chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/30/2020 07:02 AM  Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days.  12/30/2020 07:32 AM  Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any.  12/30/2020 08:41 AM  Received new orders to obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate resident family to be able to be at bedside when time comes to do so.  NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics
This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. The nurse reported that an unspecified number of patients were "probably" administered an improperly stored dose of GARDASIL (lot number not provided). Dose, dose strength and therapy dates were not provided. The minimum temperature the GARDASIL was exposed to was 31 degrees Fahrenheit for an unspecified number of hours and the maximum temperature the GARDASIL was exposed to was 55 degrees Fahrenheit for an unspecified number of hours. No adverse effect was reported. This is one of multiple reports from the same source. Other case IDs 1307USA013319 and 1307USA013320. Additional information has been requested.
After getting first shot later that evening my food tasted like metal. My sense of smell and taste has diminished. Certain foods like fish or nuts I can't taste. Peppermint tablets are mild in taste.
5 months after their 2nd dose, they both tested positive for Covid; 5 months after their 2nd dose, they both tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program regulatory authority Support via contactable nurse (patient) via medical information team . A 61-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61 years old, Batch/lot number, NDC number, Expiry Date: Not provided) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61 years old, Batch/lot number, NDC number, Expiry Date: Not provided) as dose 2, single both taken for COVID-19 immunisation. The patient medical history and other products were not provided. The patient stated yesterday, 5 months after their 2nd dose, they both; she and her husband tested positive for COVID (24Aug2021), she was a nurse, and spent some years in research and data collection, she went to get a rapid COVID test, her doctor told her that the only information they report to the county was a positive test, they do not report a person's vaccination status, she questioned how was Pfizer gathering data in terms of immune response, and efficacy of the vaccine, if none of this information was being collected on the local level, how can the vaccine be improved to further benefit the patient, they were not testing for variants on the local level, how Pfizer was approaching new variants that are developing, on a local level, they were not doing genomic type testing to differentiate the variants, how Pfizer was getting the information on the variants and she explained information about the flu vaccine for each season. She wanted to know how Pfizer was getting information about the different variants coming out, how Pfizer was following breakthrough cases, how they are gathering information about it, and how Pfizer was keeping the vaccine up to date moving forward. The patient further stated that if local health professionals are not capturing data, how can the pharmaceutical companies move forward with improving their vaccines, she had no adverse events with the vaccine, she wanted to know if there was a 2nd breakthrough susceptibility even after people have been fully vaccinated and are COVID positive and they forward her question to someone from their team so that they can research about it further. The patient underwent lab tests and procedures which included rapid COVID test: positive on 24Aug2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available in the case, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.
Pt presented to the emergency department on 11/16/21 with stroke like symptoms of left sided weakness  and left sided facial droop. CT imaging revealed a intraparenchymal basal ganglia hemorrhage.
Pt. C/O vomiting x 4 episodes 1 hr post injection, tingling all over body and chills. Per provider gave BENADRYL 25 mg now, ZOFRAN 4 mg ODT now. No water/fluids for 30 min. May repeat ZOFRAN every 8 hours prn vomiting. Pt. to lay down for today and offer fluids when vomiting stops. If worsen seek medical attention.
pt recvd vax;c/o pain in rt; on exam, RN noticed a large red swollen area on rt deltoid;
Exposure to unvaccinated child with chicken pox (varicella), papular erythema rash on trunk and spreading to head and extremities, uniform no crusting.
Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous report from a contactable Nurse (patient herself).  This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142X-31-21), via an unknown route, on 29Dec2020 at 21:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant.  Relevant medical history included hypothyroidism, hypertension and COVID-19 (prior to vaccination). Relevant concomitant medications included amlodipine. The patient was vaccinated at hospital, age at vaccination was 43-year-old. No other vaccine was received in four weeks. On 30Dec2020 at 12:30 the patient developed 'left arm (site of injection) soreness/pain left underarm' and 'swollen lymph nodes'. Post-vaccination COVID test was not performed. The patient was not treated for the events. She was recovering from the events.
Fever over 105 for three days, nonstop crying for a day and night, tired, dizzy, vomiting.
Swollen thigh hardened, red & hot to touch. Limping. MOTRIN given by mom with relief.
Had shots still got it /suspected vaccination failure; Had shots still got it; one spot with blister; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shots still got it /suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had shots still got it) and blister (Verbatim: one spot with blister). The outcome of the vaccination failure was unknown and the outcome of the shingles and blister were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she had a shots but still got it only one spot with blister and had it 6 weeks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details confirming shingles were unknown at a time of reporting.
