chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent tip of the tongue numbness.; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient 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 06Dec2020 at 12:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 06Dec2020 at 12:00, the patient experienced persistent tip of the tongue numbness. The event 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 persistent tip of the tongue numbness. The clinical outcome of the event persistent tip of the tongue numbness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At inject. site of right thigh 4.5 cm area of erythema & induration 2 days /p DTP vaccine.
Approximate 3 - 4 days following vaccination with first Moderna COVID-19 vaccine, the patient develop new onset lichen planus rash affecting the trunk, arms, and axillae. She never had prior lichen planus rash prior to this outbreak.
Dizziness, fatigue, nerve twitching; 'heavy head, extreme pain and swelling of the arm. One arm is hotter than the other. Nerve twitching suggestive of nerve damage. Extreme soreness of the shoulder.
pt recvd vax & exp nausea,vomiting,& achiness;sx lasted 24hrs;
pt recvd vax & post vax exp swelling of the face & neck area;pt was observed & released;
I was 32 weeks when I received the second Pfizer dose.  Expected due date is July 6, 2021.  Around 10pm started feeling chills, fever and sweating.  Took 1 dose of Tylenol but the symptoms persisted through the night.  Still feeling very run down and sluggish today (5/11/21).
Breakthrough case admission after 5 vaccines Moderna 3/3/21 Lot# 030A21A;  Moderna 3/31/21 Lot# 025B21A;  Moderna 11/1/21 Lot# 939906;  Moderna 4/21/22 Lot# 057m21A;  Pfizer 9/30/22 LoT# GH9703
back pain; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: Reporter stated my daughter had, she had the back pain but she had the different one. She had the chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488779 same reporter/drug, different patients/AE;US-PFIZER INC-2021490065 same reporter/drug, different patients/AE
about 1 hour after being given the flu shot - felt lightheaded, hot and dizzy.  Went to the ED and BGL and EKG done.
Pt. believes the shot gave her shingles. Breakout below waist, back/bend of L knee, bottom of L foot. Went to Doctor on 05-21-2021. RX prescribed: Famciclodir 500mg, Hydrocodone 5/325mg
Dizziness, queasy stomach, headache, fever (100.5) and chills, fast, irregular heartrate (105 beats/min.). Onset 4 1/2 hrs. after injection. On doctor's advice in a phone call, took TYLENOL and generic BENADRYL. The next day was much better, with lingering dizziness, queasiness and tiredness.
I had low grade fever, some nausea, headache, a bad headache. I had shortness of breath, I cough some but when I did cough nothing to cough up very dry cough. I was very fatigued. I have an 02 monitor at home. I called my doctor to tell him my O2. He had me do a test, I did 2 tests both came back negative. My doctor felt like I had  covid and window during testing. My O2 have dropped dramatically 89-94 that is just sitting. I'm trying to find a pulmonologist in network with my insurance. I keep getting a rash on my arm. I'm super fatigued. My O2 stats are still low for me.
Pt reported having redness, firmness and swelling to upper arm that received the vaccine along with one hive at injection site approximately 3 days following vaccination.
vision loss; difficulty breathing; numbing of the mouth; dizziness; a weird taste in her mouth; high blood pressure; Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, dose and route unspecified) for prophylaxis. On an unknown date, after receiving the vaccination, the patient experienced difficulty breathing, numbing of the mouth, vision loss, dizziness, a weird taste in her mouth, and high blood pressure. The patient had to go to an unspecified emergency room. At the reporting time, the outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. The pharmacist requested a lot check for this lot number of ZOSTAVAX. Upon internal review, vision loss was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. An investigation into the manufacture of lot(s) (M034766) was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Sender's Comments: US-009507513-1611USA010078: MERCK 1611USA014390: Mfr number.
Soreness and developed a fever 10 hours later. Temperature went up to 102.8F the next morning.
a 20 month old, inadvertently, received a Quadracel vaccine instead of the DTaP with no AE; a 20 month old, inadvertently, received a Quadracel vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00385237) and transmitted to Sanofi on 08-Dec-2020.  This case involves a 20 months old female patient who was inadvertently administered a 0.5ml standard dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5763AA and expiry date: 26-Aug-2022) once via intramuscular route in the right thigh for prophylactic vaccination (Product administered to patient of inappropriate age) instead of fourth dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (wrong product administered) on 08-Dec-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) and HIB VACCINE CONJ (TET TOX) (ACTHIB) for prophylactic vaccination.  This was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency was same day).  At the time of reporting, no adverse event was reported to the patient.  Reporter asked if this dose would count in vaccination and if there were any concerns. Reporter stated that the physician did not think so and the office just wanted to know. Reporter also stated that this vaccine was used for first time in the patient.  No potential product technical complaint (PTC).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
stiffness in her hand; patient reported receiving the covid booster; patient reported receiving the covid booster; This is a spontaneous report from a contactable other hcp. This contactable other hcp reported for a female patient. A 57-years-old female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Sep2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included Rheumatoid Arthritis. There were no concomitant medications. The patient previously received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. On 08Sep201, the patient experienced stiffness in her hand, and on 07Sep2021 patient reported receiving the covid booster. Two days after the COVID booster, she has had improvement with the stiffness in her hand, but it was still present, md is not aware. Advised patient to continue to monitor and if it gets worse to notify the md and also advised to inform md during follow up. The outcome of the event stiffness was recovering.  Follow-up (18Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I started getting symptoms of a headache that I thought was a migraine. I got nauseous and vomited. That evening I developed a cough. I took an at home COVID-19 test that was positive. I contacted my doctor and was advised to do over the counter medications and my symptoms we not severe enough for Paxlovid. My symptoms did progress to fatigue and tiredness. My cough got very strong. I had no appetite for about a week. I still cough somewhat at night and experience tiredness.
