chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Administered after the 30 day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. Patient had no known drug allergy and also the patient did not have any acute illness at the time of vaccination and up to one month before. Patient had never been diagnosed with/tested positive for COVID-19.  Concurrent medical conditions included Paroxysmal atrial fibrillation (No recent change), Depression (No recent change) and Monoclonal B-cell lymphocytosis (No recent change). Concomitant products included FLECAINIDE ACETATE, PAROXETINE, LISINOPRIL, METOPROLOL SUCCINATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 08-Apr-2022 at 8:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Apr-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered after the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Administered after the 30 day use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Administered after the 30 day use by date). The by use date of vaccine was labelled as 18-Mar-2022. On 18-Feb-2022, the vial was initially stored in refrigerator. The vaccine was stored in refrigerator between 2-8 degree Celsius and there was no temperature excursion. No symptoms or side effects were reported by the patient. The event did not cause patient to seek medical care. The reporter did not report any other potential causes. It was unknown if patient experience similar events in the past. No additional doses treatments or medications have been administered in response. This case was linked to MOD-2022-536509 (Patient Link).
The evening after the shot I experienced very high fever, 104.8, chills, shaking, body aches. The next two days the fever stayed at 101 and by the third day I felt better.  Then a week later I developed dizziness, falling sensation.  A few days after that I started to feel numb on the left side of my face. Then on April 22 I went to the doctor because the numbness had moved to my hand and foot on left side.  It was determined that I wasn't having a stroke and that my iron levels were low after blood test.  I was given Ferrous Sulfate tablets to start taking.  My symptoms persisted and the dizziness and numbness continued to worry me.  I called the doctor again who said to take  steroids (prednisone) for one week.  He thought I might have Balls Palsy even though my face wasn't drooping.  The steroids did not change my symptoms.  On May 31st the dizziness felt more spinny and I had awoken with severe headaches the past two mornings.  I went to Urgent Care where they performed and EKG and blood glucose.  All was fine.  She sent me to the ER to rule out brain tumor, MS, or aneurysm. I had four MRI's done and all were fine and normal.
After shot no problem, then 3 weeks broke out with rash that itches all over my body left arm and back of neck most severe.  Cannot sleep for itching have sprayed with anti itch medicine used creams, lotions anything to keep skin moistened but  still persisted  Finally on April 24 I was so miserable I went to Urgent care and received a steriod shot which helped for a wee then itching returned and I went back and thy said no more steriods and tried a benedry shot which put me to sleep until the itching woke me up.  My friend was having the same problem but went on and took her second shot and ended up in ICU in town and they have recently moved her to hospital.  I did not take the second shot and want to know what to do for relief.
Approximately 30 minutes post injection patient had numbness in vaccinated arm which over the course of time moved to the left leg and eventually the right leg as well.  Pharmacy was made aware of this problem at second vaccine appointment. Patient was instructed to contact Dr before receiving second dose.
Tinnitus, hearing loss in left ear started on 12/31/2020 and has not resolved.  Vertigo and vomiting started on 1/12/2020 with a duration of approximately 48 hours then resolved.
pt w/fever 103, nausea/vomiting x 24hr;sore arm;
HAD SHOT ON 11/19/09 ABOUT 2:30PM.  STARTED ITCHING FRIDAY 11/20/09.  WOKE UP SATURDAY 11/21/09 WITH HIVES AND ITCHING AND THROAT WAS SCRATCHY AND FELT LIKE I WAS SHORT OF BREATH SO WENT TO ER.  WENT TO MD ON 11/23/09 FOR CONT. RX.  Still had hives on 11/23/09 so her private doctor increased the prednisone given to her at the ER to 80 mg. Doctor also incresed her Tagamet to 80mg and gave her Adara 50 mg. 11/27/09 patient went directly to hospital and was admitted staying until 12/3. Feels the increased increased prednisone and Tagamet caused issues and she felt that she had increased heart issues. Patient will be going back to ER today. Claims to have "blood clots" in one arm causing swell. Claims other arm is also swelling. "Popeye arms." Patient had H1N1 vaccination because she had a heart attack in August 209 and wanted to prevent illness. Feels she is allergic to H1N1. Is not allergic to eggs or chicken. Has not had seasonal flu shot this year."   12/10/09:  ED records, discharge summary and hospital records received for dates of service 11/27/09 to 12/3/09:  Dx:  H1N1 Reaction, presumptive serum sickness, anxiety, DVT, non-cardiac chest pain, HTN.    24-48 hrs. after H1N1 developed full body erythema and welts with itching, also c/o chest discomfort, anxiety and difficulty swallowing. Cardiology consult concluded non-cardiac chest pain, EKG reassuring. Also c/o of R forearm pain and warmth.  US showed R cephalic vein thrombus.  Treated with warm compresses. Discharged on prednisone taper.
