chrisvoncsefalvay/vaers-outcomes huggingface dataset:
died from the shinglesvax; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's comment: This case was reported by the patient's friend via interactive digital media. The reporter stated that the patient recently died from the shingles vaccine, so be careful on what they put inside you. Additional supportive information: Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Redness and tenderness started 5/18/10. Seen in office today. Has 5"x6.5" erythema and hot to touch. Rx with ABX. Reaction below site of injection according to pt. Rx with KEFLEX 500 mg, 2 caps BID x7 days.
This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-FEB-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R025732, expiry date: 25-MAR-2020) for prophylaxis (Product storage error). Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was six of nine reports mentioned in the report.; Sender's Comments:  US-009507513-1903USA009054:Master case#.
product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 at 16:00 as dose 3 (booster) single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. No known allergies. COVID 19 Treatment with Paxlovid from 04May2022 to 09May2022. Patient had severe head cold, watery eyes, sneezing, scratchy throat, headache started on 15May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
syncope; POTS; autonomic dysfunction; orthostatic intolerance; fatigue; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 17-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
She initially had COVID infection in January with dyspnea, chest pains, and chills which persisted for months. On March 10th she was given Moderna first vaccine. Her chest pain and chills resolved a couple of days after that vaccination. 4 days after that, she developed the migrating arthralgias which improved with movement. Labs including inflammatory markers were unremarkable other than ANA 1:320. The joint pains persisted for a couple of weeks and are now improving, but now she reports recurrence of the chills. These are disruptive and occurring suddenly multiple times daily with no objective measurable fever.   Second dose was postponed until resolution, which has not yet occurred.
Pt presented to ER with right sided facial droop and slurred speech in the am on 5/19/21. At 9pm on 5/18/21 family reports patient was "normal". CT and MRI were clear of stroke. Newly diagnosed with Bell's Palsy.
A non-serious report of gave FLUMIST that expired in April 2011 was received from a health professional concerning a ten-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 12-Nov-2011, the patient received expired FLUMIST. The product expired on 12-Apr-2011. 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.
Rash, UrticariaPruritus & Purpura Narrative: Shooting leg pains across her thighs, Bruise to her breast, Numbness in her legs, Itching with red bumps to her legs and arms.
Patient complained that her throat felt "full" and it was difficult to swallow.  She was able to swallow water without difficulty.  Denied shortness of breath, itching , or other issues.  Diphenhydramine 25 mg given as liquid and continued to observe for extended time.    Patient stated less "fullness" but her lips are tingling.  Continued to have no difficulty in breathing, no itching, no tachycardia.  Continued to have "fullness" in throat and tingling of lips.  Wheelchair obtained and patient taken to Emergency Department.  Patient was given diphenhydramine 25 mg IV Push once, famotidine 20 mg IV Push once,  Solu-Medrol 125 mg IV Push once, and Epinephrine 0.3 mg intramuscular x 1.  Patient was monitored in Emergency Department with improvement of her symptoms.  She was discharged on prednisone and antihistamine.  She was also given a prescription for an EPI-Pen.
pt recvd vax 9MAR92 & started crying screamed, cried, sobbed all evening & through noc; would doze for 15 mins then wake crying; parents gave APAp; t101 had local react, irritable next day but better ;
Received vaccine 19 days ago and now tested positive for COVID-19; Received vaccine 19 days ago and now tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 10Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine 19 days ago and now (29Mar2021) tested positive for COVID-19. The patient wanted to know if it was ok to get the second shot. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
10 days after vaccination I began having itchy hands and feet and lower legs. A few days later my whole body itched and when I scratched I would develop hives (dermatographia)
On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, strength, dosage and route unknown). On an unknown date the patient experienced local site reaction erythema, rash. The outcome of the event was unkonwn. This is one of several reports received from the same reporter. Additional information has been requested.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 17-Nov-2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-491837 (Patient Link).
On Christmas day he started not feeling well, he had a runny nose and congestion. We did a rapid home test the next day and it was positive. He had started coughing at this point. We went and got a PCR test on the 27th and that was positive as well. He really only had cold like symptoms, coughing congestion runny nose and low grade fever. He was recovered and doing better with in about give days.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not provided. On 04-APR-2016 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # L029480; dose and route not reported), which was expired on 16-MAR-2016 (Expired product administered). No adverse effects were reported. Additional information has been requested.
