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 POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:22 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:22 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, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (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.   The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/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 excursions were reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Pt has resulting cellulitis, R/O staph infection. Started on Augmentin 875 with II PO loading dose, then BID QD. Pt has 24 hr follow up scheduled.
Information has been received from a physician concerning a 10 year old white male with an allergy to cefadroxil who was vaccinated SC with a first and second dose of MMR on 9/20/95 (lot # 615609/0621B) and 6/10/99 (lot # 630118/1977H), respectively. On 1/20/05, it was reported that the patient subsequently tested positive for the mumps. The physician reported that the patient had a swollen right parotid, his serum amylase was 844 and the physician reported +MMR. Unspecified medical attention was sought. In January 2005, the patient recovered. There was no product quality complaint involved. No further information is available.
6/8/21; Left sided muscle weakness and numbness.  Lower right side of face numbness.  Spread to right side on 6/9/21.  Went to ED 6/9/21.  Admitted.  D/C 6/11/21.
7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient had been administered from an expired dose. The dose was administered after manufacturer date of expiry. It was reported that the vial didn't undergo any temperature excursions.  The dates of administration of the vaccine were 29-Mar-2022 given 1 dose and 31-Mar-2022 given 4 doses. These 5 doses were given from the vials which were initially stored in the refrigerator on 08-Mar-2022.  The other date of administration of the vaccine was 05-Apr-2022 given 2 doses. These 2 doses were given from the vial was initially stored in the refrigerator on 30-Mar-2022.  It was also reported that the patient had no side effects.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up received contains information about date of administration of vaccine and refrigeration dates. Updated the information in the I-narrative.
Starting 2 weeks after getting the injection, my arm hurts and continues to hurt from the upper right arm to right hand, wrist and fingers. It feels like I am getting severe arthritis in that arm and hand and the muscles are stiffening. It hurts every day. It's been 2 months and feels like I'm going to have a permanent problem in my right arm, hand and wrist.
H&P: Patient is a 63 y.o. female who presents for chest pain found to have NSTEMI.    No prior cardiac history who presents with acute onset left sided arm, and jaw pain. Associated with diaphoresis. Looked up "heart attack signs in women" and came to the ER after reading this. In the days/weeks leading up denies any chest pain or pressure, LH, dizziness or syncope. No exertional dyspnea, orthopnea, PND or LE edema.    BP at home are usually 130-150s. BP in the hospital is always higher because of white coat hypertension.    ER course BP 170-190s systolic, HR in the 90s, AF. EKG Q waves in the inferior lead with no significant ischemia or ST elevations. Labs notable for a troponin ~ 2000. CXR within normal limits. Given aspirin, statin, nitro and heparin.    Currently feels pain free. No other acute issues or complaints/    Smoked 3 mos after a divorce, otherwise no smoking history.  No significant family history of CAD. "  D/C summary: "Principal Diagnosis: o Myocarditis   Secondary Diagnoses:  o Type II MI o Hypertension o Hypercholesterolemia o Prediabetes mellitus o Obesity    Procedures/Diagnostics:   5/13/2021.  Coronary angiogram.  o Normal left ventricular function o Normal coronary anatomy o Right radial loop Note: A right radial loop was encountered requiring a femoral access.   5/13/2021.  Echocardiogram.   ?  Left ventricle size is normal. Mildly increased wall thickness. Normal wall motion. Normal systolic function. LV EF is 75 % , ?  Nrrmal valve function.   5/13/2021.  Cardiac MRI.  Evidence of myocarditis, with subepicardial late enhancement at the mid chamber  and apical lateral wall with associated regional edema and mild native T1 signal  elevation.   Normal right and left ventricular size. Hyperdynamic LV. No significant valvular  abnormality.    Hospital Course:  In brief, this is a 63 y.o. year old female admitted on 5/13/2021 with chest pain, troponin elevation and found to have normal coronary arteries.  Preserved LV systolic function by echocardiogram. She underwent an cMRI demonstrating myocarditis. She was started on colchicine and remained pain free for the rest of the admission.    Myocarditis: Presented with acute onset chest pain and troponin of ~2000. Diagnosed via MRI after normal coronary angiogram. Normal biventricular function. Etiology is likely idiopathic as she had no other obvious inciting events. Pain free prior to discharge.  o Colchicine 0.6 mg twice daily.  o Follow-up with Dr. on 6/8 arrival time 12:40 PM   Hyertension: well controlled today. Management per PCP o Metoprolol succinate 25 mg daily o Hyzaar 100-12.5 mg daily o Amlodipine 10 mg daily   Hyperlipidemia: tolerating atorvastatin 20 mg daily. "
Myalgia, SkinRash, Rash, HEADACHES, FATIGUE Narrative: Employee had virtual immunologist appt. Prescribed antihistamine x2 and prednisone.
