chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo was reconstituted with sterile water and administered to a patient; Menveo was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 26-SEP-2023, the patient received Menveo. On 26-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Menveo was reconstituted with sterile water and administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter called to report that Menveo was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
He has a fever of 101° today, pain at the injection site and feels tired.; He has a fever of 101° today, pain at the injection site and feels tired.; He has a fever of 101° today, pain at the injection site and feels tired.; Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (He has a fever of 101° today, pain at the injection site and feels tired.), VACCINATION SITE PAIN (He has a fever of 101° today, pain at the injection site and feels tired.), FATIGUE (He has a fever of 101° today, pain at the injection site and feels tired.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030949) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 08-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.). On an unknown date, the patient experienced PYREXIA (He has a fever of 101° today, pain at the injection site and feels tired.), VACCINATION SITE PAIN (He has a fever of 101° today, pain at the injection site and feels tired.) and FATIGUE (He has a fever of 101° today, pain at the injection site and feels tired.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 700 milligram. At the time of the report, PYREXIA (He has a fever of 101° today, pain at the injection site and feels tired.), VACCINATION SITE PAIN (He has a fever of 101° today, pain at the injection site and feels tired.), FATIGUE (He has a fever of 101° today, pain at the injection site and feels tired.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever of 101°.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient gotten all the COVID-19 vaccines available to him including a Moderna vaccine on 12SEP2023 and a dose on 8NOV2023, lot number 3030949.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.
Generalized not feeling well the day after vaccine administered then progressed to dizziness, nausea. Approx 20 hours after receiving his second dose of Moderna from Health Department he had a syncope episode with LOC of a few seconds. He sustained head injury that was treated and  sutured. No further side effects after day 2 of vaccine.
Patient received the Pfizer Vaccine when she was scheduled to get the Moderna Vaccine as she had originally been given the Moderna for her 1st injection of the series. She now has been given a mixed series of Covid-19 vaccine.
sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D21A, 046B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Asthma, Cholesterol and Blood pressure high.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Blood glucose: high (High) blood sugar was over 600.         Concomitant medications included diabetes medication, asthma medication, cholesterol medication and blood pressure medication. No treatment information were provided.  The patient got vaccine shot at around 11 A.M and by dinner time, the patient's blood sugar was over 600, and it stayed that way for about a day and a half, until it went back down on its own. Patient reported that the patient never got that sugar level high up even considering when the patient was sick.   This case was linked to MOD-2021-379419, MOD-2021-379421 (Patient Link).
Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment details were provided.
Customer was mistakenly given an empty syringe by our immunizer and was concern if it's an contaminated needle or if there was air injected. I was the pharmacist in charge and had explained to the customer our process of getting the vaccine ready and that the posibility of her getting a contaminated needle is none.  I adviced patient to monitor her injection sites and call us back if there is any issue. I called customer and followed up with her today (10/1/2021), customer has no symptoms or side effect, however she still concerned and had her blood work done to rule out any blood borne diseases.  I will follow up with customer on Monday to make sure everything is okay.
Chest pain and tightness. EKG and blood work done to check the condition on the heart. All tests came back good.
patient is way past the 42 day window for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is way past the 42 day window for the second dose) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is way past the 42 day window for the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is way past the 42 day window for the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273 (Batch number unknown) where the patient is yet to get the second dose and it is way past the 42 days window period. There are no associated AEs.
Urticarial rash noted on exam in office 9/24/05, no involvement of palms and soles. Rash diffuse pustular 9/26/05, older lesions purpuric, newer lesions urticarial, erythema multiforme. No arthralgias, arthritis or fever.
No known adverse effects; a patient received a dose of VAQTA on 13-FEB-2019 and on 05-JUN-2019; This spontaneous report has been received from a pharmacist concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 13-FEB-2019, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA) (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and on 05-JUN-2019, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA) (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). There were no known adverse effects.
Very sore, unable to lift arm, pain wakes me from sleeping etc. Limited range of motion restricts even my activities of daily living still.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 18-SEP-2013 the patient was vaccinated with expired ZOSTAVAX (lot # 671190/1270AA, expiration date 05-NOV-2012) 0.65 ml, subcutaneous. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Sore arm for first 2 days and then diarreha, chills, headache, fatigue.  Exactly seven days after shot, got very itchy rash at site of injection.      Within a day, turned into a large, bright red, raised patch on arm, approx 3"x4".  Lasted about 5 days.
local rxn of 6cm x 6cm redder area w/swelling occurred 20min p/vax & vax was given by employer as a yearly thing;
4OCT96 phone call mom reports blotchy red rash x 24hr & cough;
Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 09-OCT-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK) (lot # unknown). The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014744: US-009507513-1710USA014745: US-009507513-1710USA014746: US-009507513-1710USA014747: US-009507513-1710USA014749.
The pt experienced a fever the night before the vax of 102. Today the pt still has a fever with facial and body lesions that itch.
On Sunday the 24th, I started with a sore scratchy throat and on Monday the same thing. I was at an event Monday evening I came back to room, I felt hot and sweaty, and I could not go to sleep. I called our onsite medical office, and they told me to stay in my room and quarantine. I called Kaiser and they said they would get a hold of my doctor and they transferred a prescription of Paxlvoid. I felt very achy and had chills. The rest of the time I had just a bad head cold. Wednesday, I started feeling better. I flew home on Saturday the 30th.   On Monday August 1st I tested negative and then on Tuesday I started feeling I had a scratchy throat and Wednesday I tested positive again and had a slight relapse.
