chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sunburn-like pain on his back; Sunburn-like pain on his back; Rash on his back / patch-like rash on his back; Itching on his back; Left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER).   On 3rd March 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 4th March 2021, 1 days after receiving Shingrix, the patient experienced pain in arm. On 19th April 2021, the patient experienced pain burning, back pain, patchy rash and localised pruritus. The patient was treated with lidocaine, dermatologicals nos (Lotion) and ambiguous medication nos (Cortisone (Nos)). On 8th March 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pain burning, back pain, patchy rash and localised pruritus were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, pain burning, back pain, patchy rash and localised pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient was vaccinated with Shingrix in his left arm. The patient had left arm pain next day after vaccination with Shingrix. On 18th March 2021, the patient was vaccinated with 1st dose of Pfizer Covid vaccine in his right arm. On 8th April 2021, the patient was vaccinated with 2nd dose of Pfizer Covid vaccine in his right arm. On 19th April 2021, 1 days after receiving Pfizer Covid vaccine and 47 days after Shingrix vaccine, the patient experienced Sunburn-like pain, itching and rash on his back. On 26th April 2021, the patient experienced patch-like rash on his back. The patient used over the counter lotions, cortisone, and Lidocaine P. The patient did not receive his second Shingrix vaccination. The patient did not share any information except his name and date of birth. The lot number and expiration date of Shingrix vaccination was not known.  The reporter did not share if he received his vaccine at a pharmacy or his Heath Care Professional's office. The reporter did not consent to follow up. It was unknown if the reporter considered the back pain, pain burning, patchy rash and localized pruritus to be related to Pfizer Covid vaccine.
Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable physician. A 39-year-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 20Jan2021, first dose on 30Dec2020, both at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none. Known allergies was no. If COVID prior vaccination was no. If COVID tested post vaccination was no. If other vaccine in four weeks was no. Other medications in two weeks was no. Concomitant medications were not reported. Patient developed right Bells Palsy on 18Feb2021. AE resulted in emergency room/department or urgent care. AE treatment included prednisone, magnetic resonance imaging (MRI) in Feb2021. The outcome of the event was not recovered.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, drug causality cannot be completely excluded. Serious Facial paralysis may be considered as late sequel to BNT162B2 injection, due to appropriate chronological relation. 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.
Generalized Vaccinia, lessions on back- abdomen, arm, head, and bridge of nose/eye lid, and testicle.  Lessions occured 8 days post vaccination and sm reported to health clinic at day 10. Reportsfatigue, malaise, dizziness. Sleeping 18 hours per day, feeling feverish.  Lessions itch but are generally painless.  First lession scabbed rapidly, new lessions are red on arm and bridge of nose/eyelid.  Exam done in clinic, given consult to optometry where an eye exam was conducted. Was directed to his quarters, where his roomate (seperate sleeping arrangements) is prior vaccinated. Was instructed to care for each site the same as his original smallpox site. Given 21 days quarters, and a follow up appointment tomorrow.
associate states she has hx of allergic reactions to vaccines; i.e flu.  patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
Chills, feel tired/sick, sore and swollen on left arm. Rest, sleep and lots of fluid. Pt recovered on 9/9/15.
This case was reported by a other health professional via call center representative and described the occurrence of increased blood pressure in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2019, 1 days after receiving SHINGRIX, the patient experienced increased blood pressure and high pulse rate. On an unknown date, the outcome of the increased blood pressure and high pulse rate were recovering/resolving. It was unknown if the reporter considered the increased blood pressure and high pulse rate to be related to SHINGRIX. Additional details were provided as follows: The lot and expiration date were not provided. The anatomical site of administration (which arm) was not provided.
