chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; High fever; Nausea; This is a spontaneous report received a contactable consumer (patient himself). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not provided) as single dose for COVID-19 immunisation. Medical history included COVID from 2020 to 2020 (Previously had COVID last year). The patient's concomitant medications were not reported. The patient took the first dose of the covid vaccine on Saturday. The patient had reactions of high fever, some nausea, and headaches on an unspecified date in Feb2021 and then that passed. He declined to complete a report. The patient underwent lab tests and procedures which included body temperature: high on Feb2021. Outcome of events was recovering.  Information on the lot/batch number has been requested.
PERICARDITIS; This spontaneous report was received from literature: Myocarditis and Pericarditis After Vaccination for COVID-19. 2021 Aug 04. This report concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced pericarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210809585-COVID-19 VACCINE AD26.COV2.S-pericarditis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
25yo healthy patient who received typhoid vaccine 18 JUL 2016 lot # K17061 and developed anorexia and abdominal pain2 days later and at day 5 fine papular dermatitis to arms which continued through when seen on day 16. The lesions were fine, papular, but no vesicles, pustules or macules. The involved areas are limited to arms, does not involve palms or extensor surfaces, and she denies oral lesions or any other sites including back, torso, legs or skin folds. She self treated with OTC topical hydrocortisone cream and has one dose of cetirizine, neither which helped. She states she had not immediate adverse effects such as hive, oral face or throat swelling. She reports local site pain at the injection site for 2 days but no erythema or edema. She denies fever, chills, headache, chest pain, myalgias or arthralgia's. Treatment triamcinolone, oral ZYRTEC. Patient did not respond to followup contact attempts.
no adverse event; administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a practice manager referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.  On 10-MAR-2020, the patient was inadvertently vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021322, expiry date: 09-JUL-2021 for prophylaxis (strength, dose number, anatomical location, route was not reported) (product storage error). It was reported that the vaccine was exposed to a temperature of -8.3 degree Celsius for a time frame of 24 minutes. There was no previous temperature excursion reported. Data logger was involved. The vaccine was reconstituted with properly stored sterile diluent. No adverse events were reported. No product quality complaint was involved.
This spontaneous report as received from a pharmacist via Pfizer refers to a female patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in December 2017, the patient was vaccinated with PNEUMOVAX23 (dosing details were not reported) for prophylaxis. On an unknown date in December 2017 (a week after injection) the patient experienced nerve pain (neuropathy). The outcome of neuropathy peripheral was reported as recovered/resolved completely. The pharmacist (the reporter) believed that this reaction was to something else (captured as not related), but the patient felt it was from the vaccination.
Case of shingles; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. 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 08Apr2021, the patient experienced a case of shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event shingles and included treatment with Antiviral. The clinical outcome of the event shingles was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse reaction. Client had been given two doses of pediatric Hep A in 2011 and 2013 and was given an adult dose of Hepatitis A on 12/12/2017.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 49-year-old female patient who experienced uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it is in her hairline and her hands, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included allergy with Sulfa. The patient's concomitant medication included Tri-Lo-Mariza 25mcg daily. The patient's family history was not provided. Notes: Received the flu shot previous three years without developing the current symptoms she is experiencing. On 01-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI997AA, expiry date 30 Jun 2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it was in her hairline and her hands (urticaria) less than 48 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient denied any pain, redness or swelling at injection site. Nurse may be sending the employee to the Emergency room for evaluation and possible treatment of presenting symptoms. Lab data was not provided. Final diagnosis was uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it is in her hairline and her hands. The patient was treated with BENADRYL, however symptoms persist and continue to worsen. The patient outcome was reported as Not Recovered / Not Resolved on an unknown date for uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it is in her hairline and her hands. List of documents held by sender- none.
devel temp to 104.9 & several hr post vax persistent for 48hr;extremely irritable & uncontrollable post vax;
Vaccine dose 1 given in left deltoid at approx. 3:10 pm 1/28/21. No symptoms until 10:00 am 1/29/21. Symptoms include dizziness and nausea, left arm soreness near injection site, no redness or swelling.