Issues with menstrual cycle increased pain, intensity, length, flow, and more frequent and irregular. Extreme Fatigue
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 12-APR-2016 the patient was inadvertently administered ZOSTAVAX (lot # L000449, dose, strength and route unknown) that had expired on 08-MAR-2016. No adverse effects reported. Additional information is not expected as the physician refused to be contacted.
gotten sick; Swollen arm; felt lousy; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (unknown demographics) who experienced sick (illness), swollen arm (peripheral swelling) and felt lousy (feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  Past vaccination included Every time taken the flu shot in the last 30 years and gotten sick, and every time.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness), swollen arm (peripheral swelling) and felt lousy (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that over the years job has pressured me to get one, and every few years give into the pressure, telling them all the time what would happen and it never failed. Now, all these years later, you can't make retired nurse wife take a flu shot. Sometimes, remind her of that first time she talked me into taking one 30 years ago.   Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
hands are swollen and painful; hands are swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 84 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 84 years as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "hands are swollen and painful".  Additional Information: The report did not related to a study or programme. She got the Pfizer Covid booster shot and the caller states that her hands are swollen and painful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer vaccine given IM and approximately 13 minutes after injection pt states that his throat felt tight and "funny".  States he can swallow but it felt "funny".  Denied shortness of breath or any other symptoms.  Oxygen sat was 96%.  BP 172/80 pulse 74.  He was on hemodialysis treatment at the time.  No other medications had been given.  After initial assessment, S Standish, NP notified and Diphenhydramine 50mg was given IV and oxygen was given.  Pt states he felt sleepy and after about 30 minutes his symptoms subsided altogether other than feeling anxious.  Nursing staff stayed right with pt and helped to let him know that we were with him and pt verbalized that he was "fine."   Vital signs remained the same and treatment continued.  Pt left after his 3:30 treatment with all symptoms completely resolved.
This spontaneous report was received from a 68 year old male consumer referring to himself. The patient's pertinent medical history was not reported. Concurrent conditions included hypertension and diabetes mellitus. Concomitant therapies included high blood pressure and diabetes medication. Drug/allergies reactions included allergy to penicillin (unspecified). On 14-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not reported) for prevention of pneumonia. On 18-DEC-2016,  the patient experienced cold symptoms (nasopharyngitis), extreme fatigue and severe breathing when walking (respiration abnormal). No treatment was given for the events, no laboratory diagnostics were performed. The patient did not seek medical attention and no product quality complaint was involved. The outcome of nasopharyngitis, fatigue and respiration abnormal was reported as not recovered. The relationship between the aforementioned events and PNEUMOVAX 23 was not established or mentioned by the reporter. Additional information has been requested.
Unknown amount of vaccine was squirted out at the luer-lock junction between the syringe and needle at initial vaccination on 4/10/2021. Per agency Interim Clinical Considerations provided when we contacted the Janssen Medical Information Center, for doses less than half (or unknown), we readministered another vaccination to the patient on 4/12/2021.
Pt states that he states he received 2 doses of COVID vaccine. Now hospitalized with chest pain.
6 month booster given early.  2nd dose was 6/5, so should not have been due until 12/5.
On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 patient reported beginning 2/5/21 early evening she began having overall body rash and body ache that progressed over the next few days to sore/swollen throat, voice loss, nausea, intermittent fever, loss of taste and smell, headache, and diarrhea. Tested COVID-19 negative 2/9/21, still having symptoms. Stated has not seen her healthcare provider but will contact for care.
Patient noticed his blood pressure has increased since his booster shot. Reports typical BP of 129/69 and at his annual exam his BP was 153/75. Patient also reports increased tiredness and mild tightness of the chest. PCP is putting the patient on statins to treat elevated BP.
Patient's son said his moms started talking gibberish. He called the pharmacist to ask questions the pharmacist instructed the patient to seek medical attention if she continues to talk gibberish. The patient's son called an ambulance to go to the hospital. Patient was diagnoses with a stroke.
Took the shot Wednesday April 7, 2021 at appx 530pm. Woke with stabbing intermittent pain on lower right quad of stomach Saturday April 10, 2021 at 745AM.  It progressively got worse and I ran a low grade fever of 99.7 F. Drove to ER Sunday April 11, 2021. They (and I thought) appendicitis. Admitted asap. It was my kidneys. My ureter on the right caused the pain, and it spread to the right kidney in back. It is April 19, 2021 now. It eventually spread to my left ureter and left kidney. I had zero, ZERO illness and NO signs of a bladder infection prior. I've had 2 bladder infections in my 42 yrs and I went from fine to so sick I was scared. No trouble urinating, urine cloudy, pain etc. Just woke up literally 2 and a half days after my 1st shot and was sick. Am currently taking cefuroxime (Ceftin generic) 500mg every 12 hrs for 10 days I picked up Monday April 12. Also now took 12 mg Ivermectin (prescribed by a physician) Thursday April 15, 2021. A second dose Saturday April 17, 2021. Then I take it 2 weeks from the 17th, and 1 more time 2 weeks later.
Received vaccine at 8:00 am on Monday, October 29. Normal work day, went home worked in the yard, went in to view TV from 7-9:30 pm.  While reclining on couch, left arm became extremely sore at shoulder blade joint. Pain worsened by 10:30 pm was unable to move arm without excruciating pain.  Pain was in should, elbow, and wrist area. Awoke husband at 12:00 am, Tuesday, Oct. 30th and had him take to hospital ER.  It was felt that patient was having a heart attack.  Around 1:00 am administered 2 baby asprin and 3 nitro. Pain subsided almost immediately.  Patient was placed in CDU (Critical Decision Unit) for observation.  4/5 EKG's were administered and blood drawen at 3 different times checking for enzyme levels.  EKG's normal, and blood draw indicated no enzymes.  Physician on duty Tuesday morning, felt symptoms were reaction to vaccination, previous morning.  Patient was released after 16 hr observation, at 4:00 pm on Tuesday, Oct. 30.  Next morning, Wed. Oct. 31, patient experienced pain in left ear.  Patient went to see family physician as instructed by ER.  Dr. indicated that he felt the episode was due to the vaccine.  No infection was evident in the ear drum and Dr. gave patient Nasonex to unclog the ear canal. Stress test was no taken.
This case was reported by a other health professional via call center representative and described the occurrence of hives in a 44-year-old female patient who received ENGERIX B adult (batch number GR55T, expiry date 28th August 2020) for prophylaxis. Previously administered products included Hepatitis B vaccine (In 2000, received 1st dose). On 18th June 2018, the patient received the 2nd dose of ENGERIX B adult (intramuscular) 1 ml. On 18th June 2018, less than a day after receiving ENGERIX B adult, the patient experienced hives (serious criteria life threatening and other: serious as per reporter), fever (serious criteria life threatening and other: serious as per reporter) and drug dose administration interval too long. On 19th June 2018, the patient experienced shooting pain (serious criteria life threatening and other: serious as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the hives, shooting pain, fever and drug dose administration interval too long were unknown. The reporter considered the hives and fever to be possibly related to ENGERIX B adult. It was unknown if the reporter considered the shooting pain to be related to ENGERIX B adult. Additional details were provided as follows: No adverse event of previous vaccines was reported. The patient received ENGERIX B adult in the left deltoid. After receiving ENGERIX B adult, the patient developed a fever of over 102 degrees F and hives all over her body and in her mouth. One day after receiving ENGERIX B adult, the patient experienced shooting pain. The patient's primary care provider advised her over the phone to take BENADRYL every 6 hours. After 3 or 4 days, the patient missed a dose of BENADRYL and the hives returned. The patient missed 2 days of work. The reporting healthcare professional had an appointment with the patient on the reporting day.
24 hrs after injection, redness appeared. 48 hrs after inj. red and inflamed, warm to touch
Patient was given incorrect vaccine for primary series 10/17/22 at another location; Local Family Practice. Patient was given the bivalent at his first dose for the primary series. Presented 11/7/22 to our clinic (the little clinic) for second dose and noticed that incorrect primary series was given. Did give the second dose of the monovalent vaccine 11/7/22 per CDC guidelines at the little clinic. No adverse reactions were reported by patient.
Site of injection had red rash twice a size of an egg; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Site of injection had red rash twice a size of an egg) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE RASH (Site of injection had red rash twice a size of an egg). On 01-Apr-2021, VACCINATION SITE RASH (Site of injection had red rash twice a size of an egg) had resolved. Not Provided    No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The symptoms started on Tuesday, 05/17, mostly sinus related and then I did not have a fever until Thursday 99.1-100, low grade fever, and no other symptoms. And I have been on an antiviral since Thursday night. And most of my condition was sinus related. My first rapid test was Tuesday, 05/17 it was negative. And the rapid PCR test on Thursday, 05/19 and it was positive.
The patient has extremely painful charley horse like pain in his neck, beginning this morning. He has tried to resolve the pain by taking a steam shower, taking ibuprofen, and drinking plenty of water. He has been alternating hot and cold, additionally.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-DEC-2017, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX injection, vial 19400 PFU (lot # M037653 with expiration date on 29-NOV-2017; dose, route of administration, indication were not reported). Concomitant therapies included sterile diluent. No adverse effects were reported.