chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 96 y.o. female with a past medical history of dementia who presented from assisted living on 2/9/23 with dyspnea and cough, found to have COVID-19 and acute respiratory failure with hypoxemia. Treated with decadron and remdesivir with clinical improvement. Required low flow nasal cannula which was weaned to room air. Course complicated by hospital delirium. Patient to be discharged back to assisted living under hospice care.    Comments/Problems to be Addressed after Discharge Not applicable, patient is under hospice care.   COVID-19 infection -Vaccinated x 3 with Moderna (last dose 11/2021). Symptom onset 2/8. Positive COVID-19 test at assisted living on 2/9. -CTPA on admit without pneumonia and mild bilateral lower lobe atelectasis.  -Required low flow nasal cannula during stay. Treated with prednisone 60 mg once (2/9) followed by dexamethasone 6 mg daily (2/10-2/13).  -Weaned down to room air, dexamethasone and remdesivir to be discontinued upon discharge.    Acute hypoxemic hypercapnic respiratory failure, resolved -In the setting of COVID-19. No baseline oxygen requirements.  -Mild hypercapnia up to pCO2 of 59 noted on VBG.  -Treated with low flow nasal cannula, weaned down to room air.    Acute encephalopathy  -Likely hospital delirium in the setting of known dementia and hospitalization.  -Optimized sleep/wake cycle. Steroids discontinued upon discharge.    Asthma  -Continue albuterol nebulizer prn.    Dementia Anxiety  -Resides at local assisted living (and memory care unit).  -Continue home seroquel and celexa.    Incidental CT findings  -CTPA 2/9/23 with age-indeterminate T11 compression fracture and left adrenal nodule (most likely adenoma).
Pt. states the injection hurt when she got it and then was really hurting by the time she got to her car. States vaccine was given in (R) arm and the pain goes all the way around her arm where it was given. C/o pain in (R) shoulder & states its hard to dress & undress c/o fingers tingling at times. Saw chiropractor. Got to Dr next wk.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX. On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced appetite lost and fatigue. On 12th September 2018, the patient experienced pain in arm, swelling arm, skin warm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm, appetite lost, skin warm and erythema of extremities were not recovered/not resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the pain in arm, swelling arm, appetite lost, skin warm, fatigue and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The day before the reporting day, she started feeling fatigue and had a loss of appetite. On the reporting day, the redness appeared an inch below the injection site and it was moving down and around the arm. It was also painful and hot to touch. The patient provided contact details of physician.
Swollen lymphnodes and breast tissue on same side as vaccine; Swollen lymphnodes and breast tissue on same side as vaccine; BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge; Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of BREAST SWELLING (Swollen lymphnodes and breast tissue on same side as vaccine), LYMPHADENITIS (Swollen lymphnodes and breast tissue on same side as vaccine), EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2022 at 4:07 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022 at 4:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). On an unknown date, the patient experienced BREAST SWELLING (Swollen lymphnodes and breast tissue on same side as vaccine), LYMPHADENITIS (Swollen lymphnodes and breast tissue on same side as vaccine) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge). At the time of the report, BREAST SWELLING (Swollen lymphnodes and breast tissue on same side as vaccine), LYMPHADENITIS (Swollen lymphnodes and breast tissue on same side as vaccine), EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  It was reported that Moderna vaccine was pulled from freezer on 16-Dec-2021, BUD Date of 15-Jan-2022 was printed on top of boxes. On 26-Jan-2022 staff brought it to attention that it was still in fridge. On 31-Jan-2022 Moderna responded that revaccination was not required. It was also reported that Patient reported adverse effects. Per society of breast imaging COVID Vaccine can cause abnormal mammograms up to 6 weeks.   No Treatment was reported.
Moderate migraine, body aches, chills, hot flashes, fatigue, lack of appetite.
Pharmacist asked patient about his past history of vaccinations. Patient reported no past history of dizziness, fainting, or adverse reaction to any vaccine. After administering both vaccines, pharmacist informed patient he needed to stay around for a minimum of 20 min. to ensure that he had no severe reaction that required medical attention. He was told to let the pharmacist know if he started feeling funny. He immediately told the pharmacist that he felt as if he were going to faint. At that time the patient closed his eyes. The pharmacist called out to patient and asked if he was ok. The pharmacists patted the patient to see if he was still conscious. The patient did not respond. The pharmacist then proceeded to stand up beside patient in case he were to go limp and/or fall out of chair. Pharmacist informed the other pharmacist on duty of the patients condition and requested a cool compress from the emergency supply kit. The cool compress was applied and the pharmacist continued to call out to patient. The pharmacist checked the patient for a pulse. A strong pulse was present. The other pharmacist present retrieved an epipen from the emergency supply kit in case it was needed. The The pharmacist had someone bring some orange juice to the patient to drink. The pharmacists observed the patient for approx 30 minutes after the incident. Upon leaving the patient reported having no more symptoms and told his coworks he was fine to drive. The pharmacist called the patient that evening at 7:45pm. The patient said he felt fine and had no more complications. The patient's primary doctor was notified the next day of the incident.
