chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gillian Barre - First noticed as weakness in both hands/fingers. Then could not straighten fingers. Traveled to legs and feet. Could not walk. Spent 1 week in hospital. at wich time I was given medication through an IV. 5 vilas  given 1 vial a day. Transfered to in patient rehad facility for 1 week. Finally had months of out patient rehab (ot and pt treatments) As of today, 12/10/2021 only about 80% recovered. Must use a cane when walking. Can not walk far (get tired very easily) 50% recovers in hands/fingers. Can not still straighten fingers and very little griping strength
Experienced sore left shoulder, body aches, joint pains, chills, and headache 8 hours post injection.  Approximately 20 hours post injection, experienced fatigue, joint pains, and body aches. Approximately 28-40 hours post injection experienced severe headache. Approximately 3 days post injection, experienced warmth at the injection site, redness, a burning sensation at the injection site, pain, and a red rash with blistering consistent with dermatitis.
So the symptom is bilateral ring (tinnitus) in the ears and no specific treatment for it. I try to use background noise to keep me a where of it. It is in both of my ears. I have been to an ENT and audiologist. I will be seeing my general doctor here soon.
ADVERSE EVENT:  POSSIBILITY OF VACCINE STORAGE IN UNAPPROVED FREEZER TREATMENT:           NONE OUTCOME:                NO ADVERSE SIGNS OR SYMPTOMS WHATSOEVER
No adverse events, but patient was due for pfizer #2 monovalent and I ordered the bivalent booster, which was given instead, so reporting per CDC recommendations
Ran fever of 102F and screamed with shot. For the next couple of months, he started not have eye contact, lack of facial expression, starring spells and bizarre mood swings. Per doc 199569, patient ran fever day of injection, crying. The annual follow up states still autistic like behaviors, no eye contact, speech delay.
This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with ROTATEQ oral injection, (dose, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.; Sender's Comments: US-009507513-1702USA008447: US-009507513-1702USA011949: US-009507513-1702USA011950:
PFizer vaccine was administered after being discovered that the vaccines were kept in the freezer for 11 days longer than the two week standard time.  Patient was notified and given option for additional dose.
Pt had swelling in left shoulder, upper and lower arm and back of head. Pt started taking Celebrex on 11/3 and swelling/ pain were gone by 11/5.
Sudden loss of strength in left hand/arm involving wrist extention and radial deviation and grip strength. Normal range of motion is still present but stregth is significantly diminished and has reurtned only minimally.  Right arm is normal.
My mother is extremely healthy and active. She had labs completed in October and all values were normal. She has never been on medication.   She experienced a heart attack and under more scrutiny found a blockage which required a stent.   Her doctor refused to report the adverse event.  This goes against everything I know about medicine.
I had chills, felt achy, I was talking to my partner, she suggested that I take a COVID-19 test. It came back positive immediately. I called my doctor, had a virtual visit, I was prescribed the PAXLOVID that my partner went to the pharmacy to pick up for me. I started it that night. By the next day I was feeling better. I did get severe diarrhea from taking PAXLOVID and the taste in my mouth was horrible. I am feeling better thank goodness.
Starting 12 hrs after injection, Muscle aches, fatigue, fever 101 (while taking 600mg advil every 6 hours) for 2 days, followed by left arm rash (2 days), period 18 days early in cycle, followed by another period 2 weeks later, starting  11/7 extreme lightheadedness (constant buzzing feeling base of skull) and brain fog, inability to multitask, slow thinking and significant memory lapses/brain processing issues for 1 month (began noticing improvement December 4 timeframe),  11/28 brief blurred vision in left eye followed by scintillating scotoma 2 hrs later (never occurred before), doctor discovered high BP, hospital visit to rule out stroke, BP 109/106, elevated diastolic since then (86-90), prior history of low BP before second vaccine dose. Theses were similar, but prolonged symptoms as compared to  what was experienced after second dose of vaccine (second dose- fever, extreme fatigue, 5 periods in 12 weeks, concussion like symptoms, including brain fog and constant headache for 10 days starting day 4 after second dose)
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 30-MAR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX (which had a lot # of L035129 and an expiration date of 14-SEP-2017; however dose, dosage number and route of administration were not reported). The temperature excursion involved was 13F and the time frame of the excursion was 4 hours. However, no adverse effects were reported. Additionally, it was stated that there were no previous temperature excursions. Also, no product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
catarac in r eye; Deficiency in vitamin B12; leg started to heal and look so much better and the last scab was finally gone; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (catarac in r eye) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Have skin cancer and had two surgeries in the past to help. It has been a few years since the last surgery.). Concurrent medical conditions included Skin cancer and Wound oozing (3-4 inch bumpy non-healing area in right knee constantly oozing a bloody to pinkish fluid.). Concomitant products included METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), CARVEDILOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN B12 NOS for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CATARACT (catarac in r eye) (seriousness criterion medically significant), VITAMIN B12 DEFICIENCY (Deficiency in vitamin B12) and THERAPEUTIC RESPONSE UNEXPECTED (leg started to heal and look so much better and the last scab was finally gone). The patient was treated with IBUPROFEN for Throbbing pain, at a dose of 400 mg three times a day. At the time of the report, CATARACT (catarac in r eye) and VITAMIN B12 DEFICIENCY (Deficiency in vitamin B12) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (leg started to heal and look so much better and the last scab was finally gone) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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 25-Jul-2021: Significant follow up was received. New event- cataract added. Case was upgraded to serious.; 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.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 176th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
3-31-21 6PM STATING PT PASSED OUT AND HAD A SEIZURE; HE WAS HOLDING HIS VACCINATION CARD IN HIS HAND - REQUESTING PHONE NUMBER. CALLED FOR TRANSPORT TO ER.  4-6-21 10AM PT STATES HE HAS A HX OF BECOMING LIGHTHEADED FOR MANY YRS. HE WAS IN THE CHECK OUT LINE  AND 'FELT LIGHTHEADED AND WAS GOING TO GET SOME CANDY TO FIX IT(HADN'T EATEN MUCH THAT DAY)'. BYSTANDER STATES HE PASSED OUT AND HAD A SEIZURE. HE DID FX RT SHOULDER. HAS AN APPT TO SEE PCP FOR F/U.
she had swollen lymph nodes on the left side where she was administered the vaccines; her arm was very painful; She had fatigue with the Bivalent vaccine, and also with the other doses too.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL8982, Expiration Date: May2021) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "She had fatigue with the Bivalent vaccine, and also with the other doses too."; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "her arm was very painful"; VACCINATION SITE LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she had swollen lymph nodes on the left side where she was administered the vaccines". Therapeutic measures were taken as a result of vaccination site lymphadenopathy, vaccination site pain.  Additional Information: Reporter reported that After the 1st vaccine her arm was very painful, she took Advil but it didn't improve the pain so she used ice, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine, she would like to add that with the three previous vaccines (the first two and a booster) She had the nodules inflamed but on the left side, where they gave her the vaccine. There is a product complaint to report, The sample of the product not available to be returned; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036537 same patient, different vaccine dose number, different event;
PATIENT STATED HAD HIVES/RASH A FEW DAYS LATER  AFTER THE VACCINE, WHICH HE ANTICIPATED DUE TO HIS ALLERGY TO NEOMYCIN. HE TOOK BENADRYL AND HAD SOME RELIEF. RASH IS MORE UNBEARABLE ON 11/8/22 AND TODAY HE CALLED TO ASK FOR FURTHER SYMPTOMS ALLIEVATION, IN WHICH ORAL CORTICOSTEROIDS WAS RECOMMENDED.  PT ALSO USED TOPICAL STEROIDS THAT HELPED BUT TOO SHORT OF DURATION.  PREDNISONE WAS PRESCRIBED BY HIS DOCTOR AND PRESCRIPTION WAS PICKED UP THIS EVENING 11/10/22. PATIENT WAS RECOMMENDED TO START WITH OTHER HEPATITIS  B VACCINES, BUT AGAIN INSURANCE REQUESTED PRIOR AUTH FROM DOCTOR, HENCE PATIENT WAS RECOMMENDED TO GET SERIES AT DR OFFICE.
This spontaneous report as received from a health worker refers to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
I had to go to the ER 1 week after my first shot and I got diagnosed with Bell?s Palsy. I am unsure if this is linked to the vaccine but I have seen that this is a potential side effect and thought it may be linked but unsure. They diagnosed me with Bell?s Palsy and my right side of my face has still not been working properly.
I tested positive for COVID-19 on 12/20/22. I had a cough, sinus drainage. I thought it was a common cold and I talked to my friend that is a doctor and she told me to go get tested. I went to the doctor, tested positive, and was prescribed 5 days' worth of PAXLOVID. I had no other symptoms at that time, but I developed a terrible sore throat, low-grade fever, fatigue, chills, loss of appetite, and altered taste. Things still don't taste right from time to time, but overall, I am fine now.
Patient came to pharmacy described swelling on (R) arm below injection site at 5:45pm. Inj was given at 10:30 am. Approximate 3-4 inches in length swelling. Pt apply ice and Ibuprofen since painful.
