chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itch on her feet and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch on her feet and hands) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch on her feet and hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of used it as a cream; CORTISONE for Itch, at an unspecified dose and frequency and CAMPHOR, MENTHOL (SARNA [CAMPHOR;MENTHOL]) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (itch on her feet and hands) had not resolved.            Concomitant medications were not reported.   The patient had a delayed reaction, 8 days after receiving of 3rd dose. She then said the delayed reaction started 25-Aug-2021.  The patient was still experiencing the reaction and it was reported as "just consistently bad."  She looked online and it was mentioned as delayed reactions. She went to a doctor but had not gone for this reaction yet.  The patient stated that she had tried everything,and it felt like it was in her nervous system.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information is expected.
This spontaneous report as received from a pharmacy technician concerning a currently 13 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 07-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), DISCOMFORT (uncomfortable), BACK PAIN (pain in the back especially when I stretch), FEELING HOT (felt really hot) and DISORGANISED SPEECH (I was mixing up my words and saying the wrong things) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE and CARBAMAZEPINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (sore) and DISCOMFORT (uncomfortable). On 19-Mar-2021, the patient experienced BACK PAIN (pain in the back especially when I stretch) and FATIGUE (fatigue). On 21-Mar-2021, the patient experienced DISORGANISED SPEECH (I was mixing up my words and saying the wrong things). On 22-Mar-2021, the patient experienced FEELING HOT (felt really hot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Mar-2021, PAIN (sore) and DISCOMFORT (uncomfortable) had resolved. At the time of the report, BACK PAIN (pain in the back especially when I stretch), FEELING HOT (felt really hot), DISORGANISED SPEECH (I was mixing up my words and saying the wrong things) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
First evening, fever, chills and body aches and tired/exhausted. Those lasted for about a day. April 20th or 21st, I had intense stomach pain in the lower right quadrant of my abdomen. I ignored it - but I had some constipation. It got worse through the 22nd. I went to the hospital - They gave me an MRI and then they took me by ambulance to the ER - they diagnosed with acute Appendicitis - and turned it was Perforated appendix. I was admitted to the hospital and I was put on antibiotics for three days. Another 10 day dose antibiotics - and then to the hospital for surgery about six weeks later ( June 1st) and had my appendix taken out. It was laparoscopy and in and out in 4-5 hours.
Information has been received from a nurse in a physician's office concerning a pediatric patient who may have been vaccinated with a dose of Varivax (lot# not reported). Subsequently, the patient developed a mild case of chickenpox, 8-15 lesions. The patient's outcome was not reported. Additional information has been requested.
Extreme exhaustion/fatigue, right side headache and eyeball ache, cough, fever, loss of appetite,weakness, jitters, tire very easily Dexamethazone, albuterol, vitaminC , vitamin D3, Mucenix expectorant,  decaf green tea  Exhaustion - 2 wks, jitters  3 wks, fatigue - 4 wks, Tiredness -ongoing
The patient presented to the Outpatient pharmacy requesting her first dose of the Janssen CV-19 vaccine (Lot# 1855194). After administration, patient was told to sit in the waiting area for observation for 15 minutes. After a few minutes, patient approached the pharmacist on duty and stated that she was experiencing tingling in her arm and neck. The pharmacist immediately informed the nurses in the clinic, who observed the patient. Nurses stated that there was no redness at the injection site, and that there was no discoloration in her arm. Patient stated to nurses upon observation that she was feeling better, and the nurses advised her to seek the ED if she experiences any other symptoms or issues later on. She verbalized understanding.
today pt has swelling of left upper arm where injection was given. last night pt states there arm was red and hot.
Sore arm that radiates to the hand and to the back.  Has been hurting times one week.
