chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Face to hurt; Some type of nerve issue; Hot and cold sensation on the left side of her mouth; Which tooth was bothering her; Tired; Headache; Aching pain and sensitivity in teeth; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Aching pain and sensitivity in teeth), PAIN IN EXTREMITY (Sore arm), FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue) and ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for Vitamin supplementation.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced TOOTHACHE (Aching pain and sensitivity in teeth), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache). On an unknown date, the patient experienced FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue), ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth) and DENTAL DISCOMFORT (Which tooth was bothering her). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form; ACETYLSALICYLIC ACID (ASPIRIN 81) for Headache, at a dose of 1 dosage form; IBUPROFEN for Pain, at a dose of 1 dosage form and GABAPENTIN for Nerve pain, at a dose of 300 mg three times a day. At the time of the report, TOOTHACHE (Aching pain and sensitivity in teeth) had not resolved and PAIN IN EXTREMITY (Sore arm), FACIAL PAIN (Face to hurt), NERVOUS SYSTEM DISORDER (Some type of nerve issue), ORAL DISCOMFORT (Hot and cold sensation on the left side of her mouth), DENTAL DISCOMFORT (Which tooth was bothering her), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The other concomitant was cholesterol medication and blood pressure medication. The Patient went to the ENT for Nerve Pain and take her a CT scan. The patient treatment medications includes Antibiotics and steroids.   This case was linked to MOD-2021-067637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The Significant follow up received in which treatment information is added.(Gabapentin).
Information has been received from a RN concerning a 52 year old white non-smoking female pt with no known allergies, no chronic illness and no illness at time of vaccination who on 07/19/00 was vaccinated with a first dose of hepatitis B vaccine recombinant (yeast) in the left deltoid (Lot # 635178/0473K), a second dose on 08/23/00 in the left deltoid (Lot # 635178/0473K), a third dose on 01/26/01 in the right deltoid (Lot # 636021/0839K).  On 06/27/02, anti-hbs titer was negative.  A booster series was administered-first booster dose on 07/09/02 (Lot # 642096/0069M), a second booster dose on 09/10/02 in the left deltoid (Lot # 642096/0069M), and a third booster dose on 01/13/03 in the left deltoid (Lot # 644078/0940M).  On 06/27/02 and 02/18/03, the pt failed to respond to the vaccine (had not converted to immunity after 6 hepatitis B injections).  Concomitant therapy included hydrochlorothiazide (manufacturer unknown) indicated for fluid retention.  It was also noted that the pt developed a 100lb weight loss in the 3 years that she received injections and that her weight was 300lbs.  On 05/21/00 and on 05/05/02 her weight was 200lbs.  The outcome was unknown.  Additional information has been requested.
pt recvd vax 11JUL95 & 4 days p/vax pt devel a fever ranging from 102.5 to 103;had no other sxs;fever lasted about 3 days then disappeared;MD felt fever was not related to therapy w/varicella vax
administered an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult male patient who received HAB (Twinrix) (expiry date 01-JAN-2023) for prophylaxis.   On 30-JUN-2023, the patient received the 1st dose of Twinrix (intramuscular, right arm). On 30-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-JUL-2023 The pharmacist reported that she administered an expired dose of Twinrix to a male patient in his late 30's which led to expired vaccine used.
Fatigue, Fever, aches, chills from evening. Fever broke in the middle of the night. About 6p -3am
Post herpetic neuralgia; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a  currently 69 year old female patient (pt). No information was provided regarding concomitant medications, concurrent conditions or medical history.   On unknown date, zoster vaccine live (ZOSTAVAX) was prescribed by health care provider and on or about 16-AUG-2011, the pt was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) for routine long-term prevention of shingles and zoster-related conditions.(strength, dosage schedule, route, lot number and expiration date were not provided).  On an unspecified date, the pt developed herpes zoster and post herpetic neuralgia. The pt was treated by physician. As result of these injuries, the pt experienced economic problems. The outcome of the events was not provided.  The reporter considered herpes zoster and postherpetic neuralgia  result from  zoster vaccine live (ZOSTAVAX) use.
SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: Nucleic acid amplification test (NR: not provided) positive, SARS-CoV-2 RNA (NR: not provided) positive, and SARS-CoV-2 RT-PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for his staff member. The age at vaccination was not reported. The patient experienced flu like symptoms which impacted him for a few days. The patient stated that he would be receiving the second dose of SHINGRIX. The reporter did not agree to be followed up. This is 1 of the 6 cases reported by same reporter.
high grade fever, polymorphous rash, bilateral bulbar conjunctivitis, cervical lymphadenopathy, erythematous palms and soles, swelling of hands and feet (consistent with Kawasaki disease); given IVIG at 2g/kg and ASA 100mg/kg with improvement of symptoms. no cardiac abnormalities on echo.
