chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider: DO Admission Date: 7/22/2022 Discharge Date: 8/2/2022  PRESENTING PROBLEM: Pneumonia [J18.9] Weakness [R53.1] COPD exacerbation [J44.1] Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: 81-year-old male past medical history of lung cancer status post resection and chemotherapy, chronic obstructive pulmonary disease with active tobacco use, dementia, who presented after he was found on the floor by daughter.  Evaluation in the emergency department revealed the patient was positive for COVID-19.  Chest x-ray was negative.  Patient had mild hypoxia on ambulation down to 88% and was placed on 2 L of oxygen.  He had elevated creatinine, CPK, and sodium.  He was started on IV fluids and was admitted for further management.  Patient was started on Decadron 6 mg daily.  His oxygen was weaned of quickly.  His creatinine improved back to his baseline chronic kidney disease stage 3. He was evaluated by PT and OT who recommended discharge to subacute rehab.  He had a 15 minute episode of tachycardia into the 150s to 160s that reverted back to normal sinus rhythm spontaneously. Cardiac monitoring was continued and he had no further episodes of tachycardia. He was discharged to SAR in stable condition on 2L supplemental O2 via NC.
Patient started to daze in and out of consciousness sitting down. He said he was feeling dizzy and disoriented. Gave patient a cold pack to place on chest and got him a cold water. Patient slumped over (had someone call 911 in meantime) and looked as if he was about to have a seizure, mom and I  had him lay on the ground. Once he felt better, I had him lay flat and put his feet up. EMS told us to give him a Benadryl (25 mg) even though he was not having any breathing issues, rashes, or swelling. Patient was sweating and disoriented but had no issues talking or breathing. EMS said all his vitals were normal and he didn't need to be transported to the hospital unless mom wanted them to. Mom did not have him transported, she was going to monitor him at home.
This case was considered medically important. Information regarding Prevnar was received from a nurse regarding a 3 year old Hispanic male patient who received the third dose on an unspecified date at 6 months of age. Between the ages of 6 to 9 months, the patient began to experience seizures. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 0.5mL 1 time per day (intramuscular). Concomitant vaccines included unspecified vaccines. Event Details: At the age of 6 months, the patient received the third dose of Prevnar. The reporter noted that the child received "routine immunizations" on unspecified dates. At the of approximately 6 to 9 months, the patient began to experience seizures (convulsions). As of 13 April 2006, it was unknown if the patient recovered from the event. No additional information was available at the time of this report.
Approximately 1 minute after receiving the vaccine, patient felt light headed and experienced a temporar y loss of hearing.  After eating several graham crackers, hearing returned (within 1 minute).  An ice bag was applied to patient's neck while she sat quietly eating graham crackers.  Patient stated that she had not eating prior to receiving vaccination.  After eating, she departed the building with her mother.  The suggestion was made to the mother that prior to any future vaccinations, she make sure there is some food intake.  BP100/62, P 52, RR 20, TEMP 97.3, 02 99%
two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 13Jan2021 at 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. The patient has no known allergies. Concomitant medication included topiramate (TOPAMAX). The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient had two inches of redness and swelling at the injection site that is tender to touch. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
2/8/21 Caregiver came back to Vaccine clinic at 1410 and talked to  Nurse manager of Occupational Health.  Caregiver states after her 15 min observation time she went back to her unit and developed a flush face, feeling of being hot and having a redness on her chest and one raised bump was noted. Nurse placed caregiver back in Observation.  RN was the observation nurse.  At 1421 caregiver states she was feeling very warm, felt flush, face was red and chest was red in color per RN.  Caregiver was given 60mg Fexofenadine PO per protocol for symptoms..  At 1435 vital signs: bp=113/75, HR 100, Sao2 100% on room air and Temperature was 36.9.  At 1440, Observation nurse  states the caregiver c/o her heart racing.  Her heart rate was 120 via radial pulse..  At 1442, vital signs: bp= 107/74, HR= 104, sao2= 100% on room air.. At 1450, RN Staff nurse came to observe caregiver.  Patient is alert and oriented x3.  Respirations easy and nonlabored.  No redness noted on chest but cheeks are still flush.  Apical Heart rate at 96, regular and respirations easy at 20..  At 1500, Caregiver states she still feels "hot" and full feeling in her face. She also c/o her heart rate increasing and decreasing.  Denies any heart history.  States she "did have some flushness with her first dose but not to this degree."  Vital signs: bp=113/67, HR=97, RR=18, Sao2=100% on room air.  AT 1523  RN states caregiver states feeling better--denies feeling dizzy, lightheaded, denies sob or chest pain.  Face still with some redness but less and caregiver c/o still feeling "full" in the head and a headache.  Caregiver advised to seek medical attention if symptoms increase.  Caregiver encouraged to go home and rest if she is able to.  Caregiver denies need to go to Emergency room to be evaluated. At 1527 caregiver discharged from observation room with steady gait.:
Very sick for 4 days after; Legs aching; No appetite; Shaking; Diarrhea; Lethargic for last 10 days; Vomiting; Chills; Temp over 102 until 3rd day; Very exhausted, fatigue for last 10 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking) and DIARRHOEA (Diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), LETHARGY (Lethargic for last 10 days), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Temp over 102 until 3rd day) and FATIGUE (Very exhausted, fatigue for last 10 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Temp over 102 until 3rd day) had resolved. On 19-Mar-2021, ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, LETHARGY (Lethargic for last 10 days) and FATIGUE (Very exhausted, fatigue for last 10 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 102 (High) Over 102 until 3rd day.
