chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I can no longer taste any of the food I am eating; This case was reported by a consumer and described the occurrence of taste loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th March 2020, the patient received the 2nd dose of Shingrix. On 9th March 2020, 3 days after receiving Shingrix, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved.   It was unknown if the reporter considered the taste loss to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had the 2 part SHINGRIX shot. The patient could no longer taste any of the food after eating. The patient thought it would come back but it has not yet after a month (from the day of reporting).
RAN A LOW GRADE FEVER FOR THE FIRST 24 HOURS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced ran a low grade fever for the first 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ran a low grade fever for the first 24 hours. This report was non-serious.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fever-Mild, Additional Details: all the symptoms gone away but pt wants to report events
Patient was given Pediatrics Pfizer Bivalent and not the 2nd dose of the Primary Series. Management was notified, NP notified and patient and parent was immediately consulted. Patient and Parent remained at facility under careful watch for any side effects after vaccine was given. No side effects occurred.
The patient was admitted with Acute on chronic stage 3a CKD, Hypoxia, COVID 19, Afib RVR, Chronic diastolic CHf, Type 2 MI. . He was treated with 5 days remdesivir and decadron. He was weaned off oxygen to room air. He did have new onset afib RVR while he was here. Cardiology placed him on Eliquis and cardizem which kept him rate controlled. He had a low risk VQ scan and no DVT on doppler. He was started back on his lasix at D/C but his ace was held. He was asked to follow up outpatient.
Pain in left arm; Tenderness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm) and VACCINATION SITE PAIN (Tenderness on injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm) and VACCINATION SITE PAIN (Tenderness on injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in left arm) and VACCINATION SITE PAIN (Tenderness on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021 contains information regarding the route of Moderna vaccine.
She got her vaccines, she started running a fever once they got home.  At 3:00 PM yesterday the fever went away, then she mentioned to her husband that it was gone, and then she got up and then she realized that she started to loose her balance, and her motor skills on her right side, right arm and right leg were adversely affected and started to loose control of it, had trouble walking.  They felt that it might be something that was going to go away, she could not sleep all night and she called him this morning and she needed help to get up and get around.  Her husband called pharmacy and he explained what was going one, and she informed him that it could be a stroke.  He called Medical Center and explained what he was e explaining to me, and they felt that it might be a stroke, and they told him to bring her to the ER.  In the ER at 8:00 AM this morning, and they did a CAT scan, the doctor came in and told them it was not a stroke, and that they recommended that she see a neurologist.  They indicated that one would be in during rounds, they waited 2 hours and nobody talked to them, and they decided since she did not have a stroke that they needed to go home.  Her husband did bring it up that he had seen that peripheral neuropathy was a cause of the vaccine, but nobody wanted to talk about that.  He had an article that showed what treatment and prescription and they stated that they had never heard of it.    His wife has never had any health issues, and she has never had such issues like this prior to the vaccine.  He feels it was due to the vaccine and if they had known what type of reaction she could potentially have that she would not have had the vaccine.  The pharmacist said that they were going to file a report.    She has feeling in her arm and leg, she has strength, has good hand strength but she has difficulty writing her signature, but she can hold a pen, but controlling it the way her mind wants to is difficult for her, which is exactly what the peripheral neuropathy is.
12/29/20  New throat tightness & nasal congestion that worsened over the first 15-40 minutes post-vaccination.  Patient alerted observation staff & requested a drink of water to see if that would help or perhaps resolve throat soreness.  While drinking, the congestion was confirmed since mask was off.   Symptoms did not worsen, but EMS team was called in per protocol for further review.  Blood pressure was WNL for this patient (~ 100/60); SpO2 98%, CO2 monitoring WNL.  Patient reported *possible* similar reaction to Flu vaccines in past years that were deemed "within expected reactions to flu vaccination" that resolved within 24hr.  Patient was given Diphenhydramine 50 mg PO & released to home.  Follow-up phone call later confirmed that the symptoms had improved. 12/30/20 - Upper respiratory symptoms resolved.  Patient reports unusual taste in mouth with blunted flavor from food, also described as faintly metallic. Had used new mouth rinse for last several days, so she will stop using that product to confirm if this new symptom is from the vaccine or the mouth rinse. 12/31/20 - continued odd taste sensation. (Not using Crest mouth rinse.). Will continue to monitor & any future symptoms will be reported via the v-safe application.   **This report is being filed via VAERS only because the initial V-safe check in for 12/29/20 timed out & would not allow the patient to report the URI symptoms that happened immediately post-vaccination.