Chills; body aches; nausea; dizziness; cold fingertips; headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 14:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy in 2001 and allergy to antibiotics; both from unknown dates. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and levothyroxine sodium (SYNTHROID 112mg); both for unspecified indication from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Unknown) via an unspecified route of administration in the right arm on 07Mar2021 at 15:15 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021, the patient experienced chills, body aches, nausea, dizziness, cold fingertips and headache. 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 treatment for the reported events. The clinical outcome of the chills, body aches, nausea, dizziness, cold fingertips and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Nurse drew up one dose of Pfizer vaccine before diluent added, and administered all 6 doses to patient instead of one dose. Patient was informed and will watch for adverse reactions.  We are reporting the vaccine administration error, as required in the CDC guidance on vaccine administration errors.
Initial report received from a health care professional on 08 June 2011. A 23-year-old male patient, with medical history not reported, received an injection (route and site not reported) of MENACTRA, sanofi pasteur lot number not reported, in July 2005. On 27 May 2011, the patient was admitted to the hospital and subsequently diagnosed with meningitis. The strain or the serogroup has not yet been identified. The strain was a strain of N. meningitidis. The patient did survive and has not suffered any amputations nor loss of limb due to this event. The patient was currently being rehabilitated. The outcome was reported as not recovered. Documents held by sender: None.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 35-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 08-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly. Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus. Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date. No adverse reactions were identified.
Once injected my entire arm burned, it became splotchy, my hands and fingers swelled up, went cold, tingled and felt like pins and needles. This lasted about 14 hours. Shortly after it was administered, at the injection site, my muscle was hypertonic and swollen with severe pain extending down from my shoulder to fingers that lasted a week and a half. I couldn't move my arm because of the pain and it was extremely sensitive to touch. I had a running fever of 101-102 for 3 days. Severe neck and back pain, fatigued, nausea, loss of appetite, head ache, sinus pain. These symptoms lasted about 2 weeks after the injection. I still have lingering back pain after 7+ weeks.  I was diagnosed with Covid-19 November 2020 and was extremely sick and bedridden for over a month with lingering lung complications to this day.
3:00PM- rapid heart beat, shortness of breath, RR 26, Pulse 110. Resolved within five minutes. 3:20pm- Patient complained of shortness of breath, RR20, pulse 88, EMS activated, recipient refused EMS care and transport.
Pt reported red, swollen, extremely painful arm x3 day. Pts states "arm swelled up twice the size of normal". BENADRYL and compresses given.
This spontaneous report was received from a healthcare professional (Nurse practitioner) via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 injection, via intramuscular route for prophylaxis (strength, dose, frequency, lot number, expiry date unspecified). On an unknown date, the patient left her GARDASIL 9 at home in room temperature for about 2 weeks before having the vaccine injected. The office staff were not aware of improper storage of vaccine at the time of injection. No adverse effect reported. No product quality complaint (PQC) was involved. No additional adverse event (AE) information provided. The patient did not discontinue the therapy. The outcome of product storage error and no adverse event was unknown.
VOMITING; NAUSEA; FEVER; HEADACHE; MUSCLE ACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 10:45 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021 01:00, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, fever, headache, muscle ache and fatigue was not reported. This report was non-serious.
rash appearing 3 days p/vax;red raised rash on forehead, neck, abd & back;called 22MAR99 rash has gone away yesterday lasted only 2 days;states MD didn't need to see, because did not have a temp w/it;
Guillain Barre Syndrome. Feet paralyzed next day after vaccination. Had been in and out hospital few times during past 2 mths. Symptoms come and go.
rash developed 1 day after receiving vaccine. Fatigue and headache. rash begin to spread, red, inflammed and itchy.
Approximately 4 hours after shots had episode of inconsolable crying for about 3 hours. Seen at Peds Urgent Care.