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 70-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 16-Nov-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:30 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 concomitant medications on use were not 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 one month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 16 Nov 2021. 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.  No treatment information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
I started getting symptoms of allergies symptoms and coughing. I went to a clinic and took a rapid COVID-19 that was positive. I also developed congestion. I was prescribed Paxlovid and cough medications. Those medications did help. I did an at home COVID-19 test 6/2/2022 that was negative.
pt recvd vax & devel vertical nystagmus, inc incoordination & developmental delays; seen by MD 26MAY89; referred to neurologist; cont to have coord & balance deficits, speech & language deficits;
itching all over; hives on chest; thickness feeling in throat; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received the second the dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8783) via an unspecified route of administration in the left arm on 02Apr2021 at 19:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 19:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 02Apr2021 at 21:30, within 1.5 hours of second shot, the patient experienced itching all over, hives on chest and thickness feeling in throat. The patient was treated with diphenhydramine (BENADRYL) 50mg for the reported adverse events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events itching all over, hives on chest and thickness feeling in throat was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown date, the patient was vaccinated with a dose of GARDASIL (strength, lot number, expiry date, route and dose were not reported), which was improperly stored by exposed to 31.5F for 29 hours. No adverse effects were reported. This is one of several reports received from the same reporter. (Linked to 1501USA008154. 1501USA12473, 1501USA012475, 1501USA012474). Additional  information has been requested.
Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
Patient developed chills/shivering/tingling day 4 post-injection.  The episodes are occurring every 10 minutes and last 30-45 seconds.   Symptoms continue at day 11 post injection.   Symptoms are similar to the patients pre-ictal aura.  However, no generalized seizures have occurred.
Vaccine was administered to patient who did not meet current CDC eligibility criteria for a second bivalent dose of the Moderna COVID vaccine. She was not 65 years or older and not immunocompromised.
2 weeks after the vaccine was given, the left arm is still sore and knotted up. It also had a scab.
This is the patient's spouse reporting.  The day following the vaccination, wife began to suffer mild, common vaccination symptoms such as fatigue, hills, and joint pain.  In the days following, in addition to those symptoms, she began to cough and had a sore throat.  By March 8th, she had lost her sense of taste and sense of smell. We realized we needed to have her tested for COVID-19. We went to a testing area. She was seen and tested. She tested positive for COVID-19 (as did I).  The belief was that our illness was uncomplicated and we were sent home with instructions to monitor our symptoms.  On 03/14/2021, I took her to the hospital because her condition was worsening.
first dose of the vaccine two months ago and missed my second dose appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose of the vaccine two months ago and missed my second dose appointment) in a female patient of an unknown age 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 PRODUCT DOSE OMISSION ISSUE (first dose of the vaccine two months ago and missed my second dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of the vaccine two months ago and missed my second dose appointment) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Medication error, Pt 13 years old, was given Moderna vaccine instead of Pfizer vaccine.  Pt has no adverse reaction to the Moderna vaccine.
This spontaneous report as received from an office manager refers to a male patient of unknown age.   On 02-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011305 and expiration date on 20-JAN-2019, 1 DF, intramuscularly for prophylaxis. In August 2017, the patient experienced injection site erythema and pain in extremity. The patient visited the physician but it was unknown if he received any treatment for the adverse events. No any laboratory study was performed. The outcome of injection site erythema and pain in extremity was reported as not recovered/not resolved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1708USA002956: US-009507513-1708USA004753:
Sick; Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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: ILLNESS (non-serious), outcome "unknown", described as "Sick"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms".   Additional information: Report 3 of 3. Report 3 is caller discussion her daughter's father. Caller stated that her daughter's dad had the vaccine, and was sick for several days with flu-like symptoms but no rash.  Follow-up attempts completed. No further information expected.
WOKE UP THE NEXT DAY STUFFY NOSE, GENERAL SICKNESS, TIRED.  THE NEXT DAY MY COUGHING STARTED AND GOT WORES THROUGOUT THE DAY. STILL RUNNY AND STUFFED NOSE, TIRED, FEELING LIKEI HAVE THE THROW UP.  MY LEFT FOOT BEGAN TO TINGLING AND FEEL LIKE ITS THROBBING.  THE NEXT DAY THE FOOT FELT BETTER, STILL COUGHING AND GENERAL SICK AND TIRED.  MY HEART STARTING TO BEAT EITHE REALLY FAST, OR REALLY SHOW, SKIPPING BEATS, MY CHEST FEELS HOLLOW AND I CAN FEEL EVERY BEAT.  5 DAYS AFTER THE SHOT I GET THIS REALLY BAD HEADACHE, THAT DID NOT GO AWAY WITH MEDICINE.  STILL HAVING HEART PALPATATIONS.  VISOIN BECOMES A LITTLE BLURRY RANDOMLY.  APPATITE HAS GONE DOWN, NOT FEELING ABLE TO EAT.
I have had the vaccine and I still keep getting this chickenpox virus; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chickenpox (Verbatim: I have had the vaccine and I still keep getting this chickenpox virus).  The outcome of the chickenpox was not reported.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.   It was unknown if the company considered the chickenpox to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that it's been almost two years, he/she had the vaccine and still keep getting this chickenpox virus. Follow up was not possible, as no contact details were available.
Severe chills,  chattering teeth, spasms, aching neck, some soreness at injection site
This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age and of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The reporter stated that "Vax killed my stepdad". The patient died from an unknown cause on an unspecified date. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20211256224-COVID-19 VACCINE AD26.COV2.S-Killed (Death). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH