chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Progress Notes Expand AllCollapse All    COVID VACCINE CLINIC 2/24/2021    Subjective Pt. is a 53 y.o. male who was seen at COVID Vaccine Clinic today for his first  dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the right deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience numbness in right forearm and headache.  He denied difficulty breathing, difficulty swallowing, itching and lightheadedness.   This provider was notified of patient reaction and he was then assessed in the emergency area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and skin changes.     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches    Numbness right forearm.:     Previous Reactions: None    Objective    Vitals Vitals:   02/24/21 1208 BP: 124/77 Pulse: 83 SpO2: 95%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Musculoskeletal:        General: No swelling or deformity.     Comments: No rashes noted on right arm where injection was given. Equal strength in bilateral upper extremities.   Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included:  Tylenol 1000mg and water. Follow up response to treatment: good. Sx completely resolved. Discussed that he may take Ibuprofen this evening if he experiences some numbness in the right forearm or fingers. He denied symptoms of headache and numbness resolved prior to discharge. I walked with patient to exit the facility. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash)   Electronically Signed 2/24/2021 12:09 PM
Janssen vaccine is viable for 6 hours after the vial is punctured.  This vaccine was given past that time.  The vial was punctured on Tuesday June 8th and administered to the patient on Friday June 11th.
This spontaneous case report was received from a pharmacist (PVX2019-412) on 13-Feb-2019. The report describes an adult female nurse who was bare handed came in contact with the mixing stick of VAXCHORA. The consumer was receiving VAXCHORA for an unknown indication. It was reported that the nurse accidentally came in contact with the mixing stick of VAXCHORA bare handed. The action taken with VIVOTIF with respect to the event bare handed came in contact with the mixing stick of VAXCHORA was not applicable. The clinical outcome of the event bare handed came in contact with the mixing stick of VAXCHORA was unknown. Company's Comment : In this case an adult female nurse accidentally came in contact with the mixing stick of VAXCHORA bare handed.The causality of the event "bare handed came in contact with the mixing stick of VAXCHORA" was considered as not applicable.; Sender's Comments: Company's Comment : In this case an adult female nurse accidentally came in contact with the mixing stick of VAXCHORA bare handed. The causality of the event "bare handed came in contact with the mixing stick of VAXCHORA" was considered as not applicable.
She started having chest pain shortness of breath racing heart throbbing heart pinching in heart dizziness lightheaded was fluttering at times to the pain t she asked me to take her to a heart doctor
dizziness; muscle weakness; er energy would just be zapped and she couldn't do much; even walking around was a lot; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness), ASTHENIA (er energy would just be zapped and she couldn't do much), GAIT DISTURBANCE (even walking around was a lot) and NAUSEA (nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness), ASTHENIA (er energy would just be zapped and she couldn't do much), GAIT DISTURBANCE (even walking around was a lot) and NAUSEA (nausea). In October 2021, GAIT DISTURBANCE (even walking around was a lot) had resolved. At the time of the report, DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nausea) had not resolved and ASTHENIA (er energy would just be zapped and she couldn't do much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided.  No treatment medications were provided.  After she got the vaccine, she had dizziness, nausea, and muscle weakness. It was every day; she had to be on the couch. Even walking around was a lot. It lasted about two weeks, where her energy would just be zapped, and she couldn't do much. Now she still had the dizziness, nausea, and weakness, but It was just less than it was. It was not every day; It was more intermittent. Patient added that she had some muscle issues.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 54-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine and the 2nd dose of Hepatitis B vaccine. In November 2017, 20 years after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported but could be 33 or 34 years. Approximately 20 years ago, in 1997, the patient received 2 doses in a series of Hepatitis B vaccination. In November 2017, the patient had a blood test performed and the results of the test showed the previous vaccination did not stay in her blood, which led to the patient to be therapy non-responder. The patient's physician recommended the patient to be vaccinated against Hepatitis B again. The patient received 1st dose of ENGERIX B at the end of November 2017 and expected to get the 2nd dose at the end of December 2017. The dental assistant called to find out how quickly after the second of the three-dose series for ENGERIX-B could expect to have the titer test show positive for this vaccination. A clarification request was raised for vaccination schedule, as the information could not be obtained, the case was kept valid. This case was associated with medical information inquiry and the package insert was mailed to the dental assistant.
12/12/21 - evening after vaccine started with chest pain. EKG and labs pending. PT has not been to the hospital.
Post vax, the patient developed what "appears" to be chicken pox. Unspecified medical attention was sought. Additional information has been requested.
shortness of breath Narrative:  Witin hours after 2nd COVID vaccine, patient began to have SOB,fever and lethargic. With hx of DVT and currently on Apixaban, patient was admitted for observation and was given Tylenol and fluids.
6 patients received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) outcome was unknown.        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 reported that date the vial was initially stored in the refrigerator on 04Nov2021 and 01Dec2021 The nurse clarified that the lookup tool said the expiration date was 09Oct2021, so the patient received two expired doses.   This case was linked to MOD-2022-497418 (Patient Link).
