chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient transferred from long-term care at department of correction Medical Center Emergency Room with altered mental status and hypoxic respiratory failure. Patient was unresponsive on arrival to the ED with agonal breathing on non-rebreather, BP was immediately intubated for airway protection with improvement in oxygenation. Chest x-ray with significant bilateral ground-glass opacities and infiltrates. Rapid COVID was negative, started on antibiotics and received 3 L normal saline bolus by the ED. Of note patient had a recent multifocal CVA (01/25/2022) involving the cerebellum, frontal, and parietal lobes. He has residual expressive aphasia and right hemiparesis. Per documentation from Department of Corrections the patient has been running a fever since 1/25 /22 when he was admitted to their long term care area. The patient was much more altered today prompting transfer to ER. At baseline patient is alert and oriented x3, bed ridden, urinary/bowel incontinence, expressive aphasia, right hemiparesis. In ER, patient was hypoxic with a sat of 60 and hypotensive with a systolic blood pressure of 70, immediately placed art line and started vasopressors, quickly escalated to max pressers. Central line was placed. He required neo synephrine sticks to get is blood pressure up. COVID PCR came back positive after initial rapid was negative. Starting Decadron and RDV. Continue broad-spectrum antibiotics for suspected secondary bacterial pneumonia and what appears to be septic shock with an added component of cardiogenic shock. Patient's oxygenation continued to worsen despite max ventilator support. Family at bedside. Patient passed away at 12:41 pm 2/21/22
PAINFUL/SORE SHOULDER, NUMBNESS AND TINGLING THROUGHOUT ARM AND HAND.
Adverse Event: High fever, joint pain, dizziness, weakness, cold sweats, change of taste of food, loss of appetite, left arm pain where injected. Treatment:  Stay hydrated, stay home in bed. Outcomes: Joint pain went away in one day, fever broke after 3 days, cold sweats continue, weakness continues.
(R) thigh 9x10 cm erythemic subcutaneous reaction slightly warm to touch 2mm clear vesicle at insertion site.
I've broken a bone.; bones hurt; sore throat; a stuffy nose; a little hangover headache; After the second injection, I had arm pain, it was more severe than after the first one; After the second injection, I had arm pain, it was more severe than after the first one; Flu-like symptoms the next day; seasonal allergy symptoms after receiving vaccine injections; Felt wet on my arm, and it was not saline colored; really bad sinus; This is spontaneous report from contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Nov2020 (at age of 36 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on Oct2020 (at age of 36 years old) as single dose for COVID-19 immunization had Chills, Headache, seasonal allergy symptoms after receiving vaccine injections, had arm pain, it was more severe than after the first one. On unknown date, The patient experienced a sore throat and a stuffy nose, but is has been getting better. Patient reported in interview that during her participation in the COVID-19 vaccine clinical trial, in which she received the live vaccine, the staff who administrated injections "missed taking some vitals and I know they missed a pregnancy test before one injection." She also reported, "l think the nurse pulled it out a little too soon. Felt wet on my arm, and it was not saline colored." Patient also reported experiencing seasonal allergy symptoms after receiving vaccine injections: "We've been playing 'is it allergies or is it COVID.' I had a really bad sinus thing a few weeks before and reported it and they did not call me. After the second vaccine, patient reported: "About 18 hours later, it was like a bus hit me full-force, was in bed, shaking, my bones hurt. I could not explain how my bones hurt and I've broken a bone. My immune system was like, ON. A lightbulb went on, we knew from the people who'd reacted, hang on for 24 hours. It didn't even take that long. By the next day it was like had a little hangover headache." "After the second injection, I had arm pain, it was more severe than after the first one, but again, not that bad. But I almost had flu-like symptoms the next day, They were very short-lived, it wasn't bad. The outcome of the events sore throat and a stuffy nose was recovering, for Flu-like symptoms was recovered on unknown date, for other events was unknown.  Information on the lot/batch number has been requested.
Reddened area with rash, underarm where vaccine was administered and both sides of groin. Rash has spread since I first noticed it this morning. The physician this afternoon (4:15 PM) said it was a drug related allergic  reaction. The only medication I took within the last 48 hours was Ibuprofen.  I have taken this medication many times in the past without any reaction.
DEVELOPED COUGH, RUNNY NOSE, CONGESTION, HEADACHE, MYALGIAS ON 10/09 TESTED (+) AT AN URGENT CARE ON 10/14 AND THEN ADMITTED TO 10/15 TO HOSPITAL DUE OT LOW OXYGENATION
pt recvd vax 26FEB91 & 30SEP92 & almost immed became very ill & leg swelled to twice its size;disabling injuries are allegedly irreparable & permanent;
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Batch/Lot number: unknown) and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing negative 10 days prior; Positive, notes: Rebound positive home antigen tests x 4 days after testing negative 10 days prior. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti viral treatment with Paxlovid from 15Jul2022 to 19Jul2022 (route of administration: oral) for covid-19. Patient experienced rebound positive home antigen tests x 4 days after testing negative 10 days prior (Mild symptoms). No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included blood pressure, lymphoma (non-hodgkin's) (Recovered), chemotherapy and splenectomy. Concomitant products included nebivolol hydrochloride (Bystolic), thyroxine sodium (Levothyroxine) and progesterone (Prometrium). On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On 3rd June 2018, the patient experienced discomfort. On 4th June 2018, the patient experienced breast pain. On 5th June 2018, the patient experienced rash, skin lesion and skin irritation. The patient was treated with acyclovir, lidocaine and hydrocodone bitartrate + paracetamol (Vicodin). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the discomfort, breast pain, skin lesion and skin irritation were unknown. The reporter considered the injection site erythema, injection site swelling, injection site pain, rash, breast pain and skin lesion to be related to SHINGRIX. It was unknown if the reporter considered the discomfort and skin irritation to be related to SHINGRIX. Additional details were provided as follows: The patient stated that in the past she had non hodkigns lymphoma and had her spleen removed in February 2017. In 2017, the patient went through 6 rounds of chemotherapy. At 14:30, the patient received SHINGRIX on left deltoid. The patient stated that she experienced redness, swelling and pain at the injection site which started the next day after receiving the vaccine. The symptoms were got worse for next 5 days and resolved completely after 7 days from the beginning of symptoms. On 3rd June 2018, the patient felt discomfort beneath her breast under the first rib. On 4th June 2018, the patient experienced stabbing pain beneath her breast on the left side and she visited her Cardiologist on same day where EKG (electrocardiogram) was performed and it was negative. On 4th June 2018, the patient was then sent to the emergency room at Hospital. The patient had a full work up done for her heart including treadmill test, x-ray, and left quadrant test and all tests were negative. On the same day, at 4:30 pm, the patient was discharged with pain medication and lidocaine patch to place underneath her breast.  The patient was told to leave the lidocaine patch on for about 12 hours and take it off next morning. On 5th June 2018, when the patient woke up and took the patch off the area underneath was red and irritated and noticed bright red lesions on the left side of her back and spreading to lower first rib area underneath her breast.
30 minutes after vaccination felt throat sore and voice hoarseness, sneezing a lot. Yesterday stayed the same in bed. Today just hoarse not sore, runny nose yesterday. Soreness and redness at site of injection wouldn't be able to lay on it.
Palpitations for 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations for 4 hours) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PALPITATIONS (Palpitations for 4 hours). On 16-Jan-2021, PALPITATIONS (Palpitations for 4 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-040876 (Patient Link).
Headache & Fever Narrative: fever chills, ha, nausea day 1
FELT DIZZY/FELT FAINTING; HEAD SPINNING; HANDS SHAKING; DROWSY; VISION BLURRED; MOUTH DRY; ONE SIDE OF TONGUE WAS HEAVY; WEAKNESS; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included influenza vaccine for prophylactic vaccination, and acetylsalicylic acid.  On 23-MAR-2021, the subject experienced felt dizzy/felt fainting. On 23-MAR-2021, the subject experienced head spinning. On 23-MAR-2021, the subject experienced hands shaking. On 23-MAR-2021, the subject experienced drowsy. On 23-MAR-2021, the subject experienced vision blurred. On 23-MAR-2021, the subject experienced mouth dry. On 23-MAR-2021, the subject experienced one side of tongue was heavy. On 23-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt dizzy/felt fainting, drowsy, vision blurred, mouth dry, one side of tongue was heavy, hands shaking, head spinning, and weakness. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
tenderness and pruritus at injection site. Pruritic is raised. Pt advised to used Benadryl and if swelling increases Keflex was prescribed. Still recovering swelling and redness decreasing
DEATH; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, 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, expiry date: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unknown whether the autopsy was performed. Reporter stated that "I know a lot of people suffering after having your jab, one is dead". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220562523.; Sender's Comments: V0:20220601898-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Moderna COVID-19 Vaccine EUA.  Axillary swelling or tenderness (i.e., lymphadenopathy: localized axillary swelling or tenderness ipsilateral to the vaccination arm
Child found pale blue limp and not breathing by parent. CPR performed. Child transported to ER. Admitted to hospital.
Vertigo beginning in mid March.  Dizziness at rest sometimes and when bending down to pick something off of the floor.  I also had dizziness when doing yoga in positions as downward dog.  I have been doing yoga for over 20 years.
