chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of his upper range hearing; sound gets muddled when he hears the whoosh sound making it difficult to hear; can't concentrate when ringing is most intense; headaches when ringing is most intense; nausea when ringing is most intense; chills; metallic taste; ringing in his ears, experiencing whoosh sounds; arm was sore for 2 days just at injection site; bad fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (loss of his upper range hearing) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001c21a and 003b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included LISINOPRIL, ATORVASTATIN and PREDNISONE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (bad fatigue). On 22-Apr-2021, the patient experienced TINNITUS (ringing in his ears, experiencing whoosh sounds), DYSGEUSIA (metallic taste), CHILLS (chills) and VACCINATION SITE PAIN (arm was sore for 2 days just at injection site). On an unknown date, the patient experienced DEAFNESS (loss of his upper range hearing) (seriousness criterion medically significant), HYPOACUSIS (sound gets muddled when he hears the whoosh sound making it difficult to hear), DISTURBANCE IN ATTENTION (can't concentrate when ringing is most intense), HEADACHE (headaches when ringing is most intense) and NAUSEA (nausea when ringing is most intense). The patient was treated with PREDNISONE for Adverse reaction, at an unspecified dose and frequency. On 23-Apr-2021, FATIGUE (bad fatigue) had resolved. On 24-Apr-2021, VACCINATION SITE PAIN (arm was sore for 2 days just at injection site) had resolved. On 25-Apr-2021, DYSGEUSIA (metallic taste) had resolved. At the time of the report, DEAFNESS (loss of his upper range hearing) and CHILLS (chills) outcome was unknown and TINNITUS (ringing in his ears, experiencing whoosh sounds), HYPOACUSIS (sound gets muddled when he hears the whoosh sound making it difficult to hear), DISTURBANCE IN ATTENTION (can't concentrate when ringing is most intense), HEADACHE (headaches when ringing is most intense) and NAUSEA (nausea when ringing is most intense) had not resolved.            On an unknown date, patient had consulted an ENT. The patient had loss of upper range hearing. His low and middle range hearing was fine. Patient had no prior history of tinnitus and earaches as an adult.  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.; 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.
If the vaccine doesn't work right; Gave the Rabavert in my butt; Case reference number US-BN-2021-002029 is a spontaneous case report initially received from a consumer via regulatory authority (reference number USBAV21-0298) on 23-Jun-2021, and concerns a 27 year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medications included HRIG (immunoglobulin human anti-rabies, given in both arms).  On 21-Jun-2021, the patient went into the emergency room (ER) and received RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at a dose of 1 mL, administered intramuscularly, in the gluteal region (Product administered at inappropriate site), for post-exposure prophylaxis, stating that she had a small break in the skin and that it was not a bite. The patient worried if the vaccine will not work right (Drug ineffective) and considered the event as serious.   At the time of this report, it was not known whether the patient experienced any adverse events due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: Drug ineffective and product administered at inappropriate site are listed by convention. Reportedly, the patient received RabaVert, administered intramuscularly, in the gluteal region, for post-exposure prophylaxis which is considered as product administered at inappropriate site. The patient worried if the vaccine will not work right which is considered as drug ineffective. No adverse events were reported. Product administration error is not related to RabaVert, but to human action. In this case, drug ineffective is not related to RabaVert, either.; Sender's Comments: Drug ineffective and product administered at inappropriate site are listed by convention. Reportedly, the patient received RabaVert, administered intramuscularly, in the gluteal region, for post-exposure prophylaxis which is considered as product administered at inappropriate site. The patient worried if the vaccine will not work right which is considered as drug ineffective. No adverse events were reported. Product administration error is not related to RabaVert, but to human action. In this case, drug ineffective is not related to RabaVert, either.