Intussusception - open reduction after failed enema reduction. Presenting sx: listlessness, decreased feedings (fluid intake) increased sleep.  3/3/09 MR received for DOS 1/10-xx/2008 with DX:  Intussusception.  Pt presented with acute onset of bloody stools and lethargy with decreased po intake.  PE (+) for mild dehydration.  IS dx by X-ray confirmed by BE which was only partially able to reduce. Admitted for surgical consult which dx IS. Admitted for Laparoscopy with attempted reduction of IS.  Unable to reduce laparoscopically, so laparotomy performed with appendectomy. No post op data available.
Initially had fatigue, diarrhea, and loss of appetite. Tested positive for COVID 19 on 5/28/21 , during surveillance testing related to a facility COVID Outbreak. He went to ED 5/28/21 for decrease level of consciousness, high blood pressure, low blood sugar, anorexia. Once stabilized, transferred back to facility. On 6/7/21, transferred to ED for COVID pneumonia and hypoglycemia, treated with Dexamethasone and oxygen. Discharged back to facility 6/10/2021. On 6/12/2021, went to ED for ischemic stroke. Died 6/13/2021.
This event occurred to the parent unclear if any relationship to vaccine. On 7/9/07 child received Rotateq, DTaP, IPV, PCV7, Hib-Hep B. On 7/16/07 Dad developed acute arthritis both knees, and then toes. (He also had some back pain around this time). He has been suffering greatly from this arthritis, which is thought to be reactive. (He was previously healthy; no co-worker or other contacts with gastroenteritis when to be some ill in July).
A patient had an exposure and received day 7 dose on day 5; Case reference number US-BN-2021-002264 is a spontaneous case report initially received from a pharmacist via regulatory authority (reference number: USBAV21-0465) on 09-Sep-2021 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 04-Sep-2021, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided; Expiry date: Jan-2024), at a dose reported as one vaccine per dose, administered intramuscularly, and for post-exposure immunisation.   On 07-Sep-2021, the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided; Expiry date: Jan-2024), at a dose reported as one vaccine per dose, administered intramuscularly, and for post-exposure immunisation.   On 09-Sep-2021, the patient was vaccinated with the third dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided; Expiry date: Jan-2024), at a dose reported as one vaccine per dose, administered intramuscularly, and for post-exposure immunisation.   The reporter stated that the patient had an exposure and requested to get the day seven dose on day five. The reporter confirmed that the patient was vaccinated on day five (explicitly coded as Inappropriate schedule of vaccine administered').  It was not reported if the patient experienced any adverse event due to RabAvert.  The reporter assessed the event as non-serious and not related.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert for post-exposure immunisation, on day five, instead of day seven, which is considered inappropriate schedule of product administration. It was not reported if the patient experienced any associated adverse event. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert for post-exposure immunisation, on day five, instead of day seven, which is considered inappropriate schedule of product administration. It was not reported if the patient experienced any associated adverse event. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered as non-serious.
1 inch x 1 inch indurated, hot to touch, red and bruising 2 ins. below injection site, itchy.
