chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Metal taste still in mouth April. Getting worse, had to seek drs advice; This is a spontaneous report from a contactable 45years old female consumer (patient). A 45-year-old female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot: EL8982) second dose via intramuscular, administered in left arm on 11Feb2021 11:30 AM and first dose via intramuscular, administered in left arm on 21Jan2021 10:15AM (Batch/Lot no: EL3246) as a single dose for COVID-19 immunization. Vaccination administered at living facility. The patient medical history included fibromyalgia, IBS, unknown heart issue causing hypertension. The patient concomitant medications the patient received within 2 weeks of vaccination are Omeprazole, losartan, atorvastatin, metoprolol. The patient underwent lab test and procedures which included COVID-19 tests, Prior to vaccination, was the patient diagnosed with COVID-19 was yes, Since the vaccination, has the patient been tested for COVID-19 was No. Allergies to medications, food, or other products:Sulfa based drugs . Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 patient experienced with metal taste still in mouth April. Getting worse, had to seek doctors advice. The outcome of the event was not recovered.  No follow-up attempt are needed. further information is expected.
I woke up that morning and I was swollen and red and looked bruised almost my entire top arm.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age. The patient's medical history was not reported. On 20-MAY-2015, the patient was inadvertently administered a dose of PNEUMOVAX 23 lot # J011045, expiration date 15-MAY-2015, 0.5 ml, intramuscular. No adverse effects were reported. Additional information has been requested.
pt recvd flu vax 28NOV93 & approx 14DEC93 began to devel sx of GBS; remains hospitalized as the date of this report in stable condition;
Diagnosed with stomach cancer 1st stage; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE and LISINOPRIL for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) (seriousness criterion medically significant). At the time of the report, GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Information has been received from a registered nurse concerning a 12 month old white female who on 10/6/03, at 16:15, was vaccinated SC in the left arm with the first dose of varicella virus vaccine live (lot # 643593/0868M). Concomitant vaccinations on that same day and time included the fourth dose IM in the right arm of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (PREVNAR)(lot # 493472). There was no illness at the time of vaccination. The RN reported that on 10/21/03, the patient developed a mild case of chicken pox. On 10/23/03, the patient presented to the office with a rash characterized by small clear pustules and macules in different stages of evolution mostly on the extremities, although there was also one on her trunk. Subsequently, the patient recovered from the chicken pox. Additional information is not expected.
The patient has a history of asthma. She complains of sinus pressure that spread to behind her ears. The patient was placed on 15 min secondary observation after which she stated the pressure was still present but refused to be seen in the ED at the present time. The patient was released to go home.
adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 12-year-old of male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 16-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
At 1:09 pm after client received her vaccine client states she felt lightheaded. Vital signs obtained by EMS BP 150/95, pulse 75, O2 sat 100%.  At 1:15 pm client states she feels better. Advise to follow with PCP. Discharged home by EMS.
Rash on trunk on 3/12/04. By 3/15/04 rash was also on extremities by 3/17/04 her head was involved. Sun in ER 3/19/04 and she had with Atarax. Prescriptions given for Atarax & Elires 20 m  thought had something she ingested. Temp on 3/16/04 99 degrees. Saw doctor at office. Break-out (rash) all over body. Itches. Recent MMR of recent low grade fever, URI, rash improved with Atarax.
I got up in the middle of the night and fainted. I have been on the medications I listed for years and take them every night and this has never happened to me aside from the night after I received the HPV vaccine.
A few hours after receiving vaccine, patient reported she had a seizure. She went to the emergency room. Her family members gave her aspirin 325mg and it helped. She experienced chest pain and dizziness. No history of seizures.
Information was received from a licensed practical nurse regarding a male patient of unknown age, who on 07-OCT-2014, was vaccinated with a dose of M-M-R II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
patient passed out a few minutes after recieving his second moderna dose, he recovered quickly but opted to be transported via ambulance to hospital and released with a diagnosis of syncope.
Swelling under jaw along jawline (R) side. Pt. felt swelling when opening mouth wide, turning head & swallowing. No DOE no SOB no tongue swelling no itchiness. BENADRYL 50mg po taken.
I got one large blister on my left back flank, as well as 8 other areas of red spots on both sides of body, tingling and numbness down right leg and foot. On 9/2/16 I was placed on anti vaccine medicine Valacyclovir 1mg as well as Gabapentin 100mg. On 9/10/16 due to ongoing neuropathic pain down my left leg and foot, I was placed on Prednisone 20 MG and Hydrocodone 5-500mg.
Tachycardia started 40 minutes after administration. Resolved after patient slept. Severe depression and crying bouts, feelings of hopelessness on day 2 and 3.
24-48 hrs after dose of vaccine, patient begin to develop cramps in bilateral calf muscles, she describes it as aching, crampy and painful, she also developed what she thought to be mild petechie that had resolved by the time she saw the provider. She is 7 days post vaccine and still having bilateral leg cramping, that worsens when flexing the foot.
This case was reported by a physician via sales rep and described the occurrence of injection site exfoliation in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site exfoliation. On an unknown date, the outcome of the injection site exfoliation was unknown. The reporter considered the injection site exfoliation to be possibly related to SHINGRIX. Additional details were provided as follows: The doctor said that the patient received the SHINGRIX injection at a pharmacy about 5 weeks before the date of reporting. The physician treated the patient about 3 weeks before the date of reporting (2 weeks after the injection because her skin was peeling like bad sunburn at the injection site. The physician thought the skin peeling was most likely related to the SHINGRIX injection. This was much as he could remember but he would research for additional information and would like to be contacted for additional information. This case was linked with A0916427A and A0653798A, reported by the same reporter.
8/18/2021 client received an expired dose of Moderna.  10/4/2021 2:44 pm called patient, left message to return call.  10/18/2021 11:35 am called patient, left message to return call.  10/18/2021 2:24 pm Text message and email sent via vaccine portal.  12/23/2021 2:04pm Message sent via vaccine portal to call before next COVID-19 vaccine. Note left in vaccine portal to give client a full dose of Moderna at the next vaccination visit.
Like others I had dizziness, headache after first vaccine. After second Moderna again like others, I was extremely ill with forceful vomiting and nausea, massive headache, dizziness, fever, chills, body aches. Etc.  My concern is that since the vaccine I have been having periods of major headaches with slight nausea but also bouts of dizziness.  I have NEVER had headaches. I also never got nausea while I lift weights,  workout or sometimes after sex. It seems when my heart rate gets elevated I?m having these reactions.   I?m writing tonight because I got a migraine style headache with dizziness after sex and I?m getting anxiety that these symptoms will not go away. Wanted to report them to see if I?m not alone. I?m a very healthy 46 year old. Had blood work tested recently.  I tested my blood sugars during these episodes as well and I used a pulse oximeter to test oxygen and all normal.   Thank you
Her first dose was March 5th and 2nd dose was March 26th.  She developed sharp pain in bilateral hands that radiates up both arms. She has joint welling and stiffness in MCP joints of hands since the first vaccine.  This is new for patient.  Pain is intermittent and she is using naproxen for pain.  She has not followed up since her 5/6/2021 appointment.
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: patient bled immedately after injection. A small bump formed at injection site. bleeding stopped after compression with a cotton ball.-Mild, Additional Details: patient bled excessively from injection site and a small bump formed at injection site. advised patient to ice arm and monitor it for the next 72 hours. if it worsens contact md. on 8/2/21 at 11 am i conctacted patient, her daughter answered. Daughter stated her monther is fine she is not experiencing pain, site is still a bit swollen but she is okay and was able to return to work today.
Headache Chills, fatigue, Elevated temp of 99.6 Narrative:
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022 at 4:12 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2022 at 4:12 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix. On 10th September 2020, 24 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: Reporter was physician assistant. On 10 September 2020, the patient experienced an episode of shingles after been administrated with Shingrix. The reporter consented to follow-up.
15MAR99 illness consistent w/varicella occurred p/exposure to (wild-type) varicella in fellow day care attendee;lesions were #30, smaller vesicular component than usual varicella disease;
Headache, Sedation, Myalgia, Fever, Chills, pain at the injection site Narrative:  Other Relevant History:
Six days after immunization child developed fever x 2 days (highest 101 degrees), swelling of (R) cheek, jaw & glands, headache, and swollen throat bilaterally which mother described as "white with red veins through it". Glands still slightly swollen.
Information has been received from a licensed practical nurse concerning a retired white female with polymyalgia, hypertension and rheumatism who, during a routine physical exam, on 06/28/2004 at 0930, was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647271/1238N).  On the afternoon of 06/28/2004 the patient developed erythema, pain, and swelling of the left deltoid to the elbow, flushing, and a fever.  On 06/29/2004 the patient was afebrile.  No medical attention was sought.  No diagnostic lab tests were performed.  Approximately 3 to 5 days later the patient recovered.  It was also noted that the patient had had no adverse events following prior vaccinations.  No further information is expected.
