chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:54 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. Number of doses/vials- 280 doses. Dates the vial was initially stored in the refrigerator, 29 Oct 2021, 02 Nov 2021, 03 Nov 2021, 04 Nov 2021, 05 Nov 2021, 16 Nov 2021, 19 Nov 2021, 23 Nov 2021 and 30 Nov 2021. Date vial(s) moved from freezer to refrigerator, if applicable 19 Nov 2021 is when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator.  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow up received. No new significant information was added.
Child was noted to have red raised rash, with patches of white swollen areas on abdomen, legs and back. Mom gave child Certizine medication and with in 1 to 2 hrs rash had mostly resolved.
I had a nosebleed after the vaccination, and it took a long time to stop the bleeding. Headaches every night and body aches. My doctors up the high blood pressure medicine because they thought it was my blood pressure. The head scan and blood work came normal.
A 20 month old patient was administered a moderna bivalent vaccine meant for ages 6 years and older. The event was discovered when the MA scanned the vaccine after administration and there was an error code. The patient was given moderna bivalent booster 50 mcg/0.5 mL intramuscularly in her arm. In the clinic, we are more regularly administering the vaccine meant for 6 years and older. We administer 6 different types of covid vaccines. There was also the same error with this patient's sibling. The patient was observed for 15 minutes following administration and no changes in health status occurred.   For error prevention, we have included more signage in our covid vaccine area with a warning to stop and confirm patient's age. We have created more visual cues with the vaccine to indicate if it is bivalent or We have also recommended always scanning the vaccine first to ensure there are no errors before drawing up and administering the vaccine.
9 days post 1st vaccine of Moderna and arm at injection site is swollen, red, warm, and itching.
Weak; Allergic reaction to an ingredient in the vaccine; tired; Dizziness similar to vertigo; Dizzy/ feeling of room spinning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/ feeling of room spinning), ASTHENIA (Weak), VERTIGO (Dizziness similar to vertigo), ALLERGY TO VACCINE (Allergic reaction to an ingredient in the vaccine) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis and Hypersensitivity reaction. Previously administered products included for an unreported indication: SEROQUEL (taken orally). Concurrent medical conditions included Shellfish allergy (Anaphylaxis reaction), Drug allergy (Aspirin- Anaphylaxis reaction) and Asthma. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression and Pain, VITAMIN D [VITAMIN D NOS], CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DIZZINESS (Dizzy/ feeling of room spinning) and VERTIGO (Dizziness similar to vertigo). On 10-Apr-2021, the patient experienced ASTHENIA (Weak), ALLERGY TO VACCINE (Allergic reaction to an ingredient in the vaccine) and FATIGUE (tired). On 23-Apr-2021, DIZZINESS (Dizzy/ feeling of room spinning) and VERTIGO (Dizziness similar to vertigo) had resolved. At the time of the report, ASTHENIA (Weak), ALLERGY TO VACCINE (Allergic reaction to an ingredient in the vaccine) and FATIGUE (tired) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she was prescribed with Meclizine by her health care professional for dizziness but she didn't took it because previously when taken it caused her drowsiness and did not treat her dizziness.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 2-AUG-2021. Patient demographics, Medical history, 1st dose information, concomitant medications were added : Xanax,calcium and multivitamin, Event outcome reported: Dizziness like vertigo was resolved.
Not an immediate reaction. I have diabetes. I go to have blood work every 6 months to monitor effects. After my third dose blood work showed a decrease in magnesium. I started on a magnesium supplement and went to have levels rechecked. On the recheck I showed a marked drop in iron levels.I also feel quite tired much of the time.  I now take an iron supplement. I was diagnosed with diabetes at least 15 years ago. Neither of these deficiencies have ever been an issue before. Obviously I can't say if they are related to the vaccine but they both occurred after my third dose. I had my second booster on April 23, 2022.