Pt recvd 1st dose of Hep B vax on 30JAN92 & exp severe h/a;
achy body; fever; This case was reported by a consumer via call center representative and described the occurrence of general body pain in an unspecified patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were unknown.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Shingrix had an achy body and fever within twenty four hours. The reporter did not consent to follow up. The reporter declined to provide any additional information for this case.  The reporter abruptly hung up. This case linked with US2020202277, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202277:Same reporter
This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (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: Bnt162b2 (Her first dose of the Pfizer BioNTech Covid 19 vaccine on 25Feb2021), administration date: 25Feb2021, for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Rash"; URTICARIA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Hives". Additional information: On question, Allergist was calling on behalf of a patient, female, aged 52 who received her first dose of the Pfizer BioNTech Covid 19 vaccine on 25Feb2021 and the second dose on 18Mar2021. Three weeks later on 08Apr2021, she developed a persistent rash and hives. It was still ongoing but intermittent, it occurs in certain areas but has been all over. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. The lot number for [BNT162B2], was not provided and will be requested during follow up. Follow-up (01Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Received the 1st dose > 35 Days and is determined not to get the 2nd one.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
On 4/5/2021 I woke up with upper left arm pain,  an itchy and raised red rash ( welt-like) area surrounding injection site. By late morning the redness had spread to most of my upper left arm, from about 2 inches below the shoulder to the elbow area. Area is painful, swollen, very warm to touch, and it feels like my left arm is in a tourniquet around armpit/ shoulder area.  On 4/6/2021 saw my PCP, she said I developed a cellulitis and prescribed a course of Keflex.
Headache began the evening of trhe day of vaccine, Followed the next day by fever up to 101.7 degrees F and chills. Had Presycopal episode got weak and collapsed. Called 911 but improved and not taken to ER. On the next day ( 2 days after vaccine) still weak and woozy.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hyperventilation-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Within about five minutes of vaccine, patient started to not feel well, was breathing rapidly and felt dizzy with blurry vision.  Blood pressure was taken and was low (in the 90s over 50s). Had patient lie down.  Took BP after five minutes, had gone up to 117. After 30 minutes patient was feeling much better, was able to sit down.  Blurry vision and dizziness were gone. Stayed an additional 15 minutes and then went home with his mom and girlfriend. would not be driving
ACUTE NON ST ELEVATION MI DEMAND ISCHEMIA  1/11/2023 -- RECURRENCE OF SAME SYMPTOMS
Emergency Room Visit, Specialist, Family Practice Visits Severe pain, legs arms, face,  neck, trouble walking, rising from sitting, fatigue,   Prednisone
This is in follow-up to report (s) previously submitted to 7/6/2007. Initial and follow-up information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL. It was reported that the patient had received one dose of GARDASIL and fainted. It was not reported, if she was one of the patient's that had not eaten that day prior to her vaccination or if she was one of the patients that had received another vaccine at the same time. The patient was observed at the office for an unspecified period and then was allowed to leave. It was reported that the patient recovered. This is one of two patients. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. In follow-up it was reported by the registered nurse that she did not know which patient was described and was unable to look up the lot number or give any more information. Additional information is not expected.
Itchiness started after approx 36 hrs after booster shot. Hives/redness/itchiness on neck, arm pit, groins
At 9:02 am mother called and was worried about pt's lip doing a funny thing, immediately spoke to mother concerning pt, and stated that pt's lip had been doing something funny and had been crying and sounded a little congested and rattling, but had received shots yesterday and been put on Zantac for reflux, pt's eyes had not been moving, but now were closed she thought she was tired from crying, noticed earlier that her forehead looked purple but better now and her buttocks looked a little purple but didn't know why, stated her lip was getting better now, but her brother had tried saying her names but pt. did not focus her eyes on him just looked straight ahead, asked if pt was having distressed breathing and mom stated no, breathing fine, advised mom to bring pt. now to see Dr. and have pt looked at, ask pt. again if pt was having any distressed breathing, mom stated no, mother called back after getting off the phone with her at approximately 9:05am, mom called back 2 approximately 2 minutes after hanging up with her and told me that baby was not breathing and limp, advised to call 911 and told me she had, told her to start CPR, mom stated already had started CPR, wanted to know how many compressions, told mom 15 compressions with 2 breaths, advised papaw was doing breaths and she was doing compressions, advised to keep doing CPR till ambulance arrived, mom stated looked like the stomach was rising, keep doing CPR don't stop, ask her to check for pulse, explained to where to check for pulse on infant, brachial pulse, but stated she was trying but couldn't feel anything, advised keep doing CPR, don't stop, the nurses here again called for an ambulance and told us they were 2 in route but didn't know where they were located at, advised keep doing CPR, mom stated thought she heard some gargling, Dr took over phone call.