Patient presented to our health clinic with c/o a rash on his bilateral arms, back, and waistband areas of his body. Describes as mild discomfort of itching and stinging pain (#3/10 scale). DENIES: headache, fever, chills, chest pain, shortness of breath, difficulty breathing, swelling of face/tongue, abdominal pain, nausea, vomiting, or myalgia.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), an unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as H02002 and 08-AUG-2015 respectively, dose and route unspecified) which was exposed to as low as minus 1 degrees Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 09-JUL-2018, the patient was vaccinated with an unspecified dose of improperly stored M-M-R II (strength, dose, frequency and route of administration was not provided) lot# reported as N039914, expiration date 26-SEP-2018, for prophylaxis. Concomitant therapies included sterile diluent (MRK STERILE DILUENT). The doses of M-M-R II were exposed to a temperature excursion of 47 °Fahrenheit (°F) to 77°F during a time frame of 30 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Lot Number N039914 is NOT valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Sinus Tachycardia, fever, chills and muscle pain.  (7-8 hours in duration)
EVENING AFTER VAX PT EXP BACK PAIN,URINE GOLD COLOR. TREATMENT:  TYLENOL, BEDREST. OUTCOME:  SELF-LIMITING.
covid arm? big red area around the injection site about the size of a tennis ball. the injection site is itchy,sometimes burns and stings. day 3 the injection site is still red. this is not a bruise and i have pictures if you need to see.
Client called 2 hrs after leaving clinic, stated feeling very fatigued, had funny taste in her mouth and felt like her throat was swollen, no difficulty breathing, no fever, rash, or unusual pain in throat or arms. Advised to call 911 if conditioned worsened and to call her PCP now for additional advice. Asked her to call back, client called 8/22/12 is back at work, still has slight HA. Taking BENADRYL and TYLENOL as advised by her doctor.
Caller states that 5 deaths, from that vaccine was reported; This is a spontaneous report from a contactable consumer reporting for a patient received from a Pfizer-sponsored program. This is the 2nd of 5 reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKOWN, SINGLE for Covid-19 immunization, age at vaccination unknown. The patients medical history and concomitant medications were not reported. Consumer stated that he did took a survey in his neighborhood, going door to door, and some people had taken the vaccine and some had not. Consumer stated that 5 deaths, from that vaccine was reported, and over 50% of people reported a debilitating disease, or cannot function, and have thousands of dollars in medical bills. The outcome of event was fatal. Autopsy was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100913512 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: Consumer stated that 5 deaths, from that vaccine was reported
Right arm became swollen. Was admitted to hospital 4/5/05 with MMR reaction; rule out cellulitis.
Patient states she is having referred sensation in her face. For example, when touching the roof of her mouth with her tongue, she can "feel" a sensation on her cheek similar to a finger touching her cheek. Or when she touches the side of her nose she can "feel" a sensation on the skin beneath her eye. The sensation is not associated with pain or numbness, is just strange.
Autoimmune diseases: Thyroid issues (Hashimotos), Type 2 adult onset Diabetes, Mitro valve prolapse, high blood pressure, high cholesterol, Vertigo all day every day, possible stroke. The usual treatments of drug prescriptions that I turned out to be allergic to so quit taking them. All happened over the years of taking a flu vaccines.
This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. No pertinent medical history or concomitant medications were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB pediatric formulation, lot # L040458 with expiration date 04-FEB-2018 and lot # L033343 with expiration date 13-SEP-2017 (dose and route of administration not provided), and improperly stored RECOMBIVAX HB adult formulation, lot # L042846 with expiration date 15-SEP-2017 and lot # L014419 with expiration date 15-APR-2017 (dose and route of administration not provided). The vaccine products were exposed to the following conditions: temperature 0.3 degrees Celsius for 8 hours. There was no previous temperature excursions. The temperature excursion was captured via a Digital Data Logger. This is one of several report from the same reporter. Additional information has been requested.