Elevated systolic blood pressure to 200, resolved with rest, time and lisinopril 5 mg daily. Headache, blurry vision that improved with Tylenol and blood pressure control. Also, arm soreness
Japanese Encephalitis vaccine given on 1-16-17. On 2/13-14/2017 had fever 102, headache/nausea - sick x 4 days then cleared up. Did not have JE booster. On arrival at destination 3/1/17 had hearing loss Right ear, no improving on oral steroids. 4/17/17 recovered from fever, nausea and headache. Still recovering from hearing.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K018180, expiry date: 17-SEP-2016). Medical assistant reported that the vaccine underwent temperature excursion at 54 degree Fahrenheit for 36 hours and 30 minutes. She stated that the vaccine underwent temperature excursion at 48 degree Fahrenheit for 3 hours and 10 minutes, previously as well. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient had chronic RA that mainly affected her ankle, some OA that wasn't bothering her when she had the shot, GERD and frequent UTIs. She had likely had COVID-19 a little while before she got the shot. She had symptoms, was tested and was negative, but then noted to have antibodies present on a test done in February 2021. She was feeling better and otherwise doing well, doing such activities as hiking without difficulty, at the time of her vaccine which was April 1, 2021.   In May of 2021 she noted that her feet felt heavy, then her legs felt heavy. She was having trouble being able to hike by June 2021. She saw her rheumatologist and tried Orencia and had swelling at the injection sites both times she tried it. She noted having weakness in her legs and that her swelling in her legs had gotten worse. She had traveled and she was spending a lot of time in bed, reports that she was in bed for weeks, and she was feeling sicker. She developed right sided pleuritic chest pain. She felt her legs were getting weaker starting in her feet moving upwards. She felt weakness in her upper extremities that started in her shoulders but she also felt it in her hands. Additionally, she noted paresthesia.   She eventually felt bad enough that by September 1, 2021 she went to the ER. When she was there they were concerned that she may have a PE as her labs showed an elevated D dimer. She had a CTA chest which didn't show any PE. She was given a steroid taper and sent home. She has since continued to struggle with paresthesia and some of the other symptoms. She has some other abnormal labs, such as an elevated platelet count and some unexplained lymphadenopathy in the pelvis for which she is being worked up. So far paresthesia has only shown a questionably low normal B12.
May 10: 2:30pm headache and fatigue  May 10: 6:30pm chills and fever (Tylenol) May 11: 3:00am chills and shaking (Tylenol) May 11: 8:00am fever, chills, body ache Tylenol) May 11: 1230pm fatigue  May 11: 1200pm night sweats and small bumps on left thigh  May 12: 7:30am rash on left thigh and behind the knee, small red raised bumps
This spontaneous report as received from a physician refers to 3 patients of unknown age. The patients were vaccinated with improperly stored VAQTA (lot# reported as 0273AE; expired date: 06-DEC-2014) on either 05-NOV-2012 or 06-NOV-2012. (The physician was not sure of the exact date of administration). No other co-suspects were reported. No concomitant medications were reported. The VAQTA was exposed to 50F for 120 hours. No known adverse effects. Additional information has been requested.
Pt (PREGNANT) recv vax end of August;  pt was in 1st trimester; EDC-5/17/99
Severe headache and weakness immediately after vaccine for 30 minutes. vitals were stable. no syncope
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On 07-OCT-2012 the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX23 (lot # (667995/1150Z), expiration date 04-MAR-2012) intramuscularly (IM). No concomitant medications were reported. Reporter stated that an unspecified patient was administered an expired dose of PNEUMOVAX23. No adverse effect reported. No further information is available. This is one of the several reports from the same reporter. Additional information has been requested.
12/08/2010: R shoulder is swollen and markedly tender to palpation.  No ecchymosis, no erythema, no lymphangitis 12/10/2010: right arm: +erythema, +edema, +tender mod size tattoo of flowers over upper/lateral aspect measures 2 cm larger than left at 11 cm above olecranon erythema from distal aspect of deltoid nearly to elbow, and nearly  circumferential with region over triceps spared -- margins marked tender over areas of erythema, also over deltoid and inguinal region,  though no palpable nodes
Covid Arm  (started two weeks after injection).  Red, raised, hot rash on upper arm.
SECOND DOSE OF JYNNEOS WAS ADMINISTERED ON DAY 18 INSTEAD OF DAY 28 (INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
Rapid drop in blood pressure. Almost fainted. Ended up on floor of pharmacy with legs elevated. Symptoms cleared after 10 minutes.  Headache developed within 1 hour.  Pain went away with 400mg ibuprofen.
Sore arm; Swollen arm; Red arm; Itchy arm; Left eye is swollen; Fatigue; A little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little pain), PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm) and PRURITUS (Itchy arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (A little pain) and FATIGUE (Fatigue). On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm), PRURITUS (Itchy arm) and EYE SWELLING (Left eye is swollen). At the time of the report, PAIN (A little pain), PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm), PRURITUS (Itchy arm), EYE SWELLING (Left eye is swollen) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  No treatment was reported for the events.  Patient stated that she took second dose on an unknown date.   This case was linked to MOD-2021-114193 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated all events outcome from unknown to recovered on an unknown date and provided the second dose details.
