chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on the trunk and extremities, including injection site; full body rash / rash on the trunk and extremities; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site rash and generalized rash. On an unknown date, the outcome of the injection site rash and generalized rash were recovered/resolved.   It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the Shingrix was given concomitantly with High dose Flu vaccine a week or so ago, patient developed a full body rash including a rash on the trunk and extremities, including injection site. The healthcare professional would like guidance on the 2nd dose of Shingrix. The reporter consented to follow up.
Approximately 16 days post 2nd Pfizer injection, woke with hissing and compromised hearing in both ears, still continuing to-date. Although I am not experiencing loss of hearing, the way speech is perceived to me has drastically changed and is challenging to understand.  It is hollow, tunnel-like, muffled and I struggle to understand the words.
On 03/02/2001 the patient experienced "about 15 chicken pox like lesions". No other symptoms were reported. Unspecified medical attention was sought. FOLLOW-Up information received from the the doctor's office reports that the child was not vaccinated at their facility. The nurse also reports that the parent of this child is a physician and "refused to bring in the child so the varicella could be documented'. No further information is available.
throwing up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (throwing up). At the time of the report, VOMITING (throwing up) outcome was unknown.            The concomitant medications included medication shots. No treatment medications were reported.
Headache. Chills. Feverish. Body aches. Loss of appetite. Fatigue.
Broke out in hives all over neck, abdomen, chest , back, face and arms about 10-11 days after injection. Hives initially treated with topical cortisone but kept reappearing. After medical consultation, hives were treated with regimen of prednisone and three different antihistamine/allergy medicines for a period of 7 weeks. Hives mostly disappeared after a day or two of treatment beginning.
I received the vaccine on Friday the 12th. On Sunday the 14th I noticed that I had a sort of "wound" in my left lower back. It was causing me some pain when the tip of my backpack touched the area. On Tuesday the 16th I visited the doctor who gave me the news that I had shingles. He discovered that it was actually spreading a little bit more around the original that I saw on Sunday. I'm already on medication for that.
dry stuffy nose; fatigue; muscle aches; headache; chills; arm soreness; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), RHINORRHOEA (runny nose), NASAL CONGESTION (dry stuffy nose), FATIGUE (fatigue) and MYALGIA (muscle aches) in a 57-year-old female 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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm soreness), RHINORRHOEA (runny nose), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headache) and CHILLS (chills). On 25-Mar-2021, the patient experienced NASAL CONGESTION (dry stuffy nose). On 24-Mar-2021, RHINORRHOEA (runny nose) had resolved. At the time of the report, VACCINATION SITE PAIN (arm soreness), NASAL CONGESTION (dry stuffy nose), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-significant Follow up Appended - reporter email address added
did not receive their 2nd dose of GARDASIL 9 on schedule; This spontaneous report was received from a pharmacist and refers to a 34-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 11-DEC-2009, the patient was vaccinated with the first dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. On an unknown date, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1614897, expiry date 20-SEP-2021, for prophylaxis. The second dose was not administered on schedule. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614897; expirationdate: 20-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided  Date of Refrigeration was 07-MAY-2021  This case was linked to MOD-2021-365177 (Patient Link).
Inflammation; radiating pain; Arm pain; Shoulder pain; Joint Pain; Muscle Spasm / Muscle spasm of the left shoulder, upper arm and neck; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 31st May 2021) for prophylaxis.   On 6th February 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, between 4 and 5 months after receiving Shingrix, the patient experienced joint pain, muscle spasm, radiating pain, pain in arm and shoulder pain. On an unknown date, the patient experienced inflammation. On an unknown date, the outcome of the joint pain, muscle spasm, inflammation, radiating pain, pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the joint pain, muscle spasm, inflammation, radiating pain, pain in arm and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. Since receiving the vaccine patient experienced joint pain in the arm she received the Shingrix vaccine in.  The pharmacist stated he received a letter from patient's physician dated 23rd July 2019. The letter stated that since past 3 weeks patient experienced sharp and electric like pain that radiates down from back of shoulder and left upper arm.  The patient was also experienced increased muscle spasm of the left shoulder, upper arm and neck.  The patient had tried physical therapy and it did not improve symptoms.  In the letter physician noted that the way injection was given might have caused patient to developed inflammation. No further details were provided. The reporter gave permission to follow up. As per sales data sheet reported batch number was changed from 273B2 to 273BZ.
