chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6/3 @ about 10:00Am felt warm sensation in my head then 3 bouts of disinyness in succession.  I had to sit on the ground for a couple minutes because I felt I was at risk of passing out
Pt recvd vax 28JUN91 became cranky all afternoon & had high fever late evening w/t104, followed by febrile sz; hospitalized for 48hrs while treating w/DPH & fluids; dx febrile sz probably 2ndary to DTP immun;
loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable consumer (patient's daughter).  A 55-year-old female patient (reporter's mother) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 12Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 13Apr2021, the patient and today (14Apr2021) patient had a new symptom of loss of taste and smell. Reporter would like to have her mother evaluated by an HCP as soon as possible for these new onsets of symptoms. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
soreness on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness on the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. was supposed to get Boostrix vaccine (Tdap) but was given Shingrix. He had already completed his Shingrix series in 2018
Information has been received from a physician concerning a patient who had been vaccinated on unspecified dates with "3 or 4 doses" of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, it was reported the patient did not seroconvert.  It is unknown whether medical attention was sought.  Additional information has been requested.
Plaque psoriasis; Back pain/pain in back; arthritis pain/pain in elbows; Pain in fingers; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis), BACK PAIN (Back pain/pain in back), ARTHRALGIA (arthritis pain/pain in elbows) and PAIN IN EXTREMITY (Pain in fingers) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication. No Medical History information was reported.   On 01-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. In 2021, received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis), BACK PAIN (Back pain/pain in back), ARTHRALGIA (arthritis pain/pain in elbows) and PAIN IN EXTREMITY (Pain in fingers). At the time of the report, PSORIASIS (Plaque psoriasis) was resolving and BACK PAIN (Back pain/pain in back), ARTHRALGIA (arthritis pain/pain in elbows) and PAIN IN EXTREMITY (Pain in fingers) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient complained of pain in his back, fingers, and elbows without any arthritis inflammation with Skyrizi, his plaque psoriasis was better. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment details were reported.  The reporter's causality for the event(s) of arthritis pain/pain in elbows, pain in back, pain in fingers and plaque psoriasis with Janssen Covid Vaccine was possible. The reporter's causality for the event(s) of arthritis pain/pain in elbows with skyrizi(risankizumab) was no reasonable possibility. the reporter's causality for the event(s) of pain in back, pain in fingers and plaque psoriasis was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
I received my second shot at 2:30 pm.  by 4am I was vomiting, teeth chattering, sweating, incredibly tired and was in bed for 2 days.  I then started showing bruising on both feet as well as behind my knees- in which I still have.  I am concerned as I am reading about lack of platelets.  I have had symmetrical bruising on both feet and behind both legs.
Three days after receiving my first dose of Moderna, I noticed this loud noise and sensation from what appeared to be coming from my left ear and head.  Coincidentally,  I received my vaccine shot on my left shoulder, and my left ear is effected. I made an appointment to see my ENT Doctor three days later to be told that my hearing test came back normal, but I had tinnitus. I have never experienced this before, and wanted to report  it because it did not occur  until I had my first vaccine shot. I am now 16-days in after my first shot, and the sound has not eased up, but has gotten worst and is continuous 24/7. I cannot sleep with the constant buzzing and humming in my ear, and I am unable to concentrate.
Heart arrhythmias; Insomnia; POTS; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Heart arrhythmias) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 ARRHYTHMIA (Heart arrhythmias) (seriousness criterion medically significant), INSOMNIA (Insomnia) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS). At the time of the report, ARRHYTHMIA (Heart arrhythmias), INSOMNIA (Insomnia) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) had not resolved.            Patient stated that the company ruined the life when adverse events experienced 2 weeks after the booster dose. Patient mentioned 6 months after patient was still dealing with it. No concomitant medication information was reported. No treatment medication information was reported.  Company comment: This spontaneous case concerns a 24-years-old, unspecified gender with no medical history, who experienced the unexpected serious (medically significant) AESI event of arrhythmia and unexpected non serious AESI event postural orthostatic tachycardia syndrome, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. It is reported that 2 weeks after booster vaccination patient had adverse events lasted for 6 months. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 24-years-old, unspecified gender with no medical history, who experienced the unexpected serious (medically significant) AESI event of arrhythmia and unexpected non serious AESI event postural orthostatic tachycardia syndrome, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. It is reported that 2 weeks after booster vaccination patient had adverse events lasted for 6 months. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Approx 2 wks p/immun onset of swollen glands & lymph nodes; All resolved x/one behind ear;
Moderna Covid-19  My hair comes out when I comb it also without being combed.
Patient c/o of Left arm pain and was given TYLENOL for pain. At noon the following day 9/19/18 was sent to the nurses office for vomiting. At 2:50 school nurse called to report fever of 102.0 F.
mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose; mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose/mixed two vials incorrectly, gave it to 2 patients.; Mild Discomfort; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) from medical information team for a Pfizer sponsored program Support.  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Sep2021 16:00 (Lot number: FC3183) at the age of 12 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 07Sep2021 15:30, outcome "unknown", described as "mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose"; PRODUCT PREPARATION ISSUE (non-serious) with onset 07Sep2021 15:30, outcome "unknown", described as "mixed 0.8ml of the diluent instead of 1.8mL with Pfizer vaccine resulted in a higher dose/mixed two vials incorrectly, gave it to 2 patients."; DISCOMFORT (non-serious) with onset 07Sep2021 15:30, outcome "recovered" (Sep2021), described as "Mild Discomfort".  Additional information: It was the first dose for the one patient and as second dose for the other patient. Facility Type: doctor office. Prior vaccination: None. Concomitant medication included Ongoing Multivitamin used for Supplement via Oral route of administration. Allergies to medications, food, or other products: NA. Other illnesses at the time of vaccination and up to one month prior: None. Chronic or long-standing health condition: No. Patient was able to participate in sports same day in arm of incident. Investigation Assessment: Not Provided. Relevant test: None.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169694 Same reporter/ drug/ event for different patients
Abdominal discomfort and blood shed from uterus. Not on time with cycle due date.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medication were not reported.  Reporter reported that the vaccines were stored in freezer and they take out one to two vials and place in fridge each day as needed.
when she administered the vaccine into the muscle A large amount came out maybe about less than half came dripping down patients arm/ with no AE; when she administered the vaccine into the muscle A large amount came out maybe about less than half came dripping down patients arm/ with no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.   This case involves (unknown age and gender) patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ292AA, Expiry date: 10-Jun-2020) into the muscle in arm and a part of the vaccine touched the skin of the patient on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication Exposure via skin contact and vaccine underdose.   It was reported that Pharmacist stated that when she administered the vaccine into the muscle a large amount came out maybe about less than half came dripping down patients arm..  At the time of report 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 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.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L028082 with expiry date 18-SEP-2017; dose and route were not reported). No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
Patient presented to Clinic requesting Moderna Booster. Pt did not have his card. He stated it had been 5-6 months since last dose in series. Pt given Moderna Booster dose 0.25ml IM LDI. No computer access at clinic. Nurse found while documenting the vaccine in system, this was 4th dose. Pt had booster dose on schedule 12/29/2021. No booster needed at this time.
Chills, fatigue, body aches, headache that lasted for approximately 24 hours
Began noticing cardiac issues (rapid or pounding heart, increased HR, shortness of breath) in March of 2021.  I went to my physician and they took three separate BP readings and they were all concerningly high.  I purchased an at home monitoring system and began recording my BP daily.  My BP readings were 152/84 on average with an average pulse rate of 83.  When I returned to the doctor for a 3rd follow up in August my in clinic BP was very healthy.  Thus, no future treatment plans were made.
After receiving the Covid-19 vaccine shot, it has disrupted my menstrual cycle. I have always had a regular cycle and now my menstrual cycle is every 2 1/2 weeks.
100.6 fever; chills; body aches; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was administered with first dose of bnt162b2 on unspecified date for COVID-19 immunization (lot/batch number was unknown). On 12Jan2021, the patient experienced 100.6 fever, chills and body aches. It was unknown if treatment was given for the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Vaccine was expired at time of administration.  It was past bud of 10 weeks in the fridge.  It expired on 3/30/22.  Called patient to discuss cdc recommendation for re-vaccination.  Left message, will call again
Son woke up with mild fever and tummy hurt...fever progressively got higher. Started vomiting and progressively got hotter...his temp reached 104.3 in the night even while alternateing Tylenol and Motrin.... we are on day 3 and still low grade fever.  Our daughter got the same vaccine on the same day and she woke up with fever as well...
Circular rash on left shoulder around injection site. This occurred 10 days after Moderna vaccine was received. Rash began to fade the next day. Primary Doctor was notified the following day and he suggested taking 50mg of Bendryl prior to receiving 2nd dose of vaccine.
Nausea, vomitting, diarrhea, fever, lethargy, pain at injection  site
bp 187/88, HR 100+ ~30 MIN AFTER VACINE.        6-7 HOURS LATER, BP 176/88 TO 182/87, HR 97 TO 88OXYGEN SATS 98.  PATIENT WAS RANDOMLY TAKING VERY LARGE BREATHS.  NO SITE REDNESS AND SWELLING
Moderna COVID-19 Vaccine EUA Evening of shot: pain at injection site 1 to 3 days after: pain at injection site, general achy-ness, severe fatigue, short dizzy spells, multiple headaches per day. All symptoms mostly treated by ibuprofen. 7 days after: tenderness at injection site, swollen and hard mound at injection site, mild to moderate hives at injection site. Mostly treated by ibuprofen and hydrocortisone cream.
Patient received COVID vaccine  and felt dizzy and nauseating 10 minutes after.  Later developed palpitation.  Vital and O2 Sat stable. MD on site examined the patient and triaged to send patient to ED. Symptoms recovered when presenting to ED.