Narrative: Patient who DID NOT received a covid from facility, has a record of receiving a covid EUA (J&J) vaccine on 3/17/2021, place unknown & details unknown. Pt died on 12/12/2022, place and cause and circumstances of death unknown. No available notes in chart regarding pt's death. Reporting this since vaccine was EUA status.
AT 15:58 PATIENT BECAME VERY DIAPHORETIC IMMEDIATELY AFTER INJECTION. 16:04 VITALS WERE AS FOLLOWS: BLOOD PRESSURE 102/65, HEART RATE 78 AND 02 SAT- 99%. STILL DIAPHORETIC. AT 16:15 , PATIENT IS BETTER NOT DIAPHORETIC. VITALS WERE CHECKED AGAIN AT 16:25 BLOOD PRESSURE 109/70, HEART RATE 73, RESPIRATION 20 AND 02 SAT 98%. PATIENT WAS INSTRUCTED NO TO DRIVE AND IF SYMPTOMS REOCCUR CALL 911 OR GO TO NEAREST ER.
AT 9:45 patient was administered their 2ND dose of the GARDASIL 9 VACCINE. Parents were aware that patient would need to wait 15 min. After administration to monitor for any kind of adverse reaction. Mother and father gave verbal  understanding.  AT 09:55 I went back into the room to  look at the supper bill. I found  the patient sitting on the chair in the room trying to vomit but very little was coming up. I asked the  father if the patient started feeling upset to his stomach when the blood was being drawn from the sibling or if it was all of a sudden. Father stated that patient had said he felt very sleepy and then sat down in the floor so the dad picked him up in to the chair and that is when he started vomiting. I OPENED THE DOOR TO THE ROOM AND HAD employee GO ASK DR TO COME TO THE ROOM. I STOOD BY THE PATIENT AND THE PATIENT WAS SITTING UP BUT SUDDENLY ALMOST FELL TO THE FLOOR, I GRABBED HIM UNDER HIS ARMS FROM BEHIND. DR WALKED IN AND PT WANTED ME TO LET GO, I EXPLAINED WHAT WAS GOING ON TO DR AND EXPLAINED IF I LOOSEN MY GRIP ON THE PT THAT HE STARTS TO SLIDE OFF THE CHAIR. DR ASSISTED ME IN MOVING THE PT TO THE EXAM TABLE WHERE WE PLACED HIM IN A SIDE LYING POSITION. PT STATED HIS CHEST WAS HURTING THEN VOMITED ALMOST IMMEDIATELY. PT WAS ASSESSED BY DR AND WAS IN A STABLE CONDITION. PT WENT TO SLEEP HOWEVER STABLE CONDITION REMAINED. PARENTS WERE ADVISED TO STAY IN THE ROOM SO WE COULD MONITOR THE PT AND WE STEPPED OUT. AT 10:20 PT WAS STILL ASLEEP AND IN STABLE CONDITION. AT 10:25 employee TOLD ME PARENTS SAID PT HEAD WAS HURTING. I WENT TO THE ROOM AND PATIENT WAS LYING ON BACK HOLDING HEAD AND CRYING SAYING HIS HEAD HURT REALLY BAD. PT WAS COUGHING WHAT SOUNDED LIKE HE WAS TRYING TO THROW UP SO I IMMEDIATELY TURNED HIM ONTO THE SIDE AND DR CALLED BACK TO ROOM. DR CAME IN AND ASSESSED PT, PT WAS STILL CRYING AND WOULD NOT RESPOND TO ANY QUESTIONS ASKED AND SUDDENLY FELL ASLEEP AGAIN. 02 STATS WERE WITHIN NORMAL LIMITS AND VARIED FROM 97-99% AND HEART RATE VARIED FROM 67-78 BEATS PER MIN. MADE SURE PT WAS STABLE AND ADVISED PARENTS TO WAIT IN ROOM. DR EXPLAINED TO PARENTS PT WAS STABLE BUT WAS HAVING BAD REACTION TO VACCINE. HE STATED THAT IF PT WOKE UP WITH HEAD HURTING LIKE BEFORE TO SEND HIM TO THE EMERGENCY ROOM, MOTHER GAVE VERBAL UNDERSTANDING. AT 10:40 employee INFORMED ME THAT PATIENT HAD LEFT THE ROOM. Employee AND DR FOUND THE PT AND ASSESSED HIM BEFORE LEAVING. PT WAS SAID TO BE IN STABLE CONDITION. LVN 5/24/17 3:42PM. INCIDENT AS REPORTED ABOVE BY LVN; ALL INFORMATION OF INCIDENT REVIEWED AND ACCOUNTED FOR CORRECTLY PATIENT DID LEAVE ON OWN W PARENTS BEFORE WE WERE READY FOR THEM TO LEAVE. WE DID ENCOUNTER THEM IN THE PARKING LOT. Patient WAS AWAKE, ALERT AND ORIENTED. HE SAID HE FELT BETTER AND HEAD NO LONGER HURTING. REVIEWED W PARENTS THAT HE SEEMS TO HAVE HAD AN ADVERSE REACTION TO THE VACCINE. HE LOOKED OK TO GO HOME. ADVISED IF INTENSE HEADACHE RECURRED HE SHOULD BE TAKEN TO ER FOR RE-EVAL. PARENTS EXPRESSED UNDERSTANDING AND NO FURTHER QUESTIONS. MD 5/24/17 10:36AM.
Information has been received from a registered nurse concerning a female pt whose younger sister was vaccinated with varicella virus vaccine live. The pt in this report was never vaccinated with varicella virus vaccine live. The pt was receiving unspecified chemotherapy. In November 2001, the pt develped shingles at the same time her five year old sister developed chickenpox. Unspecified medical attention was sought. The pt's younger sister developed chickenpox post-vaccination with varicella virus vaccine live (WAES01120544). No further info is available.
FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
chest pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain). At the time of the report, CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medication information reported.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 24-JUN-2016, the patient was intramuscularly vaccinated with one expired dose of GARDASIL (injection, lot number: K001502 with expiry date of 06-AUG-2015). No concomitant therapy was reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
This initial report was received from a nurse via other company, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, strength, dose number, route of administration and lot number were not reported). On an unknown date, the patient experienced an allergic reaction to preservatives in PNEUMOVAX 23. At the reporting time, the outcome of the reported event was unknown. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
Fever (100.7) Chills Headache Body ache Fatigue Started a little less than 24hrs after vaccine, gone by the next morning
Swollen Arm; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70-year-old female patient. The patient was a non-smoker. Her medical history included chicken pox (in 1954). Her concomitant medications were not reported.  On 07-JAN-2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. On an unknown date, the patient had swollen arm.  The outcome of the event was not reported. The reporter considered swollen arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Severe headache 15 hours after getting second COVID vaccine.  Relieved partially with acetaminophen.  Dull headache second day. Headaches are very unusual for me.
Pain and redness at injection site, muscle pain, fever, chills, headache on right side, extreme fatigue, painful pimple-like sore on my right upper lip (sore subsided within 24 hours   Under skin, never erupted)
Patient stated that after receiving his vaccination (approximately 2 days afterwards) his arm was sore, hard to move a and little yellowish.
Took one VIVOTIF capsule at 9:30 pm, 2.5 hours after ingesting evening meal, at 5 am next day experienced strong abdominal cramps, nausea, fever, chills. Attempted to go to work but came home because of discomfort. Pain lasted 24 hours.
Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 16Mar2021 at 09:30 (at an age of 47-years-old) as  single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration  on 23Feb2021 at 09:30 (at an age of 47-years-old) as single dose for COVID-19 immunisation. On 17Mar2021, the patient experienced fatigue and headache. The patient didn't receive treatment for the events. The clinical outcome of fatigue and headache were recovered on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
Diarrhea, nausea, gas, vomiting, chills for 2 days.
She had a fever of 101.8, a dose of Ibuprofen brought it down, then afternoon was up to 106 temporally and now not drinking and very irritable and lethargic.
Patient notified that the vaccine received had a potential temperature monitoring event prior to its arrival at the clinic.  Recommendations are to revaccinate.
no additional adverse effects reported; patinet received improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 05-MAR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency and anatomical location were not reported) via unknown route of lot # S025609, with an expiry date of 18-AUG-2021 for prophylaxis (Product storage error). The concomitant medication included sterile diluent(STERILE DILUENT) which was reported to be stored properly. No additional adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (-9 degree Celsius (C) to 8 degree Celsius (c)) -5.48 C for a time frame of 7 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Headache; Muscle pain/ache; chills; This is a spontaneous report from a contactable Consumer (Patient's Girlfriend). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, muscle pain/ache and chills in Dec2020 (pending for clarification). The reporter was looking for extended adverse events of headache, muscle pain/ache and chills information. Serious criteria was no. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
2 wks after MMR, varicella vaccine developed red rash over all of body without vesicles. Had runny nose several days before rash, 0 fever, 0 malaise
significant flare in herpes gingivostomatitis with severe pain requiring valtrex and additional supports
Right upper arm began aching evening of 08/18/2003-day that PV injection given; developed pink, tender region below site that radiated to inner aspect, patient afebrile, no drainage at site; ice applied to site; patient encourage to use analgesics as needed.  If problems persist MD will contact local MD.
Felt cold; Low back was achy; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 13:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and HTN (hypertension). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS), metoprolol (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC) and MVI (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. 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 left arm on 16Feb2021 at 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient previously received celecoxib (CELEBREX) and famciclovir (FAMVIR), for unknown indication from an unknown date and experienced drug allergy. On 10Mar2021 at 16:00, 24 hrs after 2nd injection, the patient felt cold and her low back was achy. Took paracetamol (TYLENOL) and it went away in a few hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events which included treatment with paracetamol (TYLENOL). The clinical outcome of the felt cold and her low back was achy was resolved on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning a 5 year old male who in June 2004, was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on an unspecified date in June 2004, the patient experienced a varicella like rash.  Unspecified medical attention was sought and no treatment was required.  A product quality complaint was not involved.  Additional information has been requested.