Moderna COVID- 19 Vaccine EUA No reaction reported until day 3 post vaccination. Patient reports a red rash that erupted over his upper body. He also reports itching and swelling at injection site. Patient was treated by his primary care physician with steroids. Rash still reported today, but he states it is improving.
Patient states at 10 min mark post vaccination (around 17:15 PM) that she developed sweats/clammy, some lightheadedness while waiting her 15 minutes in the lobby post vaccination injection.  There was no rash, throat swelling, dysphagia, drooling, angioedema, rashes, etc in clinic.  Vitals were taken  in clinic which were WNL (O2 -98%, RR-16, temp- 98.6, BP - 100/60 (this is Normal for her), and HR -74).  Patient states this has happened to her previously receiving injections and has had vagal responses.   A cold pack was given to patient to place on head and Patient was monitored for an additional 20 minutes in exam room/clinic without complication.  No epi/Benadryl was given/needed and I felt patient was stable/safe for discharge home.  No signs of anaphylaxis.  However, strict ED precautions given to patient.  Patient was in right mind state and capable of making proper decision making.
She was exposed to Covid; aches; fever; chills; lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (She was exposed to Covid), MYALGIA (aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (lack of energy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (lack of energy). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (She was exposed to Covid). On 12-Mar-2021, MYALGIA (aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (lack of energy) had resolved. At the time of the report, EXPOSURE TO SARS-COV-2 (She was exposed to Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-279619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 6-Aug-2021 contains significant information - event exposed to COVID-19 added.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/02/21 2nd dose01/23/21 Diagnosed covid positive:09/10/21 Symptom onset:09/08/21 Exposure:travel Symptoms:cough, muscle aches,sore throat,runny nose,HA
0.5ml H1N1 was administered to a patient less than 36 months instead of 0.25ml
pt recvd vax;devel fever 103 & became irritable;48-60 hrs later gen,blotchy red rash;MD visit required & 24 hrs later, fever & rash resolved; recovered;
After 1 day of getting the vaccine, I had COVID arm. My arm became red, with about a golf size bright red circle. I also had swelling and pain in my arm.  I wanted to note this because most people get COVID arm significantly later than after a day, at least according to search results. Also, I already take Allegra, Pepcid, dymista, and quercetin for allergies, so I should be pretty protected.   Arm was basically fully healed within 4 days, also a nice recovery time.   I did not contact a doctor about it because by Monday I was already in better shape and on Friday I was too fatigued to manage the problem.
no additional AE; temperature excursion for VARIVAX/Clarified that the only vaccine administered to patient was VARIVAX.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reaction and allergies were not reported.  On 05-APR-2023, the patient was vaccinated with a first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W031813, expiration date: 05-OCT-2024, (strength, exact dose, route and anatomical site of vaccination were not provided) for prophylaxis (product storage error). The patient had no signs or symptoms of adverse event. No additional adverse event (AE) (no adverse event). For the suspect vaccine, temperature excursion was reported as 20.6/14 up to 46 Fahrenheit (F) degrees for 1 hour 30 minutes. There was no previous temperature excursion.  This is one of two report from the same reporter.; Sender's Comments:  US-009507513-2304USA005318:Original Case : 2304USA001854
Began with mild itching, now it is red and inflamed almost all the way around upper arm and warm to the touch.