Patient was given Meningitis A vaccine first. Tolerated well. Men B vaccine was given next. Medical assistant turned away for a second and patient, who was standing, lost consciousness, fell forward and hit forehead on the ground. Per father, patient began to "seize." His whole body shook. Lasted for a few seconds. I assessed the patient about a minute after the episode and he appeared back to his regular state. no Post ictal state noted.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female who on 21-AUG-2008 and 03-MAR-2009 was vaccinated with her second and third dose of GARDASIL (lot number of the 2nd and 3rd dose was 661952/1129X, the lot number of the 1st dose was 659184/0843X) 0.5ml IM. There was no concomitant medication. The patient had a pregnancy test and was now pregnant. The last menstrual period was 27-JAN-2009. The estimated delivery date was 03-Nov-2009. The patient had not experienced any known symptoms. The patient sought medical attention. Follow-up information has been received from the nurse via a pregnancy questionnaire. The patient with a questionable no previous pregnancies and a questionable history of rheumatoid arthritis on 20-MAR-2009 underwent elective termination (methotrexate). Products of conception were not examined. No further information is available.
fever of 102, chills, all over body aches and pains- couldn't lay down in bed everything hurt. headaches.  hot painful flareups mostly on back and hips.  symptoms started 7 hours after shot and lasted for approximately 24 hours. Tylenol provided little relief, ibuprofen was better.
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced a sore arm afterwards. On an unspecified date the patient was vaccinated with the second dose of GARDASIL in the hip, since she had a sore arm after the first dose. The nurse practitioner did not know if the vaccine was given intramuscular or not. On an unspecified date, the patient was given the third dose of GARDASIL in the arm. Medical attention was sought, the patient spoken to the nurse practitioner. Subsequently, the patient recovered on an unspecified date. Additional information has been requested.
Worst body aches ever; brain felt like was in a bubble, a complete fog; Fever; lack of energy; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0202) via an unspecified route of administration in the left arm on 06Jul2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received cefalexin (KEFLEX) taken for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0176) via an unspecified route of administration in the left arm on 25May2021 at 16:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021 at 01:00, the patient experienced worst body aches ever, brain felt like the patient was in a bubble, a complete fog, never experienced anything like it before in her 51 years. The patient had fever, lack of energy and reported that it was horrible, and lasted for days. The patient hoped that she or no one else had to go through these side effects, never again she will put herself through that. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events worst body aches ever, brain felt like was in a bubble, a complete fog, fever and lack of energy were recovered on an unknown date in Jul2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 20Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Mitral Valve Prolapse" (unspecified if ongoing); "Sulfer Drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow up attempts are needed. No Further information is expected.
pt recv vax 28SEP98 & exp severe muscle pain in both legs started 2OCT98 PM became sores 3OCT98 AM diff walking w/problems of coordination, ?fever was taking motrin;
On 3/20/21, patient was seen in ER. Patient with c/o chest pain, body aches, fever, diarrhea, vomiting blood, and "pain from head to toe." Patient transferred and diagnosed a heart attack with cardiopulmonary shock. Patient received heart catheterization.  On 5/2/21, patient again seen in ER at for SOB and low blood pressure. Patient again transferred to.  On 6/4/21, patient was seen by family practitioner. Patient c/o pain to medial joint line of left knee.
boils on stomach lower right quadrant, sharp pains in abdomen, pancreatic , has lost 20 lbs, appetite changed,  Pt is now experiencing sensation from one shoulder blade to another, not painful can only feel something there
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-AUG-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot# L031721 and expiry date: 19-NOV-2016), subcutaneously. No adverse effects were reported. The temperature and time frame of ZOSTAVAX exposure was 7 Fahrenheit (F) for 15 minutes, 6F for 1 hour and 7F for 2 hours. There was no previous temperature excursion and data logger was reported as yes. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
4-12-10 immunizations given: DTAP Rt upper leg. MMR Rt lower leg. VARIVAX Lt leg. 4-14-10 mother called office stating Rt upper leg red and swollen - told her to bring child in - Dr looked at leg - states local reaction - inst. to use warm compresses - 4-16-10 KEFLEX rechecked area still red - had drainage (pus) pt. saw Dr.
On 19 April 2021 patient developed left-sided facial weakness in the afternoon, seen in the ER that evening and diagnosed with left-sided Bell's palsy. No associated loss of hearing or taste. No other symptoms of weakness or diplopia. Does have a history of multiple sclerosis (on disease modifying treatment).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: 6H9694) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Clindamycin, reaction: "known allergies: Clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 10-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ with lot # M025568 and expiration date on 07-NOV-2017 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA002269: US-009507513-1706USA002268: US-009507513-1705USA011335: US-009507513-1706USA002267.
Rheumatoid arthritis; incurable. Information from Medical records states depression, shoulder pain as conditions. msv
hot flashes;flush face;welt devel around sit of inj;also reddened area 4" diameter;itchy & warm to touch 1hr past inj;pt took med;
The morning following my shot, my arm became much more sore at the injection site; I tried massaging and using throughout the day at work (office) because I could feel through my shirt it was developing a hardened and larger lump (3 inch) around the injection site. It hurt worse as evening began, I looked at it and it was red (1 1/2 inch) so I iced it some to lessen the pain. Last night I woke up with some respiratory conditions (wheezy, phlegm, heaviness on my chest) and a headache, and my arm is still red and sore. I will visit ER if condition continues or worsens.