chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a mild sore throat; it was a little different than sore throats in the past. I wanted to cough to get my throat cleared, I was very tired, I wanted sleep, like when I have the flu, a low-grade fever that lasted a little more than a day. I tested for three days in a row, and it was not until day three that it came back positive, by then I felt as if my symptoms were starting to wane. I called my doctor to have a telehealth visit to discuss my positive test result, and my symptoms. I was able to take the Paxlovid and was feeling much better in 2 days. Ten days later I got rebound COVID-19, I did test negative ten days later.
Pain and reduced mobility of LUE started soon after vaccine administration. Pt thought it was due to the tetanus vaccine however the pain continued. Pt experiencing pain with abduction, extension of LUE, has difficulty raising hands above head. Pt is icing and using NSAIDs with some relief. Currently complaining of pain and reduced mobility day 8 post injections. Vaccine was given close to greater tubercule of humerus. Pictures available for documentation.
I started with a slight sore throat and then I also had a headache. It was a bad headache. I started getting congestion as time progressed with my sinuses. My wife said to test and I was positive. We were driving to see family but halfway through we stopped and went back home. It moved a bit into my chest and I had some general weakness. It was mainly those symptoms that day. I went to the urgent care on the way home and was prescribed PAXLOVID. They also gave me benzonatate for a cough. I used throat lozenges as well and I contacted my daughter who is a physician and she told me to take MUCINEX as well. It took the pressure off my sinuses. We continued two more days traveling home and the headaches continued and the sore throat. Four days into the infection, I used chloraseptic throat spray. I only took two of the pills for coughing because I didn't cough too much. I had a lot of congestion. I took ROBITUSSIN DM each night. Each day got progressively less as far as the headache. I do still have a lot of build up in my sinuses. As soon as I wake up in the morning, my sinuses are typically full. I no longer have a headache or sore throat. I do experience some weakness resulting from any exercise. We can't figure out where or how I ended up with COVID-19. I would say I'm 95% recovered, but still dealing with the sinus issues. I still do not feel 100%.
I GOT SICK THE DAY AFTER THE MIST ???; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history and concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported that patient had the same reaction every time. She had the mist the day after. She was told that it was a coincidence she got sick and probably already was it happened twice, the day after the mist (preferred term: Malaise).     The outcome of i got sick the day after the mist  was unknown.    The i got sick the day after the mist  was considered non-serious by comapny physician.
Patient received GARDASIL #1 around 2 am.  At 2:20 pm, patient developed dizziness and right leg cramp followed by locked jaw C-1.  Patient remained alert.  Sent to ER - patient received IV turodol and recovered in 5-10 minutes and discharged from ER.  Phone patient at 2 am 8/20 - patient ok.  8/22/2008 ER record received for DOS 8/20/2008 with DX:  Trismus-resolved. Pt presented to ER from PCP office after receiving 1st Gardasil.  Following shot, pt's jaw locked and couldn't open mouth.  Pt c/o 8/10 jaw pain. Toradol given IV.  Full ROM of jaw 40 minutes later. D/c home
DAY 2 AFTER VACCINE SIGNIFICANT SWELLING/TENDERNESS OF LEFT AXILLA. ON DAY 9 SIGNIFICANT HIVES/ITCHING STARTED ALL OVER BODY (HEAD,NECK,CHEST,ABDOMEN,LOWER EXTREMITIES) UNRELIEVED BY OVER THE COUNTER ANTIHISTAMINES. SEEN BY PRIMARY CARE TODAY.PRESCRIBED 10 DAY COURSE OF ORAL STEROIDS AND ADDITIONAL ANTIHISTAMINES. NO RECENT CHANGES IN HEALTH,MEDICATIONS,PRODUCTS OR DIET. NO KNOWN ALLERGIES.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: 1802070), in right arm, on 28Oct2021 as dose 2 single (Lot number: Ff2593), in right arm and on 13May2022 as dose 3 (booster), single (Lot number: Fm0173) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "high cholesterol" (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 Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (10Oct2022) Positive, notes: tested positive again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking other medications/ products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient had no known allergies. After fever, sore throat, headache and overall feeling badly resolved with Paxlovid, cough and congestion continued. After testing negative for five consecutive days beginning on day 5 or 6 after symptom onset, tested positive again for COVID on 10Oct2022. This was a full 15 days after beginning Paxlovid. Adverse event was rebound COVID.