Dizziness. Seen by an onsite EMS.  Discharged home at 12:40 p.m. Recorded by employee.
Resident has been declining. However, day after receiving vaccination had hypoxia and wheezing. Stat labs were ordered, but not obtained prior to death.
Information has been received from the physician via Market research Agency concerning a patient of unknown gender and race, which was the one out of 100 patients, aged between 11 to 22 years old (exact age not reported), who were enrolled in the program. The patient had no relevant medical history or concurrent conditions. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and lot # not reported). There was no concomitant medication. On an unknown date, the patient fainted after vaccination with GARDASIL 9. Then the patient woke up, stayed at pediatrician's office for 15-20 minutes and the blood pressure was checked before the leave (results not provided). No tests were carried out for diagnosis. The administration of the subsequent doses was not prevented and action taken with GARDASIL 9 was reported as continued. The outcome of the event was reported as recovering. The physician considered the event to be related to GARDASIL 9. Additional information is not expected because the physician was not willing to be contacted.
Initial information has been received from a nurse supervisor concerning a female nurse Practitioner who held a ZOSTAVAX clinic last week and administered ZOSTAVAX to numerous patients over 2-day period. As of 21-Oct-2008, it was reported that nurse practitioner was having red blotches and vesicles all over her body and was not recovered. The nurse District Health Department 4 was planning to see her physician that day. Follow-up information was received from the 45 year old nurse practitioner. She reported that she had current open wound infection in lower leg, allergy to DEMEROL, allergy to cephalosporins  and a history of chickenpox disease in 1992. On 14-Oct-2008 she administered several doses of ZOSTAVAX (lot# 658207/0883U) to people. The last doses were given at around 3:30 pm that day. She reported that she also gave one varicella vaccine. She mentioned that she had no recent exposure to chickenpox and shingles but one patient may have had shingles . concurrently, she also took TOPROL XL tablets, ORTHO-CYCLEN. On 17-Oct-2008, Friday midday, vesicles were noticed. The herpetic/ vesicles rash started on arms, most of rash located on both arms, chest and scalp. There were also lesions on both legs, abdomen, back, buttocks, perineal area, ears and hands. The maximum body temperature was 99.0. She also experienced burning skin and itching. She developed herpes zoster. The rash remained. The nurse practitioner was enrolled in the Zoster Virus Identification program to identify if VZV is present and if it is present to identify  if it is associated with the wild-type (WT) VZV strain or with the OKA/Mereck vaccine VZV strain. The sample of the lesion was collected on 22-Oct-2008. The sample was taken from a vesicle lesion on the right arm and right leg. The results revealed negative for the sample from the right leg and inadequate for the sample from the right arm. Additional information is not expected.
Patient felt nauseus approximately 10 minutes after the imz, then proceeded to vomit, She then stated that she felt better. She stated she gets herself worked up
Ecchymosis, induration & tenderness over left triceps compartment. treatment: Medrol dose pack & Zyrtec
Two wks after receiving vaccine developed a rash on her neck that tested positive for varicella.
Egg shape lump on the right cheek-bone; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Egg shape lump on the right cheek-bone) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Cholesterol and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DOXYCYCLINE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MASS (Egg shape lump on the right cheek-bone). At the time of the report, MASS (Egg shape lump on the right cheek-bone) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She reported that the Dermatologist administered Saline injections and another round of antibiotics.   This case was linked to MOD-2022-482189, MOD-2022-482235 (Patient Link).
Temperature excursion in vaccine refrigerator - vaccines marked do not use and someone took one out and administered it while on the phone with Merck checking the stability. - MMR only vaccine that was not stable.  Occurred at time of well visit check.
Blood clot in my eye causing a hemmorage and now I can't see out of lower part of my eye. Vision is expected to come back in 2-4 weeks.  My lymph nodes in my armpits are swollen and I have exhaustion. I was sick and my body ached the day after but that was it.
Patient with "easy bruising" went to PCP who sent patient to ED. Platelet count found to be 9000 when two months prior was 200,000
Significant soreness in vicinity of injection site, muscle aches, body aches, headache, shivering, night sweats, fatigue, tiredness into the second night after the injection.  This felt like a case of the seasonal flu.  By the second morning after the injection I awoke mostly recovered from all the symptoms.
She reports on the evening of 12/29/2020 that she noted her arm/injection site was uncomfortable so took Tylenol. She comes to work on 12/30/2020 and by 1200 c/o's of chilling, extreme severe body aches, headache, feels like she has the flu, c/o's being tired but reports that she is afebrile. Pt. was instructed to contact her PCP and she reports that she was seen in the clinic on 12/30/2020. She reports being afebrile in the clinic but upon returning to her home she had a temp. of 101.6. On 12/30/2020 she reports having a temp spike of 103.6 and reports feeling as if she had "Covid all over again".  She reports not being able to return to work until 01/04/2021 due to cont. s/s of body aches, headache, and fatigue.