chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine at 10:00 am on 8/18, monitored for 15 post-vaccine, noted unresponsive at 12:30:Pt was noted to be unresponsive to verbal and tactile stimuli. VSS: BP 72/48, Pulse 116, Placed on nonrebreather at 15LPM. O2 sat 98%. NP in the building called and responded. 911 called and responded. HCP niece declined for the resident to be transferred to the hospital.   8/19/2021 09:07 am  Resident expired, Code Status: DNR. Dr. was notified. Pronounced at the facility by the RN
had 6 inches long raised area that is hot to touch, feels firm, red, painful and bumpy; right after her father received the vaccine he felt hot and flushed; This is a spontaneous report from a contactable Other HCP via medical information team. A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included diabetic. Patients concomitant medication were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization and experienced heaviness in his chest and flutters. Caller stated her father received the second dose of the vaccine three days ago around noon and was experiencing a reaction on his arm. Caller stated her father had 6 inches long raised area that was hot to touch, feels firm, red, painful and bumpy. Caller stated he said it was not itchy. Caller stated he was sent to the emergency room and was checked out, but everything was fine. Caller stated it started 18 hours after receiving the vaccine and he took some Tylenol. Caller states she also remembers right after her father received the vaccine, he felt hot and flushed and took some Benadryl. The outcome of event was unknown.  Information on the lot/batch number has been requested.    Follow-up attempts completed. No further information expected.
5.1x3.8cm area of edema, erythema and heat around injection site 1 day after immunizations.  Given pt advised to use Benadryl and ice packs.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 72 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 136 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Felt feverish a few hours later. About 10 hours later a lot of mucus get produced in the throat. Cant sleep. Throw up a few times.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition. medical history and pertinent drug allergies of the patient were not reported. On 30-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PWC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Anaphylaxis, admitted to hospital. Began 10 min after admin of meds. Received epinephrine, BENADRYL and steroids.  11/2/09:  Emergency Department Records received for date of service 8/5/09.  Dx: Anaphylaxis Assessment:  Presents 15 minutes after administration of multiple vaccines with hives, difficulty swallowing and drooling.  Epinepherine, Benadryl and IV Solumedrol given with resolution of sx.  Admitted of observation.
only received the DTaP/IPV of the Pentacel/no AE; Initial information received on 27-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old male patient who onlyreceived DTaP/IPV portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 27-Apr-2019, the patient received a dose 3  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6327AA via intramuscular route in the left thigh.  It was of actual medication error due to  Inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This female patient received her second Moderna vaccine after experiencing no side effects from the first. She has a history of anaphylaxis to foods so she was observed for 30 minutes without any issues. As she went to her car to leave, she began feeling some throat itchiness and returned to let us know. We went to our first aid room and observed her further. Vital signs were taken and she had a slightly elevated blood pressure but good oxygenation and no change in voice character or breathing.  She was very anxious at this point and began saying she felt like her throat was going to swell .  It was decided to administer Epi and as soon as the needle inserted, she expressed immediate relief of her symptoms. An ambulance was summoned and she was brought to the ER.
Information has been received from a physician referring to a 13 years old male patient. There were none pertinent medical history, concomitant therapy and drug reactions/allergies. On 08-OCt-2008 and 04-OCT-2004, the patient was vaccinated with doses of VARIVAX (strength, dose, frequency, lot number and expiration date were unknown). On an unknown date in September 2016, the patient developed a facial rash that resembles varicella and meningoencephalitis "within the past two weeks."  The patient was admitted to hospital on 22-SEP-2016, reported as "6 days ago."  The patient was treated with acyclovir since admission since he tested positive for varicella by unspecified laboratory tests, and the patient was recovering. The patient would be discharged from the hospital tomorrow, 29-SEP-2016. The causal relationship between VARIVAX and the event was unknown. The physician states  that her facility has retained a specimen of cerebrospinal fluid (CSF) for the patient, and she is interested in sending the specimen for analysis. VZVIP faxed to the physician to the nurses' station. She states that microbiology lab director, has the CSF sample, and she can be called. Left voice mails with the physician's cell phone number and case number.  This  AE will be e-mailed and  employees  and  VZVID mailbox. Additional information has been requested.
Chest and Jaw pain, shortness of breath. EMS called as he c/o chest pain and SOB relieved with nitro SL x1
Menorrhagia began in 2003 and became extreme in 2011--leading to uterine ablation.  Chronic Migraines began 2011.
Information has been received from a registered nurse concerning a 31-year-old white female pt w/NKDA who on 08/29/2000 was vaccinated with a first dose of varicella virus vaccine live. Subsequently on 08/29/2000, the pt developed a localized cellulitis and a localized reaction of redness and swelling that required unspecified antibiotic therapy. This was not "witnessed by the staff, but they were informed by the pt". The patient fully recovered from her experience after the course of antibiotics. The pt sought unspecified medical attention. Additional information is not expected.