pain in nervous system of back, arms and legs; fatigue; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia. Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced fatigue and muscular back pain. On an unknown date, the patient experienced pain in arm. The patient was treated with ibuprofen and biofreeze (nos) (Biofreeze). On an unknown date, the outcome of the fatigue, muscular back pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscular back pain and pain in arm to be related to Shingrix.  Additional details were received as follows: This case was reported by the patient's husband. The age vaccination was not reported. The patient woke up very fatigued with pain in her muscles of her back after receiving vaccine. The patient saw her healthcare professional and they did blood work but did not find anything. The patient was concerned that getting the 2nd dose 4 days early case more severe reaction. Emergency room visit was required. The reporter stated that the patient called back asking about specifics around immunosuppressive medications the effect on the vaccine. The patient was still suffering from pain in her nervous system of back, arms and legs. The patient tried rubs, ibuprofen and biofreeze which offered temporary relief but the pain returned. The reporter did not consent to follow up. This case has been linked with case US2019118444, reported by the same reporter.      Lab Comments: On an unknown date blood test was done
Resident present with new onset fever, cough, and muscle aches. Assessment performed with V/S: T- 100.5, BP- 152/80, 78, 20, 96% RA,. Primary care provider notified. Ordered to give PRN acetaminophen 500 mg. No complications noted. Medication effective. Will continue to monitor
Hives all over body, shortness of breath, treated with IV (Benadryl, Prednisone and Pepsid)
Severe nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 12:00 (Lot number: Ew0182) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Antidepressant" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for antidepressant therapy. The following information was reported: NAUSEA (non-serious) with onset 04Jun2021 02:00, outcome "recovering", described as "Severe nausea"; VOMITING (non-serious) with onset 04Jun2021 02:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of nausea, vomiting. Follow-up attempts are completed. No further information is expected.
COAGULOPATHY, UNSPECIFIED TYPE 3/22/2021 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY COAGULOPATHY, UNSPECIFIED TYPE 3/22/2021 METABOLIC ENCEPHALOPATHY COAGULOPATHY, UNSPECIFIED TYPE 3/22/2021 ATRIAL FIBRILLATION, PAROXYSMAL
Got mine last month now I have the flu; I feel terrible for a week now; Initial information was received on 01-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who got Influenza vaccine last month now have the flu and feel terrible for a week.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination last month now have the flu (influenza) and feel terrible for a week now (feeling abnormal) (unknown latency). Must have been a weaker flu shot.  Action taken: Not applicable.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the events.
Employee had immediate reaction to administration of flu vaccine on 10/19/04. She felt burning at the injection site, then in the affected arm and up into her neck. Sent her to the ED where she was treated and admitted with allergic reaction, for administration of steroids and breathing treatments. Employee was admitted to inpatient and received medications for SOB. Discharged on 10/21/04. Discharge summary states neck tight, allergic reaction, difficulty breathing and itching. msv
Given second shot on Wed 2/24 at 12pm -- Had flu like symptoms for one day.  Woke up on Sat 2/27 with sudden hearing loss in left ear. Hearing loss was accompanied by a loud static sound and pressure. Saw ENT specialist on Tue 3/2 -- no evidence of any wax buildup. She immediately sent me for hearing test; showed 70% loss. Both doctors feel this is a Viral infection and that it may have occurred due to my strong  immune response I had to the COVID vaccine. Was prescribed 60mg of Prednisone for two weeks; am on day 3 as of writing this. Am going to see another specialist tomorrow, 3/5/21. I am a healthy 50yr old male with no previous hearing problems. The only change in my life was getting the vaccine. I think this important to report, although I have yet to find any link between vaccine and SSHL. I have been tested over the last year a few times (mouth swab) and all test were negative. I have not been tested since my hearing loss, though I don't feel sick at all. I have read that some people who actually had COVID experienced new or increased tinnitus but did not find anyone who had actual hearing loss -- this was just doing some online reading; not actual study reports.
Lightheadedness with hot flashes, tunnel vision, and near syncope. Fatigue and body aches
red rash over her torso including her back and lower stomach and a slight rash on her arms and legs; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) in a Public Health Clinic, via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization.  Medical history included diabetes and high blood pressure both from an unknown date and unknown if ongoing. The patient had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. The patient has not been tested for COVID-19 post vaccination. Concomitant medication included metformin hydrochloride, pioglitazone hydrochloride (ACTOPLUS MET), olmesartan medoxomil (BENICAR), loratadine (CLARITIN) and montelukast sodium (SINGULAIR). The patient had red rash over her torso including her back and lower stomach and a slight rash on her arms and legs on 24Jan2021 at 12:00. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient was administered a steroid shot by her primary physician as treatment for the event. The outcome of the event was not recovered.
Case number PHEH2011US02400 is an initial spontaneous report received from a nurse on 22 Aug 2011. This report refers to a male child. His concomitant medication included MIRAMAX oralle at a unknown dose for an unknown indication. He was given only the MenCYW lyophilized liquid conjugate component of MENVEO (batch number: 090901) intramuscularly on 15 Jul 2011. On the same day he was also given the second dose of BOOSTRIX (batch number: unknown). No other adverse reaction was reported.
No symptoms or additional adverse effects reported; patient received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 27-JUL-2020, the patient was vaccinated with unspecified dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # T003714, expiration date 29-JUL-2021, (exact dose, injection site and route of administration were not reported) for prophylaxis. Sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine experienced the temperature excursion of -9.2 degrees Celsius for 3 hours and 20 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010467:
Headache Narrative: employee states: she has done well except for a periodic headache which is not painful but is annoying
FLUBLOK was administered to 9 pediatric patients with no reported adverse event; Initial information was received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a healthcare professional.  This case is linked to cases 2022SA418226(CLUSTER), 2022SA419186(CLUSTER), 2022SA419213(CLUSTER), 2022SA420021(CLUSTER), 2022SA420094(CLUSTER), 2022SA420025(CLUSTER) and 2022SA420021(CLUSTER).  This case involves a 2 years old female patient and reporter reported Influenza quadrivalent recombinant vaccine [Flublok] was administered to 9 pediatric patients with no reported adverse event .  No other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 10-Oct-2022, the pediatric patient received a total dose of suspect Influenza quadrivalent recombinant vaccine 0.5 ml (with unknown strength and formulation) (lot: QFAA223, expiration date: 30-Jun-2023) via intramuscular route in the left deltoid for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  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 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.
Irregular heartbeat; Hives on cheeks, ring finger and on different parts of the body; Hives like "bombs"; Regular "flu-like" symptoms; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001BZ18A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals NOS (Allergy to yellow hair dye 5) and Allergy to chemicals NOS (Allergy to yellow hair dye 6).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Hives like "bombs"), INFLUENZA LIKE ILLNESS (Regular "flu-like" symptoms) and VACCINATION SITE PAIN (Pain at the injection site). On 12-Apr-2021, the patient experienced URTICARIA (Hives on cheeks, ring finger and on different parts of the body). On 22-Apr-2021, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat) (seriousness criterion hospitalization). The patient was hospitalized on 22-Apr-2021 due to HEART RATE IRREGULAR. At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat), URTICARIA (Hives on cheeks, ring finger and on different parts of the body), INFLUENZA LIKE ILLNESS (Regular "flu-like" symptoms) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown and URTICARIA (Hives like "bombs") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took ice and other natural things as treatment for non-serious events.  On 22-Apr-2021, patient got hospitalized for irregular heartbeat and went in ambulance. She said irregular heartbeat may be due to stress. As doctor suggested she didn't take 2nd shot.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up TCR form was received on 04-May-2021. Patient had new events and was hospitalized.; 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.
flu symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that:  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as single dose for COVID-19 immunisation and experienced sore arm. On an unspecified date in 2021, the patient experienced flu symptoms for 36 hours after receiving the Pfizer-BioNTech COVID-19 vaccine. The clinical outcome of the event was reported as recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected
Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she was drugged/felt foggy; Feeling out of it, like she was drugged; Feeling restless at night; She hasn't been able to sleep at night; This is a spontaneous report from a consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 on the left arm at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). Medical history included ongoing Grave's disease from 2007. There were no concomitant medications. On 16Dec2020 (19:00), the patient was feeling out of it, like she was drugged, and felt foggy. On 17Dec2020, the patient had felt exhausted. In Dec2020, the patient was feeling restless at night; and has not been able to sleep at night. On an unspecified date, the patient had felt like her thyroid was off and could not function well. The outcome of the events was recovered in Dec2020 for 'feeling out of it, like she was drugged, and felt foggy'; was not recovered for 'feeling restless at night' and 'has not been able to sleep at night'; and was unknown for all the other events. The patient was leery about receiving the second COVID-19 vaccine dose.
During observation patient developed 1 red raised area on left arm. Per patient ?I feel dizzy, lower lip tingles.? Given Benadryl po, Orange juice and water. Patient was observed for 30 minutes. Hive decreased in size. Per patient, ?I feel fine.?
REPORTED TODAY REDNESS ABOUT 4 INCHES IN DIAMETER, WEAKNESS, FATIGUE - ONSET TIME APPROXIMATE.
VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.29 LATE AFTERNOON.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 02 May 2008 from a consumer.  A 61-year-old female patient, whose medical history was not provided, had received a tetanus immunization (trade name, manufacturer's name, route and site of administration not provided) on an unknown date.  At an unspecified amount of time later, the patient experienced shock.  Treatments received and diagnostic tests performed were not provided.  Recovery status of the patient was not provided.  No other relevant medically significant information was provided.
Pt reported severe redness and swelling at the injection site the day after receiving the vaccine that prompted her to go to the emergency room. She was diagnosed with cellulitis and given antibiotics. She reported the incident to us on 11/21 (received vaccine on 11/5) and was recovered by the time of the reporting.
This spontaneous report as received from a other registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose and lot # not reported) orally. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Dizziness, dizzy spells 4x/day for 6 days, then 3x/day for 5 days, then 2 dizzy spells/day for 3 days, then 1 dizzy spell per day for 3 days, then dizziness/dizzy spells subsided and I experienced no more dizziness.