chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear infection; Sinusitis; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) and SINUSITIS (Sinusitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced EAR INFECTION (Ear infection) (seriousness criterion medically significant) and SINUSITIS (Sinusitis) (seriousness criterion medically significant). At the time of the report, EAR INFECTION (Ear infection) and SINUSITIS (Sinusitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, Body temperature: 103 f (High) Temperature of 99F which increased to 103F. On an unknown date, Chest X-ray: normal (normal) Clear Results. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Clear, Antibody test showed patient had got vaccine..   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided. The treatment medication was reported as some unknown antibiotics and steroids for sinusitis and ear infection.  On an unspecified date after the second dose patient had got sick for another week. Patient had been sick for 5-5 weeks.  Company Comment: This case concerns a 63-year-old female patient with no relevant medical history reported who experienced serious unexpected events of sinusitis and ear infection. The events occurred after the second dose of Spikevax however, the exact time to onset was unknown. Rechallenge was not applicable since the events occurred after the second dose of Spikevax. The reporter did not provide causality assessment. The benefit-risk relationship of drug is not affected by this report   This case was linked to MOD-2021-319851 (Patient Link).; Sender's Comments: This case concerns a 63-year-old female patient with no relevant medical history reported who experienced serious unexpected events of sinusitis and ear infection. The events occurred after the second dose of Spikevax however, the exact time to onset was unknown. Rechallenge was not applicable since the events occurred after the second dose of Spikevax. The reporter did not provide causality assessment. The benefit-risk relationship of drug is not affected by this report
warm to touch; itchy; Swelling of injection site; hurts pretty bad; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PAIN (hurts pretty bad) and VACCINATION SITE ERYTHEMA (red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VALSARTAN for Blood pressure.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PAIN (hurts pretty bad) and VACCINATION SITE ERYTHEMA (red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ALCOHOL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PAIN (hurts pretty bad) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also included cold compression and rubbing alcohol.
He said he felt light headed at first then like he was going to throw up. Then he started to black out and did blackout eyes went to the back of his head lips turned blue. Then when he came to throat started hurting lungs were tight started sweating. Then his back started hurting and had the cold chills.  This was terrifying!!
Son forcibly blinks his eyes 5-10 times in repetition. He will do this out of the blue and while otherwise playing normally. His eyes are not dry and he says they are okay when we ask if they are bothering him. This excessive blinking is completely out of character for him and seems to correlate with him receiving the intranasal Flumist vaccine for the first time.
Information has been received from a license practical nurse concerning her 19 year old daughter with no pertinent medical history who on 20-JAN-2009 was vaccinated with the third dose of GARDASIL (lot# 661531/1311X).  Other suspect vaccines received on that same date included: MMRII (lot# 656034/0182U), VARIVAX (Merck) (lot# 659845/0270X) and MENACTRA.  Subsequently, on the same day the patient developed vision problems.  Few days later she complained of pain in her right eye.  She saw many "floaters" in her field of vision.  Patient sought medical attention.  She went to see an ophthalmologist and tested normal.  Then she became sensitive to the outdoor and indoor lights.  She saw a specialist and he determined that she had "inflamed retinal bilateral".  She was given steroids into her eye but the pressure still increased.  She then saw another  doctor who determined that she had massive pressure in her right eye with "rainbow vision" and performed a surgery on her right eye on 23-JUN-2009 in an outpatient clinic.  At the time of this report the patient was in post surgical treatments, recovering.  Additional information has been requested.
Mom reported patient awoke from sleep a few hrs after vaccine. Was screaming, had pinpoint rash on left at site of 2 injections. Temp 103.7. Went to ER. Was given steroid shot. 4/22/08 - no rash or fever
Pain in upper left arm that lasted 8 days.  Around the 5th day after the 2nd shot my left arm began to hurt more and it went up into my neck on the left side.  About the 7th day when I woke up in the morning My glands on the left side of my neck were swollen.  From that day on I've had a sore throat, body aches, headache, nausea and just general tiredness that won;t go away.  It is May 1st and the last shot was March 20th and I am not feeling any better.  I thought 2 days ago I started feeling a bit better but by today I am feeling worse.
A 72-year-old male patient, after receiving his first dose of PFIZER, found himself in the observation area waiting for his 15 minutes and reports feeling dizzy. Patient is transferred to the incident observation area to have his vitals taken by EMT. The vital signs were: P-67, Sat- 99%, B / P-120/70 and Dxt- 387. At 11:42 am, Doctor is called to consult the case, which indicates that they transfer it to hospital.
Mucousy stools, Diarrhea, and fussiness worse than first set of vaccines at 2 months. Administered all vaccines except Rotavirus at 6 month visit and he had no adverse reaction.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pt indicated that her arm is swollen and hard in the area of injection. I explained that this is a common after effect of vaccine administration. swelling and redness
Narrative: 70 YO male who received the Moderna COVID-19 vaccine on 1/27/21 and 2/23/21. Patient has a history of chronic lymphocytic leukemia. He was hospitalized at outside hospital on 3/2/21 with platelet count of 8, diagnosed with immune thrombocytopenia, and started on prednisone 60 mg daily. Per hematology/oncology provider, immune thrombocytopenia may have been associated with the COVID-19 vaccine. Eventually platelet counts returned to normal limits and prednisone was tapered.
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 PFU for unknown indication (route, dose and frequency unknown). Concomitant medications were not reported. On an unknown date, the patient experienced a patient received ZOSTAVA and alter developed shingles. The outcome of shingles was unknown. Causality assessment was not reported. VZVIIP packed faxed. Product quality complaint was not reported. Additional information has been requested.
Fever to 104 and febrile seizure < 24 hours after vaccine administration. Seizure duration was about 15 minutes. Paramedics transferred patient to ER. Seizure resolved after PR versed administered.
Headache, pain at injection site, headache, fever around 100, and I was very tired. I mostly recovered after a couple of days, but still have some headache.  Then yesterday, 6 days after injection, I started experiencing vertigo. It is like my vision is shifting quickly and I lose my balance. It happened yesterday morning when I first woke up, and cleared up in a minute. Then it happened again in the afternoon when we were on a long hike, and I fell into some bushes. Last night it happened 3 more times as I awoke from sleep.
the pt lt the office w/o significant crying; pt began to cry @ 1PM to 130PM & then fell asleep; 2PM began a high pitch cry that lasted for 15 mins;  mom stated pt never cried like this before;
I tested positive in the middle of Jul; I tested positive in the middle of Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "weak lungs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered", and all described as "I tested positive in the middle of Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had been vaccinated and boosted. He/She had weak lungs and was very nervous about getting covid 19. He/She tested positive in the middle of Jul. He/She contacted his/her doctor, and he prescribed the medicine Pfizer developed to help me beat Covid. He/She was sick for 10 days but recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea/vomiting, chills, lightheadedness, headache, flushing
one dose more than 1 year ago; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 1 year ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The reporter was chatting from pharmacy. The age at vaccination was not applicable. The reporter had a client who did not received 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter reported that the patient's doctor now only prescribed the patient one shot. The reporter asked that kindly advised to see if the patient needs the series or one was enough. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with GARDASIL (Lot number J008423, expiration date 21-JAN-2016, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Slightly sore arm after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 25Mar2021 10:45 (at the age of 50-years-old), as first dose, single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced slightly sore arm after first dose on an unspecified date. Treatment was not given as a result of the event. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
some mild arm tenderness as typical with vaccines; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the COVID-19 vaccine earlier today and had some mild arm tenderness as is typical with vaccines (unspecified date). The outcome of the event was unknown.    Information on the lot/batch number has been requested.
10/12/2022, I am being monitored every 3 months. I had a blood test and my PSA was very elevated. I had another blood test a month later and it was higher yet. I am waiting for a doctor to review my records.
Tuesday, I had body aches, fatigue and general not feeling well. Early Wednesday morning. 03:00 am - over 101 fever. I took Tylenol -  it didn't go down and in 30 minutes it was 102. I was treated that Wednesday after the second dose in ER. They gave me IV fluids and super strengthen Ibuprofen because I had already taken extra strength Tylenol. They were able to bring the fever down after treating me with fluid intake and the ibuprofen. I was released after the fever went down. I was given two days off work to make sure I didn't spike any more fever.
3rd day after the shot, I awoke with large red spot spreading down from injection site; it was very sore to the touch and very warm.  Each day since the redness has spread and now covers a large portion of my upper arm. Today (6 days post shot) the large red area is no longer painful to touch, but it is still spreading, very warm and has started to feel itchy.
nausea; strange feeling on my chest/ Knot in chest; stomach cramping and nabbing; Light headedness and feeling faint; not feeling well; faint feeling; knot in her stomach and chest that is churning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11May2022 at 15:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high Has been normal for some time now. Does not feel like it is relevant. Concomitant medication(s) included: TURMERIC [CURCUMA LONGA], start date: 2022. Vaccination history included: BNT162b2 (Dose 1, LOT: EL9267, NDC, EXP, Dose: Unknown, Right arm), administration date: 22Feb2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, LOT: EN6207, NDC, EXP, Dose: Unknown, Left arm), administration date: 15Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, LOT: FF2589, NDC, EXP, Dose: Unknown, Given at withheld pharmacy store number: #, Left arm), administration date: 15Oct2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 12May2022, outcome "not recovered", described as "Light headedness and feeling faint"; DIZZINESS (non-serious) with onset 12May2022, outcome "not recovered", described as "faint feeling"; NAUSEA (non-serious) with onset 12May2022, outcome "not recovered", described as "knot in her stomach and chest that is churning"; MALAISE (non-serious) with onset 12May2022, outcome "unknown", described as "not feeling well"; ABDOMINAL PAIN UPPER (non-serious) with onset 12May2022, outcome "unknown", described as "stomach cramping and nabbing"; CHEST DISCOMFORT (non-serious) with onset 12May2022 at 05:00, outcome "not recovered", described as "strange feeling on my chest/ Knot in chest"; NAUSEA (non-serious) with onset 12May2022 at 13:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.
pt recvd flu vax & devel lymphadenopathy described as soreness w/ a raised area (3cm x 3xm) in the lt axilla; pt declined to seek medical treatment;
Information has been received from a registered nurse concerning a 17 year old female with penicillin allergy and venereal warts (condyloma and Chlamydia) who on 31-MAR-2011 was vaccinated intramuscularly in the right arm with the first dose of GARDASIL (Lot number 667930/1561Z) and on 27-MAY-2011 received the second dose of GARDASIL (Lot number 667930/1561Z) intramuscularly in the left arm. There was no concomitant medication. The registered nurse reported that over the weekend the patient developed a blister at the injection site in the arm, she returned to the office and the site was a "1 cm blister that had popped on 31-MAY-2011". It was reported that no redness, swelling, itching or pain were noted at the site. No respiratory distress or difficulty breathing were noted. The description of the fluid within the blister when it popped was not known. No exposure or injuries were noted. The registered nurse stated that the patient did not have any difficulties following the first dose. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. Additional information has been requested.
This spontaneous report was received the patient's mother and refers to her 5 year old female daughter. There was no pertinent medical history, drug reactions or allergies nor concomitant therapies reported. On 21-APR-2017, the patient was vaccinated with PROQUAD (dose, route, lot number and expiration date were not reported), along with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, route, lot number and expiration date were not reported) and poliovirus vaccine inactivated (unspecified) (dose, route, lot number and expiration date were not reported), all vaccines for prophylaxis.   On 22-APR-2017 (reported as the next morning), the patient wake up with fever of "103.4 (units not reported) and chills, and shaking". The patient's mother contacted the physician to verify the other injections administered to her daughter and to inform of her daughters symptoms. The reporter stated that the physician's staff only gave the information of the other injections, but did not recommended any treatment for her daughter symptoms. The mother stated that on 23-APR-2017 (at the next morning), the patient was a lot better. The outcome of the events was reported as recovering. No labs diagnostics studied were performed.  The causal relationship between the events and the suspect therapies PROQUAD, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and poliovirus vaccine inactivated (unspecified) was not provided. Additional information has been requested.
9 days after 2nd covid vaccine Awoke with severe vertigo and nausea/vomiting Lasted 6 hours Then started to subside Since then no dizziness but feels "drunk" dizzy.  Her husband needs to drive her.  Does not feel comfortable with big body positions  did not have any particular head motion that started the vertigo.
The next day had vomiting and severe diarrhea for 12 hours/then, 6 days later, I had a repeat of the vomiting and diarrhea for another 12 hours; The next day had vomiting and severe diarrhea for 12 hours/then, 6 days later, I had a repeat of the vomiting and diarrhea for another 12 hours; The following day I became nauseous; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 14:45 (at the age of 69-years-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; primidone taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; paroxetine taken for an unspecified indication, start and stop date were not reported; all these medications were in two weeks. No known allergies. No other vaccine in four weeks. No COVID prior vaccination and no covid tested post vaccination. On 16Apr2021, 13:00 (the following day), the patient became nauseous, and then on 17Apr2021 (the next day) had vomiting and severe diarrhea for 12 hours. Then, 6 days later, the patient had a repeat of the vomiting and diarrhea for another 12 hours. No treatment received for events. Outcome of events were recovering.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
can't stop talking as one of the after effects; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOGORRHOEA (non-serious), outcome "unknown", described as "can't stop talking as one of the after effects".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.