Moderate pain throughout arm, took TYLENOL and pain slowly decreased over period of one week. Rash began and slightly spread over upper arm, patient was instructed to use BENADRYL/hydrocortisone cream. If no resolution to visit doctor office. Unknown resolution of rash as this was reported today to pharmacy. Instructed patient to please follow up with resolution.
terrible headache; it was itchy; rash on the arm of the injection; red blotches on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE RASH (rash on the arm of the injection), VACCINATION SITE ERYTHEMA (red blotches on the arm of the injection) and HEADACHE (terrible headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE RASH (rash on the arm of the injection) and VACCINATION SITE ERYTHEMA (red blotches on the arm of the injection). On 22-Mar-2021, the patient experienced HEADACHE (terrible headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (it was itchy), VACCINATION SITE RASH (rash on the arm of the injection), VACCINATION SITE ERYTHEMA (red blotches on the arm of the injection) and HEADACHE (terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Pt came to ED stating she received a pneumococcal vaccine that morning at 11am and she noticed swelling of the LUA around 1 pm progressively getting worse. And local edema, erythema and itching and pain.
A couple of days after getting injection, I started to get weakness and stiffness in the arm of the injection site, my thumb is twitching and pain in my forearm
moderate side effects; hip replacement surgery; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (moderate side effects) and MUSCULOSKELETAL DISCOMFORT (hip replacement surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Shingles. Previously administered products included for Prophylactic vaccination: INFLUENZA VACCIN. Past adverse reactions to the above products included Vaccination adverse reaction with INFLUENZA VACCIN.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (moderate side effects) and MUSCULOSKELETAL DISCOMFORT (hip replacement surgery). At the time of the report, IMMUNISATION REACTION (moderate side effects) and MUSCULOSKELETAL DISCOMFORT (hip replacement surgery) outcome was unknown.            Pfizer covid-19 booster shot approximately 8 months after receiving 2 dose series of modern Covid-19 vaccine. The day after booster the patient spiked a fever ranging from 100.4-102 degrees. Two days after booster the patient developed a lump under her armpit to the side of her breast.  Patient also had a hip replacement surgery two weeks before the booster shot was received.  No concomitant medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from the physician and refers to a 61 year old male patient with chronic shoulder pain, allergy to aspirin and allergy to LIPITOR. On 15-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot # and expiration date, dose were not reported). Concomitant therapies included VICODIN, ibuprofen, BENICAR, LEXAPRO, amlodipine, tramadol hydrochloride, testosterone, PREVACID, diazepam (manufacturer unknown) and ADDERALL tablets. The patient with pre-existing and chronic shoulder pain prior to receiving ZOSTAVAX needed to receive a localized steroid injection following the administration of ZOSTAVAX which was performed on 15-NOV-2013. The patient was given VICODIN, ibuprofen for the treatment of adverse event. No lab diagnostics studies were performed. The patient sought medical attention, he had office visit. The outcome of needs to receive a localized steroid injection was reported as not recovered/not resolved at the time of the event. The relatedness between ZOSTAVAX and the adverse event was unknown at the time of the event. Additional information has been requested.
When pt came in for his PPD reading, I noticed the patient favoring right arm. He was given DTaP and HAV in the deltoid several days before the SX. The area was hot, indurated 50x50 with erythema. MOC denied he had any other SX. He was given a MMRV SQ in the left upper arm which had no visible reaction.
became febrile w/in 4-6 hrs following immun; 14 hrs following vax pt brought to ER p/sz 3-5 mins; t103.6 pt given APAP suppository; adm as inpt for observation overnoc; dx febrile sz;
Took 1st dose 01/27/12021 . 8days later developed  rash on right arm where vaccine  given. Took benadryl  orally and topically  cortisone  cream .Gone after 4days. Got 2nd dose 02/27/21. Next day developed  fever 101.6 with rapid heart  rate took tylenol . Had to go to hospital  because  heart rate remained 120 to 130. All lab normal EkG tachycardia came down on own
Headache; Fever; Body ache; Weakness; Fatigue; Severe lower back pain; Flu; Felt so ill; did not have an appetite for a week; This is a spontaneous report from a contactable consumer (patient) reported for herself in response to non-Health Care Professional letter. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8730), via intramuscular route of administration in right upper arm on 26Mar2021 at 14:10 (at the age of 61 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199), via intramuscular route of administration in right upper arm on 05Mar2021 at 02:10 PM (at the age of 61 years old) for covid-19 immunisation and patient experienced headache, fever, body aches, weakness, fatigue, severe lower back pain, flu, felt so ill. She saw her physician after her second dose because she did not have an appetite for a week after the vaccine in 2021. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understands that all these are possible side effects after receiving the vaccine on Mar2021. She felt like she had the flu after each dose. Her Symptoms began the night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. No relevant tests were performed. The events resulted in physician office visit. The patient did not received treatment due to the did not have an appetite for a week. The outcome of did not have an appetite for a week was recovered on an unspecified date in 2021, while with other events was unknown.   Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Onset of fever approximately 24 hours after receiving vaccination. Fever range from 101-103 degrees Fahrenheit.  Decreased appetite, coughing, labored breathing.
Patient has history of passing out 3 times after a biopsy right after stitches were removed and 3 times after blood drawing. He was instructed to remain for 5 minutes after shots and was fine but suddenly became pale and about to faint - pale, bradycardia. He recovered in 1 minute. He was laid down and given O2.