Pain up and down the arm; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported of pain up and down the arm on an unspecified date which subsided in a day or two.  The patient was recovering from the event pain up and down the arm.  No follow-up attempts are possible, information about batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 89-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL8982), on 10Feb2021 as dose 2, single (Lot number: EN6201) and on 24Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 88 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (booster), single (Lot number: 002M21A) for covid-19 immunisation. The patient's relevant medical history included: "2 recent TIAs", start date: 23May2022 (unspecified if ongoing); "2 recent TIAs", start date: 10Jul2022 (unspecified if ongoing); "MGUS" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM, start date: Jan2010. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (Jul2022) positive, notes: Tested positive again on day 11 with symptoms (congestion, cough, etc.). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid Covid 19 treatment from 12Jul2022 to 17Jul2022.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; 4 wks later pt failed to seroconvert;
Confusion, Dizziness, N/A Narrative: DIZZINESS HEADACHE MALISE CALLED OFF FOR 2 DAYS AFTER
Tongue tingling/swelling, face flushing, difficulty swallowing, sense of doom, heart racing, nose running. Onset 30 mins after vaccine, tongue swelling went away a bit and then came back about 1 hour after initial symptoms. Went to ER, received IV benadryl and went home after observation
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Excessive crying for about 20 hrs p/recving #3 DPT; was consolable but crying again shortly afterwords; "twitching arms & legs" while asleep; Temp no > 101.3 (ax);
Sometime in May I noticed a rash had started on my left foot and leg. Since then it has spread to both legs, both lower and upper, the back of my hands, and my left forearm. It was diagnosed by Dr. either excema or psoriasis, but has not responded to a topical steroid cream. At this point it seems to have gone systemic.
fever; chills; body aches; diarrhea; left arm pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in left arm on 29Mar2021 (age at vaccination 52 years) as DOSE 1, SINGLE for COVID-19 immunisation. Patient medical history included lyme disease and Covid 19. The patient had known allergy: seasonal and penicillin allergies. There were no concomitant medications. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 and not tested for COVID-19 since vaccination. On an unspecified date the patient experienced fever, chills, body aches, left arm pain, and diarrhea. The patient did not receive any treatment for events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event; Patient administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) 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 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster).    This case contains information for the 11th of 16 adult patients described by the reporter. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:master case
Patient arrived at vaccine site at approximately 1415 reporting that she had received dose 1 of the Cansina COVID vaccine on 4/29/2021. She requested to receive the Janssen COVID vaccine. PHN called PHN supervisor and the medical team. Doctor from medical team approved Janssen vaccine for the patient. Patient received the Janssen COVID vaccine (lot 1822809) and Fluarix influenza vaccine (lot 3NA4M) at 1500. Patient waited in observation area, no report of adverse symptoms. Patient left walking at 1512 with steady gait.
Patient developed a papular itchy rash 2 days after receiving the moderna vaccine on 04/01/2021. Patient was seen in clinic today and prescribed a predinsone taper and hydroxyzine.
Rash developed at site of injection 1 week afterwards.  It started as 4 small red dots, then grew & coalesced to a solid 4.5 cm diameter red raised area by the following morning.
7 days after vaccination had fever, crying, decrease appetite and activity for 3 day. Fever to 101. No one in family was ill. No evaluation or office visit.
Patient received Janssen vaccine via IM into left arm at 519PM. This RN was called to patient side at 525PM due to patient feeling faint. RN and RN already at patient side. Patient was noted to be sitting in chair slumped over and diaphoretic. Patient not responding to questions or speaking. EMS called to scene. Cot immediately moved over next to patient and patient picked up via 3 person lift and laid onto cot. Patient eyes open and looking around with symmetrical chest rise and no appearance of difficulty breathing, patient pale and diaphoretic - vital signs at 529PM = manual BP 110/56, HR 48, SpO2 95% on room air. At 1732 patient became more coherent, GCS 15, alert and oriented x 4, patient remained diaphoretic and pink/pallor noted to skin. Vital signs at 1734 = manual BP 108/54, HR 77, and SpO2 99% on room air. EMS arrived on scene at approximately 545PM. EMS evaluated patient who remains alert and oriented x 4, GCS 15, and is now pink warm and dry. EMS allowed patient to go home after signing necessary paperwork on their end. Patient observed self-ambulating out of vaccination site with cousin at side.
Pt given high dose FLUZONE vaccine on 9/11/13 around 11:30 AM. Pt immediately with diaphoresis and pale. Was laid down and given compress and O2. Pt had possible seizure or vasovagal response around 11:40 AM. Ambulance called and arrived about 8-10 min. later pt blood sugar 161. Pulse low 60's throughout, unable to hear BP. Pt sent to ER via ambulance.
SHORTLY UPON RECIEVING THE FLU MIST ONE OF HER CHEEKS SHOWED QUARTER SIZE RED MARK, THE NEXT DAY THERE WAS RED SPLOTCHES ON BOTH CHEEKS WAR TO THE TOUCH, BOTH ARMS WERE ALSO INFLAMMED AND SHE EXPERIENCED SLIGHT PAIN, NEXT DAY EVERYTHING WAS CLEARED UP, PT WAS GIVEN ZYRTEC AND COLD PACKS WERE ADMINISTERED BY MOM AT HOME.
In the afternoon, I experienced a nosebleed.  The weather was not overly dry, I was well-hydrated, and I was confused why I would experience a nosebleed.  The bleed was not excessive, and I considered coincidence.  An hour or two later in the late afternoon, my wife noticed that I had a ruptured capillary in my left eye.  She was very concerned since it appeared very bloody even though it did not cause me any significant pain.  The affected eye was mildly itchy afterward.  I was not hit in the eye or scratched it in any way.  I associated the capillary bleeding events as related to each other and potentially related to my vaccination.  However, both events were minor and passed, cleared up in 72 hours.  I have a photo of my eye that is available upon request.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 27-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (route, anatomical location and dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
lt leg turned bright red,entire leg swollen;unconsolable screaming x 6 days;60hrs p/shot turned to a high pitched scream-poss (sz?);lt side weaker,stopped rolling over,pain in neck,loss of muscle tone,floppy,hypotonia,neuro damage
Patient received pediatric COVID-19 vaccine prior to turning five years old. No harm caused at this moment in time, documenting that it was administered younger than 5.
1.)  1 Day after receiving 2nd Covid19 vaccine had a low dose temperature between 99.6-100.6 degrees, achy joints, and fatigue. 2.) 1-2 days after receiving the 2nd Covid 19 vaccine had a local reaction in left arm where i recieved the vaccine.  Itchy , red, warm to touch and sore.
She received RZV/ Shingrix #1 on 3/21/22 at clinic. Then she received #2 apparently on 3/26/22. Then she developed swelling 3x5 inches on the left upper arm just below the vaccine site. She also developed swollen lips and small painful excoriations on the lips. These symptoms have been roughly unchanged the past 1-2 days. She is currently afebrile, HR 105. She has no issues breathing. She is distressed by the symptoms and wonders if they are due to the RZV. She is able to eat and drink. She says she cannot blow the crossing guard whistle right now. Presumably her lip swelling and arm swelling are due to the RZV but I don't think she has angioedema.
pt recvd vax 12OCT94 & 14OCT pt broke out in a generalized urticarial rash; seen by MD & treated w/DPH
Case number PHEH2013US017744 is an initial spontaneous report received from a physician on 19 Aug 2013. This report refers to a patient of unknown age and gender. It was reported that the patient received only Men CWY 135 liquid component of MENVEO (batch number: unknown) intramuscularly without being reconstituted with Men A lyophilized conjugated on an unknown date. Client reported that Men A powder vial was discovered in the refrigerator. No adverse event was reported following this administration error. No further information was provided.
itchy rash; eyes are itchy; blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows; Rash; This is a spontaneous report received from a contactable consumer reported for herself. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection,Lot number: EN6201) via an unspecified route of administration in left arm on 15Feb2021 as single dose for COVID-19 immunization. Patient medical history and Concomitant medications were not reported. No other products or investigation assessment was reported. On 20Feb2021,the patient experienced itchy rash, eyes are itchy, rash, blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows, stated her eyes were itchy and where the rash was itching. Age at time of onset of reaction/event was reported as 81. Stated that she was due for her second dose on 8Mar2021. Reporter wanted to know if the rash will happen again with her second dose. The patient was not recovered from the event.  Follow up attempts are completed. No further information is expected.
Patient was flushed and sweating, seemed to be a little dizzy. Vitals were all okay and within normal limits (BP, glucose, O2 Sat, HR).  I administered a Benadryl 50mg IM injection to the patient, and the hospital staff later gave her a dose of Zofran as she felt nauseous. Since then the patient seems to be reacting well to treatment.