chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended by her physicians for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 12-JUN-2016, the patient was treated at a hospital center for the development of herpes zoster and was prescribed valacyclovir hydrochloride (VALTREX), acetaminophen (+) oxycodone hydrochloride (PERCOCET), and gabapentin by a physician for management of her shingles-related symptoms. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Headache nasal congestion Narrative:  Employee states that he developed headache and nasal congestion almost immediately after receiving the his second dose of the vaccine. "They gave me a Tylenol & Zyrtec, the people that administered the shot." Pt contacted on 3/11/2021 for f/u due to side effects from COVID vaccination #2. Pt reported congestion, fatigue,headaches, myalgias, chills today.
He reports on the morning of 9 May he awakened with swelling of his lips and around his eyes and a generalized rash (described as non-pruritic, red, coin-shaped/sized ?patches? sparing palms and soles). He took a dose of oral Benadryl with some improvement and then presented to the ER where he received an oral corticosteroid. Total serum tryptase level draw in the ER normal. His rash resolved over the next 24 hours. Lesions not pruritic or painful; resolved without post-inflammatory changes. No laryngeal, rhinoconjunctival, pulmonary, GI, neurologic, or cardiovascular symptoms. No blistering lesions, mucosal ulcers, fever/chills, or painful/swollen joints. Episode not associated with cold, food, heat/sweating, exercise, medications, NSAID use, latex exposure, alcohol, or insect bites/stings. While he had ingested beef the night before he reports he has since ingested and tolerated beef without adverse reaction. He received his second dose of the Moderna mRNA vaccine three days prior.
Immediate severe pain at site, whole left arm feeling heavy and noticed numbness and tingling in my left hand same day, following day entire arm swelling including forearm bulging up. I am having numbness & tingling in both hands as well as muscle weakness (grip strength reduced) numbness in lower extremities and intermittent tingling in feet and legs as well. Fingers were pruning and swelling up and down visibly for several days, I still feel I am retaining fluid but visible swelling reduced. Overall severe exhaustion 6 days post injection, my blood pressure is up which is not typical.
FINAL DIAGNOSIS:   1. Covid-19 Virus Infection 2. Acute hypoxemic respiratory failure 2/2 COVID 3. Mild Hyponatremia - 130 on admission - repeating CMP today  4. HTN 5. Hx frontotemporal dementia 6. Hx of CVA and TIA with aphasia 7. Obesity with BMI 31.44 Elevated LFTs         REASON FOR HOSPITALIZATION AND ADMITTING DIAGNOSIS:   Illness Hypoxia Fever, unspecified fever cause COVID-19 virus infection   HOSPITAL COURSE:  Date of onset of symptoms:  Unknown Symptoms present on admission: Hypoxemia Date of covid positive test:  12/7/2022 Unknown when SNF test was positive Vaccination status:  Vaccinated Imaging:   12/7/2022 CXR no acute process Oxygen requirements on admission:   no home oxygen - 3-4LPM/NC Current oxygen requirements:  4LPM/NC  Medical therapy: Decadron started 12/7/2022   Consultants following:  NA Anticipated special isolation end date 12/17/2022   Obtained from EMR as patient is aphasic Patient is a 65 y.o. year-old male, who presented with illness. From ECF with known positive COVID, hypoxemia, increased AMS, and fever.  Patient is there for rehab after having a fall.  Per records patient was discharged from hospital on 12/1 where he had subdural hematoma and subarachnoid hemorrhage.  Per records patient also has frontotemporal dementia and Parkinson's likely.  Per report patient has been getting IV fluids/hydration at nursing facility and has diagnosis of COVID.  Per report patient is full code.  Per report patient running fever and more altered therefore sent to the ER.  Patient is awake but has difficulty speaking/giving history.  He is able to give yes and no answers.  No family present at this time.  Upon arrival to the ER patient was found to have fever of 101.6, tachycardia of 114 respiratory rate of 20.   Patient now on room air.  Improving with current therapy being provided.  We will discharge to skilled nursing facility for continued PT/OT.  Patient in agreement with plan.  All cultures have remained negative.
This spontaneous report was received from a physician via a company representative, referring to a 67 year old female patient. The patient's medical history included mental status changes approximately on 02-JAN-2018 (reported as "symptoms of alternate mental status one month prior to admission to the hospital on 02-FEB-2018"). The patient did not have any known allergies. No information was provided regarding the patient's concurrent conditions or concomitant medications. On 18-JAN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician reported that on 02-FEB-2018, the patient was admitted to a hospital complaining of alternate mental status and was tested for meningitis infection which was negative. It was also stated that the patient received treatment for the adverse event (unspecified treatment). The outcome of mental status changes was unknown. The physician considered mental status changes to be not related to ZOSTAVAX. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the ZOSTAVAX vaccine and the remaining reported event of Mental Status changes cannot be established. Missing important information includes medical history, comorbid conditions, concomitant medications and clinical course. Company Comment- No changes to the Zostavax product safety information are warranted at this time.  Merck and Co., Inc., continues to monitor the safety profile of the product.
red, swollen, large area 26x24cm,  itching. Very painful at administration of shot.
She feels like she was working all night when she exerts herself; body pain; very thirsty; headache; arm pain; cold; weakness/very week; fever; ver tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), THIRST (very thirsty) and FEELING ABNORMAL (She feels like she was working all night when she exerts herself) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), PYREXIA (fever) and FATIGUE (ver tired). On 17-Mar-2021, the patient experienced THIRST (very thirsty), MYALGIA (body pain) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (She feels like she was working all night when she exerts herself). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), THIRST (very thirsty), MYALGIA (body pain), PYREXIA (fever) and HEADACHE (headache) was resolving and FEELING ABNORMAL (She feels like she was working all night when she exerts herself) and FATIGUE (ver tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Event information updated
pt recvd vax; 2 hrs later, exp palpitations, GI upset, d, cramps & ha for 12 hrs; subsided
Chief Complaint   Pt was sent over from Dr's office for left brain swelling. He would like for the pt to see a neurologist. She is also complaining of back pain and severe depression.  History of Present Illness    Patient is a 74 year old female with a PMH significant for CAD, CHF, PPM, CVA, depression, DM, HLD, HTN and chronic back pain who presents to the emergency department from her PCP office due to concerns of ventriculomegaly on CT head and L sided weakness. Daughter at bedside provides most of history. Patient has been living with her daughter for some time now and her husband passed away in March of 2021. Daughter reports since her father died, her mother has steadily declined. She states she no l In the emergency department, neurology was consulted. Pt underwent repeat head CT which showed no acute abnormality. Outside CT head reported as ventriculomegaly concerning for normal pressure hydrocephalus however felt to be likely due to cerebral atrophy and stable when compared to previous CT scans. CTA head/neck without occlusion or significant stenosis noted. MRI unable to obtain due to MRI incompatible pacemaker in place. Laboratory studies significant for acute renal failure with a creatinine of 2.0. Pt was given 1L normal saline. The hospitalists were called for admission.Hospital Course:  Patient was admitted to the hospital medicine service and Neurology was consulted.  She had a CT head CTA head and neck that did not show acute findings to explain the patient's symptoms.  Neurology did not feel the patient had acute stroke.  She could not undergo MRI due to a pacemaker.  She did well during hospital stay and return back to her baseline.  She work with Physical therapy who recommended home health physical therapy which she or he had in place and will resume at discharge.  We discussed reducing her home narcotic dose as this was recently increased.  Also discussed discontinuing marijuana gummies.  She did have acute kidney injury and this resolved with IV fluid hydration.  She had abnormal urinalysis but had no symptoms and therefore has asymptomatic bacteriuria and requires no treatment.  I advised her to monitor blood pressure closely and follow up with PCP next week for this.  She will also follow up in the neurology clinic 1 month.  She will be discharged home in stable condition.   Patient was discharged on 2/10/22 but her family could not pick her up and since she has covid a ride could not be arranged. She left on 2/11/22 and was discharged that day prior to me seeing her.
Weakness, Chills, Headache, Nausea and vomiting (probably caused by headache). After the vomiting, my breathing became labored (as I fell in and out of sleep I felt the sensation of suffocating).
I had  first  dose  of the  vaccine .  03/24/2021 .. 5  days  after  began feeling  stuffed up  left ear .. not  clearing .. Persistent  blockage and some hearing  loss   on  left  side . to this  day  4/4/2021.
Headaches; chills; nausea; pain; lack of appetite; fever; This is a spontaneous report from a contactable consumer (patient) via  Sales Representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced headaches, chills, nausea, pain, lack of appetite and fever. 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.
Patient got their 1st dose on 1/11/21 and 2nd dose on 2/8/21 via LTCF clinic. Today at our third round of LTCF clinic the facility informed us that this would be patient's 2nd dose and also handed us a CDC Vaccine Record card that was dated 2/8/21 for 1st dose so upon verification with the facility and the vaccine record card they were given another shot today which makes it the 3rd dose actually and not 2nd as the facility informed the vaccine team. No adverse reaction has been reported as of yet.
more sick; body aches; weakness; fever; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported 3 reports. This is the first report. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6204, Expiration Date: 03May2021), intramuscularly, administered on left deltoid, on 03Mar2021 at 12:00 (age at vaccination was 45-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included heart burn. Concomitant medications included esomeprazole 20 mg taken for heart burn from an unspecified date of 2019 and ongoing. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EM9810, Expiration Date: 02Nov2021), intramuscularly, administered on left arm, on 02Feb2021 at 11:30 (age at vaccination was 45-year-old) as dose 1, single for COVID-19 immunization and experienced being sick, body aches, fever and headache. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On 04Mar2021, the patient experienced being more sick, body aches, weakness, fever and headache. It was further reported that the patient was more sick than the first dose that the patient could not get out of bed for a night. The events started 12 hours after vaccination and lasted another 3 days. Therapeutic measures were taken as a result of the events included paracetamol (TYLENOL); ibuprofen and diphenhydramine citrate (ADVIL PM) and vitamin C. The outcome of the events was recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021363289 same reporter and drug, similar events, different patients.;US-PFIZER INC-2021363288 same reporter and drug, similar events, different patients.
A medical assistant reported VARlVAX was improperly stored and administered.; This spontaneous report was received from a medical assistant, referring to a 12-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 04-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T021824, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of 16.1 degrees Fahrenheit (product storage error), for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA000920:Case number 01835185 US-009507513-2101USA000916:Case number 01835180
Started getting dizzy and then all day on 02/01/2011 (the next day) I had a pretty bad headache which subsided by the evening.
pfizer vaccine was mixed with bacteriostatic saline and administered to the patient, agency  and pfizer advised to readminister
Soreness radiating from injection site from shoulder blade to fingers, like getting punched. Not unusual for me. 12ish hours later, lethargy, feeling like I'm on the verge of crying, body aches, chest tightness, tightness of jaw, nausea, headache, chills, dizziness, emotional sensitivity, palpitations, still numb in the left arm.
No adverse event; Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-May-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report 2 patients received a vaccine pass 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient had any diseases and had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was reported that the vaccine was punctured around 12:15 pm yesterday (07-May-2023) and was administered to 2 patients at 9:58 am and 10:02 am the following day (08-May-2023). This case is reported for patient 1 out of 2 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723414 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723414:Patient 2
This spontaneous report was received from a Pharmacy technician refers to a patient of unknown demography. On 05-DEC-2013, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). It was reported that on 20-FEB-2014, at 8 PM, the patient told the pharmacist that at the injection site there is still small purple raised area that is oval shaped, very red and irritated after the shot on an unknown date in December 2013. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Site: Redness at Injection Site-Mild, Additional Details: child would not sit still and was scratched with needle. new needle obtained attemtped again but child  would not behave and RPh deemed it a safety issue and refused further attempts
Shortness of breath, exhaustion, headache, chills, nausea, diarrhea, weakness, sore arm
received a Tdap vaccine 2 years ago and had a seizure immediately after; This case was reported by a nurse via call center representative and described the occurrence of seizure in a elderly female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, immediately after receiving Tdap Vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Tdap Vaccine.  Additional information was received as follows: The age at vaccination was not reported. Two years before the date of reporting, the patient received Tdap vaccine and had seizure immediately. The reporter consented for follow up. This case has been linked to US2020045174, reported by same reporter.
Patient (12 y.o.) was given a pediatric dosage of Pfizer by mistake instead of the recommended adult dosage. No other adverse reactions to report
He reported severe headache around 6pm the day he got the vaccine, followed by hives/itching. Denies difficulty in breathing or closing of the throat. Hasn't been able to eat, experiencing nausea and GI discomfort (noted flatulence for over an hour). Pharmacist recommended he take Benadryl for hives/itching. Patient did not have any at home and did not feel like going out to buy some. Recommended going to the ER if it gets worse. (Call came into pharmacy on 9/25 around 1:30pm - Day after vaccine). When I talked to him today Monday (4 days post vaccine) He stated his headache got better on Sunday. He still has some itching. He has noticed a sore throat, spot on tongue, and bumps on elbows. He noted he took Sudafed - a couple doses. He is going to the Dr. tomorrow.
Right upper leg redness noted day after vaccines administered. Also 2 blistered areas noted in the reddened area on Right upper anterior leg. Treated with cephalexin 250 mg/5 mg suspension 10ml. by mouth 2 times a day for 7 days. This 4 year old male is brought in by his father this morning for concerns of redness and blistering of his right anterior thigh. Patient was given DTAP/IPV vaccinations on Wednesday. Dad noticed the following morning some redness about the size of his palm. This redness increased circumferentially throughout the day and two blisters appeared. This morning he is seeking recommendations. Patient has no complaints of pain, itching, fever, cough, runny nose, sore throat, nausea, vomiting or diarrhea. He is sleeping well. Appetite unchanged. Activity level is unchanged. No outpatient prescriptions have been marked as taking for the 6/16/18 encounter (Office Visit) with PA. No known allergies.
the patient came back med opts 1 shaky, warm, and slightly sweaty. she said her tongue was itchy and had slightly labored breathing.  Patient also said she was diabetic and was given apple juice.  Vitals- TIME: 4:37 HR: 116 RESP: 14 BP:168/100 SP02: 94%
Within 10 minutes after the vaccine I started to feel very faint and eyes became very blurry and couldn?t see. The pharmacy gave me water and kept making me drink water and kept checking on me. The vaccine spiked my blood sugar. After a little while my sugar went down and I was fine.    That evening I had the worst migraine ever and it lasted 3 days. I also had body aches and chills  for 3 days as well and fatigue.
Per telephone call from pt's mother; pt developed a rash to chest and upper thighs, 24 hours, post vax. Rash "looks like red, raised bumps" and she is complaining of itching but not severe.
Tdap was given during a school clinic on 3/8/13. Approximately two hours following the immunization patient reported to the nurses office with c/o tightness and feeling of fullness in the fatty area between the thumb and forfinger of the left hand. No redness or edema was noted by the nurse at that time.