I had a sore arm for about a day after receiving the vaccine. I have a history of sinus infections in the spring and fall time frame. I had a sinus infection 05/2023. I contacted my doctor via telehealth visit, and I was put on an antibiotic, prednisone and cough suppression. As of today, I feel better with no lingering issues.
lt thigh swollen, red & hot 2in around inj site;tx cold compress & DPH;
This spontaneous report as received from a medical assistant refers to a 15 years old female patient. The reporter reported the patient received her first and second doses of GARDASIL (lot # were unknown) on unspecified dates when the patient was 12 years old and was now in the office inquiring if she could receive her third dose. The patient was now 15 years old. No adverse symptoms reported. Additional information has been requested.
off label use; Booster; COVID-19; Covid 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer, DOSE 1 to 5), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of off label use, immunisation, drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Pt. presented to office for VZV vaccine with no complaints. Given VZV vacc s.q. in (R) deltoid, about 15min later, pt. went out doors & began sneezing, nasal congestion, hives on eyelids, eye redness, & itching hands, feet. No dyspnea. Received BENADRYL susp 25mg po x 1 dose. Symptoms decreased then resolved.
Patient reported severe reaction. Patient unable to move his arm, and reported no strength. Patient stated that he "dropped a plate of food at dinner b/c of the weakness in that injected arm." He presented himself to a primary care provider which recommended him to see a neurologist.  Appointment pending in 3 weeks.
Shots given 12/15/10 child's arm was warm, red and causing pain 2 days after vaccine was administered. Mother states child had fever of 101.3 at home and vomiting. Fever and vomiting began the night vaccines were given and continued the day after. Child temp now 97.1 oral. Called on 12/20/10 child is better no fever, no redness, no pain, according to mother.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 2:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 2:30 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 33.05 for the dose received on 03-Mar-2021 and 33.13 for the dose received on 31-Mar-2021.  Concomitant medication of the patient was not reported.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature of 51 degrees Fahrenheit at 09:00 AM, 34 degrees Fahrenheit at 10:00 AM and 35 degrees Fahrenheit at 01:00 PM. These vials were moved to fridge on 24-Feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. The vaccines moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. The vaccines moved to clinic on 31-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 6:29 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 6:29 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant & treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
About 6 hours after the shot the patient experienced a fever and headache that lasted about 12 hours and then resolved.
Headache, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, chills, sore throat, L arm pain Narrative:   Other Relevant History:
Patient up to date of COVID pfizer vaccinations who tested detected for COVID during hospital admission during routine testing after admission for a fall.  No respiratory symptoms during stay.  Provider discharge note below:  "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented after unwitnessed syncopal episode at home, falling suspended by pressure placed under both arms for a few hours. R arm was weak after so came to the ED. CPK elevated significantly, improved some after gentle IVF given CHF/AS. Weakness/pain in R upper extremity improved significantly during admission.   stroke pathway in ED showed CT perfusion which initially had occlusion then re-canulized during procedure, likely representing TIA with thrombolysis. MRI brain negative. Neurology saw and stated no need for aspirin.    She had new onset atrial fibrillation rapid ventricular response treated with increased metoprolol and addition of digoxin. Eliquis was started after risk v benefit discussion.    Syncope probably from severe aortic stenosis. Cardiology consulted, will plan on initiating outpatient TAVR planning once improved from current illness. Patient/family wished to discharge and consider proceeding with TAVR as outpatient, but wanted to go home today.   covid without hypoxia."
Drug ineffective; has covid; This is a spontaneous report received from a contactable reporter.  An adult male patient received bnt162b2 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome unknown; SUSPECTED COVID-19 (medically significant), outcome unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient said his lymph nodes were swollen and on day 8 a entire layer of his hands peeled off.  Patient presented on 5/6/21 still with peeling on his hands.
Severe Allergic response; This is a spontaneous report from a contactable nurse. A 36-year-old female nurse reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 08Jan2021 at 12:00 PM administered at hospital for COVID-19 immunization. The patient had received the first dose of BNT162B2 intramuscular into left arm on 21Dec2020 at 02:30 PM into left arm. Concomitant drug included Lovenox. Medical history included factor five Leiden and allergy to shellfish. On 08Jan2021 at  01:00 PM the patient experienced a severe allergic response. The patient received two shots of epi pen, round the clock IV steroids, pepcid and Benadryl and was admitted into the hospital. Duration of hospitalization reported as 6. The adverse event resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm to the touch), RASH (Rash on her left arm) and VACCINATION SITE PAIN (Left arm was sore) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced FEELING HOT (warm to the touch), RASH (Rash on her left arm) and VACCINATION SITE PAIN (Left arm was sore). At the time of the report, FEELING HOT (warm to the touch), RASH (Rash on her left arm) and VACCINATION SITE PAIN (Left arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided.  No Treatment Medications were provided.
Extremity pain, paresthesias, weakness  began worsening 1-2 days after vaccine administration.  Course has fluctuated with treatment but symptoms persist.
Information has been received from a pharmacist concerning a 73 year old female who on 28-JUL-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (route, dose and LOT# not reported). Within a week of vaccination, the patient experienced shooting pain in her sternum. The patient was seen by a physician in office. An unspecified diagnostic test (unknown if MRI, ultrasound or CT scan) was performed that showed nothing abnormal. Physician ruled out physical reason and cardiac problem. The patient was not recovered at this time of the report. Follow-up information has been received from the pharmacist. It was reported that on 06-OCT-2009 the patient said the "twitch" seemed had traveled to her face. The pharmacist said she couldn't pinpoint where in the face, if it was superficial or deep, but thought the patient have said it was in her jaw. Follow-up information has been received from the pharmacist concerning the 73 year old female with no pertinent medical history no pre-existing allergies and no illness at time of vaccination who on 28-JUL-2009 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (LOT# 664321/0561Y). There was no concomitant medication. On 06-AUG-2009 the patient experienced radiating severe pain in sternum and breast bone. The patient also developed "flush chest area" for 1-2 weeks. The mammogram and chest x-ray were performed and outcome was unknown. The patient was undergoing Chiropractic care. The patient's outcome was unknown. The pharmacist considered the radiating severe pain in sternum and breast bone and flush chest area to be disabling. Additional information has been requested.
pt adm to hosp 8/24/99 AM w/a sz;pt seen in ER;dx sz like activity;suspect secondary to decreased sodium;Candida diaper rash;
This case was reported by a pharmacist via call center representative and described the occurrence of Bell's Palsy in a 51-year-old female patient who received FLUARIX TETRA (batch number L2DR5, expiry date 7th May 2017). Concomitant products included VALTREX. On 12th September 2016, the patient received the 1st dose of FLUARIX TETRA (intramuscular). On 17th September 2016, 5 days after receiving FLUARIX TETRA, the patient experienced Bell's Palsy (serious criteria GSK medically significant), lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection. On an unknown date, the outcome of the Bell's Palsy, lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection were unknown. Additional details were provided as follows: After vaccination, the patient's lip were swollen and she also experienced numbness and tingling in her face. Pharmacist told the patient that it would be unlikely the flu shot. The patient went to emergency care and they told her it was caused by virus and it was Bell's Palsy. It was unknown if the reporter considered the Bell's Palsy, lip swelling, numb lips, numbness facial, tingling lips, tingling and viral infection to be related to FLUARIX TETRA.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 31-AUG-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Information has been received from a physician concerning a 2 month old patient who was vaccinated PO with the first dose of Rotateq (human bovine). The physican reported that, within a week, the patient experienced vomiting. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.
Erythema and swelling of injection site, temperature of 99F, nausea, body aches. Resolved over 3 days.
I contracted Covid about a month after the vaccine. I was exposed. The symptoms lasted about 7 or 8 days. I had fatigue, sinus pressure, congestion, and coughing relating to that. I didn't really get a fever, but the fatigue and head congestion were the worst. My doctor prescribed PAXLOVID and the symptoms felt like they went away naturally.