Initial report was received from a consumer on 30 August 2013. A 4-year-old male child had received the following vaccinations on 28 August 2013: a dose 5 left deltoid intramuscular injection of DAPTACEL (lot number C4345AA) and a dose 4 left arm subcutaneous injection of IPOL (lot number J1406). On 29 August 2013, 1 day later, the patient presented with left upper arm red, swollen, hard, warm to touch, and slurring words and lethargic. the patient had no fever and no tingling. The patient took prednisolone (15mg/5ml) 15 mg daily for three days. The patient also took BENADRYL twice daily. The patient had a history of laryngomalacia. The patient had no illness at time of vaccination. The patient had no diagnostic or lab testing. The patient's outcome was reported as recovered. Documents held by sender: None.
Seizure 7 day post immunizations. EMT called no treatment followed with Pediatrician.
Information has been received from a RN concerning a 37 month old male who on 04/24/02 was vaccinated SQ in the RA with a 1st dose of varicella virus vaccine, live. Concomitant therapy that day included a 1st dose of MMR vaccine administered SQ in the LA. On approximately 05/19/2004 the pt developed breakthrough chickenpox. The reporter indicated that the pt was seen in the office with lesions and was Dx: chickenpox. No fever was noted and no TX was given. It was noted that the pt recovered and that his chickenpox lasted 4-5 days. No further information is expected.
Pt was given HPV immunization (1st dose) and advised to wait 20 min in lobby; pt began to feel "hot all over my body and inside my head". Pt became unstable on chair and had to be supported; a large red area appeared at injection site. Pt was escorted back to exam room where he was immediately evaluated by Dr., pt was administered 10mL of Q-DRYL to stop allergic reaction symptoms. Pt. remained in exam room for 20 min more and Dr. re-evaluated pt a final time and then allowed pt to leave clinic as his condition had stabilized.
This spontaneous report from a contactable Healthcare professional. A patient of unknown age, gender and ethnicity received TRUMENBA at 0.5 ml single dose on an unspecified date. Concomitant medications and medical history were not reported. The patient had lip swelling shortly after receiving it. Outcome was unknown. Follow-up (11MAY2016): Follow-up attempts are completed. No further information is expected.
Pt came to me approx 5 min after injection complaining of significant itching. Ice was applied and pt took benadryl in her possession. I checked her every few minutes. After 20 min and still no call back from her doctor. Pt left with intent of going to see doctor. I will follow up with her through the day. Dr contacted. Per MD pt's sx have completely resolved as of 12:15 PM.
Varicella Information has been received from a consumer concerning a 5 year old male with no medical history or allergies who in approximately 2002, at 2 years of age, was vaccinated with a SC 0.5ml dose of varicella virus vaccine live (Oka/Merck). There was not concomitant medication. On 21-OCT-2005 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought but no labs or diagnostic tests were performed. At the time of the report the Patient had not recovered. Additional information is not expected.
1 of 4 pts vaxed during the last yr (different lots) who exp large hives @ inj site; hives described as red mound-not abscessed, quarter to 1/2 dollar size; pt also dx w/Bell's Palsy; No further details available
Vaccination site warmth; Vaccination site pruritis; Vaccination site swelling; Vaccination site pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritis), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) 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 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritis), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritis), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
This case was received from a health professional on 31 July 2009. SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT. A 37-year-old female patient, with no reported medical history, received an intramuscular injection of Tetanus Toxoid Absorbed Preservative-free (lot number U2883BA) on 18 July 2009. The patient was taking ADDERALL-XR and levothyroxine concomitantly, and was participating in a tetanus hyper-immunization program to manufacture tetanus immunoglobulin. Per the reporter, the patient had not received any previous tetanus immunization. One day after receiving the vaccine, on 19 July 2009, the patient developed redness and swelling at the injection site. She also experienced fatigue, fever up to 103 degrees Fahrenheit, dehydration, and swollen axillary lymph nodes. She was seen in the emergency department and treated with intravenous fluids, DECADRON, MOTRIN, and acetaminophen. She responded well to treatment, and was released home feeling well.
Hives, redness, and itching of skin. the symptoms are getting worse even with medication. Currently taking Prednisone for 5 days and Benadryl at night. Using anti-itching lotions as wells as a body wash.
Loss of sense of taste a week after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of sense of taste a week after vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, CELECOXIB (CELEXA [CELECOXIB]) and PREDNISONE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of sense of taste a week after vaccination). At the time of the report, AGEUSIA (Loss of sense of taste a week after vaccination) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Infant received PEDIARIX, PREVNAR, PEDVAX and ROTATEQ vaccines on 3/2/16. He had slight fever that evening. In AM afebrile, eating well. Mom put down for nap and 2 hrs later found him unresponsive.
Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe