chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received and experienced chills refer linked case US2018164482). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was taken based on the product indication as no other patient details were provided. The healthcare professional stated that the patient experienced more severe fever and chills with dose 2 of SHINGRIX. The healthcare professional heard this information about a patient's experience from a healthcare professional outside of her facility. The healthcare professional did not had any patient information or vaccine information regarding this adverse event. The healthcare professional heard it second hand, and had no access to the patient or the vaccine.
PATIENT RECEIVED THE VACCINE FROM EITHER LOT # 024C21A OR # 007C21A. IT IS NOT KNOWN WHICH LOT. BOTH LOTS WERE OUT OF THE FREEZER FOR 4 TO 18 DAYS MORE THAN THE RECOMMENDED 30 DAYS.  MODERNA EXPECTS VACCINES TO HAVE REMAINED SUFFICIENTLY EFFICACIOUS.  PATIENTS DID NOT HAVE ANY NEGATIVE OUTCOMES SO FAR.
Pt developed hives encompassing his entire body after the vaccines were given (within 24 hours).
Felt electric shock in hands and from knees to feet, chest pain, nausea, coughing, chills, body and headaches and 104 fever.
PATIENT REPORTED TO PHARMACY 11/2/2018 IN PM TO DISCUSS REACTION SHE HAS EXPERIENCED. THE LEFT ARM HAD AN AREA OF ABOUT FIST SIZE REDNESS WITH A SMALL RAISED WELT IN THE MIDDLE OF THE RED AREA. THIS REACTION SITE WAS ABOUT 2 TO 4 INCHES LOWER THAN WHERE THE INJECTION WAS GIVEN. SOME HEAT WAS FELT IN THE RED AREA. PATIENT STATED SHE DID FEEL SOME PAIN IN THE AREA ALSO. THE REACTION OCCURRED ABOUT 4 HOURS AFTER THE VACCINE. TOLD PATIENT TO USE COLD COMPRESS AND IBUPROFEN AND WOULD FOLLOW UP IN 48 HOURS. ON 11/4/2018 PATIENT WAS REACHED AND STATED SHE HAD BEEN USING BENADRYL YESTERDAY AND THE SITE WAS BETTER. NO SYSTEMIC EFFECTS, (NO FEVER, CHILLS, OTHER ILLNESS) ONLY LOCALIZED SITE REACTION AND DISCOMFORT.
son tested positive for COVID-19 on Tuesday, they are asymptomatic; This is a spontaneous report from a contactable consumer (parent) via Medical Information Team. A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 08Apr2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Apr2021, the patient tested positive for COVID-19 and patient was asymptomatic. Their second dose was scheduled on 29Apr2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on 20Apr2021. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Patient felt lightheaded while walking out of the store 5 minutes after receiving PNEUMOVAX injection. While he went to sit down on the floor, he felt his back muscles spasm. Patient then lied down on the floor. Lightheadedness immediately resolved, but back muscles continued to spasm for several minutes (~5 min). Patient also reported discomfort radiating from site of injection on left arm. I provided the patient water, which he drank a few sips of. Patient continued to lay prone on floor for about 7-10 minutes and then stood up and felt better. I walked with him to the pharmacy waiting area, where he sat in a chair for another 10 minutes. Patient refused my recommendation to call an ambulance. He also refused my offers to call a family member or a taxi service. Patient walked out after stating he felt fine to leave.
Red at the injection site; Swollen at the injection site; Induration at the injection site; Pain at the injection site; Injection site lump; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season .5 ml. In October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site swelling, injection site induration, injection site pain and injection site lump. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site induration and injection site lump were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, injection site pain and injection site lump to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The patient received Fluarix Quadrivalent 2019-2020 season on left deltoid. Within 24 hours after receiving vaccine, the patient experienced red swollen soft ball size induration and pain at injection site.  The patient had to take Benadryl for days. The patient did seek medical attension at the medical practice she worked. The patient said that the pain resolved but still had slight lump.
doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date/ Removed from freezer at 8am, on 25-10-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Vaccine was removed from the freezer on 25-Oct-2021 at 08am.
Legs felt heavy and numb. She says this is similar to the first time she had shingles
I had COVID symptoms - cough first, fever, head pain, chills, body aches; lost of taste and smell - overall I had 11 days of symptoms. Once I got better, I was fine. I was given Ivermectin I took a dose on the 8th of Jan and a dose on the 10th - and another antibiotic - that I took for seven days. (Had second dose of vaccine on January 26th.)  Telemed visit with Doctor on January 8th.
w/in 3-4hr p/vax pt devel gen erythema, urticaria, angioedema of lips;
Patient has a history of lymphoma and presented requesting an "additional dose" COVID vaccine. She was under the belief she could receive this at this time and her doctor recommended it as well.  She received Pfizer vaccines on each of the following dates: 1/27/2021 EL9264 2/17/2021  EN6200 9/28/2021  FF2588  Staff including myself believed booster and additional doses could be interchangeable for timing dependent upon the patient's medical history. I also believed that multiple additional doses could be administered given the additional dose time spacing. Both of these beliefs were incorrect.  This 4th dose was administered two weeks short of the recommended administration date.  I have been re-educated on the proper timing for additional and booster doses. Additional training is being distributed to staff this week to ensure clarity.
Patient received Covid  19 Vaccine at 3pm. approx 3:14 patient states that she feels like her throat is tightening. Brought to triage area via wheel chair, as assessment is being completed, her speech appeared to be slurred. BP 197/94, HR 84, O2 100%. Request to lay  down. While she is being monitored,  her symptom start to improved however a visible carotid pulse was  noted aprox. 3:45. 3:50 her speech start to slur again with noted weakness on the right side. Medical director informed of patient status. instructed to proceed  with a call to EMS. EMS arrived at 4:16 Patient discharged to EMS at 16:32 in stable conditions. B/P 154/92, HR 80, O2 SAT 98%.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX vial (dose, lot and expiry date unknown), subcutaneous. The patient was inadvertently administered a partial dose of ZOSTAVAX due to a separation of the syringe from the hub of the needle. The pharmacy student adds that some of the ZOSTAVAX may have gotten on her face, and possibly in her mouth, due to the leakage from the syringe (linked case 1311USA008437). This is 1 of 2 reports from the same reporter. Additional information has been requested.
Rea vaccine 3/22/10 in afternoon. Afternoon of 3/23 pain and limited motion of left arm began. 3/30/10-Pain and limited movement of left arm continues-Reports can move arm and left to side but unable to lift arm toward front without pain. Hurts worse in am. Has subsided slightly past few days.
muscle tightness in shoulders/feels like her upper back and shoulders; slept for 20 hours; light sensitive; hard to go to sleep; has been doing less than normal because she does not feel good; all over achy; wrap around headache/has to limit herself reading because it makes her head hurt; severe fatigue; 101 Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tightness in shoulders/feels like her upper back and shoulders), SOMNOLENCE (slept for 20 hours), PHOTOPHOBIA (light sensitive), INSOMNIA (hard to go to sleep) and MALAISE (has been doing less than normal because she does not feel good) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 007MZ0A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (101 Fever). On an unknown date, the patient experienced MUSCLE TIGHTNESS (muscle tightness in shoulders/feels like her upper back and shoulders), SOMNOLENCE (slept for 20 hours), PHOTOPHOBIA (light sensitive), INSOMNIA (hard to go to sleep), MALAISE (has been doing less than normal because she does not feel good), MYALGIA (all over achy), HEADACHE (wrap around headache/has to limit herself reading because it makes her head hurt) and FATIGUE (severe fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (muscle tightness in shoulders/feels like her upper back and shoulders), SOMNOLENCE (slept for 20 hours), PHOTOPHOBIA (light sensitive), INSOMNIA (hard to go to sleep), MALAISE (has been doing less than normal because she does not feel good), MYALGIA (all over achy), HEADACHE (wrap around headache/has to limit herself reading because it makes her head hurt), PYREXIA (101 Fever) and FATIGUE (severe fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has applied ice pack and heat pack for her neck.   This case was linked to MOD-2021-375409, MOD-2021-375417.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 09 nov 2021 contains no new information. Medical history, treatment medications added from initial document.
I am not aware of any exposure to COVID-19 but the evening of 06/05/2022 I felt a bit tired and a little heady but was basically ok. I woke up the next morning with a cough and a sore throat. As the day progressed I became increasingly tired and my headache worsened which persisted through the night. I took an at home COVID-19 test which came back negative. I continued to feel sick with the same symptoms and increased fatigue. I tested myself again and the results were positive. I called my doctor who prescribed Paxlovid which I began immediately. After a day, my symptoms began to improve. By the fourth day, I was feeling symptom free with the exception of fatigue which lasted another day or two but after that I've been feeling well.
Patient states that approximately 5 minutes after her influenza vaccine injection, she started having a racing heart. This continued for about one hour after it began. She states she has never had this reaction in the past when receiving a vaccine. She states she has not experienced it prior to the vaccine or since this one instance.
Patient received Pediatric Covid 19 Pfizer on her 2nd dose instead of Covid Pfizer for 12 years and older.
completely lost feeling in his left leg from the knee down; Arm soreness after receiving the shots; dose 1 24Mar2021; dose 2 24Mar2021; Irregular heartbeats; Hypervitaminosis B6; paresthesia; palpitations; Tremors; Bradycardia; Uncontrolled hypertension; Peroneal neuropathy; Blurry vision; Dizziness; Angina; Tinnitus; lameness; limp in his left leg; allergies; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 24Mar2021 11:30 (Batch/Lot Number: ER8730), at the age of 45 years old, as dose 1, single, and then via an unspecified route of administration, administered in left arm on 24Mar2021 (Batch/Lot Number: ER8371), at the age of 45 years old, as dose 2, single for covid-19 immunisation administered in a pharmacy of drug store. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and losartan taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. The patient was healthy and athletic with no known allergies to vaccines, 45 years old, male, 160 lbs. He had no immediate reaction other than arm soreness after receiving the shots on 24Mar2021. He never felt any sickness or immune response after the 2nd shot. He walked 8 miles after receiving the 2nd dose. He takes his BP regularly and began detecting irregular heartbeats on both his BP monitor and on his smartwatch during Mar2021-Jun2021. His doctor ordered an echocardiogram and 72 hour holter monitor in 2021 and neither showed anything alarming. On 20Jun2021, he completely lost feeling in his left leg from the knee down. He was sitting with his left leg crossed over his right leg, and his left leg went to sleep. It never woke up. After vaccination, on an unspecified date in 2021, he had been diagnosed with hypervitaminosis B6, parasthesia, palpitation, tremors, bradycardia, uncontrolled hypertension, peroneal neuropathy, blurry vision, dizziness, angina, tinnitus, lameness, irregular heartbeats. He was perfectly healthy before the vaccine. Now he has a limp in his left leg. Known allergies: Pfizer Covid Vaccine. The events resulted in doctor clinic visit and emergency room/department or urgent care. The events were reported as serious - life threatening illness (immediate risk of death from the event), and disability or permanent damage. Treatment included acute care, medication, and physical therapy stress ma (as reported). The patient has not recovered from the events.
About 12hrs after getting the vaccine I had serve pain in my back and inability to pee.
Pale, fainted, vomiting x 24 hours prolonged (sudden onset) nausea and several episodes of vomiting x 24 hours, then symptom free.
Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monitoring my blood pressure which had gone up to 159 (usual is around 120), began uncontrollable shaking.   After about 1 1/2 hours my blood pressure lowered to 136 and I was transported by wheel chair to car to return home.
Patient was waiting for 15 minutes in observation after receiving her first dose of Pfizer COVID-19 vaccine. Pt. approached writer and notified she had hives on her left hand and arm at 11:43 A.M.. Pt. denied difficulty breathing and throat/tongue swelling. Writer advised her to take a seat notified HVA to take vital signs while writer drew up medication. HR: 103 bpm; RR: 16; O2: 98%; BP 112/68 mm Hg R. Arm sitting. Writer administered 50 mg of Benadryl IM at 11:47 A.M. in the right upper arm. HVA reassessed vitals after Benadryl administration and they were WNL. Patient will wait 30 minutes after administration of Benadryl to continue to be monitored. Advised Pt. to call an UBER because she says she "walked here alone and does not have anyone to pick her up".
This spontaneous report as received from licensed practical nurse refers to her husband of unknown age. The patient was vaccinated with a dose of .65 ml ZOSTAVAX (Lot# not reported) via intramuscular route rather than subcutaneous route on 09-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced little bit of pain at the injection site. The nurse also stated that most patients (specific number of patients unspecified) who received ZOSTAVAX in her office would say they did not feel anything at the time of injection but felt medication in them after little while. The patient did not seek medical attention. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
She began to feel nauseated and "distant", which she describes as being somewhat separated from her surroundings.
fever is 38 Celsius; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever is 38 Celsius) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever is 38 Celsius). At the time of the report, PYREXIA (fever is 38 Celsius) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Client diagnosed on May 30, 2019 as having Bell-Palsy. Currently being treated by private provider. Left eye does not close and left side of lip drooping with no feeling.  Right side fully functioning. Treatment includes Valacyclovir 1g TID; Prednisone 6 tabs daily, dosage unknown at this time.
Patient received vaccinations. Left the immunization room and was speaking with her mother. Fell onto her mother's chest and onto the floor. Patient hit her head on mother's chest during the fall. Able to roll patient onto her back. Patient was able to sit up and was alert and oriented.
On the left arm where shingles shot was given:  a lot of pain (next day),  burning, itchy, red, warm splotchy areas started a few days after.  Stuffy nose started a few days later.    My husband had same shots a week earlier.  His shingle shot arm was worse than mine.  Softball size swollen sore arm.  Red and warm to the touch.  I'm not sure of the exact flu shot given.  Did not have any problem with that arm.
had difficulty mixing; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, her partner pharmacist had difficulty mixing a Shingrix vaccine, which led to inappropriate preparation of medication. The reporter stated they no longer had the adjuvant vial due to this difficulty. The reporter was not sure of the details of what occurred. The reporter was unable to provide answers to questions to rule in or rule out PQC (product quality complaint). The reporter requested replacement product, but unable to provide until PQC ruled in. The reporter stated, the pharmacist directly involved with incident would call back. The patient details and PQC question answers unavailable as the reporter was not the pharmacist directly involved with incident. The reporter did not consent to follow-up. No additional details provided by the caller.
Entire R underarm from elbow to armpit red, warm, tender. Nothing at inject site. Generally not feeling well. Slept alot. 2wks to resolve.