Next day had some pain in her arm; tiredness; experienced a bad headache after her second shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Batch/Lot number: unknown) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single, Lot number: unknown), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 24Apr2021, outcome "recovered" (25Apr2021), described as "experienced a bad headache after her second shot"; PAIN IN EXTREMITY (non-serious) with onset 25Apr2021, outcome "unknown", described as "Next day had some pain in her arm"; FATIGUE (non-serious) with onset 25Apr2021, outcome "unknown", described as "tiredness".  Additional information: that patient experienced a bad headache after her second shot and slept that day. Next day had some pain in her arm and tiredness but her headache was gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I tested positive for Covid (3 rapid tests to confirm); I tested positive for Covid (3 rapid tests to confirm)/dry cough; sinus infection; Runny nose; sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EL1238) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. On 07Apr2021, the patient experienced sinus infection, runny nose, sinus pressure, dry cough and on 10Apr2021 COVID-19. The patient underwent lab tests and procedures which included COVID-19 test positive, on 10Apr2021 two times test was done and on 11Apr2021. Outcome of these events was recovering.
Approximately 24 hours from vaccine administration I noticed that I was reacting adversely to the shot. I had swelling and redness and itching about a 4"x5" area on the back of my left arm. I went to the base clinic where the arm was outlined and instructed to call if worsened which happened at 4pm that night. I went to the ER and received a Benadryl shot.
Pt called to notify us of an approximately 4" oval-shaped red, hot place that has developed in her arm about 2-3" below where the Fluzone HD shot was administered on 10/6/20. She stated it is not really painful at this time. She also stated that she did not see anything in the direct area where the flu shot was actually administered. She stated that she noticed soreness in the arm develop on Tuesday 10/8/20 in the evening and then the red spot developed on her arm on Wednesday 10/7/20. She stated her temperature usually runs around 98 regularly. She took it at 5 am today 10/8/20 and it was 99.1. She repeated her temperature again today 10/8/20 around 10:30am and it was down to 97. The patient was counseled to closely monitor her symptoms and use Tylenol/ice as appropriate. The patient was also counseled to contact her physician if she was concerned or if any additional symptoms presented or worsened. The patient was also counseled to notify us of any changes or worsening of symptoms. The patient seemed satisfied with the resolution at this time.
Patient reported large rash originating from injection site down to elbow. Mild swelling and mild pain also reported
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Parent reports day after administration of vaccines pt complained of Rt upper arm pain, no fever. Parent reports arm with redness and swelling(ab deltoid area). Parent did not notify office until 5/21/03. At that time minor redness, not pain; no fever. Pt examined, no further treatment necessary.
Information has been received from a physician concerning several females who on unknown date were vaccinated with GARDASIL vaccine. On unspecified date the patients experienced mild nausea and vomiting. At the time of reporting, the outcome was not reported. Attempts were made to obtain additional identifying information to distinguish the individual patients mentioned in this report. The reporter did not know how many girls or their names. This is one of the several reports from the same source. No further information was available.
Patient c/o fever, chills, body aches and slight swelling at injection site 6 hrs after receiving PNEUMOVAX injection.
Pt presented today for 2nd dose of Covid-19 vaccine.  Pt received Moderna 0.5, IM, Right deltoid, lot: 003K21-2A, exp date: 05/13/2022 Pt awaited the proper 15 min wait time w/o noted side effects.   Upon review, pt received the Moderna vaccine that was inactive due to being at room temp greater than 12 hours, improper dosing, and improper age to receive the Moderna vaccine.   Nurse contacted Moderna directly, spoke to staff, a healthcare advisor. Nurse informed advisor of information listed above and how to properly handle. Advisor suggest continue to monitor any potential side effects and immediately repeat with proper dosing to complete the covid-19 series. If the vaccine given was not inactive due to room temp time, the series would be considered complete. Patient will need to repeat the 2nd of the series to be considered complete.   Nurse contacted mother of pt, informed of information listed above, asked if any new side effects noted after vaccine received this morning, and explained pt will need to repeat 2nd vaccine to complete his series. Mother voiced understanding, no noted side effects at this time.  Nurse informed front office staff of needed nurse time appt scheduling.
