chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with tingling in left leg, leg spasms, twitching, pain and STILL battle muscle aches, twitching and other sensory issues.  10/23/2009 Received medical records (office encounter notes) DOS 6/3/09-9/29/09. DX: muscle pain, neck sprain and strain, cold, cold sore. Received flu vaccine 10/2009. Same day noted tingling of L extremities. ED visit. Told follow-up with neuro. Spine and brain MRI (-) x2. Tingling continues intermittently w/fatigue more mild. Occurs more frequently at menses, but also random. Post vaccine syndrome. Does not fit profile for Lyme or fibromyalgia. Subsequent office visits reveal cold virus with oral lesion consistent with viral infection, neck sprain and strain occurred when coughing, cold sore at base of nose, late menses. Pregnancy negative.10/23/2009 Received medical records (PCP office encounter notes)   DOS 6/3/09-9/29/09. DX: muscle pain, neck sprain and strain, cold, cold sore, post vaccine syndrome. Received flu vaccine 10/2008. Same day noted tingling of L extremities. ED visit. Told follow-up with neuro. Spine and brain MRI (-) x2. Tingling continues intermittently w/fatigue more mild. Occurs more frequently at menses, but also random. Post vaccine syndrome. Does not fit profile for Lyme or fibromyalgia. Subsequent office visits reveal cold virus with oral lesion consistent with viral infection, neck sprain and strain occurred when coughing, cold sore at base of nose, late menses. Pregnancy negative.  10/26/2009 Medical records received (neurology visits) for DOS 11/3/08-1/28/09.  DX: Post vaccine syndrome.  Flu vaccine received L delt . Later same day developed persistent fatigue. Progressed to intermittent pain, parasthesia all extrem. Heaviness in arms. Burning sensation throughout body. HA. Vertigo. Anxiety s/to sx. Also L ear pulsation, aching jaw and  limbs stiffness.  PE consistent neuro intact. Romberg(-). DTRs symmetric. Adverse rx to steroid tx. D/C after 9 days. SX decreasing over time.   11/02/09 Medical records received for DOS 4/16/09. Neuro office visit.  CC parasthesia. C/O since d/c twitching noise L ear, flaming sight, fatigue, L transient calf muscle spasm, multifocal fasciculations, migratory spotty tingling, pain zaps, all on L except for fasciculations.  Now muscle aches, L eye fasciculations, L perioral tingling. But generally better.  Head pressure. PE all normal except for slight L facial flattening with synkinesis. Repeat MRI.  No change.   Parasthesia possible myelopathic, not an isolated syndrome or CNS event.  Recovered well.   ICD9 Codes: 782.0, 794.09, 388.31, 351.0.
Information has been received from a medical assistant concerning a 68 year old female with iodine and rofecoxib (MSD, WAES#0807USA02273) allergy, Barrett's esophagus and GERD who on 18-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck) (LOT #659409/0409X) 0.65 ml, intramuscularly in the right arm. Concomitant therapy included (CELEBREX) and (FLOMAX). The medical assistant reported that on 19-JUN-2008, the patient developed pain at the injection site. On 21-JUN-2008, the patient experienced pain. She had multiple vesicular lesions on her left T6-T9 dermatomes. Her temperature was 97.5. It was unknown if the patient had a recent exposure to chickenpox and there was no recent exposure to shingles. On 23-JUN-2008, the patient was diagnosed with shingles. The patient's symptoms were pain and an unspecified rash on the left chest under the left breast. The patient was prescribed (VALTREX) and (LORTAB) for symptom relief. No other symptoms or treatment reported. At the time of reporting the patient was recovering. As of 30-JUN-2008, the patient still had shingles on the abdomen. The patient sought medical attention. Additional information is not expected. This is in follow-up to report(s) previously submitted on 9/24/2008. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) ZVZ strain or with the OKA/Merck vaccine VZV strain. Follow up information was received from the VZV identification program which reported that the sample of the lesion was collected on 25-JUN-2008. The sample was taken from a vaccine. The VZV DNA was amplified, the VZV strain identification was wild type. The interpretation of the result was adequate specimen, wile type strain. This is an amended report. Information regarding results of the VZV identification program were added to the laboratory field and narrative. No further information is available.
Initial misuse report received from a healthcare professional on 20 February 2014. The cases were received on 20 March 2014 at GPV. A dose of YF VAX was inadvertently reconstituted with sterile water and administered (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
01/29/2021- Toward the end of the day I got chills and felt feverish but had no fever, got home, around 4:30pm and my fever spiked to 102.0 scratchy throat, 1/30/2021, my throat was very sore, at the end of the day I had white patches, went to ER and I had strep.
