chrisvoncsefalvay/vaers-outcomes huggingface dataset:
metallic taste and smell; metallic taste and smell/diesel taste and smell; diesel taste and smell; This is a spontaneous report from a contactable consumer (patient himself) via Pfizer. A 68-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 02Mar2021 at around 13:00 (as reported) as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Patient medical history was not reported. The concomitant medications included amitriptyline had been on for 20 years, patient takes as needed because he was in a bad car accident at a dose of 10 mg, butalbital, caffeine, paracetamol (FIORICET), cyclobenzaprine, had been on for 20 years at a dose of 10 mg taken for headache. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 09Feb2021 at around 14:00 (as reported) as dose 1, single for COVID-19 immunization. Patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (First dose last 09Feb2021 & Second dose on 02Mar2021). He reported to have had a metallic taste and smell, like a diesel engine. Patient mentioned he was unsure when this started but it had been 3 months already. He also stated that he saw a physician, but he still wanted to know if it had been reported. He had an awful taste and smells the same odor. It had been a few months with the metallic taste in his mouth. Patient added that diesel taste and smell started about the time that they got the shots. Patient stated that he did say it was metallic earlier but he would not say it was metallic, he thought that people who do not have experience say it was metallic. He stated it was more like diesel fumes and a bitter taste that he tastes and smells. He did not know when this started but stated that it just stays the same. Patient was asked when symptoms started and he stated he could not really say that. He never thought about it until the last months or so he noticed he had it for a while. He smelled the same odor and taste if that makes any sense because taste and smell are related. Patient added he had never been sick or had any childhood diseases. He wanted to know if it was something because the doctor wants to test his kidney and liver. He had no health problems. He had bloodwork a month before the vaccines and everything was fine and they want to use him as a lab rat right now. Description of Product Complaint included patient was discussing the treatment for his diesel-like taste and smell that he was experiencing for a while. The doctor gave him a pantoprazole 40 mg for acid reflux. The adverse events resulted in physician office visit but not the emergency room visit. Patient received pantoprazole at a dose of 40 mg for acid reflux. The outcome of the events was not resolved.   Additional information about batch/lot has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 11-NOV-2013 the patient was vaccinated with a dose of improperly stored PROQUAD, (lot # J008574, exp date 12-JAN-2015), 0.5 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
Initial report received from a healthcare professional on 07 August 2013. A female patient (age at the time of vaccination not reported) had received first dose of Tdap vaccine (lot number: "L4464AA" (invalid lot), anatomical site of administration was not reported) intramuscularly on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 29 December 2012 and the estimated date of delivery was 28 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA". At the time of this report, the patient had not experienced any adverse event. Treatment for infertility was not reported. List of documents held by the sender: none.
Headache; Feeling of malaise; Sore joints (wrists, elbows, knees); Fatigue; Feel like a mental fog; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 13Apr2021 at 08:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (Mangoes). Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. 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 13Apr2021 at 21:30, the patient experienced headache, feeling of malaise, sore joints: wrists; elbows; knees, fatigue, felt like in a mental fog. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, feeling of malaise, sore joints: wrists; elbows; knees, fatigue, felt like in a mental fog was recovering.  No follow-up attempts are possible. No further information is expected.
4-month old female patient received an expired pentacel dose with no reported adverse event; Initial information received on 14-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old female patient who had received an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine; and Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 13-Jun-2023, the patient received 0.5 mL dose 1 of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ666AAA; expiry date: 04-May-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 4-month old female patient received an expired pentacel dose with no reported adverse event.  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 the guidelines. 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.
Patient returned to clinic at 4:20pm - 2hr after receiving vaccine - reporting of difficulty breathing and dizziness (both 7/10). Patient reports unable to work. HR=74, RR=16, SP02=98% on room air. Received liquid benadryl 30mL/75mg PO. Symptoms improved following administration and was able to speak without gasping per clinic staff. Patient was released to home and transported there via the company vehicle following resolution of symptoms at 4:40pm.
The pt suffered persistent diplopia and was diagnosed with VIth nerve palsy; Information has been was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 29-SEP-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for the prevention of shingles (herpes zoster) (dose, route, anatomical site, lot #, and expiration date were not provided). On an unspecified date (reported as shortly after receiving the vaccine), the pt. suffered persistent diplopia and was diagnosed with 6th cranial nerve palsy (VIth nerve paralysis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered VIth nerve paralysis to be disabling event.  Upon internal review, the event VIth nerve paralysis was determined to be medically significant.
After 2 hours sore throat. After 4 hours extreme fatigue, dizziness, asthma flare up.  Walking and talking became a challenge. After 8 hours body aches, very painful at vaccine site and difficult to move arm. Dizziness, extreme fatigue, asthma flare ups continued for at least 3 days.  About 24 hours later fever of 100 for 3 days. After 24 hours diahrea and strange stomach ache that lasted at least 3 weeks.
Information has been received from a physician concerning a 2 year old female who on 21-SEP-2007 was vaccinated with a first (date unknown) and second (21-SEP-2007; 2 mL po) doses of Rotateq. On 29-OCT-2007, the patient experienced intussusception and melioration. Subsequently, the patient did not experience an adverse event with the first dose. The patient was hospitalized and had surgery. No further information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. 11/28/07-operative report and lab reports received for DOS 10/29/10/31/07- Operative report:exploratory laparotomy, reduction of intussusception. Ladd procedure with appendectomy. on 10/29/07 3:00 a.m. emesis followed at 9:00 a.m. with bloody stool and became progressively lethargic. During reduction found patient was malrotated that the entire right colon was not fixed, that there were Ladd's bands which crossed the duodenum which gave a very narrow mesenteric width. Could not completely mobilize the duodenum.  11/28/07-vac record received VAERS updated.  12/04/07-DC note received for DOS 10/27-10/31/07-DX Intussusception. Presented on 10/27/07 with acute onset of vomiting and bloody stools during night. No fever. Listless. Refusing oral intake.
Severe chills, fever, migraine, joint pain all over, excruciating lower back pain, extreme fatigue, injection site bruising, swollen lymph nodes,
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 06-MAR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Hospitalized with a major surgery/ Some blood leakage in brain; Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Brain operation in March 2021.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine). The patient was hospitalized on 01-Mar-2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) and PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  Patient had received the first dose of the Moderna Covid-19 vaccine and ended up being hospitalized in March with a major surgery that involved some blood leakage in brain. Patient had essentially missed the second Moderna Covid-19 dose scheduled in mid-March and at the time of reporting patient was about 90 days after receiving the first Moderna Covid-19 vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up received on 11-May-2021 Updated the Reporter, patient information  and serious event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been requested.
Pt first became viremic on day 9 after vaccination with myalgia, arthralgia, swollen lymphnodes and malaise. Day 10 chest pain onset substernal sharp constant in nature, exacerbated with deep breaths. Pt went to the ER. Where Troponin I elevated at 4.66, BNP wnl, ESR wnl, CRP wnl, Chest PA/Lat unremarkable. Ketoralac given with resolution. Pain returned next day. Pt was.
Within 10 minutes of receiving immunizations, pt develop4ed urticaria on face and head. Pt was given Benadryl 50mg/ml 0.05ml IM. Urticaria resolved within 15 minutes. Was also given Benadryl Elixir 0.05ml orally QID. Mom contacted on 06/09/04. Baby is doing fine. Developed redness at site of Prevnar injection on 6/8/04.
Exhaustion, insomnia, fever, swollen lymph node in right underarm. Painful to the tough and without. Grew to size of a golf ball.
Tinnitus; This non-serious case was reported by a consumer and described the occurrence of tinnitus in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 74FB9, expiry date 30-NOV-2023) for prophylaxis.   Concomitant products included hydrochlorothiazide and testosterone (Testim).   On 24-OCT-2022, the patient received Shingrix .5 ml. On 25-OCT-2022, 1 days after receiving Shingrix, the patient experienced tinnitus (Verbatim: Tinnitus).  The outcome of the tinnitus was not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.     It was unknown if the company considered the tinnitus to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-AUG-2023 The patient reported that he received Shingrix vaccine and experienced tinnitus. The reporter stated that the symptoms was did not treated. The reporter did consent to follow up via email.
presents with symptoms of shortness of breath and bilateral leg pain. Sx onset: 6/10/22.  Positive Test: 6/11/22.