Some arm rash, red and swollen almost to elbow. Trouble breathing (more than normal). Patient stated was shoveling snow post immunization. Stated has COPD. He was advised to go to ER. Pharmacist called patient Tues morning to follow up and patient stated he did not go to the ER but took doses of diphenhydramine and was fine. All symptoms resolved as of 1/30/18.
swollen lips & throat, vomiting, fever & convuls as described by mom who think ER rpt the rxn;
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild
Case completed primary 2 dose Covid series in February 2021, then was hospitalized for  Covid in August 2021 and died of it in September 2021. Following first hospitalization 8/28/21 to 9/1/21: * Pneumonia due to COVID-19 virus Assessment & Plan The patient is vaccinated but risk factors for severe covid infection include obesity, sleep apnea, lymphoma with immunosuppression medication use, and asthma. Symptoms started 8/20. Tested positive for covid-19 on 8/24. Presented to the ED on 8/29 with worsening dyspnea, cough. CXR with patchy infiltrates. CRP 11-- >7.4.  - Last fever: 8/28 - Continue dexamethasone 6mg daily upon discharge for a total 10 day course - Finished 5 day course of remdesivir today - Frequent ambulation, IS, and self-proning encouraged - Using CPAP Acute respiratory failure with hypoxia (HCC) Assessment & Plan Secondary to covid-19 infection. Treating as noted elsewhere. Still needing 2-3L, arranged for home  Following Second hospitalization from 9/9/21 until death 9/11/21: The patient is a 71-year-old woman who presented to the hospital after being found down with acute hypoxemic respiratory failure secondary to Covid pneumonia. Her past medical history is remarkable for B-cell lymphoma with pulmonary amyloidosis. She initially experienced very slight improvement with aggressive medical therapies including noninvasive positive pressure ventilation, high-dose steroids, and antibiotics. Her oxygenation remains very tenuous. Her condition worsened. In accordance with her wishes, intubation and mechanical ventilation was not considered. As her oxygenation continued to worsen, her family was called. Her daughter was present at her bedside. As it became apparent that the patient was not going to recover from her hypoxemic respiratory failure, she was transitioned to comfort measures only in accordance with her wishes as previously expressed to her treatment team.
Patient was admitted to hospital with cardiac ischemia on the 29th of November.  He subsequently coded and was taken to cath lab and found to have clot in RCA.  Clot removed and stent placed.  He then became unstable again and found to have clotted off his brand new stent.  He was already taking eliquis and ASA prior to admit and was started on heparin gtt on admission.  He was transferred to our facility on November 30th for cardiogenic shock with in stent re-thrombosis despite anticoagulation.  He underwent repeat RCA PCI and impella LVAD device.
Hives post-injection.  Helped by administering Benedryl at onset of hives, but hives continue to persist for ~1.5 weeks, continue to treat with Benedryl.
The night of the vaccine I felt like I was coming down with a cold, had chills, felt cold and my body temperature was 100.4.  A week later I still have adverse symptoms such as laryngitis, sore throat, runny nose, watery eyes and cough.
Immediate pain in arm, wrists, hands, fingers, back of knees, tops of feet. Within weeks, pain expanded from soft tissue to all joints and then started impacting heart, kidneys, liver, bone marrow and started having a fever by February. From December to February treated with prednisone 40 mg without a diagnosis. By end of February bed ridden with pain. Husband obtained a wheel chair and took me to a facility. After 11 days if testing, team of docs diagnosed me with Lupus.
Information has been received from a physician concerning an 18 year old female patient who on 6-DEC-2007 was vaccinated with the first dose of GARDASIL (lot # not provided). On 09-APR-2008 the patient received the second dose of GARDASIL (lot # not provided). A colposcopy done approximately on 3-DEC-2008, "2 weeks ago", showed the patient was high risk HPV. Possible exposure to HPV through her boyfriend. Patient went to the doctor's office. At the time of the report the patient had not yet recovered. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th August 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, rash and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the shingles, rash and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Three days later experienced the shingles including rash and pain on the right side of her back and rib cage. The patient planned to continue follow-up with her physician on an unknown date. Consent to follow up was given. This was 1 of 3 cases reported by same reporter.
information has been received from a physician concerning a 17 year old female with amenorrhea, hirsutism and a CECLOR allergy who on 01-DEC-2006 was vaccinated IM with a first dose of Gardasil (yeast). The patient received Menactra concomitantly. Other concomitant therapy included Ovcon 50. On 16-DEC-2006 the patient developed erythema nodosum. The patient sought unspecified medical attention. The patient was treated with a course of steroids and has fully recovered. No laboratory diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested.