I administered both immunization into the patients right arm about 2 inches apart. The patient was nervous about getting the injections. Gave both fine and he was fine when finished. I advised to his mother that he hang around for 20 minutes in the store to make sure that he didn't have any issues with breathing or respiratory issues. Approximately 5 minutes after the injections he became lightheaded and pale and fainted. We rushed to him and evaluated the scene. He was conscious and gaining color back. He was lucid and I checked his pulse/bp which was 121/74 with a pulse of 94. He kept telling me he was fine but I kept him on the ground until ems arrived approximately 5 minutes later. They evaluated him again and he was lucid checked his bp/pulse and got him on his feet. He was still slightly pale but stated he felt fine. His mother transported to the hospital to make sure everything was ok.
pt recvd DTP on 18AUG92; woke up inam 19AUG92 w/3" area of errytherma, induration & bullae;
patient receiving 3 doses; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacy student requested information about the patient receiving 3 doses of the Shingrix, which led to extra dose administered.  She did not have any information about the patient. The reporter did not consent to follow-up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 12:45 as dose 1, single (Lot number: FR8730), in left arm, on 15Apr2021 at 10:30 as dose 2, single (Lot number: EN5318), in left arm and on 18Nov2021 at 18:30 as dose 3 (booster), single (Lot number: FH8030) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The patient did not receive any other medication in 2weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; negative; positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event: On day 11 of after symptoms started, 4 days after I ended the Paxlovid treatment, and 3 days after testing negative, I have tested positive again. Adverse event country: reported; Adverse event start date: 21May2022; Adverse event start time: 07:45 AM; Anti-viral details: Product: COVID 19 Treatment; Brand: Pfizer paxlovid; Treatment start date: 12May2022; Treatment stop date: 17May2022; Lot number: GC0466; Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
I am very dizzy; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included depression (take lot of medications), blood pressure high and cholesterol.   On 18th May 2020, the patient received Shingrix. On 19th May 2020, 1 days after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and felt dizzy. The reporter wanted to know does dizziness was related to Shingrix. The reporter just drove to get gas and was got scared because of the dizziness.  The reporter wanted to know how long this would last.
Narrative: 1/12/23 - Pt presented to ED with c/o feeling rough. Pt has cough, chest pain (pt BIBA for chest pain rated 5/10), and SOB. Pt also reported 5 episodes of diarrhea within 3 days, weakness, n/v, poor appetite, and intermittent numbness in chest. Pt reported low grade temp last night. Pt diagnosed with COVID x 1 week. Cardiac stents placed 4 months ago. Pt given 324mg ASA in ambulance with some relief of chest pain = 3/10. EMS placed on 2L oxygen via nasal cannula for comfort. Pt was diagnosed with COVID while at facility 5 days ago. Pt admitted to hospital on 1/12/23 with Primary Diagnosis: Covid 19 Dehydration Acute kidney injury chest pain HOSPITAL COURSE: Patient presented with nausea, vomiting and dehydration. He was found to have AKI which resolved with IV Fluid hydration. He was COVID (+) and because of multiple co-morbidities, he received 3 days of Remdesivir treatment. He was severe weak. He underwent Physical Therapy and it was recommended for STR vs LTC. It is most likely his high dose of Metformin 2gm bid also contributed to his weakness. He was d/c'ed off of Metformin and started on Lantus 20 units qhs. His electrolytes were replaced (Low K and Low Mg). He is stable and will be transported to skilled nursing facility today. Weakness/Decondition: - Continue PT/OT evaluation. -PT RECOMMENDATIONS: STR- to LTC at this time. - Skilled nursing facility today Covid 19 infection - on room air with oxygen saturations 96-100% - continue supportive care - Remdesivir day #3 (Completed) AKI (baseline creat ~ 1.2): Resolved - monitor renal function Hyperkalemia: Resolved - Patiromer x 1 - K 4.8 -> 4.4 -> 4.1 -> 4.4(today) Hypomagnesemia: - Mg 1.3 -> 1.6 -> 1.5 - Supplement w/Mg 1 gm IV today. Chronic Medical Problems: Seizure Disorder - continue with home Keppra (dose adjusted for renal function) T2DM/w/Hyperglycemia: - D/C'ed home metformin - Started Lantus 20 units qhs - carb controlled diet COPD - not in exacerbation HTN - continue with carvedilol, amlodipine HLP - holding home atorvastatin due to weakness - resume if weakness improves CAD - continue with aspirin, plavix, carvedilol, imdur - continue home ralonazine RA - home hydroxychloroquine - continue with home prednisone Dementia POA pressure injury Stage 2 left ischium with friction component too POA right lateral ankle Stage 3 Hypomagnesemia: Resolved DVT prophylaxis - sq heparin
1/9/21 after 2nd dose on 1/7/21 I had a moderately severe headache and severe fatigue.  By 1/10/21 AM I was fine.   3/1/21 I developed moderately severe dry mouth and dry eyes that haven't resolved.
