chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 60-years-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EN6203) via an intramuscular route of administration, administered in Arm Left on 10Mar2021 at 18:00 (age at the time of vaccination was 60 years old), as DOSE 2, SINGLE dose for COVID-19 immunization at Public Health Clinic/ Veterans Administration Facility. The relevant medical history included High blood pressure, Depression, High cholesterol, and Heart condition; all were ongoing from an unspecified date. Concomitant medications were not reported. The patient had no other vaccinations within four weeks prior to the first administration vaccine. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EL9266) via an intramuscular route of administration, administered in Arm Left on 17Feb2021 at 12:00, as a DOSE 1, SINGLE dose for COVID-19 immunization. Vaccine was not administered at Military Facility. Other Product were reported as no. On 11Mar2021, the patient experienced Fever, Fatigue and Headache. No treatment was received for adverse events. Emergency Room visit was not required. The clinical outcome of Fever was Resolved on 14Mar2021, clinical outcome of Headache was Resolved on 16Mar2021, while the clinical outcome of Fatigue was Resolving.  No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 16Jan2023 to an unspecified date in Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Device issue; Vaccination site pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE ISSUE (Device issue), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled syringe. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced DEVICE ISSUE (Device issue). In 2021, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) had resolved. At the time of the report, DEVICE ISSUE (Device issue) had resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622914.
Provider ordered correct vaccine, staff member collected, drew and administered incorrect vaccine. Age of patient at time of event: 14 years. Contributing Factors: Staff selected wrong immunization.
no adverse effect; received second dose of HPV series on 9/24/2015 and 3rd dose of HPV series on 9/9/2016 after received 1st dose of HPV series, GARDASIL, on 7/21/2015; This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 21-JUL-2015, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route, lot# and expiry date were not reported) for prophylaxis.  Other suspect therapies included quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (route, lot# and expiry date were not reported) for prophylaxis.   On 24-SEP-2015, the patient received the second dose in the HPV vaccination series   It was unknown if it was Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).   On 09-SEP-2016, the patient received the third dose in the HPV vaccination series and It was unknown if it was Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration) (unidentified Merck hpv vaccine administered (name and lot number not provided).  It was reported that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was chosen as product although it was unknown if Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) for second and third doses of HPV series. No adverse effects reported. No  additional information provided. Causality was not reported.
Fatigue; Muscle burning; Low-grade fever; Headache; Muscle pain; Chills; Tiredness; Feeling unwell; Feeling unwell and weak; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 08Apr2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity 35.5 Body Mass Index (BMI), cholecystectomy and thyroid nodules. The patient had no allergies to medications, food, or other products. The patient received unspecified concomitant medications 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 08Apr2021, the patient experienced fatigue, muscle burning, low-grade fever, headache, muscle pain, chills, tiredness, felt unwell and weak. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events fatigue, muscle burning, low-grade fever, headache, muscle pain, chills, tiredness, felt unwell and weak were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
From correspondence received on November 19, 2001 it was reported on that a 2-month-old female patient received an ActHIB vaccination lot#UA604A2 administered on November 8, 2001 in her left thigh. The patient also received an IPOL vaccination lot# T1128-2 and an Infanrix vaccination lot# DTPA507AZ both administration in her right thigh. It reported to physician that a local reaction of redness and moderate swelling occurred 2 hours post immunization. The physician prescribed acetaminphen, which was effective. the child was rechecked November 11, 2001 and reaction was noted to have resolved.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 10-MAY-2012, the patient was vaccinated with improperly stored VARIVAX lot#: 1273AA, dose number 2. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 21-MAR_2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours This excursion was found due to a data logger. Additionally, it was stated tat no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
About 10 hours after receiving vaccine in left arm, I noticed I developed ringing in my left ear (left ear only).  As of this writing at 7:00 am the following morning, it is more pronounced.
Patient given Moderna vaccine taken out of the freezer for 42 days (12 days past the beyond-use-date). Parents notified and encouraged to repeat the dose.
