chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High blood pressure; Heart palpitations; Dehydrated; Nervousness; Shaky; Dry mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated) and NERVOUSNESS (Nervousness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated), NERVOUSNESS (Nervousness), TREMOR (Shaky) and DRY MOUTH (Dry mouth). The patient was treated with CLONIDINE on 27-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated), NERVOUSNESS (Nervousness), TREMOR (Shaky) and DRY MOUTH (Dry mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Event outcomes updated.
Prevnar 20 given to patient when it should of been Prevnar 13. Last dose of Prevnar 13 was 02-21-23
Muscle pains and aches in legs, back and chest. Pain at injection site. Headache, and sweats
1/2hr p/vax c/o vertigo, tightness in throat & chest;T104 by 4AM 31OCT97;pt had taste of alcohol in throat & vertigo immed post inj;did not seek med help;pt did not tell nurse felt dizzy;c/o tight throat;next AM all sx gone;
This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION URGENCY (urinary urgency/has an intense urge to urinate, but barely excretes anything when she goes to the restroom), PAIN (pain), DIZZINESS (light headedness), CHILLS (chills) and PYREXIA (fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) for Hormone replacement therapy.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MICTURITION URGENCY (urinary urgency/has an intense urge to urinate, but barely excretes anything when she goes to the restroom), PAIN (pain), DIZZINESS (light headedness), CHILLS (chills) and PYREXIA (fever). At the time of the report, MICTURITION URGENCY (urinary urgency/has an intense urge to urinate, but barely excretes anything when she goes to the restroom), PAIN (pain), DIZZINESS (light headedness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol, 4 pills.
I didn't have an allergic reaction but the next day the injection site swelled up and got red and my whole arm swelled up all the way down to my wrist and was vey painful for quite some time. I was lying in bed and husband would touch my arm and it would hurt. I had a little fever at beginning which went away and I just felt really tired and I can't remember anything else except my arm pain and feeling knocked down. The arm pain lasted for two weeks. The fever and fatigue lasted for 3 days.
MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193307, 2019SA193303, 2019SA193302, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 18 years old male patient with who was vaccinated with 0.5 ml once first booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 03-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  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 Directiveand Module VI of the 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 document held by sender: none.
Patient notified the medical over watch of feeling lightheaded and muscle weakness. Team nurse reports the patient was cool and diaphoretic. Pulse was in the 40s. BP was 106/64. Patient was AAO, however continued to close his eyes. No respiratory symptoms. EMS was called, responded <3min. Patient had improvement of symptoms while EMS was on scene. Patient declined EMS transport and left with co-worker with instructions for returning to ED for medical care. No medication or treatment was given on site.
Day after I went to the ER after my symptoms came about that evening. My tongue swelled up and moved back to the back of my throat. I was having difficulty swallowing but no issues with breathing. At the ER, I received an EpiPen and an IV of epinephrine and Benadryl as well and also an acid reducer. My symptoms almost immediately came down and then after a few hours I was discharged from the ER. The next day they were completely gone, and no reoccurrence has happened since. I am taking a lot of antihistamines, prednisone.
mom said pt OK 14JAN94; 15JAN & 16JAN94 pt wakeful-would not nap, irritable, local reddness & swelling, t101;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 06-NOV-2015, the patient was vaccinated and an expired dose of PNEUMOVAX 23 (lot # K007824, expiration date 05-NOV-2015) intramuscular (dose was not provided). Concomitant medication was not reported. No known adverse effects. Additional information has been requested.
Pt had T & malaise X 3 days-saw MD 25Feb-DX : /w flu-Started c/o of legs hurting walking on tip toes 27Feb-T.C.to mother 4Mar91-states still c/o legs hurting-said Dr. felt like flu had settled in her legs.
Follow up: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up, patient reported soreness to arm, fever of 99.9 and high blood pressure.  Wife thought he was anxious.  Follow up 2 hrs later and next morning, he reported he was "fine'.  Received COVID vaccine on December 31
Upon leaving clinic, patient bacame sleepy, cold/clammy, blue lips, vomited 3-4 times, and eventually became limp and unresponsive.
wife is experiencing severe nerve pain / the pain started on 3/2/2021; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 2nd March 2021, unknown after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's husband. The age at vaccination was not reported, but it could be 56 or 57 years. The reporter reported that patient received first dose of Shingrix on an unknown date. After texting with patient, sheet clarify that the pain started on 2nd March 2021. The reporter consented to follow up.  For tolerance of 2nd dose, refer case US2021062031.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062031:same patient, same reporter - 2nd dose
felt bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 72 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "unknown", described as "felt bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother noted small blister to (L) leg day after vaccines administered. States child had fever (unknown amount) on 01/20/10 and was given TEMPRA. Today mother noted more blisters to (L) leg, (L) thigh very red, warm to touch. States child states area painful, tries to scratch. Child returned to Doctor (per mother request) for evaluation.
I had a really bad headache, I ached all over. It felt like the flu. I had terrible chills and couldn't warm. This lasted about 6 hours.
THIS IS NOT AN ADVERSE EVENT. JUST MADE AND AN ERROR BY GIVING PATIENT MODERNA THAT WAS BEYOND USE DATE BY 1 DAY.  ALREADY CALLED MODERNA TO SEE IF WE NEED TO REVACCINATE PT AGAIN. PATIENT IS FINE, HAS NOT COMPLAIN ABOUT ANY SIDE EFFECTS
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.
A non-serious spontaneous report of administration one week prior to 2yo birthday was received from a health professional concerning a 23-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Nov-2011, the patient received FLUMIST one week before her second birthday. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 02-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
16 hours after administration had intense chills and body ache, about 2 hours after that chills were replaced by fever, the fever lasted about 7 hours. About 38 hours after shot until 4 days after the shot I had a migraine and runny nose. 3 days after the shot I started having difficulty breathing although not as bad as with the first shot, and that lasted two days. After that there was some coughing that lingered for about a week after which it subsided. From the time the injection was taken until the end of the third day I took 750 mg of tylenol every 6 hours.
Red nickel to quarter size welts on face, neck, arms and legs approx 12-16 hours after receiving the vaccine.
ELEVATED LIVER FUNCTIONS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included auto immune hepatitis. 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 elevated liver functions. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Results not provided, and Hepatic enzyme (NR: not provided) over 1300. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated liver functions was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Vial was not diluted prior to administration. No adverse events were reported back to us. Will contact patient's PCP this week since this is a weekend and offices are closed.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
1/7 Vaccination; Drove home; within 20 min of vaccine. My eyes started to itch, my nose was runny and itchy, my cheeks were tingling, my upper lip tingling. My whole body was covered in rash within the next 35-40 min. Called co worker, guided to urgent care. Received steroid shot. I used my albuterol inhaler every 4 hours for next couple days. I spoke to allergist over phone; prednisone for 5 days. Double up on Allegra. By 3rd day, Albuterol was 2-3x day.  *Plan is to do a skin test when opening back up, the unit. March / April timeframe. They may end up doing a 10% diluted vaccine. **dr stated anaphylactic episode.
Chills,  Muscle or body aches,  Runny nose/Congestion,  Sore throat,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Chest pain,  Fatigue or tiredness,  Headache, Breakthrough COVID-19 Case, Hospitalization
One week after receiving the first dose of the Moderna COVID vaccine my upper arm developed an oval shaped rash around the vaccine injection site.  The next day it had grown in size and was itching.
Headache; Left arm sore from injection; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on an unspecified date (Lot number and expiry date was not reported) as single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis, upper respiratory infections and she was diagnosed in 2004. Stated that she recovered completely from stopping Methotrexate and Enbrel. Stated that she stopped taking Enbrel in late 2004 then she switched from Enbrel to Humira in 2004-2005. When she took Enbrel and used to get huge bruises on her legs that everything was black and blue. Temporary stop on Methotrexate in 2008-2010 due to being in remission. Stated that she had a permanent stop on Methotrexate injections a couple of years before. Stated that she took it for a 9-month window. The patient's Concomitant medication included Tofacitinib citrate (XELJANZ XR). On 08Mar2021 the patient experienced headache, left arm sore from injection. The patient underwent lab test and procedures which included blood test: result unknown an unspecified date. The patient took Tylenol as a therapeutic measure for the events. The outcome of the headache was recovered on 09Mar2021. The other event was recovered on 11Mar2021.  Information about batch/lot number has been requested.
1/29/2023 symptoms started with aches, congestion, headache. The next day symptoms continued, with loss of taste being added. Tested positive 1/31 at home COVID-19 test. Televisit on 2/3, doctor prescribed PAXLOVID. Voice loss also started that day. 2/4 voice returned. Symptoms tapered off gradually and were gone by 2/12, except nasal congestion which lingered until 2/15.
She complained of a headache and body aches. Recommended that she take 2 ibuprofen 200mg every 6 to 8 hours as needed until symptoms are relieved.
The same day of shot I started feel achey. I started running fever from 99-100 every day since. Her nurse said I had a virus and I am still sick. My daughter and grandson has gotten what I have I am still sick
Three months after receiving the second dose of the Covid 19 vaccine, he  began complaining of chest tightness and also had difficulty catching his breath after participating in strenuous activity. He initially believed he was experiencing Exercise-induced asthma, which he had experienced in the past.  He was prescribed an Albuterol Sulfate HFA inhaler.  He believed he felt some relief while using the inhaler; however, at some point, it was no longer helping.
over 42 days, 1st dose 08/15/21, 2nd dose 10/23/21
Few days after my first vaccine my post operative site was itchy around the site but I just ignored but as the goes by the itch was increasing and still did not ask for any medical advise.  After my second dose, I had rashes in so many unusual sites and the itch around my post op site getting worse so I self medicated in applying some moisturizer but did not help. So today, December 11 I went to walk in clinic and showed all the areas affected and gave me topical cream and also advise to report this reaction to VAERS
got deathly sick; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves a 76 years old and unknown gender patient who experienced got deathly sick while receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In1967, on an unknown date the patient received a  dose of suspect Influenza Vaccine.produced by unknown manufacturer (formulation, strength, dose, route, expiry date and batch number: unknown) in unknown administration site for prophylactic vaccination. Information on batch number is requested.  On an unknown date, the patient reported got deathly sick (illness) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event sickness.  At time of reporting, the outcome was Unknown for the event sickness.
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information was reported.  Upon internal review on 24-May-2021, the age was corrected to unknown.
patient received 1st dose of pfizer COVID 19 vaccine and while waiting her 15 minutes she passed out
That evening/early morning: fever in access of 100 degrees, muscle pain, headache, and chills. Body aches, headache continued during the day. Currently 9 hours into effects.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.10 for dose administered on 07-Jan-2021 . No concomitant medications were reported. Batch number 025L20A underwent temperature excursion on 07-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.