chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered a dose on 17Jan2022 that had expired 01Jan2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number 95SN2, expiry date 1st January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 17th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered a dose of Engerix-B on 17th January 2022 that had expired 1st January 2022, which led to expired vaccine used. The reporter consented to follow up.
Sore right wrist  nearly immediately after shot for a few hours. Right shoulder had mild soreness later that evening. Next day had mild body aches and a slightly elevated temperature (98.2 instead of my normal 97.5). Felt very mild chills. Diarrhea on days 2-4 after shot. Less appetite.
hives on arms and legs with no itching or pain; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced side effects of hives on arms and legs with no itching or pain. Patient asked that is this a common side effect and what is an anaphylactic allergic reaction. The outcome of the event was Unknown.  No follow up attempts are needed. No further information is expected.
Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 06Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on an unknown date at 15:45 as a single dose for COVID-19 immunisation. On 07Apr2021 at 21:00, the patient experienced difficulty breathing. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event difficulty breathing was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
severe pains right underneath her breasts; like a huge belt was tightening and tightening; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: PFREL1283, expiry: 30Apr2021) intramusculary into the right arm on 15Jan2021 15:30 at a single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. On 16Jan2021 04:00, patient started to get severe pains right underneath her breasts, it was like a huge belt was tightening and tightening. Patient thought maybe she was getting a heart attack. It was further reported that at 06:30, it stopped and she has been fine ever since. The patient did not require an emergency room or physician office visit. Outcome of events recovered on 16Jan2021 06:30.
12 days after receiving vaccine he developed scattered papulovesicular rash over back and trunk. Total of 12-15 lesions. Afebrile and asymptomatic.
a staff member accidentally gave the Moderna Covid-19 Vaccine to a 13 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a staff member accidentally gave the Moderna Covid-19 Vaccine to a 13 year old) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a staff member accidentally gave the Moderna Covid-19 Vaccine to a 13 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a staff member accidentally gave the Moderna Covid-19 Vaccine to a 13 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not provided. The patient had no adverse effect from the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Information regarding adverse events updated.
Almost immediate ocular issues. Shortly after receiving the 2nd shot I started having black spots in my vision, however, if I closed one eye the entire view field of the open eye was fully intact and in color. I also had some halo-ish, not really tracers, but more like weird folding in my view field. For example, I tried to read on my phone and chunks of words weren?t visible. The beginning of the word was there, the end of the word was there, but the middle wasn?t but there wasn?t a visual gap.  I could move the screen somewhere else in my view and then see the complete words. It was surreal.   Initially, I did a lot of deep breathing to try to relax, which helped, but when I started driving It came back. I pulled over at a restrained, ate and drank (I hadn?t eaten much yet that day) and rested for a while.  I eventually was able to drive home, but felt very off the rest of the day. I went to bed early.  The next day I awoke with a decent amount of eye goop, which is not usual for me. Since then I haven?t had the viewfield issues, but I have had some reduction in vision contrast. It seems to be improving.
This pt experienced similar reaction to all 3 anthrax vax - two to right deltoid and 1 to left. Reports immediate onset of pain that is throbbing in nature and 5-6/10 in severity, completely resolves in 30 minutes to 1 hour. This same pain extends across chest between clavicle and nipple line and halting at opposite shoulder, not felt across back, no associated shortness of breath, diaphoresis or weakness. Mild to moderate local swelling and erythema ensues for 3-4 days.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 21-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 24, 168, 336, 1172, 80 and 416. The lowest recorded temperatures were of -3 and 30. The highest recorded temperatures were 48, 49, 59 and 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
After 2nd dose about mid-May, I woke one morning and my right ear was ringing very loud. It didn't make sense for one ear only. Loud ringing and loss of hearing. - lasting for several days and weeks coming in waves. It would seem to dissipate and then return. I visited my doctor, PCP, and he evaluated me - removed wax build up - but he was unable to determine cause. He prescribed a steroids - Dexamethasone. Everything seemed to clear up after this. About a month or so later the symptoms returned. It had actually never went away - just slight low ringing in the ear. It got worse and PCP referred me to ENT. About late August, I saw the ENT. On my first visit they did audiogram. Loud ringing and hearing loss. Significant hearing loss found as compared to hearing test previous year.  ENT requested CT Scan. Another round of the steroids seemed to help. Since then the heavy tinnitus has not been too bad but still comes and goes. As of today my hearing has returned.
Patient called pharmacy on 9/22/17 and stated his left arm was completely numb. Patient states he feels it is due to flu shot administered on 9/13/17. Patient states he felt administration was "a little hard" and began experiencing pain and numbness 2 days after administration (9/15/17). Patient did not report any side effects to pharmacy prior to his call on 9/22/17. Patient was advised to seek medical attention due to description of symptom as "arm feeling dead".
The day of and the following morning I had sever pain in my right arm. I also had a large red bump that was hot to the touch. It turned into a bruise that lasted for 12 days. In addition my mensural cycle was 16 day late, and once my mensuration began it lasted 9 days. This is not normal for my cycles at all.  I took pictures of the site of the injection with the redness.
It looked warm; It looked pink; the site of injection was swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It looked warm), VACCINATION SITE ERYTHEMA (It looked pink) and VACCINATION SITE SWELLING (the site of injection was swelling) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It looked warm), VACCINATION SITE ERYTHEMA (It looked pink) and VACCINATION SITE SWELLING (the site of injection was swelling). At the time of the report, VACCINATION SITE WARMTH (It looked warm), VACCINATION SITE ERYTHEMA (It looked pink) and VACCINATION SITE SWELLING (the site of injection was swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Additional information received. Event information updated.
Hoarseness in throat; Burning sensation in throat; Bad headache off and on; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Bad headache off and on), DYSPHONIA (Hoarseness in throat) and BURNING SENSATION (Burning sensation in throat) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 immunisation.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEADACHE (Bad headache off and on). On 11-Mar-2021, the patient experienced DYSPHONIA (Hoarseness in throat) and BURNING SENSATION (Burning sensation in throat). At the time of the report, HEADACHE (Bad headache off and on), DYSPHONIA (Hoarseness in throat) and BURNING SENSATION (Burning sensation in throat) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
death rash following vaccination sepsis N17.9 - Acute kidney failure, unspecified multiple mylenoma
Vaccine received 14:00, 10/07.  Severe muscular pain down left side if back and left leg felt very tired at 14:30 (10/08).  Very runny, stuffy nose, could not breathe afternoon and all evening.  All night went to MD 10/09 @ 11:00.
Patient was fully vaccinated with Pfizer series. Patient arrived for routine blood work on 5/10 and was offered a COVID vaccine.  Patient was administered Moderna vaccine on 5/10 and scheduled for follow up 2nd dose.
1 of 5 pt vaxed from the same lot# who exp local rxn @ vax site;rxn described as enlarged, swollen, red & painful;exp diff moving immunized arm x several days;recovered
Itchy; After 20 days, he had rashes on same arm.After few days, it started occurring in opposite arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH (After 20 days, he had rashes on same arm.After few days, it started occurring in opposite arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rash (The patient had rash in the different arm).    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 PRURITUS (Itchy) and RASH (After 20 days, he had rashes on same arm.After few days, it started occurring in opposite arm). At the time of the report, PRURITUS (Itchy) and RASH (After 20 days, he had rashes on same arm.After few days, it started occurring in opposite arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient taken medications but they didn't help. Concomitant product information was not provided.
Woke up around 3:00 am with swollen chin and lower face. Took an Allegra tablet. face started to go down around 09:00am the same day.
1100 Patient found unresponsive to verbal stimuli by RN, lips cyanotic, color pale, lowered carefully to ground.  Pt then stated he could not breathe.  1105 epinephrine 0.5 mg  IM administered to left vastus lateralis by EMT. Breath sounds clear in all fields per EMT. BP 124/70 per EMT.  Pt began to report ease of breathing, alert and oriented to self. 1110 Benadryl 50 mg IM administered to right deltoid. Pt condition improving, color improving, alertness improving. 1115 Report given to responding ambulance crew and patient transported to higher level of care.
PATIENT FELT LIGHTHEADED AND REALLY HOT.  SHE FAINTED WITHIN ONE MINUTE OF INFORMING ME.  HER HUSBAND HELPED ME MOVE HER FROM THE CHAIR TO THE FLOOR.  WE CALLED 911 BUT LATER CANCELLED SINCE SHE REGAINED CONSCIOUSNESS IMMEDIATELY.  WE PLACED COLD COMPRESS ON HER FOREHEAD AND BACK OF NECK.  CHECKED HER BLOOD PRESSURE AND IT WAS A LITTLE LOW SO I HAD HER SIT AT THE PHARMACY TO OBSERVE HER A LITTLE LONGER.
After 23 hours of first dose had a less than ten second seizure. Last seizure over seven years ago. Had a migraine that night before bed. After 53  hours of second dose had migraine headache at that night. Not able to clearly read the number on the CDC card with the EN number.
Two weeks after my first Pfizer covid-19 vaccine dose, I began having urticaria in flexural areas (popliteal fossa, antecubital fossa) once or twice a week, which continued for the next two months. This was a new finding which I did not have before the vaccine.