1437: Pt arrived to observation area pale, diaphoretic and drooling. Pt disoriented for 4-5 minutes. Per daugher, pt not at baseline. Bp 84/52, 89, o2 sat 98% room air.      1443: Vital signs improved 142/74, 98%sat room air, no longer pail. Daughter request 911 and transfer to ER. Daughter stated pt had previously had a similar episode.    1452: pt care transferred to 911 and pt transferred to ER.
Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of HPV Vaccine. Subsequently, the patient experienced throat swelling. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
On 04/02/2021 I had all Vaccine side effects listed on FDA&CDC websites. On 04/03/2021 At about 2000 hours I started breaking out in a rash across my abdomen and face which causes me to be itchy and red. Later at about 0400 hours am while driving my cruiser I noticed my throat was starting to swell. I drove my car to the emergency room and was treated for a allergic reaction given steroids and Benadryl through IV.
pt recv vax 16JUN95 & mom states that on 18JUN early, pt devel fever & rash; pt came into the office 19JUN95 w/t105 & a fine rash all over body;
Itchy, swelling throat started first accompanied by coughing and clearing of throat with lots of phlegm. This lasted until close to 9:00pm.  Next symptom began around 8:30 with itchy, painful swollen eyes. They were red and sore and eye drops did not help at all. This symptom began to ease around 9:15 and then I got very very cold and my teeth began to chatter violently. I got in bed with all my clothes on and tried to warm up. I also began getting very achy. I went to sleep and throughout the night my fever broke and my body aches abated.
Pt given vaccination that expired 10/03/2021 and will require revaccination.
This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. Since 26-JUL-2016, the patient were administered doses of GARDASIL 9 lot numbers: K26242, expiration date 28-JAN-2017; K026247, expiration date 29-JAN-2017; L007560, expiration date 15-JUN-2017 (dose, strength and frequency were not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Guardian of pt. says symptoms began 8/25/18 with increased irritability, discoloration of skin on his back and a fever of 102. Patient was given BENADRYL for his back and TYLENOL for temperature. Says today he is back to normal.
I had shingles a few months before/ suspected vaccination failure; I had shingles a few months before; Miserable; made me tired; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: I had shingles a few months before/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles a few months before), feeling miserable (Verbatim: Miserable) and tiredness (Verbatim: made me tired). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not reported and the outcome of the tiredness was resolved.  The reporter considered the vaccination failure, shingles, feeling miserable and tiredness to be possibly related to Shingrix.  The company considered the vaccination failure, shingles, feeling miserable and tiredness to be possibly related to Shingrix.  Additional Information: GSK Receipt Date: 25-MAY-2023 This case was reported by the patient via interactive digital media. The patient had reported that, it made her tired for a couple of hours.  She had shingled a few months before and it was miserable.  She had considered her shingles to have been a lighter case.  She highly recommends getting the vaccine as she had a terrible case.  This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter thought that the event might had been related to product/device. Follow-up would not possible, as no contact, details were available.
chills in my body; a fever; a short breath; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills in my body), PYREXIA (a fever) and DYSPNOEA (a short breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills in my body), PYREXIA (a fever) and DYSPNOEA (a short breath). At the time of the report, CHILLS (chills in my body), PYREXIA (a fever) and DYSPNOEA (a short breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No adverse event; Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) 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 ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine).    No concomitant medications were reported. It was unknown if patient experienced any AE. Total 7 patients received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent vaccine. No treatment details were reported.
I began having flashes on the left side of the left eye one day ago. Today, I continue to have the flashes; I cannot focus either eye (vertical double vision).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 10:45 (Lot number: FF2587) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "cancer", start date: 2013 (unspecified if ongoing), notes: cancer (2013); "Allergy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; VENLAFAXINE; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EO6955, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 20Mar2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 27Feb2021, when the patient was 55 years old, for COVID-19 Immunization. The patient was no diagnosed with COVID-19 prior and since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PHOTOPSIA (non-serious) with onset 04Oct2021 07:00, outcome "not recovered", described as "I began having flashes on the left side of the left eye one day ago. Today, I continue to have the flashes"; VISION BLURRED (non-serious) with onset 04Oct2021 07:00, outcome "not recovered", described as "I cannot focus either eye (vertical double vision).". Therapeutic measures were not taken as a result of photopsia, vision blurred. No follow-up attempts are possible. No further information is expected.