Had 2 Febrile seizures. 1 seizure at home and 1 seizure in E.R. T 101.4.
Very hard; Very itchy; Patient started with rash all over body (arms and legs) like small pimples; This spontaneous case was reported by a consumer and describes the occurrence of Very Hard, PRURITUS, and RASH (arms and legs) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, NORVASC, PREDNISONE, and OXYBUTYNIN for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 12-Mar-2021, the patient experienced Very hard, PRURITUS, and RASH (arms and legs). The patient was treated with BENADRYL at an unspecified dose and frequency. At the time of the report, Very hard and PRURITUS outcome was unknown and RASH (arms and legs) had not resolved.            Concomitant medication included Cholesterol medication.
Day of the vaccine had sore arm and mild nauseous. Next day nauseous continued until mid afternoon and a headache along with chills and mild fever continued for the rest of that day. On the 3rd day a bruise and circle rash/ring appeared along with body aches and mild headache. Sore arm and smaller circle rash still present 1 week later along with mild body aches. While I am feeling ok im not 100% back to normal.
skin lesions across her abdomen, indicate "Shingles"; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 26-JUL-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles(herpes zoster). Several months after the zoster vaccine live (ZOSTAVAX) vaccine was administered, the pt developed skin lesions across her abdomen. Her records indicated "Shingles", for which she was prescribed valacyclovir. The doctor also documented the rash with photos. As a result, the pt sustained personal injuries. Further, the pt suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expense and other economic and non-economic damages.  Additional information has been requested.
Soreness, tenderness L hand and wrist 1/2 hr after injection. Has full ROM of hand and wrist. No numbness, no respiratory symptom.
Patient felt lightheaded following injection. Vitals 110/60, pulse 78, 02 99%, felt better with ice pack, water and food. Observed for 30 minutes d/c @ 13:20 via POV
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 15-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
This spontaneous report as received from a certifies medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L020015, expiration date 16-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a patient of unknown gender and age, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMIST quadrivalent, (intranasal) started on an unknown date. The patient experienced there was possibly an unknown number of consumers who received the FLUMIST quadrivalent during a temperature excursion for the vaccine. The outcome of the event of there was possibly an unknown number of consumers who received the FLUMIST quadrivalent during a temperature excursion for the vaccine was unknown. The report was considered to be non-serious.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Severe, Additional Details: Approximately 5 minutes after administration of moderna vaccine, pt reported feeling hot to observer. RN came out to check pt and pt then rolled eyes to left and back and passed out in chair. RN helped pt to sit upright in chair as was about to fall off chair. After 10 seconds patient able to talk with patient. She stated she still felt tingling in arms but cooling down. Had additional tingling/warm and vomitting episode. Paramedics called. Pt refused transport, parent going to drive to ER.
Pt developed a warm tender erythematous rash on (L) upper arm pattern extends 10.3cm elbow x 10.6 cm, circum of arm is 20.2 cm (R) arm with smaller pattern of eryth 3.5 cm x 2.5 cm with central clearing, pinpoint puncture central
Chills, stiffness, scratchy throat, coughing, sneezing, headache, diarrhea, nausea.
Grave's disease since last year (diagnosed after 2nd dose). Muscle weakness recently after 3rd dose. Both still occurring.
headache after vaccination. denies any dizziness or SOB. Reported feeling well after 10 minutes. Headache subsided.
approx 2yrs p/ vax pt exp approx 50 scattered papules as well as itchiness. rpt felt events were not related to therapy w/varicella
Tinnitus - Left Ear - Got 10x worse after receiving first vaccine Parosmia - After 1st Vaccine - Taste was altered Parosmia - After 2nd Vaccine - Smell/Taste is horrific - smells like rotten meat triggered by air, foods, etc
MMR given at 0930am, developed erythematous wheal, 4 cm & warm, almost immeditely and small hives down both arms and face.