Pt recvd 1st dose of Hep B vax 12APR91 & on 23APR91 & 24APR91 exp low-grade fever of 99.8, fatigue, & dec appetite; pt recovered;
Vomiting; Nausea; Lethargy; Chills; Fevers; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced vomiting, nausea, lethargy, chills and fever. On an unknown date, the outcome of the vomiting, nausea, lethargy, chills and fever were unknown.   It was unknown if the reporter considered the vomiting, nausea, lethargy, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist calling to report and mentioned a 2nd male that was with the first reported adverse event. The patient received Shingrix and had lethargic, had fever and chills, and nausea and vomiting. Limited information was known about the resolution of the symptoms. The HCP information not provided. Only initials and gender were provided for this patient as he did not receive the injection in the Pharmacist, that called pharmacy. This case linked with US2020173785, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020173785:same reporter
Sore arm and hand. started dwelling and hives appeared all over back of legs back face stomach bottom of feet. swelling was only on left side.
Moderna COVID-19 Vaccine EUA bright red rash, swelling, and itchiness at vaccination site.   Started 10 days after vaccine.
First felt a rushing sensation throughout body, then a stabbing pain in knee joints, hands, elbows. Continues from one side of the body to the other side of the body. Patient has experienced these symptoms since one week following vaccination. Continuous pain throughout the body. Has been evaluated by physician since.
Initial misuse report received from a healthcare profession on 14 October 2013.  The child patient had received FLUZONE two doses series last year and inadvertently received an extra dose this year. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
On April 7, 2021, upon waking noticed Right lower leg swelling from the knee down to the ankle.  No pain however is swollen, slightly red and firm.  Also has been lethargic since  April 3 to present, April 7, 2021 but this is getting better.
Approximately 2 weeks after having the vaccine I awoke one day unable to walk. This went on several days, then my nose started bleeding often and my blood pressure went up, I was taken to the hospital twice and during that time I had another spell where I couldn?t walk and still am very weak.
5 days after vaccine started to have sore throat x 3 days alot with painful sores on side of tongue. Sore throat subsided, 1/2 portion of anterior tongue felt like it has been burnt. Painful, it some cracking and ulcers to tip. gargled with mouth sore rinse BID x  8 days with no improvement. Still experiencing discomfort, pain, and redness to tongue.
Day 1 after vaccination developed fatigue, diarrhea, body aches, headaches, dry non productive cough, odd taste in mouth, low grade fever, decreased appetite, strong cough with post-tussive emesis, sore throat, (L) earache.
4 inch diameter itchy/rash appeared at the injection site 9 days after the injection
sweat fever out; slight fever; whole body muscle aches; headache.; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medications included losartan (LOSARTAN)m colecalciferol (VITAMIN D), vitamin b complex (VITAMIN B-COMPLEX) and magnesium (MAGNESIUM) all taken for unspecified dates and indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient receive the vaccine on 18Mar2021 and he was okay on Friday. By Saturday morning (20Mar2021 9:30), he felt pain in upper left buttocks like someone sticking with knife followed by muscle contractions in same area that would repeat 2 to three times but was intermittent for 4 hours. He felt ok with no symptoms rest of Saturday. Then on Sunday morning around 4 a.m., the same feeling came back and lasted until Sunday noon (21Mar2021). Then, his whole-body muscle aches that lasted whole Sunday along with headache. On 22Mar2021 (Monday), the patient had still intense whole-body muscle aches all day headache but no buttocks contractions. By night, he slight fever took paracetamol (TYLENOL) and also had sweat fever. By Tuesday morning, the patient still had faint muscle aches slight headache. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient did not receive treatment for the events of  pain in upper left buttocks like someone sticking with knife followed by muscle contractions, whole-body muscle aches, headache and sweat fever.  The patient was recovering from the events and was feeling much better  No follow-up attempts are possible. No further information is expected.
This is a non-serious spontaneous case, initially received from other non-health professional (reporting on himself) on 12-Jan-2018, concerning a male patient of unspecified age. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, in the past after receiving the vaccine, the patient developed soreness in arm. On an unspecified date, the patient recovered from the event soreness in arm.
Pt. lied about his previous vaccination. He requested his first dose during his appointment. After he was vaccinated with Pfizer vaccine pt. stated he had two doses of Moderna before.  Moderna 4/19/2021 Moderna 5/17/2021
Patient presented to the Emergency Dept at hospital on 10/27/2018 at approximately 22:55 with a CC of bilateral foot and hand pain, rash, and swelling. Patient presented stating she could not ambulate D/T pain. Rash was also noted to bilateral elbows. BENADRYL had been given prior to her arrival at ED. A rapid Strep test, CBC, UA, BMP, CRP, and Lyme test were done. Ibuprofen was given to patient with almost complete pain resolve. Pain later returned in her feet while still in the ED for which TYLENOL dose was given. Normal WBC count, negative Strep and urinalysis. CRP presented back mildly elevated at 31.6 which could be consistent with a serum sickness illness. Recommended to her by ED MD to continue.
On 3/24/03 PT received TD vax on left arm. After vax, PT started with swelling, redness inject site. No fever, no Sx's of infection or cellulitis.
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
This spontaneous report was received from a registered nurse regarding multiple unspecified patients. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (dose and route were not reported) Lot# L040413 and expiry date: 13-APR-2016. No adverse effects were reported. No additional information was provided and there was no product quality complaint involved. Additional information has been requested.
Gave guest her flu shot, seemed fine tolerated procedure well. I was walking out of exam room with her mom and heard her fall from exam table to floor. She was unresponsive about 45 seconds but color & VS stable. She was transported by parent car to ER after about 25-30 minutes recovery. She had 2 small facial lacerations & complained of nasal pain, headache.
Kinrix administered to a 15 months-old; Kinrix administered instead of dtap vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 25-JAN-2023 Reporter's Comments: Nurse reported a 15-month-old patient received a dose of the kinrix vaccine inadvertently instead of the dtap vaccine on 25th January 2023. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Kinrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.
This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 20Mar2021 08:30 as a single dose for COVID-19 immunisation. Medical history included cystitis interstitial and allergies: cat and bee stings. Concomitant medications included prednisone epinephrine, and chlorphenamine maleate (ANTIHISTAMIN) taken. Patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID prior to vaccination. After about 30 minutes, on 20Mar2021 09:00 AM, the patient experienced tongue started swelling and would not subside. She tried antihistamine all day with no success. She went to Urgent Care and received steroid shot and was prescribed prednisone that same evening. She was told to return if symptoms not improved in three days. The patient returned on Monday evening and was sent to the ER. She was diagnosed with Angioedema and given more antihistamines and steroid shot and epinephrine in IV. The patient was currently monitoring and seeing an allergist to follow up. Her tongue was still not back to normal. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of tongue started swelling and would not subside was not recovered, and of angioedema was unknown. The events were reported as non-serious. The patient had not been been tested for COVID-19 since the vaccination. No follow-up attempts are possible; information on the batch/lot number cannot be obtained.
Chronic Spontaneous Rash, Occasional slight swelling of esophagus, Dermatographism, hot and sensitive skin at hands, feet, ears, and face
Pt. stated that redness and swelling at injection site of Td vaccine on L deltoid started on 1/25/17. Pt. seen in clinic There was redness and swelling at injection site. Pt. stated that left arm was in pain from injection site to palm of hand.
Began Friday 21FEB92 went to ER admitted-d/c sat evening 22FEB92 dx Cellulitis
Developed  lymph nodes that were inflamed in the  neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (Developed  lymph nodes that were inflamed in the  neck) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENITIS (Developed  lymph nodes that were inflamed in the  neck) and HEADACHE (Headache). At the time of the report, LYMPHADENITIS (Developed  lymph nodes that were inflamed in the  neck) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.   It was reported that patient was scared and did not receive the second dose.  Treatment information was not provided.