Fever of 100, chills, full body muscular pain, headache  Tylenol (1000mg) alleviates symptoms for about 3 hours.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 87-year-old male patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix. In June 2018, 1 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain and fatigue to be related to Shingrix. Additional details were provided as follows: In early June 2018, the patient received 1st dose of Shingrix. In 2018, the patient experienced muscle pain close to the injection site. One day after receiving Shingrix on the following day, the patient also felt wiped out with fatigue after receiving Shingrix. For tolerance to 2nd dose refer linked case US2018149466. This case has been linked with US2018149464, reported by the same reporter.
Nephrotic Syndrome-presented with edema from 3/6/02 to 3/9/02. Seen in ER and treated with Prednisone.
16JUN during 4 min waiting time exp nausea & dizziness & paleness, lost consciousness; 17JUN flu like sx, hot/cold, stomach cramping;
16 year old was administered a dose of Flublok Quadrivalent/no AE; Initial information was regarding an unsolicited valid non-serious case was received on 10-Nov-2020 from a Other Healthcare Professional (Practice manager) via Medical Information (Reference number- 00353491) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 16-year-old male patient who received 0.5 mL dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ446AA, expiry date 08-Mar-2021) via an intramuscular route at the right deltoid on 16-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENACTRA) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency was on same day).  At the time of report, no adverse event 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 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.
T. 98.4 deg approx 12 hours after vaccine admin, left upper arm became erythematous and slightly swollen. Anithistamine and cold pack given.
itch; felt giddy; This case was reported by a consumer and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (case of Shingles 2 years ago). Concurrent medical conditions included latex allergy and immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced pruritus and felt giddy. The patient was treated with diphenhydramine hydrochloride (Benadryl Liquid) and cetirizine. On an unknown date, the outcome of the pruritus and felt giddy were recovered/resolved.   It was unknown if the reporter considered the pruritus and felt giddy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and immediately began itching. The patient felt giddy. The reporter wants to verify there was no latex in the formulation. The reporter reported the immunizer was concerned and administered Benadryl liquid adult dose and after receiving the Benadryl the immunizer watched for about 20 minutes and then went home.  The patient taking 1 0r 2 tablets of Cetirizine. The reporter did not give permission to contact HCP and was long winded, fast talker and hard to follow.
Flu-like symptoms, etc. All over body aching. Weak, light headed, headache. Slept for one and half days from fatigue and left-arm burning and raised redness where shot was given.
pt recvd vax;T 100; wheezing 3nov95; emesis; apap given; to er;
Chest tightness; Anxiety; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness) and ANXIETY (Anxiety) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and ANXIETY (Anxiety). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Chest tightness) had not resolved and ANXIETY (Anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (Anxiety) to be not related. No further causality assessment was provided for CHEST DISCOMFORT (Chest tightness).    No concomitant medications were reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient received a vaccine from a lot that had expired 15 days previously. Patient advised to RTC ASAP for repeat booster.
Covid infection - severe sore throat, severe sinus swelling, post nasal drip, runny nose, intermittent coughing, laryngitis, moderate headache. Fever 99.8F, loss of taste smell. fatigue.
Headache:  Began the following day after the vaccination.  Has a history of migraine headaches.  Restarted topiramate for treatment and will continue sumatriptan and acetaminophen for abortive therapy. Nausea and Vomiting - Continuation of Zofran for vomiting.  Will use Dexilant for GERD and start famotadine for optimal therapy
Urinary tract problems; Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks; Started getting pain in back when urinating; Experiencing a cough; Last Friday I broke out in chills, went to Emergency Room; he collapsed to the floor from pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating), FALL (he collapsed to the floor from pain) and COUGH (Experiencing a cough) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and TAMSULOSIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FALL (he collapsed to the floor from pain). On 18-Jun-2021, the patient experienced CHILLS (Last Friday I broke out in chills, went to Emergency Room). On an unknown date, the patient experienced URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating) and COUGH (Experiencing a cough). The patient was treated with CEFALEXIN (CEPHALEXINE) for Bladder infection, at a dose of 1 dosage form. At the time of the report, URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating), FALL (he collapsed to the floor from pain), COUGH (Experiencing a cough) and CHILLS (Last Friday I broke out in chills, went to Emergency Room) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Computerised tomogram: inconclusive (Inconclusive) The patient claimed that 2 out of 3 doctors mentioned no kidney stone present..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by the reporter. The action taken with the suspect product was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated patient demographics. Added concomitant and treatment medicines. Added new events Back pain, Fall, Chills and Cough.