Patient with 2 doses of Moderna who admitted with COVID complications.  Provider D/C note below:  "77-year-old female with history of MS on interferon who has also been vaccinated with Moderna for COVID but without booster shots admitted for acute hypoxic respiratory failure secondary to COVID pneumonia.  Patient 1st developed symptoms on 05/21 with date of testing on 05/24.  Procalcitonin negative and doubt concurrent bacterial pneumonia.  Patient treated with remdesivir and dexamethasone during hospitalization and was weaned down from 4 L to room air by time of discharge.  Patient will continue dexamethasone for 6 more days to complete regimen."
After the shot I had severe chills, maliege and severe headache and high fever. I did not contact any doctor and I just went to bed. It went away after 20 hours.
Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 15:45 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's. The patient did not have any allergies to medications, food, or other products. Concomitant medications included infliximab (REMICADE) and levocetirizine dihydrochloride (XYZAL) both for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Mar2021 at 15:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 03:00, the patient experienced fever and chills. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
sick; no voice for 2 weeks; spit up yellow phlem for at least a month; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via media on 30-Nov-2020.  This case involves a patient of an unknown demographics who was sick (illness), had no voice for 2 weeks (dysphonia) and spit up yellow phlegm for at least a month (sputum discoloured), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness), had no voice for 2 weeks (dysphonia) and spit up yellow phlegm for at least a month (sputum discoloured), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was resolved for dysphonia and unknown for other events.  There will be no information available on the batch number for this case.
Patient passed out after standing post vaccination. Patient responsive after around 30 seconds. Alert and oriented. States he has done this in the past after "shots". Patient provided snack and water. Patient helped to wheelchair and monitored for 30 minutes. Patient states he has returned to baseline.
Hive like rash on stomach, arms & legs which started about 8:30pm. Seen at Urgent Care center by NP. Given steroid liquid po & BENADRYL po.
Bilateral pain in both arms; Chronic pain; Headaches; High fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bilateral pain in both arms), PAIN (Chronic pain), HEADACHE (Headaches) and PYREXIA (High fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Bilateral pain in both arms), PAIN (Chronic pain), HEADACHE (Headaches) and PYREXIA (High fever). On 03-May-2021, PYREXIA (High fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Bilateral pain in both arms), PAIN (Chronic pain) and HEADACHE (Headaches) outcome was unknown. Not Provided          Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-072598 (Patient Link).
6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult).    No concomitant medications were reported.  The dose of Moderna COVID-19 vaccine reported as additional booster. Vial as was navy blue cap with purple border.  No treatment information was provided.
suspected vaccination failure; I feel an onset/ the shingles from flaring up; This case was reported by a consumer via interactive digital media and (Facebook) described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient stated that, he/she got Shingles vaccine, but it did not help. The patient's physician told him/her that, it was only effective in about 60 percent of people. The physician put him/her on Valacyclovir 1 gm. When the patient felt an onset, he/she took 2 tablets.  It had stopped the shingles from flaring up. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - urine totally colorless though I was not drinkiing anything, yellow tint gradually reappeared over next 3 days), no fever, memory and concentration much worse than usual, could not even think well, joint pain ,prolonged excessive sleepiness (nearly has resolved after 2 weeks)
pt recv vax 15JAN98 & had mild discomfort in arm for a few days p/vax;seemed fine-a few days later had generalized aching in legs & feet didn't even want to walk;flu-like sx;
Continued soreness and discomfort when raising my arm over shoulder level, even after over a week later. Discomfort when steering my car. Stiffness and pain extends past my elbow.