Body aches; Loss of taste; Diarrhea; Difficulty breathing; Dry mouth; Dry nose; Zero energy; Myalgia; Severe headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), AGEUSIA (Loss of taste), DIARRHOEA (Diarrhea), DYSPNOEA (Difficulty breathing) and DRY MOUTH (Dry mouth) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), AGEUSIA (Loss of taste), DIARRHOEA (Diarrhea), DYSPNOEA (Difficulty breathing), DRY MOUTH (Dry mouth), NASAL DRYNESS (Dry nose), ASTHENIA (Zero energy), PYREXIA (Fever), MYALGIA (Myalgia), HEADACHE (Severe headache) and CHILLS (Chills). At the time of the report, PAIN (Body aches), AGEUSIA (Loss of taste), DIARRHOEA (Diarrhea), DYSPNOEA (Difficulty breathing), DRY MOUTH (Dry mouth), NASAL DRYNESS (Dry nose), ASTHENIA (Zero energy), PYREXIA (Fever), MYALGIA (Myalgia), HEADACHE (Severe headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant information provided.
right hand started to feel like it was going to sleep; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer it has been in remission for 3 years , milk allergy, ongoing high blood Pressure, ongoing cholesterol, ongoing Diabetic. The patient historical vaccine included flu shot for immunization. Concomitant medication included lovastatin at 40 mg, twice a day taken for cholesterol, Ongoing metformin at 500 mg, twice a day taken for diabetic,amlodipine besylate;benazepril at once a day (10-40mg once a day) for high blood pressure from an unspecified start date and ongoing, vitamin d (Lot number: 507530-01 and expiration date: Oct2023) at 800 iU (takes two 400IU); ascorbic acid (VITAMIN C Lot number: 526680-01 and expiration date Sep2024) taken 1000 mg (takes two 500mg to make 1000mg) for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12-VITAMIN Lot number: 505721-03 and expiration date: MAR-2023) taken 500 mg, daily for an unspecified indication, and multivitamin. He noticed one hour after receiving the first dose of the vaccine his right hand started falling asleep. It occur only in the arm where he got the vaccine. It got better and five minutes later it happened again. Caller wants to if this side effect is associated with the vaccine. The outcome of the event was unknown
This 65 year old   female received the Pfizer Covid shot on  3/10/21    and went to the ED on  5/3/21     and was admitted  on 5/3/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) FACIAL DROOP
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M031567, expiration date 24-DEC-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA010419: US-009507513-1701USA010420: US-009507513-1701USA010421: US-009507513-1701USA010422: US-009507513-1701USA010423: US-009507513-1701USA010424: US-009507513-1701USA010425: US-009507513-1701USA010426: US-009507513-1701USA010427: US-009507513-1701USA010428: US-009507513-1701USA010429: US-009507513-1701USA010430: US-009507513-1701USA010431: US-009507513-1701USA010432: US-009507513-1701USA010433: US-009507513-1701USA010434: US-009507513-1701USA010435: US-009507513-1701USA010436: US-009507513-1701USA010437: US-009507513-1701USA010438: US-009507513-1701USA010439: US-009507513-1701USA010440.
Provider summary "This is a 64-year-old morbidly obese male a history of diabetes mellitus type 2. Patient awoke this morning around 7:00 a.m. disoriented and confused.  His roommate called EMS who arrived to find patient was hypoglycemic.  Patient was encouraged to eat and blood sugar improved.  Patient refused transport to the ER at that time.  Patient is significantly came over later that morning found his blood sugar to be 380. Patient gave himself 20 units of NovoLog.  Significant other checked on him later in the evening and noticed that he was quite lethargic and sleepy.  She encouraged him to go to the emergency department but he again resisted.  Later the patient called significant other back stating he was ready to go to the emergency department because he was ?overwhelmed and exhausted.?  Patient presented emergency department where he spent some time in the a waiting room as ER staff thought he had left before being seen.  Patient became very disoriented and lethargic.  He was found have a blood sugar of 19. Patient brought back to emergency department and his hypoglycemic event was managed.  During his stay in the ER he was became hypoxic with room air saturations in the 80s.  Oxygen saturation improved with supplemental oxygen.  Further testing showed him to be COVID positive.  Patient is still lethargic and oriented x2.  Hospitalist service has been asked to see for further evaluation and management of toxic metabolic encephalopathy due to hypoglycemia and hypoxia from COVID."   Admitted on 6/2.  Started on dexamethasone and IV antibiotics, oxygen supplementation. He did fair, sugars  stabilized, his condition improved, remains very weak.  At the time of discharge there is no confusion, no more dyspnea.  He requires 2 L of oxygen per home O2 evaluation.  He is doing spirometry.  He had issues with contraction alkalosis, his diuretics were held temporarily, contraction alkalosis improved.  His blood pressure is lower side.  He was noted to have chronic kidney disease, his creatinine remained stable throughout his hospital stay.  His ACE inhibitor was held temporarily. Blood pressure stabilized on discharge, he is being resumed on  the lower dose of ACE inhibitor.  Lasix is resumed on discharge, remains off Zaroxolyn.  Hydrochlorothiazide was discontinued permanently.  His sugars varied, his doses of insulin were adjusted.  He was noted to be persistently hypoglycemic,  he needs significantly less Lantus now been at home, doing well with 15 units every evening.  He is following a diabetic diet.   He is being discharged in stable condition, going home with visiting nurses, PT and OT, 2 L of oxygen, hospital bed was recommended as well in the setting of his acute on chronic respiratory failure  Due to covid and extreme debility."
patient passed out/seized 15 seconds after vaccine given  - 911 was called and dispatched
FORGOT TO TAKE REMAINING DOSES AFTER SECOND DOSE; This spontaneous case report (PVX2019-2440) was received from a pharmacist on 25-Sep-2019. It described a male consumer who "forgot to take remaining doses after second dose" (PT: Product dose omission), during oral Vivotif schedule, for typhoid fever prophylaxis.  Case report: The consumer took only two doses of Vivotif on day 1 and day 3. Then, he forgot to take remaining other two doses.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take remaining doses after second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take remaining doses after second dose" was considered as not applicable.
tired; This is a spontaneous report from a contactable health care professional and a consumer. A 78-year-old female patient of an unspecified age received first dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration in 2021 as single dose for covid-19 immunization. Medical history included ongoing diabetes, ongoing arthritis (arthritis pain to shoulders, knees, spine, hands, left hip), ongoing wheelchair bound, ongoing limited mobility. The patient's concomitant medications were not reported. The patient experienced tired in Mar2021 with outcome of recovering. Patient said this past month she got the first covid vaccine and felt "tired" for a couple days after the vaccine but felt better at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna COVID-19 Vaccine Vaccine Lot Number: 003C21A pt states that after receiving (covid) vaccine got a headache 4/10 with light headedness. pt moved via stretcher with vitals as noted. pt states he is feeling better in observation. after observation pt states he feel good. denies need for transport 14:49 123/56 p64 r14 14:57 116/45 p60 r14 15:07 113/58 p62 r14
Vertigo, weakness, loss of appetite, extreme fatigue, tingling in feet and hands, muscle aches, increased heart rate, difficulty breathing when lying down.  No treatment---patient lives alone and just lived in her recliner until able to walk steadily, about five days. Still recovering two weeks later.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Fever-Mild
MADE ME SICK; CONDITION AGGRAVATED; FELT WORSE; This spontaneous report received from a patient concerned. The patient's past medical history included covid. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced made me sick, condition aggravated, and felt worse. The action taken with covid-19 vaccine was not applicable. The outcome of the made me sick, condition aggravated, and felt worse was not reported. This report was non-serious.
PT was administered 1st anthrax dose. PT developed vasovagal response. Placed in supine position and given smalling salts. Reviewed immediately w/out sequellar.
Pt received vaccine 4/1/2021, started to feel ill 4/11/2021 thought it was allergies. Continued to current date 5/6/2021. Had 3 different occurrences where she passed out. Dates were 4/30/2021, 5/5/2021, and today 5/6/2021 which lead to current admission. Came to ER found to have saddle PE from CTA scan. Went to Cath Lab and had INARI procedur to remove clot. Sent to ICU afterwards, was found to have DVT in left leg from ultrasound, started on argatroban. Currently is still in ICU, was admitted to ICU from cath lab today.
ACHES; BECAME EXTREMELY SICK; CHILLS; 15 DAYS AFTER RECEIVING THE VACCINE, STARTED TO DEVELOP A RASH ON THE INJECTION ARM; RASH AROUND CHEST AREA; HEADACHES; SICK TO STOMACH; SWOLLEN LYMPH NODE IN ARMPIT OF INJECTED ARM; FEELING VERY TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced aches, became extremely sick, chills, 15 days after receiving the vaccine, started to develop a rash on the injection arm, rash around chest area, headaches, sick to stomach, swollen lymph node in armpit of injected arm, and feeling very tired. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, aches, headaches, sick to stomach, swollen lymph node in armpit of injected arm, feeling very tired, 15 days after receiving the vaccine, started to develop a rash on the injection arm, became extremely sick and rash around chest area was not reported. This report was non-serious.
very very bad rash all over her body, like blisters; still getting new blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (still getting new blisters) and RASH (very very bad rash all over her body, like blisters) 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) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced BLISTER (still getting new blisters). On an unknown date, the patient experienced RASH (very very bad rash all over her body, like blisters). At the time of the report, BLISTER (still getting new blisters) and RASH (very very bad rash all over her body, like blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact