chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 12/16/2021; COVID-19 positive 12/16/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 12/16/2021 Discharge Date: Dec 22, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Altered mental status, unspecified altered mental status type [R41.82] COVID [U07.1]  HOSPITAL COURSE:  The patient is a 62 yo woman with past medical history significant for history of left-sided brain oligodendroglioma status post resection, seizure disorder, hypothyroidism, history of CVA with chronic right leg weakness, with recent hosptialization 10/25-10/29 for weakness thought to be secondary to recrudescence of her prior CVA vs other. She was subsequently admitted at Inpatient Rehabilitation Center from 10/29-11/10/21 for ongoing right leg weakness. She was discharged in stable condition and felt she was doing well until 2 days ago. The patient was re-admitted on 12/16 due to generalized weakness, and fall as well as leftward tilting that has rapidly progresses over the past couple of days.  Patient was found to have COVID-19 infection and the working diagnosis at the time of admission was acute stroke versus regarding since of prior stroke versa generalized weakness due to COVID-19 infection versus thyrotoxicosis.  Patient's TSH was 0.09, free T4 was 1.9.  Initial CT head was negative for acute stroke or intracranial hemorrhages.  MRI of the brain was negative for acute stroke. In terms of COVID-19 infection, patient was fully vaccinated with Pfizer on 04/07 and 5/5.  Has not yet received booster.  She has not required any oxygen at the moment.  Does not appear to be in respiratory distress.  She was offered monoclonal antibodies. Patient has generalized weakness was likely is related to COVID-19 infection with associated uncontrolled hypothyroidism.  The patient 's Symptoms improved after COVID was treated and Synthroid adjusted.  Patient was evaluated by Endocrinology due to underlying hypothyroidism.  Thyroid ultrasound revealed large right lobe thyroid nodule.  Endocrinology increased her Synthroid to 112.5 mcg from 88 mcg.  Endocrine will plan an outpatient right thyroid nodule FNA - scheduled 1/6/2021 at 8:20 am. Following this, will anticipate referral to General Surgery for right hemithyroidectomy vs total thyroidectomy.  She will have a Repeat thyroid hormone blood test in 6 weeks. For age related osteoporosis, endocrine Recommend screening for secondary causes of decreased bone mass hyperparathyroidism, malabsorption/celiac disease, multiple myeloma, hypercalciuria w/ CMP, phosphorus, magnesium, PTH, celiac antibody cascade, SPEP/free light chains, 24h urine calcium/creatinine/sodium. This can be obtained with updated thyroid hormone blood tests in 6 weeks.Update as planned 1/2022 Patient was seen by PT/OT who initially recommended acute rehab but after evaluation they recommended subacute rehab. Her and her spouse were discouraged with this but ultimately accepted discharge to SAR but changed her mind that day so discharged home w/ HH RN and PT.
has been vaccinated 2 times and he has covid-19/he's had all vaccines and still got Covid then had Paxlovid and hit it again; has been vaccinated 2 times and he has covid-19/he's had all vaccines and still got Covid then had Paxlovid and hit it again; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP), Program ID: (001774; 172086; 176514). The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 12Jul2022, this case now contains all required information to be considered valid.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has been vaccinated 2 times and he has covid-19/he's had all vaccines and still got Covid then had Paxlovid and hit it again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Despite being fully vaccinated and boosted, Dr- (name withheld) tested positive for COVID -19 this month. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Is that why Dr. (name withheld), who is "quadruple" vaccinated has been sick with Covid twice now. Second time he used paxlovid and was sicker than before. Paxlovid is only extending the duration of the patient's illness. He called this medication garbage. This is a garbage drug, needs to be studied for the rebound cases of Paxlovid. Caller clarified that he is a physician, provided by inbound transfer agent only as a doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
After my booster vaccine, approximately 5 months post, my right eye on the lower eye lid, there was a small bump, bright red that was tender and painful. And then another bump came up. My eye then swelled up and looked like I had a black eye. I went to two urgent cares and then a specialist that stated that it was a extreme sty. I was given antibiotics to treat it, and now the swelling and lower bumps are gone however the lower eyelid is still red. It is no longer painful either.
Panic attack symptoms...numbness/tingling is hands, feet, lips, tongue, rapid heartbeat, trouble breathing, intense fear, trembling, etc. Severw at first then mild symptoms every day. Symptoms improved 2 days before the 2nd moderna shot. Two days after the 2nd dose, symptoms came back worse and are continuing every day.
Subsequent to receiving one dose of varicella virus vaccine live the pt was clinically diagnosed with shingles. The shingles were described as macular papular lesions covering approximately 3-4 cm of his right inner thigh. The lesions were red, painful and had begun to scab over. Pt was treated with acyclovir.
Sore arm, could not lift arm 1/5/2021 12:30PM - 11:00PM Sore arm 1/5/2021 11:00PM - current Nausea, fatigue 1/6/2021 7:00AM - current
L thigh 9cm x 12cm mild erythema no induration. + warmth and slight tender.
Later on the day I received the injection my arm became sore and I had a headache in the back of my head.  There was no redness at the injection site. I took an Aleve.  The next morning before I got out of bed my muscles ached as well as my arm aching.  I didn't feel like getting up and when I did I was very tired and fatigued. This continued all day and I did not feel like going out for my usual walk. I had very little appetite and laid on the couch most of the day.  I took an Aleve in the morning but it didn't make a difference.  The next day or two days since the injection, I felt like myself again.
On December 9, 1999 and Feb 17, 2000 the vaccinee received his first and second injections of Engerix B. Following his second dose he developed discoloration at the site. There were two concentric circles one darker and one lighter. No treatment was given.
Sore arm at sight of injection. Headache. Muscle aches. Tiredness. Stomach ache. Sore arm evening of injection. Other symptoms next day.
one day after receiving vaccine got chills and fever and didn't feel good for a week. Did not take temperature. Doctor told her not to get second shot due to many allergies. Has had worse headaches than usual for a week and blood pressure was high precipitating trip to doctor 187/101.
An adult dose of Hep A was accidently given as the second dose in the series.  No treatment after CDC was consulted.
Client in today 10/16 complaining of sore, redness, hot to touch from Pneumococcal vaccination on 10/14/03.  Client reports  pain upon elevating arm. Advised client to see PMD or ER if problem persists.
Patient was administered Bivalent vaccine instead of monovalent vaccine when patient came for her second dose of her primary series.
Muscle weakness. Fever of 101.9 Shortness of breath Pretty much like extreme sympthoms of the flu Vomiting restlessness
Pt recvd 1st dose of vax 5OCT90, uneventfully; pt recvd 2nd dose on 2NOV90 & 2-3 days later pt exp a miscarriage; In DEC90 2-3 days p/receiving the 3rd dose exp another miscarriage; Pt has no sequela; vax course has been discontinued;
I was traveling overseas. My symptoms started on 03/13/2023. That evening, I had a slight tickle in the throat. The next day, I did a 7 mile walk and I felt tired after that. I also had some nasal congestion. Wednesday morning, I took an at home COVID-19 test, and it was positive. For 2 years, I have had all vaccinations and have had most groceries pick up, and I always wear a mask. We finally decided to vacation. Before we left, friends of ours had just returned from overseas. They gave us their prescribed PAXLOVID, so I had it with me while I was overseas. I took the PAXLOVID the morning I tested positive. Within 2 days, I had no symptoms. Before we left, I was testing negative. I ended up having a slight rebound and tested lightly positive on 03/26/2023. That lasted 2 days and I tested negative after that. I took no further medications for the rebound. I checked in with my doctor who assured me that I was doing all the right things as far as isolating and treatment.
10 days after injection I had a sudden onset of severe vertigo while at work. I Recovered but have had mild to moderate vertigo many times daily since.
This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 1 patient of 25-44 years old adult with unknown gender were vaccinated with VAQTA (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of the several reports from the same source. Additional information has been requested.
Pt was very nervous about getting a flu shot. She was sitting in the chair being comforted by her dad. I gave her the flu shot and she fainted for about 5 seconds.
Patient received dose 23 hours post puncture at room temperature; Expired dose administered (one patient); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered (one patient)) and PRODUCT STORAGE ERROR (Patient received dose 23 hours post puncture at room temperature) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE (NORVASC) and CHLORTALIDONE (CHLORTHALIDONE) for an unknown indication.   On 11-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Jun-2022 at 8:00 AM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2022 at 8:00 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered (one patient)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose 23 hours post puncture at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered (one patient)) and PRODUCT STORAGE ERROR (Patient received dose 23 hours post puncture at room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated about stability issues and informed that one patient received the vaccine 23 hours post puncture. On 24-May-2022, the vial was initially stored in the refrigerator. On 07-Jun-2022 at 8:30 am the vial was first punctured. Post puncture the vial was stored at room temperature. The vial did not undergo any temperature excursions. The expiration date for the 2nd dose was not provided. The beyond used date reported as 21Jun2022.  No treatment drug details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up contains Reporter email address, Patient details, 1st dose details of suspect product, concomitant medications.
Constant ringing in both ears that started within a few hours of the second dose of the Moderna vaccine. As of today (alomst 5 months later) it has not improved any.
On 8/5/08 pt rec'd HPV-4. On 1/12/09 when nurse in contact with pt again. Pt reports injection site tingling for 2 weeks then site went numb approx 2" diameter around injection site. I informed I would check with our vaccine advisor at city health dept who advised VAERS and to give 2nd HPV. Our physician notified and documentation out in chart. Pt is refusing further HPV.
Had vaccine Monday and started with redness around (L) deltoid with 1.5 x 2 cm center deltoid.
Information has been received form a physician concerning a female who was vaccinated with a 0.5 ml dose of GARDASIL. Subsequently the patient experienced a migraine. It was unknown what dose of series of GARDASIL vaccine migraine occurred after. No lot number was provided. At the time of reporting the patient was recovered. The patient sought unspecified medical attention. Additional information has been requested.
Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time. Patient notified and given the option for an additional dose.
This spontaneous report was received from a consumer refers to a 15 or 16 years old female patient. On an unknown date in 2007, the patient was vaccinated with HPV vaccine (Manufacturer unknown). No concomitant medications were reported. On an unknown date in 2007, the patient experienced swelling of arm in one arm. No treatment information was reported. The outcome of the event was reported as recovering. The reporter considered the event was related to HPV vaccine (Manufacturer unknown). Additional information is not expected.
One day after the injection patient began to feel a tingling at injection site. It is not a constant tingling but comes and goes throughout the day. The patient came to the pharmacy complaining of pain today almost 2 months after initial injection.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine injection) was received from a nurse regarding a 7 month old female pt who experienced a fever of 101 deg. F., increased fussiness and irritability, poor appetite and an injection site reaction, characterized by redness and a large hard area in the muscle around the injection site.  The pt received the first dose on 01/05/04.  The pt had a "negative" medical history.  Indication for Prevnar was immunization.  Product was administered on 01/05/04.  Dose regimen was 0.5mL (IM).  Pt was not taking concomitant therapy.  On 01/06/04, within 24 hours of receiving Prevnar, the pt developed a fever of approximately 101 deg. F., and a local redness around the injection site.  On 01/07/04, the child was seen in the MD's office and "a large hard area approximately the size of a golf ball" was noted in muscle around the injection site.  As of 01/07/04, the infant continued to have a low grade fever, poor appetite, and increased fussiness and irritability.  No additional information was available at the time of this report.
Loud ringing in left ear, mild ringing in right ear, mild intermittent ear pain, difficulty hearing.
18 hours after vaccination onset (9/19/22): low grade fever, chills, fatigue.  9/20/22-9/22: low grade fever, fatigue, headache 9/23/22: fatigue, headache
Pts mother called the next afternoon and spoke with staff at about 3: 27pm on 10/21/2020 stating that the patient came in on 10/20/2020 and had her Tdap and Menactra and both injection sites are puffy, tender, pt is vomiting, and having body aches. Denies shortness of breath and fever
This case was reported by a consumer via call center representative and described the occurrence of amylase increased in a adult female patient who received RABAVERT. The patient's past medical history included rib pain (prior to vaccination). On an unknown date, the patient received RABAVERT. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced amylase increased. On an unknown date, the outcome of the amylase increased was unknown. It was unknown if the reporter considered the amylase increased to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to a doctor. The patient did not want to provide additional information as she was not sure it was the RABAVERT vaccine or a different rabies vaccine. The patient wanted to know in general, if a patient has the last shot in a series of a rabies vaccine then immediately has blood drawn for a pancreas test, could it result in elevated amylase. The patient had amylase level as 40 points above the high end of normal. The test was ordered, because the patient had been having pain under her left side rib cage prior to taking  the vaccine and mentioned it to the nurse who had the test ordered.
Pfizer Covid 12Y & up vaccine was given instead of Pfizer bivalent vaccine. Patient was contacted as soon as error was identified and instructions for next steps was given.
On April 9th I went to the emergency room.  I was diagnosed with Graves disease and was having atrial fibulation and a rapid heart beat.  I read an article statiing at least 5 cases of Graves disease developing within a month of receiving the vaccine.
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA004466. This case involves a 18 years old female patient who received double dose of vaccine FLUZONE QUADRIVALENT (lot number: UJ009AA, expiry date: 30-Jun-2019) via intramuscular route in right deltoid on 02-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to overdose because the patient received a 1ml instead of a 0.5ml FLUZONE QUADRIVALENT. There were no side effects after the injection. 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 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. Documents held by sender: none.
Patient within 5 minutes reported having tingling in his hands and swelling in his hands. Vitals at 9:19 am BP 132/80, O2 sat 96%, HR 102. Dr present in the hall and observed patient.  We decided to watch and wait. A few minutes later, patient started clearing his throat. Patient stated "It feels like there is something in my throat and it is getting harder to breathe". Patient has allergy to bee venom, particularly ground wasps. Dr who was on-call called to the room. Ordered 0.3 mg Epi pen and 50 mg Benedryl IM at 9:37 AM. Given. Patient stated he felt better immediately. Hand swelling started going down. Sensation of throat discomfort and difficulty breathing subsided. Patient asked to wait another 30 minutes for observation. Patient continues to state he feels fine "just a little drousy from the benedryl".    Vitals at 10:33 am HR 100, BP 122/80, Pulse ox 98.   Dr is allowing to discharge to home right now where patient states he has more epipens.
Felt like had hangover; Kinda achy; Did not feel right; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt like had hangover), PAIN (Kinda achy) and MALAISE (Did not feel right) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (Felt like had hangover), PAIN (Kinda achy) and MALAISE (Did not feel right). At the time of the report, VACCINATION COMPLICATION (Felt like had hangover), PAIN (Kinda achy) and MALAISE (Did not feel right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included a couple Bayer acetylsalicylic acid and a lot of water.
pt recv vax;fever up to 104.6 in am of 23jun;pt does not have resp problem; crying more but looked good; blood culture, no growth; given ceftriaxone
left deltoid with rash size 10 cm x 10 cm, hot, itchy, red and is getting larger in size since 01/11/21 at 06:30 pm. Denies pain.
Hospitalization for pneumonia and hypoxia due to COVID-19 on dates 10/20/22- 10/25/22. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
severe heavy, leg weakness; leg weakness; Based on information previously received, the following information that is non case was amended to valid case.  Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case from other health professional (patient's spouse) via Pfizer.  This case involves female patient of unknown age who experienced severe heavy leg weakness (limb discomfort) and (muscular weakness), after receiving INFLUENZA VACCINE.  Patient medical history includes allergy to walnuts.  Medical treatment(s), vaccination(s), concomitant 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 (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe heavy leg weakness (limb discomfort) and  (muscular weakness),  (unknown latency) following the administration of INFLUENZA VACCINE.  Reporter also reported that he was with the question "as he received the shot (PFIZER-BIONTECH COVID-19 VACCINE) 2 hours ago and states that once he received the second dose, will be immune to the virus".  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the reported events.  There will be no information on the batch number for this case.