Initial information was received on 04 November 2008 from a health care professional. A 64 year old female patient with a history of COPD (chronic obstructive pulmonary disease), smoker, hypertension, hyperlipidemia, depression, acid peptic syndrome, glaucoma, restless leg syndrome, cerebral vascular disease, migraines, colon polyp, lactose intolerance, sleep apnea, "malasia", nasal allergies, and allergies to sulfa, tenormin, methylprednisol, niacin, and lovastatin. On 24 October 2008 the patient received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2740AA). The patient reported achiness after previous flu vaccines. On 24 October 2008 within hours after vaccination the patient reported general achiness, chills, vertigo, headache, sinus drainage, breast bone hurt and her breathing was affected. The patient's oxygen saturation was 85%. The patient was sent to the emergency room and hospitalized overnight. The patient's symptoms had resolved by 31 October 2008. List of Documents held by Sender: None.
p/vax pt devel two episodes of diarrhea & vomiting;pt recovered;
Exhaustion - onging Swollen lymph node left arm pit - ongoing Lower back ache - ongoing Hair loss - ongoing
After receiving the shot, the patient experienced a lot of pain on the arm where the shot was injected. He came to the pharmacy to tell us about it and we told him to apply ice and get some acetaminophen. He came back again to say that the pain did not go away so he was told to add some ibuprofen to his regimen. He said that the pain relievers helped but the pain is still lingering.
This spontaneous report as received from a other health professional (medical assistant) refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an 10-FEB-2017, the patient was administered vaccinated improperly stored (Incorrect product storage) with GARDASIL 9 (dosage regimen were not reported) for prophylaxis. Drug was administered by patient. Temperature (32 F and 36F) excursion was because of data logger. No adverse effects (no adverse event) noted by reporter. All drop down fields apply to unknown patient. no further information to report. Additional information has been requested.
IMZ site red, puffy and 2-3 in across. Not hot, or painful.
Cellulitis of right thigh, Blue 5 cm X 5 cm circle with warmth/redness around bruise, 33 cm @ injection site around right thigh - Keflex
she gave the vaccine to a patient when it was mixed with sterile water instead of the diluent that was needed with no reported AE; Initial information received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a physician via Medical Information number: 00845695.  This case involves a 42 years old female patient who received YELLOW FEVER VACCINE - US [YF-VAX] mixed with sterile water instead of the diluent that was needed (product preparation error).   The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US lot number: UJ397AA and expiry date not reported via subcutaneous route in the left arm for prophylactic vaccination.  It was case of an actual medication error due to Wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Anxiety, decreased BP, dizziness, shock, seizing, shortness of breath. Loss consciousness ~30 sec. Regained after EPIPEN administration.
Fatigue, chills, mild fever, headache, injection site pain, swollen lymph node
I had a little soreness but I was fine/soreness in her arm; they both quarantined. She reports that they came out of quarantine this past Thursday and were told they were fine to get the vaccine. Now she worries she has covid; body aches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left (left upper arm) on 27Mar2021 (Batch/Lot Number: ER0733; Expiration Date: 31Jul2021) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she had her first covid vaccine on Saturday (27Mar2021) and reported that she felt great, she had a little soreness but she was fine, she exercised yesterday, but last night (28Mar2021) she had a temperature and body aches. She asked if this is from the first vaccine dose or could she have covid? Patient reported that her husband had covid about 1 week ago, they were able to distance in the house, she didn't have any symptoms but they both quarantined. She stated her husband had Covid and came off quarantine on last Thursday 25Mar2021. She clarifies the state Health Department called and told him he was out of quarantine. She confirms she stayed quarantined from her husband those 10 days. She slept upstairs.  She did not provide further details on her husband for report. She reports that they came out of quarantine this past Thursday and were told they were fine to get the vaccine. Now she worries she has covid. She stated her father was in memory care and she was waiting for the day she could get her vaccine so she could see her father again. She stated she felt fine, she just had some soreness in her arm (unspecified date), just a little bit. She exercised and felt great. Last night, 28Mar2021, it hit her and she started running a temperature of like a 102.She asked if this was normal for the first vaccine? She cried all morning because she was worried and wanted to know if this was normal with your first shot? She wanted to know if this is a side effect? She would rather it be a side effect than think she could have COVID. She declined to fill out a safety report and wanted to speak with someone in MI to know if this could be a side effect so she can go on about her day. While looking for information off of her vaccine record card, the She makes the comment "oh my goodness I can't see nothing" and mentions something about her contacts. The outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced problems with vaccine (more sleep than ever off and on). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
swelling of eyelids was noted 30min p/vax while on the way home;PE was unremarkable x/swelling of both the lower eyelids & hyperemic of the conjunctivae;tx w/med;
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 06-OCT-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Lightheadedness. Dizziness. Since that date, I have had my annual physical, visited emergency room, cat scan of head, chest X-ray, ekg, multiple blood tests; visited family doctor, physical therapist; ear, nose and throat doctor;cardiologist; emergency room doctor, chiropractor, optometrist. Tried meclazine; low dose aspirin; Clara tin.