chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tooth pain; tooth pain - sensitivity to hot and cold and pressure; 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.  A 73-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "recovering", described as "tooth pain"; HYPERAESTHESIA TEETH (non-serious), outcome "recovering", described as "tooth pain - sensitivity to hot and cold and pressure". Additional information: Caller stated 2 weeks ago from tomorrow she received her RSV vaccine, Abrysvo. She had a reaction to it which was tooth pain - sensitivity to hot and cold and pressure. It is starting to resolve but next week she is supposed to get a Prevnar vaccine (she does not know which one) and she is concerned she may have the tooth pain again. She did not see anything about tooth pain with the Abrysvo but when she googled it she saw many people said the same thing about Pfizers covid vaccine giving them tooth pain and some rated it 8 out of 10.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Her nose went numb pretty immediately and lips were swelling about 8 - 10 hours later; Had some arm discomfort; Her nose went numb pretty immediately and lips were swelling about 8 - 10 hours later; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection), intramuscular administered in Arm on 21Jun2021 (Batch/Lot number was not reported) (at the age of 26-years-old) as SINGLE for covid-19 immunization. Medical history included ongoing Hashimoto's thyroiditis from 2018 and allergies to shrimp and grass from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for Hashimoto's thyroiditis from 2018 to an unspecified stop date. She was diagnosed 3 years ago and that's when she was put on Synthroid. Patient had a reaction almost immediately after vaccination with nose going numb that lasted about an hour. She didn't tell the person there that she was having a reaction. She noticed that night, 8-10 hours later, her lips swelled up. that's typical to how she has an allergic reaction to something, her lips and mouth swell up (At 22:00). She didn't take a Benadryl even though mother thinks she should have. Caller stated she herself had discomfort in her arm for a couple of days. Patient had reactions to shrimp in the past and they've gotten worse and caller thinks she needs to get an EpiPen because it has gotten worse and swelling has spread through nose and mouth. Caller clarified patient did not have this reaction to Covid 19 Vaccine. Caller wanted to know if her daughter should get the second shot or not. No relevant testing but caller states that every 6 months blood work for thyroid issue. The outcome of event numbness was recovered on 21Jun2021 whereas, other events was recovered on 22Jun2021.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
PT WAS FINE UNTIL 2 1/2 HOURS AFTER VACCINATION. STARTED HAVING HEADACHE AND NAUSEA. LAY DOWN. 1 HOUR LATER, WHICH WAS 3 1/2 HOURS AFTER VACCINATION, HEADACHE/VOMITING/CHILLS/BODY ACHE. CAME TO OFFICE, HAD VOMITED 4 TIMES, HAD TEMP TO 100.3. VITAL SIGNS STABLE. NORMAL EXAM, NO SOB/TROUBLE BREATHING/RASH/ETC. SIMILAR EVENT AFTER FIRST DOSE WITH MILD FEVER AND BODY ACHES, NO VOMITING.
Incorrect Dose, Moderna booster dose administered was 0.5 milliliters. Booster dose should have been 0.25 milliliters.
Suspected vaccination failure/Got flu vaccine, got stomach virus and flu every winter; Flu/Had the shot but still got the stomach virus and flu every winter; Stomach virus; Runny nose; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, stomach virus and runny nose. On an unknown date, the outcome of the vaccination failure, influenza, stomach virus and runny nose were unknown.   The reporter considered the vaccination failure, influenza, stomach virus and runny nose to be possibly related to Flu vaccine.     Additional Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that when she was getting the flu vaccine, got stomach virus and flu every winter in elementary and middle school. The patient stopped taking them in high school and had yet to be attacked by that virus. A runny nose did not equate to flu vaccine, there were natural ways to build her immune system and help her grow healthy and strong. The medicine was not the only way. The reporter think that the event might had been related to the Product/Device. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of flu were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported information, the gender was captured as female.
Two days after having my one and only covid shot i began noticing ringing in my right ear and my hearing is not as good as is was previously. i am setting up a doctors appointment today to see what the issue is.
At approximately 1543, client received the Pfizer COVID vaccine (LOT# FP7137) at approximately 1543. At approximately 1548, client's father alerted RN. Client's father reported that client "saw black" and felt like vomiting. RNs assisted client into anti-gravity chair. RN noted palor and diaphoresis. Client denied itchiness, difficulty swallowing and difficulty breathing. Client's father reported no similar history and reported that client was anxious before vaccination. RNs recommended client to stay for 30 minutes for observation. At 1548, RNs assessed client: blood pressure 112/64 mmHg, heart rate 110 bpm, SpO2 98%, and respiratory rate 16 breaths/min. RNs placed a cool wash cloth on client's forehead and water to drink. At 1603, RNs reassessed client: 117/64 mmHg, heart rate 96 bpm, SpO2 98%, respiratory rate 16 breaths/min, and client reported feeling better. At 1603, client denied previous symptoms. At 1620, RN reassessed client. Client denied previous symptoms. RN educated client and client's father on signs/symptoms of when to seek emergency care and to sign up on V-safe. At 1621, client left facility with unlabored respirations and steady gait with father.
R aRm, R tongue tingling Tx: vitals, monitored, water  Referred to Allergy  2nd dose 1/24 -> Left after 30 min observation 2 no adverse reaction
Since covid vaccine I have been menstruating twice/month. Before vaccine very regular at 28 days
01/27/2005 Immunization given.  01/31/2005 telephone call from mother states fever up to 105 over the weekend.  Would go down with Tylenol  and Ibuprofen to 100-101, referred to ER - declined.  02/01/2005 mother and child into office, no fever doing okay no problem.
0845 Vasovagal with strong retching - no emesis Initial VS: HR 50's O2 sat 85% Subsequent VS: 110/63-HR 60-RR 20- O2 sat - 98% CBG 150 PMHx: HTN, HLD S: patient felt nauseated, dizzy, "hot all over", anxious O: Awake but unable to answer due to retching. Pale, diaphoretic, cool to touch. Cards: radial pulse thready - apical pulse in 50's RRR, no murmur. Resp: clear to auscultation. No cough or evidence of aspiration.  GI: strong retching but no emesis.  A/P: 68 y/o female who just rec'd J&J Covid Vaccine was in monitoring lot and found to be diaphoretic and retching - semi conscious.   Vasovagal response - patient recovered VS within 5 min of start of event. Wanted to go to hospital for evaluation. She was alone in her car. Called her dtr to apprise of situation. Authority parked her car and returned her car keys to her prior to transport to hospital.
Pt c/o slight throat numbness and slight dizziness  aprox 20 minutes after receiving second dose of Pfizer Covid vaccine. Pt denied experiencing difficulty breathing, flushing of the skin, and itchiness.
Body aches, migraine, fatigue (bad enough to be in bed 3days), stuffiness, generalized malaise. I felt ill for about a week, but had no fever. I only called the GP?s office, spoke to RN. She told me to observe reactions,  stay put and if develop fever to call back. I did not, and I did not take meds for the symptoms. I was afraid to damage vacccine efficacy.
expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268346, 2019SA268357, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 87 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the right deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  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.  List of documents held by sender: none.
severe body aches all over except in legs, unable to sleep, fever, MISERABLE lasted 36 hours
My first dose of the vaccine was in December 2020 (I am a hospital worker), I almost immediately started having heartburn and abdominal pain but I thought it was a virus. Second vaccine was in January 2021 and the stomach aches began to escalate until in April 2021 the pain was intractable and radiated to my back. I was hospitalized in April 2021 and had my gallbladder removed. After my booster shot in August 2021 the same thing happened but this was more aggressive pain and the reaction (in my opinion) was much faster. I attempted to again manage the pain at home but after 5 days, was unable and I was hospitalized again. To date, there is no known cause of the acute pancreatitis other than the timing of the vaccine and my symptoms.
Lethargy following vaccination. A week after vaccination, sudden onset of severe joint pain and stiffness. Began to affect soft tissues and nerves. Eventually got diagnosed with Lupus, then undifferentiated connective tissue disease, then finally Rheumatoid Arthritis. Treatment has consisted of steroids, disease-modifying anti rheumatic drugs, anti inflammatory drugs, biologic drugs, and alteration of diet. I have not gone into remission and my Rheumatoid arthritis is considered severe and active, despite my young age and no family history of rheumatoid arthritis.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Approximately 10 days, post vax, the pt developed chickenpox that consisted of small blisters which were beginning to scab over; there was no fever. Additional information has been requested.
Weak, thought that she will collapse; Feels like flu but much milder and she is not herself; Headache and now she has headaches almost everyday; Has chills often; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak, thought that she will collapse), INFLUENZA (Feels like flu but much milder and she is not herself), HEADACHE (Headache and now she has headaches almost everyday) and CHILLS (Has chills often) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (In 2018 but completely recovered.). Concomitant products included IBUPROFEN (ADVIL 12 HOUR), METOPROLOL, TRAZODONE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PARACETAMOL (TYLENOL) for an unknown indication.    On 07-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Feb-2021, the patient experienced ASTHENIA (Weak, thought that she will collapse), INFLUENZA (Feels like flu but much milder and she is not herself), HEADACHE (Headache and now she has headaches almost everyday) and CHILLS (Has chills often). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak, thought that she will collapse), INFLUENZA (Feels like flu but much milder and she is not herself), HEADACHE (Headache and now she has headaches almost everyday) and CHILLS (Has chills often) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
At time of shot fast heart rate monitored by the facility no other symptoms  Next day headache, sore injection site, swollen lymph nodes arm pit and neck on side of injection, extreme fatigue slept all day, chills, vomiting (2x), muscle aches Following days low grade fever on and off, fatigue, intermittent fast heart rate, chills fatigue  Today  day 6 much improved mild fatigue
Second dose of the MODERNA Covid-19 vaccine given to me on September 9, 2021. Subsequent prolonged and serious dizziness and ear ringing. Site of injection will not heal. Continued shot site scabbed and painful.
Adverse effects similar to first injection with slightly less severity. Slightly swollen site, painful upon touching, pain builds over 12 hrs. hrs 13-15 stomach pain, nausea need to be prone, after 24 hrs pain not as severe and declining, injection site still tender after 48 hr.
Pt received flu shot first. About 10 minutes later, pt received pneumonia shot. Immediately after the PNA shot, patient stated she needed to sit down, and slid down against the wall to the floor. ER was called, pt immediately took medication from her purse.
Information has been received from a pharmacist concerning her son with no pertinent medical history or drug allergies who on 20-NOV-2007 and 21-JAN-2008 was vaccinated PO with his first and second doses of ROTATEQ. There was no concomitant medication. In 2007 after the patient's first dose, the patient's stools became "mucousy." Subsequently, the patient recovered from stools mucousy. In 2008 after the patient's second dose the patient became constipated with stool consistency of "peanut butter." It was also reported that the patient had not experienced any bleeding or discomfort with this change. The patient did begin to eat food between the first and second doses of ROTATEQ. The pharmacist contacted the physician for medical attention. No labs or diagnostic studies were performed. The patient was noted to be recovering at the time of this report. There was no product quality complaint. Additional information has been requested.
3 patients were administered with vaccine that has been stored in the refrigerator for 31 days; 3 patients were administered with vaccine that has been stored in the refrigerator for 31 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient does not reported any adverse events so far.  The vaccine had been stored in the refrigerator on 15-FEB-2022.  No treatment medications were reported.
COVIND infection following COVID vaccine series 01/19, Pfizer, dose #1 02/09, Pfizer, dose #2 11/15 COVID swab, result: detected 11/06 pt cc: Rhinorrhea exposure: unknown
patient said the next day she had a swollen arm and when she went to the drs office a few days later she had mrsa  from the vaccine
2nd dose 3 days after the first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 26-Sep-2022 Reporter's comment: A pharmacist reported that according to a facility records, a patient received the 2nd dose of Shingrix, 3 days after the first dose.  The patient denies this information. Reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to shortening of vaccinations schedule.
sore arm; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "In 2021, patient had treatments for cancer: surgery, chemotherapy, radiation therapy, and aromatase inhibitors.", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: It was reported that Are you currently studying the outcomes of FOUR Pfizer dose vaccinations? Is it protecting me and for how long? Do I need a different vaccination for the Omicron variant? Had four doses since Apr2021, last one competed yesterday. Side effects for all four doses seems to be just a sore arm and tiredness for about 2 days. In 2021, patient had treatments for cancer: surgery, chemotherapy, radiation therapy, and aromatase inhibitors.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt BIBA with sx of stroke, including right sided weakness and numbness. imaging suggestive of transverse myelitis vs. spinal cord infarct
This was my 2nd shot.  On  the first shot my arm was ?tingly? like pins and needles and my elbow hurt .  2nd shot was Tuesday at 11 am.  I felt fine until about 9 pm and then my arm started hurting couldn?t lift it over chest level.  It hurt from shoulder to elbow.  Didn?t sleep well at all kept waking up.  Day after shot was Wednesday and I had a slight headache and arm still hurt a little.   Very tired but I hadn?t slept well.  Worked all day.  Thursday I worked all day, arm no longer hurt but elbow still feels weird.  Friday, 3 days after the shot, I felt fine until after lunch.  I got a headache that wouldn?t go away.  Started feeling nauseous about 5 PM.  Went home and had chills and shivering. Temp went up to 100.  Massive headache and horrible nausea.  Extremely fatigued.  Fell asleep about 7 PM and woke up at 9 PM.  Back to sleep by 9:30 PM and slept till 1 am.  Back to sleep at 2 am and slept till 8 am so about 12 hours of sleep which o rarely sleep more than 7.  This was 3 days after the shot.  Woke up Saturday and felt ok as I have since then.  My elbow still hurts and there may be a small lump under my skin at the elbow...or some swelling.  Had very strange vivid dreams on Friday night as well.