24y/o AD female w/Dizziness,nausea,HA,Vomiting,SOB, after receiving Moderna vaccine @0800 today. Denies diarrhea or any other symptoms.
Swelling at injection site left, palpable nodule abscess formation with 2 degree infection requiring antibiotic on 4th day following injection - left arm.
expired dose of PENTACEL was inadvertently administered with no adverse event; Initial information regarding an unsolicited valid non serious case was received from other health care professional via Medical Information (MI) (Reference number- 00850122) and transmitted to Sanofi on 09-Nov-2021.  This case involves a 6-month-old male patient receiving expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was inadvertently administered (expired product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Nov-2021, the patient received a 0.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Frequency: once, lot UJ390AA, expiry date: 15-Oct-2021, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, Strength: standard except for Fluzone HD 0.25mL] via intramuscular route in the right thigh for prophylactic vaccination.  This case is medication error due to expired vaccine used (latency same day).  It was reported "medical assistant reporting that an expired dose of PENTACEL was inadvertently administered, on 04-Nov-2021 an expired dose of pentacel was given and the product expired on 15Oct2021."  At time of reporting, no adverse event was 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 the 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.
Pt wanted the booster to the Moderna shot. I looked through the company emails and saw where it was approved but did not see where the dosage had changed to 0.25 ml instead of the 0.5 ml. Pt received the full dose of 0.5 ml. I called him on 10/29 after speaking with a Moderna representative and receiving an email on the  specifics of the Moderna vaccine. Pt explained that he did not have any side effects from the shot. After telling him what happened he said that he did think his pressure was up on Wednesday 10/27.
lost feeling in both feet; both feet numbing /Numbing of the hands; i fell fractured a rib; fell; This case was reported by a consumer via call center representative and described the occurrence of loss of sensation in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced loss of sensation, hypoesthesia, rib fracture and fall. On an unknown date, the outcome of the loss of sensation, hypoesthesia, rib fracture and fall were unknown.   It was unknown if the reporter considered the loss of sensation, hypoesthesia, rib fracture and fall to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported but it could be 54 years old. The patient experienced lost feeling in both feet and hands numbness. The patient feet  was being numb, fell and fractured a rib.
PNEUMONIA; FELT IT DOWN HER HAND, BACK UP HER ARM AND HEAD; NAUSEA; DIZZY SPELLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the patient's injection site did not hurt but she felt it down her hand, back up her arm and her head. On an unspecified date, in MAR-2021, the patient experienced dizzy spells, nausea and pneumonia. Two weeks after vaccination, in MAR-2021, she was hospitalized for pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy spells, nausea, pneumonia, and felt it down her hand, back up her arm and head was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210422308- Covid-19 vaccine ad26.cov2.s- pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event..
Case number PHEH2014US019684 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 45 years old male patient.  His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Injection site, arm muscles are weak, headaches, fatigues, muscle aches and nausea.  Intestinal pain, cramps, severe pain in left leg from heel to hip-joint;  hands, arms and shoulders  joint pain;  feet joints,  continued sleepiness and drowsiness.    Patient has not died yet.
Severe tingling weakness and numbness in right leg and foot, joint pain, muscle pain extremities, hardness in muscle spots. Was prescribed predisone 1 week course, Applying ice and heat to effected area, stretching and gym every other day Been taking  Tylenol 8 Arthritis post predisone since no effect on pain or tingling. Neurologist next step. Been 1 month 5 days post vaccine with no change in symptoms besides some increase in joint pain all over. Did not do 2nd dose. Reported to  pharmacy reasons not doing 2nd dose. They said have had others with similar side effects
My husband got a Maderna very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My husband got a Maderna very bad reaction) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My husband got a Maderna very bad reaction). At the time of the report, VACCINATION COMPLICATION (My husband got a Maderna very bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Swollen lymph nodes in arm pit on the side of the booster shot. Noticed 3 days after shot.
8 days after I received the first shot, I developed a large red spot in the area of the shot. It itched so much and anything I put on it to stop the itch didn't help.  I have taken 3 single pill doses of Benedryl which has eased the itch but it has not gone away as yet. (2/17) I have not taken Benedryl yet today but will have to, I think.
lightheadedness, dizzy sensation, flushing, lt ear tinnitus, w/lightheadedness episodes;
Red, bumpy, itchy rash in area of shot.   Size of a half dollar.