Patient is a 76 y.o. female with PMH of HTN, DM 2, CAD as well as cognitive impairment who presents to ED with chest pain, nausea and vomiting.  She was found to have COVID-19 infection and initiated on Paxlovid by ID.  She was seen by cardiology and no chest pain was thought to be due to possibly myocarditis versus hypertensive emergency.  It resolved on its own.  Patient was recommended myocarditis precautions with no strenuous activity for 3 months.  Patient was resumed on her home antihypertensives which required titration for better BP control.  She symptomatically improved with resolution of nausea and emesis.  She was seen by PT and OT and thought to benefit from skilled nursing facility.  This was discussed with patient and her family all of whom are agreeable.  Patient will be discharged to SNF in stable condition today.   Hospital course     Hypertensive emergency- resolved BP better controlled Home dose of Coreg and amlodipine continued Losartan added, titrate to 100 mg daily BP better controlled Some of the nocturnal blood pressure readings seems to be inaccurate   Acute Pleuritic chest pain-resolved Elevated troponin with NSTEMI 2 Myocarditis versus hypertensive emergency being the etiology Troponin 59, 63, 75, 105 CTA chest/abd/pelvis unrevealing Echo with preserved LVEF, grade 1 DD, trace pericardial effusion Cardiology input noted Outpatient stress test once COVID resolves Myocarditis precautions, no strenuous activity for 3 months Asymptomatic   Covid-19 infection Date of onset of symptoms: 1/21/23 Symptoms present on admission: nausea, vomiting Date of covid positive test: 1/21/23 Vaccination status: fully vaccinated per patient, no booster Imaging: 1/21/23 CT chest without infiltrates Oxygen requirements on admission: none Current oxygen requirements: None Medical therapy: Finished paxlovd  Consultants following: ID consulted Anticipated special isolation end date: 2/1/2023 Resume Lipitor from 2/1/2023   Nausea and emesis -Likely due to above -Improved -Better oral intake Generalized weakness Severe physical deconditioning Dizziness Acute dehydration  PT and OT and strongly referred to SNF -She seems to be needing a lot of assistance -Gentle IV hydration due to dizziness, may be dehydrated due to decreased oral intake in the last few days -Social work consulted to discuss SNF options -Patient is reluctant to go to SNF.  Need to review further discussion with family and explore home support -1/25-patient seems to be agreeable to go to SNF.  Spoke with CM.  Patient has been accepted to SNF and precertification obtained today.
This spontaneous report as received from a nurse refers to an 8 months 7 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Got vaccinated 6/6/16, 6/13/16 7 days later I noticed a rash on patient's (left) side of tummy that evening the rash spread to his (left) side of leg and (left) side of back. Patient was in pain screaming if I touched it. The rashes began to get worse before it got better. By 7/2/16 the scabbing went away and he is now scarred. The vaccination had spread to me (mother) on 6/16/16.
Chills, Cold Sweat, Nausea, Headache, Body Aches, Body/Skin burning, Thirst
On 1/10/2022, I started getting hives that would appear on random parts of my body, which would last about 30 minutes, then disappear and reappear elsewhere on my body. These hives are extremely painful and itchy. On 1/11/2022, I started having severe left arm pain that radiated from my neck down to my fingers. It gave my hand a numb feeling. On 1/12/2022, this left arm pain started radiating into my right arm and down my back. To this date, I continue to deal with these hives and body pain. I reported to the ER on 1/12 due to the severe arm pain resulting in no relief. I reported to an Urgent Care on 1/14 with continued hives and body pain and was prescribed a hydrocortisone cream and told to take Zyrtec allergy medicine to help with the hives.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Developed a yeast infection in my bladder 20 days later and someone from the CDC called me and told me to report this event.
Heart Beat Rising; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart Beat Rising) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart Beat Rising). At the time of the report, HEART RATE INCREASED (Heart Beat Rising) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 24 May 2021, the age was corrected to unknown age. No treatment information was provided.  No concomitant products were reported.   This case was linked to MOD21-055836 (Patient Link).
This morning and today his arm was sore.; Slightly tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Apr2021, outcome "unknown", described as "This morning and today his arm was sore."; FATIGUE (non-serious) with onset 28Apr2021, outcome "unknown", described as "Slightly tired".  Additional information: Received Vaccine at Site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm, swollen, hot, red blotches, sensitive to touch. Used ice and took ibuprofen. Did not help, went to hospitals occupational health office next morning. The following day both my eyes became irritated red, burning sensation, light sensitivity went to eye doctor and currently being treated with antibiotic and steroid eye drops. Eye doctor thinks this also may be related to flu shot.
Patient did not receive full dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported. The pharmacist administered a second dose of the Shingrix to a patient, the vaccine suspension leaked out between the syringe and needle and patient did not receive full dose which led to incomplete dose administered. The pharmacist was unsure how much of the dose the patient received but it seemed like a substantial amount of it did leak out.  The pharmacist asked if he/she need to administer a second dose to the patient to make sure if he is fully vaccinated. The reporter consented to follow-up. No further details were provided.