Arm was sore immediately after administration, at some point experienced limited range of motion - difficulty reaching back, muscle/nerve twinges.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2014 the patient was inadvertently administered subcutaneously a single dose of ZOSTAVAX lot # J000492 that had expired on 19-JAN-2014. No adverse effects reported. Additional information has been requested.
My symptoms onset right about the 24 hour mark. I thought I avoided all side affects other than a sore arm but I suddenly couldn?t walk. I couldn?t stand up straight. I screamed in pain trying to find a position to lay in. I could hardly hold my phone. My whole right side was affected from about mid rib cage to the knee area. My entire thigh and butt cheek was numb. I couldn?t use the restroom. It lasted exactly 7 days of which I was in fairly excruciating discomfort for at least 4 days. It was like I was being shocked in my back. I also had a CT scan which reflected  a fatty liver and spleen this scan was compared to a scan just two months earlier thats was unremarkable. I can?t say that was from the vaccine but I do find it odd that I would develop such condition. I do not drink alcohol at all.
Fever; Body aches; fatigue/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (fatigue/exhaustion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He had COVID in Nov/Dec) from November 2020 to December 2020. Concomitant products included ATORVASTATIN, LISINOPRIL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (fatigue/exhaustion). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (fatigue/exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient want to know wants to know if the vaccine can produce a positive COVID test.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reactions or allergies and no pertinent medical history. On 04-SEP-2012, the patient was vaccinated with ZOSTAVAX. Lot number and the dosing details were not reported. No concomitant medications were reported. On 07-SEP-2012, the patient experienced redness around injection site after receiving ZOSTAVAX. No treatment was given. No laboratories diagnostic test were performed. The patient sought medical attention spoke with the pharmacist. The outcome of redness around injection site was reported as not recovered/not resolved. Additional information is not expected.
expired vaccine is stored and then administered/ Vial refrigerated on 28 Dec 2021 after expiry.606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/ Vial refrigerated on 28 Dec 2021 after expiry.) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/ Vial refrigerated on 28 Dec 2021 after expiry.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/ Vial refrigerated on 28 Dec 2021 after expiry.) outcome was unknown. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.  It was mentioned that the vial was initially refrigerated  on 28 Dec 2021, the vial did not undergo any temperature excursion and the patient did not experienced any adverse events.
irregular heartbeat; numbness in left fingers; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced irregular heartbeat for two days one week after first injection and one week later, the patient experienced numbness in left fingers that was still occurring. The patient wondered if it could be reaction. The patient did not receive any treatment for the events. The clinical outcome of the event irregular heartbeat was recovered on an unknown date in Mar2021; while that of the numbness in left finger was ongoing at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received a Pneumococcal 23 vaccine in left deltoid on 10/16/07. Patient returned to the office 10/19/07 with 15cm x 10cm red area at site of injection.Painful,hot to the touch,vomitting, 101 temp. Patient was put on a Z-Pak and Claritin 10mg.
1:45 PM Headache, 3:00 burning skin, redness at injection site, headache much worse, 3:30 Skin on fire, back beginning to ache, right shoulder, right arm, neck and back burning tingling, 3:40 seen by RN who states "you're having a reaction" elevated BP and temp. 4:30 taken to ER. Fever, rash, elevated BP 154/81, temp 99.1 (normal 96.5-97) red-irritated blotches on legs, knees, arms, back, chest, neck and face. Headache, shaky, weak. Itching, burning. 6 PM nausea, headache worse, severe pain and burning like I am on fire. 9 PM trouble breathing, throat closing up, swelling, itching all over my body, temp 99.7. Scared!
Per MD, 35 year old female receiving second dose of Moderna Vaccine COVID-19 today. Approximately 10 minutes after vaccination patient complains of lightheadedness, increased by standing. PMH: Anemia, plus h/o vasovagal reactions after blood draws. Allergies NKA, VS-90/60, R 16, P 60, HEENT- WNL. Skin temp- cool. Heart and lungs WNL. Extended observation 45 minutes, given skin temp normal. Symptoms quit. Vasovagal reaction to vaccination resolving. Discharge home no other treatment.
mild fever with first dose; Headache with first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever with first dose) and HEADACHE (Headache with first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (mild fever with first dose) and HEADACHE (Headache with first dose). At the time of the report, PYREXIA (mild fever with first dose) and HEADACHE (Headache with first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-086025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086025:
Pain and soreness began at the injection site. These symptoms continued. Then  burning sensations up and down arm began. It's been over a month and the injection site is numb to the touch, while the surrounding area burns, tingles and is soar to the touch. If I move my arm a certain way, I will get a tingling shock in the area (feels like hitting funny bone). Muscles up and down arm burn after non-strenuous activity.