Left arm redness and swelling approximately 4 inches in diameter. Warm to touch, fever 2 days post vaccination. Dr. saw pt. Advised parents to ice area and give benadryl otc (parents have at home) Parents were told to return to clinic if not better by tommorow. No induration, 3 X 4 cm reddened area...
This spontaneous report was received from the patient's mother via company representative, concerning a currently 14-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection, intramuscularly (anatomical location, strength, dose, frequency, lot number and expiry date were not reported) for prophylaxis, by a health professional at a doctor's office. The injection was reported to be painful. On an unknown date, also reported as exact time not known, the patient complained repeatedly of pain and swelling at the injection site. Which, persisted for months. The outcome of pain and swelling at the injection site was not provided. The events were reported to the doctor, who indicated that the issues were probably not related to GARDASIL. However, the pain was localized at the injection site and a palpable swelling was present at the injection site.
I almost fainted; Nausea; Feeling sick and throw up; Feeling sick and throw up; felt very light headed/dizzy; Ear pain (right); This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at 18:00 (Lot Number: EW0162), as single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included unspecified nasal spray. The patient experienced almost fainted (medically significant) on an unspecified date with outcome of unknown, nausea (non-serious) on an unspecified date with outcome of unknown, feeling sick and throw up (non-serious) on an unspecified date with outcome of unknown, felt very light headed/dizzy (non-serious) on an unspecified date with outcome of unknown, ear pain (right) (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.
Dizziness, Headache, Hand tingling, neck pain Narrative: No treatment by PCP per employee
and said her was very sore at injection site; 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 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "and said her arm was very sore at injection site".  Follow-up (03Dec2021): 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.
Fever detected at approx 5 am, may have onset earlier during the night; runny nose as well
Major hives/rash (large and small) all around the vaccine injection spot on her thigh. Also the area was swollen for 3  weeks around the injection spot too.
Strong pain in hip area; Pain in right hip that worsened at night; Pain of left hip that made it hard to walk and this pain worsened at night; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in right hip that worsened at night), ARTHRALGIA (Pain of left hip that made it hard to walk and this pain worsened at night) and ARTHRALGIA (Strong pain in hip area) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Chronic kidney disease stage 3. Concomitant products included METFORMIN, BENAZEPRIL, TAMSULOSIN, ATORVASTATIN, PANTOPRAZOLE and REPAGLINIDE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRALGIA (Pain in right hip that worsened at night) and ARTHRALGIA (Pain of left hip that made it hard to walk and this pain worsened at night). On 06-Mar-2021, the patient experienced ARTHRALGIA (Strong pain in hip area). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. On 06-Mar-2021, ARTHRALGIA (Pain in right hip that worsened at night) had resolved. On 13-Mar-2021, ARTHRALGIA (Pain of left hip that made it hard to walk and this pain worsened at night) had resolved. On 14-Mar-2021, ARTHRALGIA (Strong pain in hip area) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received on 5-06-2021 include patient medical history and an event was added
chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to sleep, fever (I can't remember what it was), sweating (even after taking layers and blankets off), fatigue, arm swelling, and pain where the injection was, nausea, unable to stand for short periods of time, This lasted over 24 hours, the next day the same but on a lesser progression but included diarrhea and a  swollen supraclavicular lymph node being swollen-- > 5"x2".
pt recv vax & 5mo post vax pt exp gen aches & pains & muscle weakness;pt indicated that needed to pull self up the stairs & upon bending over to reach for an object on the floor had great diff standing up;sx slowly resolved;