladder concerns.   it was negative.   Backpain continued and increased in severity. On 03/02/21 i developed a large shingles outbreak on right outer back.  Started on Valtrex.
Health Center vaccine used Tdap Lot # C3898BA Manuf SP Administered IM dose 0.5 cc single dose vial to RL. Dtap ordered on 19 month old. When balancing MCIR we discovered a Dtap written with a Tdap lot number. We can believe the MA took a Tdap instead of the Dtap due to the lot number she recorded. Attached are the orders for the patient and the MA's documentation on the shot record sheet. We circled it and put a * at each end to show you. MA will have a discipline for this human error and be re-educated and given the inserts for Dtap and Tdap recommendations and age group. She has been with us for over a year now and I believe this to be human error issue since she does know the difference in the vaccines. We contacted RN BS from Immunization Field Rep, Dept of Comm Health. He stated this was considered a valid dose for this child since it was her fourth shot in the series. The patient's parents will be notified. One or more files were uploaded with this submission.
mom states on 3NOV94 p/vax given 2 hr later pt became limp & lethargic taken to ER given suppository; mom unsure of type pt fell asleep when awoke was fine w/no further problems;
I had chills, mild fever, fatigue, diarrhea, and sore throat. On the 19th I started to have pain in back of my right leg. I went to the ER. They did an ultrasound, and blood work. The blood work was evaluated. They did find anything at the time. I went to a vesicular surgeon. They found a DVT. They got me on a blood thinner. I have to go back to see how it is healing.
First redness & swelling, a typical reaction which progressed to multiple bullous lesions >50.  This was in L arm which had DTaP & IPV.