14MAR94 mom refuse #2 MMR stated pt devel the mumps p/receiving the 1st MMR 14AUG93; pt was seen in hosp ER on 23AUG & referred to ENT the same morning 1020;
Injection site started to swell and become hard and red and hurt. Injection site was the right arm where she had the Prevnar injection.
Sore arm at injection site and runs to the back of the arm. Pain pulses at injection site. Pain radiates down left arm into hand. Pain is worse above my wrist - between elbow and wrist and back of arm. Random pain shoots from injection site down arm. It only lasts for a second or two but it is intense. I have not taken any pain relievers yet.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 05-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Local reaction to left thigh, swollen and reddened area measured 2in X 2in. Seen by MD new measurements on Sat 02/21/2015 as per mom 5in X 3in. MD aware and evaluated.
FIVE MINUTES AFTER ADMINSTRATION OF THE VACCINE, PATIENT BECAME VERY DIZZY,FELT  EXTREMELY HOT, SWEATY AND BECAME UNCONCIOUS FOR ABOUT 2MINS.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). On 12th Octobeer 2015, the patient received FLULAVAL quadrivalent. On 12th October 2015, less than a day after receiving FLULAVAL quadrivalent, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: On 12th October 2015, less than a day after receiving the vaccine, the patient experienced injection site burning (injection site pain). In October 2015, less than a month after receiving the vaccine, the patient subsequently experienced swelling at the injection site (left deltoid). On 22nd October 2015, the patient visited a doctor and was treated with unspecified medication. The pain was keeping the patient awake at night. This case has been linked to 3 other cases US2015150875, US2015150886 and US2015150888, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL quadrivalent vaccine and or lot number of the vaccine.
Patient received first dose of Moderna COVID vaccine. She did note that she was diabetic and that she had not eaten prior to appointment. Within 5 minutes of vaccine administration, patient complained of being lightheaded, dizzy, and sweaty. Her skin became cool and clammy. At initial check, HR was 54, BP 88 palpable, O2 sat was 97%, and BG was 321, and became increasingly lethargic. EMS was called at this point.  Upon EMS arrival, patient's BP was 54/38 and O2 sat was 89%. Patient was taken to hospital via ambulance.
Flu like symptoms as exaggerated. Sever course of neurologic symptoms mimicking the course of the past seven years with neuro-sarcoinosis. Seem to be gradually going back to base line pile vaccination.
Vasovagal Syncope Patient was sitting in waiting area when his friend alerted pharmacy staff that he had passed out. Patient was sitting on a backless chair and fell off, but did not hit head or have any apparent abrasions.  Pharmacy staff quickly responded and patient was conscious and stated he had a history of vasovagal responses to blood draws.
SYNCOPE AND STRUCK HEAD ON CABINET WHILE FALLING. LOC FOR A TOTAL OF 5 MINUTES THEN COHERENT BUT SLOW RECOVERY.  PULSE 40 AT NADIR. PULSE OX 100% AT ALL TIMES.  BP AFTER ABOUT 4 MINUTES WAS 98/62. SLOW RECOVERY OF PULSE TO 77.  CRANIUM INTACT, MILD BLEEDING OF LOOS TOOTH.  TREATED WITH OBSERVATION, WATER, ORANGE.  VITALS NORMALIZED PRIOR TO D/C.
7 AM - severe arm pain and swelling (for about 24 hours) 12:00 PM - 10 PM: chills, fever, fatigue, malaise
Patient is unsure if related but about two weeks after 2nd dose of shingrix vaccine started developing symptoms consistent with PMR and was later diagnosed with PMR by her physician.
Pt. started with a fairly high fever (102 degrees) that same evening, took ibuprofen. The next day it had still not broken, but was lower at 99.4 degrees and generally not feeling well. Fever finally broke late Friday (10/26/18).
I was diagnosed with 2 DVT in my left leg on 19Jun2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 20Apr2021 at 18:00 (at age of 29 years old, Lot Number: EW0161) as a single dose for covid-19 immunization. No known allergies and no other medical history. The patient's concomitant medications were not reported. The patient was diagnosed with 2 DVT in left leg on 17Jun2021 at 21:00. The event resulted in Emergency room/department or urgent care. Treatment received, currently on Blood Thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.
Extreme heat of head flushed , itching of chest and arms, rapid heart beat,, extreme nausea, coughing