A non-serious spontaneous report of "full dose was given in one nostril" was received from a mother concerning her four-year-old daughter subsequent to FLUMIST. On 04-Oct-2009, the patient received FLUMIST for the first time. As of 13-Oct-2009, the patient remains fine with no complaint. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated popular of 2 years to 59 months of age for FLUMIST. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-APR-2015 (also reported as 21-APR-2013), the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, route and lot # were not reported, expiration date: 13-MAR-2015). No adverse effects were reported. Additional information has been requested.
7 days after injection, developed swelling, redness, itchiness, tenderness, heat, and discomfort at and around injection site.
Patient had started her covid 19 primary series.  First vaccine given was Pfizer in June 2022.  Patient received a Moderna Monovalent today instead of a Pfizer Monovalent to complete her primary series.  No adverse reactions noted.
pt brought to ED with c/o SOB, cough, and myalgias; found to be hypoxic; started on O2 via NC; hypotensive; AKI; started on dexamethasone and bronchodilators; developed A Fib with rapid ventricular rate; continued to hypotensive and condition declined requiring high flow O2 and NRB mask; DNR/DNI; condition deteriorated; placed on comfort based care and died in the hosp
I had a breakthrough case of Covid with stuffy nose, sinus I also experienced a bad sore throat with headache some muscle ache a high fever and my thinking was kind of fuzzy at times as well. I was prescribed PAXLOVID to negate my symptoms.
No adverse effects reported; Reporter states patient was administered VAQTA post expiration; This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, drug reactions, allergies, concomitant therapies and pertinent medical history was not provided.   On 24-SEP-2019, the patient was vaccinated with post expiration (expire vaccine used) Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml, one dose, lot number R027431, expiration date 08-SEP-2019  for prophylaxis. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA011985:
Upper torso swelling, including lips, eyes, face and throat..non life-threatening. Home treated with diphenhydramine HCI 25mg.
Vaccinated 6FEB w/in 2 hrs temp went to 105, all day long, irritable. MD saw child 7FEB. Temp 104+. No other sx. Persisted for 4 days, then gone.
1st shot - developed tendonitis in both wrists which continues today 2nd shot - Severe nausea, severe headache and fatigue for 24 hours, severe tendonitis continues 3rd shot - Severe nausea, severe headache, fatigue, fever for 48 hours, fatigue continues today as does severe tendonitis requiring occupational therapy
received a 0.5mL booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received a 0.5mL booster) in an elderly female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received a 0.5mL booster). At the time of the report, ACCIDENTAL OVERDOSE (received a 0.5mL booster) had resolved.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-365028 (Patient Link).
exactly 3 weeks after my first vaccination (I am going for my second one on 3-16-21) my left hand became red and very swollen. I was vaccinated in my left arm. The swelling extended a little beyond my wrist as well.
Doctor ran a urine sample and came back showing some bacteria; some pain on her right side; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. The patient was scheduled for the second dose of Pfizer's COVID vaccine today on 02Mar2021. For the past 5 to 7 days, she had some pain on her right side and went to her family doctor yesterday, 01Mar2021. He ran a urine sample and came back showing some bacteria and gave me an injection of Rocephin and put me on Augmentin. The patient was supposed to go for CAT scan today at 2:30. Caller stated her doctor does not recommend her to receive the vaccine and is asking if it was ok for her to have the vaccine today since she is taking antibiotics? Therapeutic measures were taken and treatment included injection of Rocephin and augmentin for event urine sample and came back showing some bacteria. The relevant lab test included test: urine analysis, results : urine cytology abnormal (bacteria). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2JAN92 unconsolable crying 5-6 hrs, pain in leg; pt took 1 hr nap in middle of crying; 3JAN92 t101.4, seen by MD 430PM; 4JAN92 rash on thighs @ inject site;
Pt had febrile seizure with vesicles/temp 103 16 days after Varivax. Had new onset ptosis of left eye which resolved in 2 weeks.
Approximately 2 minutes after receiving these vaccines the person fainted. She regained consciousness after 20-30 seconds and appeared to have no other problems afterwards.
Mother rushed into clinic with child. States her child was sick. Says he received shots yesterday and was having problems breathing and fever today. Child was crying and face was flushed. Temperature was 102.3F (ear). Mother says she did give medicine for temperature X 3. She was referred to MD.
Nine days after injection developed rash and redness with heat on left bicep where shot was given. It itches, is warm and red. Treating with hydrocortisone cream (to stop itch) and icing for the heat. This is now day 2 (1/8/21).