Fussiness, mother noticed swelling at the inguinal area 2 days back , first on one side and then became bilateral the next day. He has been afebrile. Also reported to have a loose stool. Appears uncomfortable; Marked enlargement of inguinal , cervical and submandibular LN Skin shows red macules - consistent with rose spot lesion , blanchable.
pericarditis; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". A patient was suffering from pericarditis three days after receiving the second dose of the vaccine. Consumer inquired if they can receive the booster dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt called COVID hotline about red small bumps on upper legs. COVID hotline sent pt to ED. Pt had J&J vaccine on April 10.
Received Varicella vaccine around 11:40-12:00 noon. Left here to go to grandmother's house. They were leaving & child said I think I am having a seizure to her mom. She came out of the seizure & screamed, stopped breathing. Mom started CPR until ambulance got there & took over shocked her. Took to hospital where they told her nothing else they could do for her. 10/23/2009 received hospital records for ED visit 7/20/2009. Patient presents  with sx of a seizure which resulted in cessation of breathing. Per ambulance to ED , patient unresponsive, pupils fixed and dilated despite resuscitation efforts. Final DX: Cardiac Arrest  12/8/09 Death Certificate received. DOD 7/20/09. Final cause of death: Cardiac Arrest, Seizure Disorder.
Pt c/o severe pain (L) arm the evening of the day the vax were given. The next day he noticed that his (L) arm seemed weaker while he was working out and he noticed bruising on the (L) arm. The bruising lasted 8-10 days then resolved. The weakness in his (L) tricep has been progressively worsening. The last 2 w and has resulted in atrophy of the tricep.
I started getting ringing in my ears several days ago, waking me up at about 2 am. Today while at work in my office, the ringing became very loud, and has stated that way all day. I?ve never had this before in my life, other than if because of loud concert or such 20 years ago.
Patient woke at 3:00 am on 10/16/08 with a swollen area in the right clavicle region. He had trouble turning his neck to the left. No redness or swelling was noted at the injection site. He came to Health Department and was seen by an RN. He was then sent to his physician or a walk in clinic for further diagnosis. He was taken to Emergency Department, by his mother. He was diagnosised with cervical adenitis, by Dr. Patient was prescribed Amoxicillin 500 mg, tid for 7 days, Motrin 800 mg, every 8 hours and his right arm was placed in a sling for comfort.
I have never had a seizure in my life before or since, but that morning I had five partial focal seizures in y right arm, over the course of six minutes.  As I was on the phone (to report the first one to my caregiver) when the second hit, I inadvertently punched myself rapidly and repeatedly in the right side of my head, with the phone handset functioning as an impromptu bludgeon, leaving bruises reminiscent of the victim of a fist fight.  Also at the time I had a strong headache, cold chills, a 102 degree Fahrenheit fever and body aches.  None of which persisted beyond noon.
Local red, raised reaction at DtaP site on L thigh, 8 1/2 x 11 1/2 cm with edematous margin consistent with histamine release. No evidence of abscess, etc 11/26/09.
Client was not due for an MCV4 this was given in error by a nurse in our department.  She was scheduled to receive a Men B injection.
Scratching; Burning; Trembling from head to feet; lips is burning; lips is so dry; Ears is itching; Ears is black.; Sometimes his whole head is painful/the left and right side of his head is painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning) and LIP DRY (lips is so dry) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning), LIP DRY (lips is so dry), EAR PRURITUS (Ears is itching), SKIN DISCOLOURATION (Ears is black.) and HEADACHE (Sometimes his whole head is painful/the left and right side of his head is painful). At the time of the report, PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning), LIP DRY (lips is so dry), EAR PRURITUS (Ears is itching), SKIN DISCOLOURATION (Ears is black.) and HEADACHE (Sometimes his whole head is painful/the left and right side of his head is painful) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.  Patient stated that something happens to patient after finishing the vaccination series a few months ago. Patient noticed about the symptoms at about 3 weeks before reporting.
Didn't feel well and had shakes and chills.  Also had Bright redness, Hot to touch, from injection site to 1 inch above elbow. Patient did not report this for 5 days after injection  Treated with ice and allergy med.