74-year-old with past medical history of multiple sclerosis presented to the ER care of 4 days of not eating and generalised weakness , body aches . Patient tested positive focal with in the emergency room and is being admitted for further treatment monitoring infectious disease evaluation
I miscarried; bleeding really bad the 3 day.; Starting cramping the night if my second vaccine.; This is a spontaneous report from a contactable other HCP (the patient). A 39-year-old female patient received the second dose of  BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, on 10Apr2021 at 15:30 (at the age of 39-years-old)  as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported.  The patient did not have COVID-19 prior to the vaccination. The patient had not received any other vaccines within four weeks prior to the vaccination. Historical vaccinations included the first dose of  bnt162b2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 20Mar2021 at 15:45 (at the age of 39 years old) as a single dose in the right arm. The patient previously took celecoxib (CELEXA) and experienced drug hypersensitivity and morphine and experienced drug hypersensitivity. The patient's last menstrual period was 16Feb2021. She reported that she became pregnant while taking bnt162b2.  The patient was due to deliver on 23Nov2021.  She stated that she was 8 weeks pregnant at the onset of the following reported events: The patient experienced "started  cramping" the night of her second vaccine on 10 Apr2021 and the cramping lasted for two days with outcome of recovering,  she started bleeding really bad the third day on 13Apr2021 with outcome of recovering and she reports that she miscarried  on 13Apr2021 with outcome of recovering. The patient commented further that she mscarried right after her doctor confirmed her pregnancy was healthy and her  baby had heartbeat the day before her second vaccine. The patient has not been tested for COVID-19 since vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient was fully vaccinated with Pfizer covid 19 vaccine. She received doses on 01/28/2021 and 02/20/2021. She subsequently was infected with Covid 19. Her symptoms started on 8/13/2021. She visited MinuteClinic and tested positive for Covid 19 on 8/15/2021. Health outcome is unknown.
off and on diarrhea; nausea; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (off and on diarrhea) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (off and on diarrhea) and NAUSEA (nausea). At the time of the report, DIARRHOEA (off and on diarrhea) was resolving and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication and treatment information provided
On the 3rd day experienced sudden dizziness episode while standing followed by nausea which required me to sit down. On the morning of the 4th day (today) while sitting experienced another dizziness episode which incapacitated me, following by nausea.  I have made an appointment with my primary care physician.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unspecified dates, in 2015, reported as "starting on or after 18-MAR-2015", the patients were vaccinated with unspecified improperly stored doses of VARIVAX (Merck) (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. No adverse effect reported. There was no product quality issue involved. This is one of two cases from the same reporter. Additional information has been requested.
645AM nausea, fainted, pale, blue around mouth p/taking a shower; no fever lt arm very sore; weakness all day; next day both arms were sore; 9MAR92 arms were OK & resumed nl activity;
Nausea, vomiting, weak feeling, red & left arm swollen- 104 degree temp (flu like symptoms).
I have been itching when I eat foods high in bakers yeast since I received this vaccine. I have to take a Benadryl about every three days. All the doctors claim that it is something else causing the issue but I did not start this until after I received the vaccine and upon researching and paying attention to my body I have noticed this. If I do not consume a lot of yeast I will not itch but if I do then I begin to itch.
within 5 minutes of immunization:  syncope, nausea later that day: feeling winded, lessened syncope and nausea overnight: fever 103 F, chills, body aches, headache continuing through today:  occasional, mild lightheadedness, nausea and feeling winded
I've been having daily migraines for about a month. They are starting to get better and I've been taking prescription medication for it. I went to the ER one night and they gave me meds to help and I've been seeing a neurologist.
FEELING ITCHY AROUND HER MOUTH, LOWER BACK, AND THE ARM; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced feeling itchy around her mouth, lower back, and the arm. On 14-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 14-MAR-2021, and the outcome of feeling itchy around her mouth, lower back, and the arm was not reported. This report was non-serious.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
Patient noticed redness and swelling at the injection site. The location was warm to the touch. Patient followed up with their MD and was given a course of Doxycycline 100mg  to treat an infection at the site.
Dose #2. Approx 1 - 1 1/2 hrs after 2nd dose ENGERIX B given pt developed shaky feeling, had near syncopal episode, ED visit revealed abnormal EKG --> admitted overnight --> EKG changes resolved within 24hr. Blood tests all normal. Mild reaction 3-4 days after dose #1 2/28/11 of fatigue.
Seconds after Td shot, PT passed out, eyes rolled back and started shaking uncontrollably for 3 seconds. ??? to with no signs of distress. Was able to leave office after 10 mins. Mom was advised to take child to MD's office.