Covid Arm - Slight Discomfort when using arm and Red/swollen at site immediately after getting, 8 days later the pain set in and the area became more swollen and red, and was hot to touch. Pain when used arm. I had a lot of fatigue and cold chills during the first week of receiving  and Some confusion. Second week I had bad vertigo for 4 days, which intensity did decreased day over day. Headaches followed after the Vertigo for about 3 days with some dizziness. I continued to have serious fatigue until about  2nd week in Sept. I was taking about 4-5 naps a day and didn't have the energy to do much of anything. My legs and arms felt heavy during the fatigue.
Neck and arm stiffness that lasted 24 hours. Took Advil for discomfort
vomited; nausea; I got my 3rd booster shot, Pfizer covid shot; I got my 3rd booster shot, Pfizer covid shot; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from regulatory authority (manufacturer control number: EC-2021-096247), for bnt162b2 (BNT162B2).  A 48-year-old female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 27Aug2021 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization; and LENVIMA (LENVATINIB MESILATE), via an unknown route of administration from 09Jul2021 to an unspecified date, as 20 mg for Recurring Thyroid Cancer. The patient medical history included Papillary Thyroid, "Recurring Thyroid Cancer." Diagnosis/ICD code: "Papillary Thyroid Carcinoma C73". The patient concomitant medication was not reported. On 29Aug2021, the patient experienced vomited, nausea, and I got my 3rd booster shot, Pfizer covid shot. On 26Aug2021, the patient underwent lab tests and procedures which included Blood pressure measurement: high, Blood Pressure is "getting better and better" since the dose was decreased; and Computerised tomogram: nodules had decreased, showed 2 of my nodules had decreased, in the right lung. Patient reported "my Blood Pressure was so high", so her doctor reduced her Lenvima, and patient said now her Blood Pressure is "getting better and better" since the dose was decreased. Patient reported she had her Lenvima dose decreased to 20 milligrams daily, about 2 weeks ago, cause was related to Lenvima and occurred while on Lenvima.  Follow up (30Sep2021): The following information was received from regulatory authority.
Emergency surgery of gallbladder two days after receiving the 1st dose of the vaccine; A spontaneous report was received from a consumer concerning herself, a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had emergency surgery of gallbladder two days after receiving the first dose of the vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, two days after the vaccination, the patient had an emergency surgery of gallbladder and was hospitalized. Treatment for the event included surgery.  Action taken with mRNA-1273 in response to the event was not provided.    The outcome of the event, emergency surgery of gallbladder two days after receiving the first dose of the vaccine, was considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Vaginal bleeding approximately 12 days before regular menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 (Lot number: FF2587) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 17Sep2021, outcome "unknown", described as "Vaginal bleeding approximately 12 days before regular menstrual cycle".  Additional information: Facility type vaccine was military base. No other vaccine in four weeks. Patient also received dose 2 of Pfizer covid 19 vaccine on 01Oct2021, lot number: 30145BA, arm left.  Follow-up attempts are completed. No further information is expected.
Burning sensation at injection site with loss of mobility in right shoulder.  Mobility returned in @48 hours.  Pain and range of motion remains.
Redness, warmth (L) arm. KINRIX, VARIVAX administered.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on the same date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA009925: US-009507513-1812USA009926: US-009507513-1812USA009927: US-009507513-1812USA009928: US-009507513-1812USA009929: US-009507513-1812USA009930: US-009507513-1812USA009931: US-009507513-1812USA009932: US-009507513-1812USA009933: US-009507513-1812USA009934: US-009507513-1812USA009924: US-009507513-1812USA009923: US-009507513-1812USA009921: US-009507513-1812USA009922.
Employee very lethargic almost unable to get out of bed, febrile 103.8, nausea with vomiting, extreme body aches, arm red, warm to the touch and swelling.
Post Day 8 (after vaccine) I developed a red spot on my left arm. The red spot was warm to the touch but no other symptoms. I circled with a pen and the redness grew so I went to the Urgent Care where they classified it as "Cellulitis" and gave me and RX of Keflex to treat it. By Post Day 12, it was gone.