Patient had an extreme reaction to getting a vaccine. He jerked away at the last moment. The vaccine was not given. He received a superficial scrape from the needle. Pressure and a Band-Aid was applied. Family will reschedule vaccination. I followed-up with the family about an hour later to see if he was doing okay. They said he was fine. They will probably wait a couple weeks before trying again.
Patient complained of lightheadedness and dizziness after receiving her first vaccine.  BP 127/75, HR 85, R 20, O2 sat 97%.  Patient stated that she felt better and was no longer dizzy and lightheaded. Discharged to home.
Information has been received from a physician concerning two patients who, on unspecified date, were vaccinated with a dose of GARDASIL (lot # and expire date not reported) (route not specified). The patients received GARDASIL and on an unspecified date, experienced dizziness. The patients did not seek medical attention. At the time of the report, the outcome of the patients was unknown. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
redness at the injection site includes down part,bumpimg /swollen ,presence of ecchymosis and heavy
Second Shingrix vaccination January 26, 2021. Developed Bell's Palsy on February 4, 2021.
15 hrs after vaccine, started to feel mild body aches.  Throughout the day I felt tired and weak.  I lied down most of the day and drank gatorade.  By 36 hours after the vaccine I felt fine.
This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not provided) on 01-JUN-2012. The patient had received all of her doses within the recommended time frame. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 24-MAY-2012 and an EDD of 28-FEB-2013. The patient had received GARDASIL within 30 days of becoming pregnant. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. The patient will be 21 weeks pregnant on 18-OCT-2012. Follow up information has been received from a physician concerning a 25 years old pregnant female patient, medical history included Anemia. Prenatal test were performed: Ultrasound for anatomical reasons on 06-OCT-2012 diagnosed fetal pelviectasis. Maternal serum alpha-fetoprotein (MSAFP) on 09-SEP-2012, resulted negative and on 09-JAN-2013 follow up growth of fetal pelviectasis was performed. The reporter stated that the patient did have any previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortion (miscarriage), elective terminations, or fetal deaths (stillbirths). This case is related with MAARS # 302USA009292. Follow-up information as received from a physician refers to the 25 year old female patient with anxiety and depression and no smoking and drug/alcohol use. On 01-JUN-2012 the patient was vaccinated with the third dose of GARDASIL, intramuscular. Concomitant therapies included prenatal vitamins. Subsequently, the patient became pregnant an EDD of 28-FEB-2013. On 04-AUG-2012, at week 11, ABO/RH was performed and the result was O positive. On 14-NOV-2012, at week 24, Glucose was 149 (unit unknown). Maternal serum alpha-fetoprotein (MSAFP) on 25-SEP-2012 (week18), resulted was negative. B-Strep on February 2013 (week 36) was negative. On 22-FEB-13 the patient delivered a male infant weighing 7 lb 5 oz via cesarean section. It was reported that the infant was born normal. There were no congenital anomalies in the infant. Neither mother nor infant experienced complications during delivery. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Upon internal review, cesarean section was considered to be medically significant event. Additional information is not expected.
Redness and warmth in (R) peroneal area 24 hours after given PROQUAD. No fever.
Patient is a 47 YOF who received both doses of Moderna COVID-19 vaccines (03/31 and 04/28) at another VA facility. Patient called mountain home VA on 06/23 to report that she had bene experiencing abdominal cramping and vaginal bleeding since she received her first COVID-19 vaccine. She reported this was unlike her normal menstrual cycles (much heavier, stronger cramps, and longer than usual). She also reported that she had felt fatigued, but not lightheaded or dizzy. Patient requests follow-up with PCP or consult to gynecologist to evaluate her and wished for reaction to be reported as possible reaction to COVID-19 vaccines.
ROE slightly swollen/tender and max temperature 100.2 with erythema/LN. Temp 98. Treated with Benadryl, Avelox, Medrol dose pack.