Lightheadedness and Nausea on waking following morning Severe Headache persisting approximately 12 hours
Hard and red area. When inform to Dr. Dx: Cellulitis. Treatment: Cefadroxil 500 b.i.d. x 7d, hydrocortisone 0.5 oint., mupirocin ointment
Mom reports she went into wake child.  Child snoring and had wet bed.  Child couldn't get up.  Mom lifted her out of bed and sat her on small chair in bathroom.  She leaned to right side.  Seemed to have weak hand grip on right.  Mom also stated she couldn't remember getting immunizations the day before.
Narrative: COVID infection following COVID vaccine series 03/27 , Janssen dose #1 11/08, Pfizer, dose #2n12/20 SARS-COV-2 Variant Sequencing; pending 12/2o COVID swab, result: detected 12/20 pt cc: cough, fatigue, headache, nauseam rhinorrhea, sore throat. right-side swollen throat, exposure: unknown 12/20 CXR impression: No acute cardiopulmonary disease. 12/29 clinically resolved.
Tightness of throat , shortness of breath, hoarseness of voice, wheezing, coughing, diarrhea, fatigue, sore throat, painful chest, can?t get a deep breathe in at all. I?m taking breathing treatments and also have an inhaler.
I tested Positive for CoVid 19 on July 29th.; I tested Positive for CoVid 19 on July 29th.; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Arm Right on 21Apr2021 at 10:45 at the age of (23-years-old) as a single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered on 31Mar2021 at 15:45 at the age of (23-years-old) as a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for positive for COVID-19. Medical history included none. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination There were no concomitant medications. It was reported on 29Jul2021 at 09:30 the patient was tested positive for covid-19. The patient underwent lab tests and procedures which included on 27Jul2021 Nasal Swab test: positive, on 29Jul2021 Nasal Swab: positive. Case was reported as non serious. No treatment was received for adverse event (ae). The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Original injection was to be in left deltoid but needle broke, unsure how much of the dose was fully administered. Dose repeated in RIGHT arm for patient, she is aware of the situation
My menstrual cycle started early and has not stopped . It has been 12 days of menstrual bleeding and this has never happened before. It started the week after my 2nd vaccine shot. My sister and friend; My menstrual cycle started early and has not stopped . It has been 12 days of menstrual bleeding and this has never happened before. It started the week after my 2nd vaccine shot. My sister and friend; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 3 patients (her sister, friend and herself). This is a 1st of 3 reports. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. My menstrual cycle started early and has not stopped . It has been 12 days of menstrual bleeding and this has never happened before. It started the week after my 2nd vaccine shot. My sister and friend have reported a similar side effect and we do not believe it is coincidence. We think it is a side effect of the COVID 19 vaccine. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : PFIZER INC-2021407009 same reporter/drug/event, different patient.; PFIZER INC-2021407010 same reporter/drug/event, different patient.
Patient arrival to ED on 11/24/2021 with nausea, vomiting and diarrhea.
pt recvd vax 21APR93 & exp h/a, nausea, dizziness & a local react manifested by redness, swelling, heat & soreness; pt recovered;
within about 20 to 25 minutes, I got a strange intermittent headache that affects my vision when it comes.  At the same time as the headaches started, my limbs started going numb.  I often have numbness and tingling in my arms and legs now, even sitting for more than a minute or resting my arms on a table for a few seconds.  My chest started hurting a couple days later, followed by tightness and slight difficulty getting a full breath.  I now experience severe chest pain and light headedness while exercising.
After the nurse gave me the shot, my arm was immediately very sore. I told her this and she replied stating something along the lines of "yeah, that can happen with this one." As I drove home, it was difficult to keep my arm propped onto the steering wheel due to the pain, so I decided to just drive with my right hand. When I got home, I expressed my discomfort to my wife. I would rotate my arm in circles to try and circulate the blood and hopefully help the pain go away. It hurt very bad to lift my arm, especially above shoulder height. I was nervous because I was scheduled to work my warehouse job the next day and wasn't sure I would be able to complete my work properly. The next morning, my arm was still very sore but I decided to go to work anyway and thought moving it around more and using it would help. I limited my use of my left arm, but it was still very sore throughout the day. This pain lasted for about 5 days before it started to subside slightly. It would still be very painful to lift my arm over shoulder height. After another week, it got to the point where I could lift my arm over my shoulder without any initial sharp pain, but if I lifted it up or moved it around a certain way there would be a very uncomfortable deep tissue pinching type sensation, almost like my muscles were catching onto each other. This sensation has slowly faded, but I still have hints of it to this day.