11/3/09 Received mist at 3:30 PM-30 min later c/o throat hurting (no trouble breathing), later throat hurt; woke up at 2 AM crying-throat sore-ibuprofen at 2 AM-temp up 102.9, comes down to 100.9. Has called Dr. Spoke to mom 11/4. 11/5 Mom stated child's temp was down and still responding to ibuprofen. C/o feeling wobbly and dizzy on 11/5 AM. Also c/o tingling in fingers "a little bit ago". Encouraged mom to keep an eye on her and to keep in touch with Doctor.
Small muscle twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Small muscle twitching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Small muscle twitching). At the time of the report, MUSCLE TWITCHING (Small muscle twitching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Headache began around 10 pm, I took 1000mg Acetaminophen at Midnight and went to bed.  Slept until 6 AM.  Woke with a severe headache and nausea.  Took 500mg Acetaminophen within 10 minutes I vomited.  Vomited again an hour later.  I went back to bed and slept waking every few hour to sip water and vomit.  I could not tolerate anything and had an ice pack to relieve the headache.   At 6pm the pain subsided enough to get up.   It's 1:47PM 2/11/2021 and I still feel a bit foggy.  I have a pain in my side just up and under my ribcage and around the back.   If it persists I will seek medical attention
Headache and strange tingling / slight swelling in mouth within 30 min (shortly after leaving pharmacy) and arm soreness. Headache and weird mouth sensations went away after a day, but exactly 7 days after first shot, woke up to find a huge itchy sore welt / rash at site of injection (about 5inches diameter) and a really sore swollen lymph node in left armpit, and slight mouth tingling / swelling sensation which persisted all day. Spoke to physician remotely and will check in with someone at urgent care if symptoms persist
Starting around the end of January of 2022, I developed a heavy chest. I called my doc, who told me to get a COVID test, and then put me on zinc and prednisone and Vitamin C (as if I had COVID). I was tested and ended up being positive for COVID. I got pills once I let my doctor know I was positive, and within 5 days I was completely over it.
pt recv vax; infant started crying & cried non stop for 3-4 hrs; would not even take a bottle;APAP adm;
asymmetrical sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 07-NOV-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered acute sudden hearing loss and tinnitus. The patient was diagnosed with asymmetrical sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  The event of asymmetrical sensorineural hearing loss was considered to be disabling.  Upon internal review, the event of asymmetrical sensorineural hearing loss was considered to be medically significant.
G2P0, 5w5d;  The patient is calling with vaginal bleeding in pregnancy.  Calling with c/o dizziness with headache; Has a history of migraines; States she has subclinical hypothyroidism. Has tried Tylenol 500 mg for headache that worked for a little while; She denies vomiting, but does have nausea; Will try to increase water and protein intake; Will let us know if she gets worse/vision changes and will check in with PCP as they wanted to do a VV if dizziness got worse.  Bleeding continued into following day.  Documented as likely / threatened miscarriage.
Fever >99.9 for 10 days, sore throat for first 2 days, body aches for 10 days, chills for 10 days
soreness; Bump at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and VACCINATION SITE MASS (Bump at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011A21A) for COVID-19 vaccination.     Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE MASS (Bump at injection site). On an unknown date, the patient experienced PAIN (soreness). The patient was treated with WARFARIN SODIUM (COUMADIN) at a dose of 1 dosage form. At the time of the report, PAIN (soreness) and VACCINATION SITE MASS (Bump at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable      This case was linked to MOD-2021-033458 (Patient Link).
Information has been received from a physician concerning a 2 month old female who was vaccinated with a 2ml dose of Rotavirus vaccine. On the next day, the pt died. The physician stated that the infant received all of her vaccines on time and wad in perfect health. The medical examiner ruled the cause of death as sudden infant death syndrome. Unspecified medical attention was sought. No product quality complaint was involved. NO other information was provided. The reporter considered the pts reaction to be immediately life threatening. Additional information has been requested.  12/28/06 Received autopsy report which reveals COD as Category II SIDS, cosleeping with parents in adult bed.  Manner of death undetermined.