This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 17-SEP-2013 the patient was vaccinated with improperly stored M-M-R II (H018181, exp. 05-OCT-2014), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619). Additional information has been received.
Dehydration; Drowsiness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 11Apr2021 at 15:00, the patient experienced dehydration and drowsiness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported events. The clinical outcomes of events dehydration and drowsiness were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
I traveled for meetings. I got there 9/10/2021. On 9/11/2021, I was in a large gathering, but I did wear a mask. While eating though, I did not have a mask. I had a mild cough and a sore throat. At the end of the week, my colleagues had COVID-19 symptoms. I decided to get a test done on 9/21/2021. I tested positive but at that time my symptoms were getting better. I needed to go to an Urgent Care for antibiotics. I had oral antibiotics for the earache. It did not help. I was given another antibiotic which also did not help. I went to an ENT where I was given antibiotics via eardrops in the ear which helped. I have also had some residual irritation in my lungs which has continued since. I have persistent irritation and shortness of breath. When I went to an NP, I was started on Zyrtec because she felt some of my symptoms could've been allergies. I was also given benzonatate for my cough. The benzonatate did not help much. I am still taking Zyrtec currently which seems to help.
Bright red rash devel 24 hrs p/recvd DTP/HIB/OPV; rash present from neck down to knees; some sores present in testicle area & under arms; rash improved in 2 days;
Patient said the next morning she had a fever of 102 and her arm swelled to the size of a baseball. She came in the day after that and showed it to me. Her arm was red and slightly blistered as well as bruised in the middle of the injection site. Did not continue to spread and was reportedly getting better per the patient.
Pt given Hep B Recomb, first vax uneventful, soon p/2nd dose, pt developed sore throat, backache, 17APR91 mild chest pain & some SOB; Pain inc had difficulty breathing fr pain; Hospitalized 19APR91 & chest tube placed;
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA251031 and 2018SA251068 (same reporter). This case involves 19 patients of an unknown demographics who received a 0.5 mL dose of ADACEL lot U5898AA, expiry date: 20-Mar-2020 (dose, route and site of administration were not reported) which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was also reported that refrigerator temp reached 56 F for 15 days from 01-Aug-2018 to 15-Aug-2018. It was not reported if the patients experienced any adverse event or not. 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. List of documents held by sender: none.
Incessant Cough, congestion- treated with antibiotic - cough still ongoing 3 weeks later.
This spontaneous report as received from an unknown reporter via Pfizer concerning a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL dosing (details, lot# and expiry date were not reported). On an unknown date, the patient experienced an unspecified adverse event. The outcome of the event was unknown. The reporter did not provide the causality between the event and GARDASIL. Additional information is not expected as no reporter contact details were provided.
Pt had pain, erythema and increased warmth to left arm. Biceps measurements of left arm 32.5cm and right arm 31.0cm. Had 2 erythematous patches about 8cm X 11cm noted superior and inferior to left elbow. No pain noted today. Pt treated by MD with Benadryl and ibuprofen. Left elbow measurement 30.5cm, right elbow 27.5cm. Pt feeling better today but not fully recovered yet.  Follow up 06/05/2000: "Patient recovered from adverse event."
A little itchy when went to bed 10/1/14. Woke up very, very itchy, on right side, right arm, arm pit, breast, shoulder, up neck and right side of scalp and ear. Took 25 mg of BENADRYL 9:30 am 10/2. T 99.1 - rx dr.
Redness in the area where the vaccine was administered, upset stomach is upset. Appears to be injection mechanical type injury to left upper arm.
admitted for delivery of baby; asymptomatic testing of patient before delivery resulted positive for COVID-19 by SARS-CoV-2 (COVID-19) by NAA, . Patient report never having COVID symptoms or previous positive test
A report has been received from a Physician via medical representative concerning, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started during Oct-2013. The patient experienced tested positive for Influenza A over the holidays. The outcome of the event of tested positive for Influenza A over the holidays is unknown. The report was considered to be non-serious. Corrected report: 05-Feb-2014: Key Ingredient corrected. Postal code added.
This spontaneous report was received from a registered nurse concerning a female patient under 15 years of age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 24-MAR-2016, the patient was vaccinated with the first dose of GARDASIL via intramuscular, as prophylaxis (Strength, dose, lot # and expiration date were not reported). On 07-JAN-2017, the patient was vaccinated with the second dose of GARDASIL 9. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
4 year vaccines were given on 08-15-12. Pt. started with a hive-like rash on (L) leg after vaccines were administered. BENADRYL given and rash resolved.
lingering headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (lingering headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Acid reflux (esophageal) and Lipids NOS abnormal (Antilipidemic). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE, MULTIVITAMINS [VITAMINS NOS], NITROFURANTOIN and BIMATOPROST for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced HEADACHE (lingering headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache NOS, at an unspecified dose and frequency and IBUPROFEN for Headache NOS, at an unspecified dose and frequency. At the time of the report, HEADACHE (lingering headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Heart rate: abnormal (abnormal) Heart rate going up and down at night..         This case was linked to MOD-2021-221236 (Patient Link).
Shingrix diluted with incorrect diluent; Shingrix diluted with incorrect diluent and was administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis.   On 30-OCT-2023, the patient received Shingrix. On 30-OCT-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix diluted with incorrect diluent) and inappropriate dose of vaccine administered (Verbatim: Shingrix diluted with incorrect diluent and was administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The pharmacist stated that he/she needed to speak with someone about Shingrix which was mixed with sterile diluent, not the adjuvent suspension component provided with product. The reporter had a situation where a healthcare professional diluted Shingrix with incorrect diluent and was administered to patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consent to follow up.
1/6/21 injection site discomfort, which lasted approximately 2-3 days. 1/13/21 injection site redness, itchy, hard, warm to touch - no change in symptoms at this time and no worsening symptoms, monitoring
Child received vaccine during daytime. Reportedly very lethargic sleepy late afternoon/ dinner time. Possible shivering for 5-6 minutes.
Patient received shot at 4:15pm on 02/11/2018. She reported pain, redness, swelling of 5-6 inches in length and itch on arm of injection at 8pm on the same day 02/11/2018. She went into an urgent care the next morning on 02/12/2018. She was prescribed PERCOCET 5/325, prednisone 5mg, cephalexin 250mg, and ALLEGRA 180mg.
Headache, Sedation, Myalgia, Arthralgia, Fever, chills and fatigue. Narrative:  Other Relevant History:
BRIEF OVERVIEW: Admission Date: 6/9/2023 Discharge Date: Jun 12, 2023 Discharge Disposition:  home health care  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypokalemia [E87.6] Generalized weakness [R53.1] AKI (acute kidney injury) [N17.9] Fall, initial encounter [W19.XXXA] Left upper lobe consolidation [J18.1] COVID [U07.1] Compression fracture of thoracic vertebra, unspecified thoracic vertebral level, initial encounter [S22.000A] COVID-19 [U07.1]   HOSPITAL COURSE: 72 y.o. female  COPD requiring 2.5 L O2 at baseline presents to emergency department with complaint of cough and shortness of breath x 3 weeks. Seen by PCP prescribed a 9 day taper of prednisone, completed 7 days. Patient's husband had COVID about a month ago, but patient never tested positive. She unfortunately had her sandal caught and she sustained a fall  . She presented with SOB and back pain .    Patient presents to emergency department tachycardic with heart rate to 110. She was initially placed on 4 L via nasal cannula but was weaned down to baseline 2.5 L. labs remarkable for potassium 2.8, creatinine 1.55, AST 44, ALT 43. Patient has a leukocytosis of 14.7. COVID-19 positive. Procalcitonin was at 12.9.  CTA thorax shows left upper lobe consilidation, mod-severe COPD, hiatal hernia and distal esophageal wall thickening, sclerosis and compression of T9. No evidence of PE. Patient was given 40 mEq of potassium and a 1 L normal saline bolus. CT lumbar and thoracic spine showed  age-indeterminate moderate burst fracture T9.   Seen and examined, husband and wife appreciative explained diagnosis, plans and need for ff up . Discharged hemodynamically stable.
on the same day as first dose of covid vaccine, several hours later, patient had first episode of supraventricular tachycardia. Required vagal maneuvers in ambulance to resolve. No longterm sequelae.
chills; Stomach discomfort; This is a spontaneous report from a non-contactable consumer or other non hcp. A adult male patient of unspecified age received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient previously received bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 07Jan2021 as DOSE 1, SINGLE for covid-19 immunization and had no reactions. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. No known allergies were reported. Report stated that the first shot was fine with no reactions. On an unspecified date, after second shot on the same evening, the patient woke up with chills and stomach discomfort. It did not last long and he felt at 50% the rest of the next day. The patient was fine at the time of the report. No treatment was received for the adverse events. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had COVID right after her last Pfizer shot; Had COVID right after her last Pfizer shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004210.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. 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) all with onset 2022, outcome "unknown" and all described as "Had COVID right after her last Pfizer shot". Additional information: On 11Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at dose 4 for COVID-19 immunization. It was reported the patient had COVID right after her last Pfizer shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.