Macular/papular red rash started on upper chest  then spread over weeks to both arms mostly above elbows then to back .  Basically rash is above the waist with very sporadic small red dots on legs .
I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the typical side effects that I had read about. Chills, Severe Headache,  All over body, joint, and skin pain. Then developed Fever around 102. Saturday headache was mild, very fatigued, skin felt sunburnt/pain, no fever, was still achy. Temp highest was 99.4 that evening. Noticed palpable clavicular lymph nodes that were very tender. Then noted an axillary one that was about marble sized and tender as well. Sunday about the same- was able to get up and do housework but felt fatigued easily. No temp. Sunday evening developed tenderness in neck area and possible lymph node swelling and decreased ROM.  Axillary lymph node is larger than a marble currently.  Also at times if I change positions I have a very brief  moderate headache. I did wake up in the middle of the night drench with sweat which is very abnormal for me.  Neck is the biggest complaint as of now. I called my PCP with the above complaints who referred me to employee health.
Malaise, chills, and sore arm by 5pm, Nov 19 Fever of 102 by 9pm, Nov 19 continuing to morning of Nov 21. Right arm became nearly impossible to move. Could not raise it or lift anything. Painful in armpit and around shoulder joint. Fever returned 7pm Nov 21 but stayed at 100.5. Fever returned 7pm Nov 22 but stayed at 100.5
This spontaneous report as received from a consumer via Clinic refers to a currently 3 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-APR-2017, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB 1 dose unit (lot # M025193, Expiry date : 21-MAR-2019 ) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Infant died 2 days post vaccination.  By report had been crying all day and night of 3/7/06. Started vomiting on 3/7/06 also.
Sore Arm; Sinus Pain; Chills; Headache; Fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F). On 04-Feb-2021, PAIN IN EXTREMITY (Sore Arm), SINUS PAIN (Sinus Pain), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 100F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatments were reported.
needle cap off the the entire luer lok came off and the diluent spilled all over her / no AE; Initial information received on 18-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 51 years old patient when preparing RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number R1C713M and Expiration date :30-Apr-2021)and at that time needle cap off the the entire luer lok came off and the diluent spilled all over her.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was also a case of Exposure via skin contact.  Global PTC number : 100048111 Batch number: R1C713M Expiry date: 30-Apr-2021 Investigation stats: In process  It was reported that administrator said that she pulled off the plastic cap off the diluent syringe like she always does and then secured the needle to luer Lok end and then when she pulled theneedle cap off the the entire luer lok came off and the diluent spilled all over her.  Followup information received on 18-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  PTC details were added.
The night of, I went to bed and woke up around 1:00 AM suddenly feeling very cold and shivering, under a blanket in a 73 degree room. I soon after experienced my body (especially my core) seize up for 5-6 seconds at a time for at least one or two minutes.  Next day, headache and fatigue.
L-3"xW-3" area rt deltoid-warm, red, hardened area, mom took to er where they gave her antibotics/steroids.
Low grade fever - 5 days  Malaise - 5 days  Headache - 5 days
Unable to breath, swollen, pain on whole right side (extremities), needed oxygen, was in and out of consciousness, excruciating pain.
This spontaneous report was received from a nurse, who referred to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was provided. On 16-OCT-2017, the patient was administered an expired dose of PNEUMOVAX 23 (lot# M005287 and expiration date: 08-OCT-2017; dose and route of administration were not reported) as prophylaxis. The dose of PNEUMOVAX 23 was stored properly prior to administration. No adverse effects were reported. No product quality complaint was involved.