This spontaneous report was received from a nurse refers to a 67 year old male patient. Pertinent medical history and drug reactions or allergies was reported as none. On 10-DEC-2013 the patient was vaccinated with ZOSTAVAX, 0.65 milliliters, subcutaneous for vaccination. Concomitant medications were none. On 10-DEC-2013, the patient experienced lingering joint pain in the right shoulder and itching and on his right arm, rash on his right arm the same day he received ZOSTAVAX. The only issue the patient still had was lingering joint point. Treatment given was BENADRYL and DECADRON injection. Patient sought medical attention and contacted the physician. There was no product quality complaint (PQC) involved. The outcome of itching and on his right arm and rash on his right arm is unknown. The outcome of lingering joint pain in the right shoulder was reported as not resolved. Causality assessment was not provided. Additional information has been requested.
THROAT SWELLING OCCURED 10 MINUTES POST VACCINATION; TOOK 2 BENADRYL 25 MG TABS, PEPCID 10 MG AND ADMINISTERED EPIPEN 0.3 MG, STARTED TO IMPROVE. EMS CALLED AND TRANSPORTED PATIENT FOR OBSERVATION
Patient had nausea and vomiting after the vaccine booster given. Patient explained she was a diabetic and had not taken medication or eaten yet. We were in a residential setting doing vaccines. She wanted to goto her apartment and rest. The resident employee worker checked on her throughout the  day and said she stopped vomiting.
fever, chills , vomiting's, dry eves, headache, diarrhea, slight dizziness  symptoms lasted about 24 hrs. but was week the next 2 days after
Diaphoresis, Fatidue, Voice change, SOB, cough, vomiting, weakness
Violent chills, severe headache, nausea, body aches, general ill feeling, shakes, sweating, weak, vomit one time.
Within few minutes of vaccine, patient c/o itching on her back fine flat red rash was noted covering trunk. Benadryl 25mg po given. Patient recovered without further incident.
Chills; Bad headache; Nausea; High Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (High Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-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 CHILLS (Chills), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (High Fever). At the time of the report, CHILLS (Chills), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (High Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
RED RASH/BURNING/RED WELTS BY AM BENADRYL FROM AFTER HOURS CALL TO DOCTOR APPOINTMENT FRI AM PRESCRIBED PREDNISONE CURRENTLY ON TREATMENT SLOWLY SUBSIDING
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received SHINGRIX. The patient's past medical history included back arthritis and glaucoma. On 17th May 2018, the patient received SHINGRIX (intramuscular). On 17th may 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, appetite absent, lethargy and exercise tolerance decreased. On 18th May 2018, the patient experienced fever and neck pain. On an unknown date, the outcome of the tiredness, lethargy and exercise tolerance decreased were unchanged and the outcome of the appetite absent was unknown and the outcome of the fever and neck pain were recovering/resolving. It was unknown if the reporter considered the tiredness and appetite absent to be related to SHINGRIX. The reporter considered the fever, neck pain, lethargy and exercise tolerance decreased to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced some pain at the injection site. The patient also experienced exercise intolerance. This was defined as cycling being more difficult and requiring more energy. The patient also reported he was not as hungry after injection. One day after vaccination, the patient experienced slight fever of 100.4 degree F and neck pain.
Information has been received from a registered nurse concerning a 17 year old female who in 09/04, was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Four to five hours post vaccination she developed a fever, malaise and dizziness that lasted up to 48 hours. Subsequently the patient "felt fine". Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested.
Patient felt light-headed, nauseas, tingly, tachycardic along with a hot-flash upon administering vaccine. Patient was given cold water to drink and I put a fan on her to help cool her off. Once her mouth became tingly, we agreed to call EMS to come check her out. Once EMS arrived, patient was feeling better. EMS checked her vitals and released her. We called her Aunt to come pick her up.
monday march 22nd shot at 10am , severe chills by 12midnight, took 1 tylenol every 6 hours  through tuesday and feeling tired, slept by  evening, starting to  feel better and wednesday ok .  did not call a dr.