chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; second dose should have been administered after the child turns 4; This spontaneous report was received from a office manager referring to a 14 month old patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On18-MAY-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  lot S0239311, expiring on 04-DEC-2021, for prophylaxis (dose, route and site of administration were not reported).   04-AUG-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  lot # T028297, expiring on 16-FEB-2022, for prophylaxis (dose, route and site of administration were not reported).          Reporter stated this second dose should had been administered after the child turned 4 (inappropriate schedule of product administration).  No adverse event was reported.   Lot number S0239311 is an invalid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and does not match any Company product
pt had a seizure while waiting on observation area she reports her family was with her and told her about seizures medical staff alerted and 911 called. pt awoke from seizure and declined to go to ER reports she felt okay. unclear if generalized seizure.
Nausea 3/4/21 3pm (about an our after vaccination) Tiredness 3/5 1pm Body aches 3/5 4pm (took 2 Tylenol at this time) Chills & fever 3/5 6pm  3/5 9:30pm no symptoms
Thrombotic thrombocytopenic purpura, Steroid gamma globulin platelet transfusion and chemo therapy.
Information has been received from a physician concerning a female who was vaccinated IM with Gardasil vaccine. Subsequently, the patient experienced greater than normal pain and swelling at the injection site. The vaccine was administered from a vial, not a pre-filled syringe. The patient sought unspecified medical attention. Subsequently, on therapy the patient recovered from pain and swelling at the injection site. Additional information has been requested.
red raised bumps on her ankles, wrists and elbows; patient received a dose of VARIVAX and a dose of PROQUAD during the same office visit; localized redness at her right lateral thigh; This spontaneous report was received from a registered nurse and refers to a 1-year-old female patient. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 19-JUN-2019, the patient received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, strength, route and site of administration, lot # and expiration date were not reported for any), both as 1 year old vaccinations. Varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with sterile diluent (STERILE DILUENT MRK) (dose, lot # and expiration date were not reported). On an unknown date in June 2019, the patient developed localized redness at her right lateral thigh. On unspecified dates, the patient took an unspecified number of doses of diphenhydramine hydrochloride (BENADRYL). On 21-JUN-2019, the patient developed red raised bumps on her ankles, wrists and elbows. The patient would be seeing a physician on an unspecified date. The outcome of the events was reported as not recovered/not resolved.  The causality assessment between the suspect products and the events was not provided.
pt recvd DTP/HIB/OPV on 24JUN92 & w/in 4 hrs p/vax, pt exp a maculo-papular diffuse rash; seen in office 25JUN rash persisting;
Patient was vaccinated for meningitis, Gardasil, and tetanus on 2/18/2009.  On 2/19/2009 she could hardly walk her legs were numb and very weak and she could barely move.  I took her back to the Dr on 2/20/2009 and they said she had Guillain Barre Syndrome. 3/9/09-records received-office visit 2/18/09-seen for routine visit. Office visit 2/20/09-C/O legs numb possible reaction to immunizatons. C/O numbness and weakness of both legs from knees down. Fatigues. PE:normal. DX: Paresthesia. 4/21/09-records received-office visit 3/17/09-C/O could not walk after shots last ime states had guillain barre syndrome. Day after vaccine could not walk, could walk with knees locked. Remained this way for over 3 weeks then in past 5 days progessively improved and now back to normal. No weakness of ankle movements and not unstable, describes a numb feeling without anesthesia from knee down. Sprained writs 9 months ago and has knee pain with activiites that require knee bending. PE:retropatellar tenderness bilaterally. Moves all extremities 5/5, sensation intact. 2+ DTRS. DX: muscle weakness generalized. sprain/strain wrist. patellofemoral syndrome. DX is not GBS as merely weakness of knee joint. Office visit 4/14/09-C/O left wrist pain and knees hurt. Fell down stairs yesterday.
8/4/11 - sporadic pain in right hip area 8/4/11- continued pain in hip, around 10am the glands in my neck (right side only) started to swell and the right side of my throat is slightly sore.  Also feeling some pressure in right ear. There is also some pain/swelling at injection site on right arm, and approximately 2 degree fever.
Inflamed Arm (left) from inJection sight to elbow, warm to touch, paiNfuL
Patient complained not feeling good and feeling hot. Her Blood pressure was checked. Blood pressure was 96/73 mmHg, pulse 65. Her pulse Ox was 97 %SpO2, PRbpm 53. We called 911 laid her flat with legs elevated in a few minutes she felt better. Ems arrived checked her vitals instore and released her to her friends. She explained when she gives blood she usually has this kind of episode and has always advised the healthcare personnel to lay her flat.
Patient reports feeling muscle aches and fatigue that lasted for 1 week.  She had 3 total injections and worsening symptoms with each course.  She did not notify our office of complications until today, which is months after her last shot.
patient reports that 24 hours after his vaccine he experience swelling in his arm, hand, and lips
Chills, sweats, headache, lightheaded, lethargic.  Given OTC Tylenol and cortisone topical cream.
Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022; Dose administered to patient 20 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 939905, 021C21A and 026B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Positive test on 06-Jan-2021. No hospitalization.) on 06-Jan-2021. Concurrent medical conditions included Drug allergy (Allergic to lisinopril), Allergy to NSAIDs and Drug allergy (Allergic to Statins).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 23-Jun-2022 at 09:49 AM and administered on 24-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that the 2/1 vial was initially stored in refrigerator on 17-Jun-2022, was first punctured on 23-Jun-2022 at 09:49 AM and was administered on 24-Jun-2022 at 09:25 AM and 09:30 AM. Post puncture, the vial was left at room temperature for 23.5 hours. The vial did not undergo any temperature excursion. Treatment medications were not provided.
Arm rash at site of injection about a week after it was given. Arm is sore and red. Rash is about an inch in circular diameter.
Several twinges in chest (midline) night of shot. Indiscernible from a pulled muscle or costochondritis. Looked up pain in chest after COVID vaccine and saw the myocarditis, but dismissed based on the typical demographic. No other symptoms -shortness of breath, radiating pain, so took two ibuprofen and the issue seemed to abate.  Four days later (Friday, 18 June), sitting at an event in the evening and the same twinge came back. Again, felt like a pulled muscle. Went to bed feeling uncomfortable - hurt when I moved around. Three hours later, woke with HORRIBLE pain/contractions in my chest area that left me sobbing.  Went on for approximately 20-30 minutes. No other symptoms (shortness of breath, radiating pain, etc.), so took ibuprofen. The issue seemed to abate by morning, No symptoms since (it is now Tuesday).
This spontaneous report was received from a physician via a company representative concerning a 11 year old female patient. On 22-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On 22-FEB-2013, the patient fainted in the lobby of the office after the administration of GARDASIL. Outcome of the event was unknown. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Patient reports headache, body aches, pain, and exhaustion lasting around 36 hours.
Thigh swelled and had large red mark for several days after the shot. This evening, he developed a full-body rash/hives and a slight fever. It spread quickly so we had to take him to the ER.
febrile sz last evening-seen in ER; adm to hosp 31MAR94 w/pneumonia
This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included 1 delivery of baby and 1 miscarriage at 10 weeks. On 18 June 2014 the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site and batch number). Her last menstrual period was on 15 November 2013 and estimated date of delivery was on 15 August 2014. The subject was exposed to the vaccine during the third trimester. At the time of reporting, the pregnancy was ongoing. Follow-up received on 24 October 2014: The VAERS details were provided. Weight 8 lbs 1 oz and was healthy.
Patient was given pfizer bivalent booster as dose number 2.  The regular series was not complete before the bivalent booster was given.
C/O ITCHINESS AROUND MOUTH.  OBSERVED X15 MINS.  STATES FEEL BETTER AND REFUSED ER EVAL.  TOOK BENADRYL AND WENT HOME WITH RELIEF.  VITALS STABLE. O2 SAT 98%
Death  5/5/2021 Causes of death listed on death certificate: 1) acute bleeding  2) rupture of internal iliac aneurysm
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received added second reporter information
Got very dizzy after 2 hours of 1st vaccine shot and i have been dizzy and light headed everyday since. Scared to take 2nd shot.
painful axillary swelling (lymph node?), severe headache Axillary swelling Lasting > 3 days
Cellulitis - A staph infection,mainly around the ankle; Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg; Adverse reaction; Sore arm; Ran fevers from 94.5 degrees (low) to under 104 degrees (high); This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS STAPHYLOCOCCAL (Cellulitis - A staph infection,mainly around the ankle) and STAPHYLOCOCCAL INFECTION (Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS STAPHYLOCOCCAL (Cellulitis - A staph infection,mainly around the ankle) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg) (seriousness criterion medically significant), ADVERSE REACTION (Adverse reaction), MYALGIA (Sore arm) and PYREXIA (Ran fevers from 94.5 degrees (low) to under 104 degrees (high)). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of 500 milligram; CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 milligram and DOXYCYCLINE for Cellulitis, at a dose of 2 days. At the time of the report, CELLULITIS STAPHYLOCOCCAL (Cellulitis - A staph infection,mainly around the ankle) and STAPHYLOCOCCAL INFECTION (Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg) had resolved and ADVERSE REACTION (Adverse reaction), MYALGIA (Sore arm) and PYREXIA (Ran fevers from 94.5 degrees (low) to under 104 degrees (high)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 94.5 (Low) 94.5°F and 104 (High) 104°F. In 2021, White blood cell count: elevated (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient stated that blood work was done, and everything was normal except for the white blood cell count which was elevated.  Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My wife gets one every year and she still got the flu weeks later; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (Patient's husband).  This case was linked to case 2020SA355661 (same reporter).  This case involves adult female patient for whom reported got one every year and still got the flu weeks later (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), for patient reported got one every year and still got the flu weeks later (influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Developed chills and body aches by 5:30 pm of the day of vaccine. Fever with a max of 101.1 orally by that evening. All symptoms resolved 24 hours after they began.
PT had muscle contractions. PT EPI was given @17:49, IV, benadryl) EKG , BP , BS  PT did not eat breakfast or drink water  PT transferred to healthcare facility
11/8 Flu like symptoms, chills, headache, sore arm, red, redness spread to elbow. Red underarm painful.
23SEP98 Pm elevated temp 24SEP98 elevated temp-malaise;25SEP98 no temp;26SEP98 broke out chickenpox-loaded back, face etc;29SEP98 pox scabbing;
Redness, swelling of site.  Pt received Pneumovax 05/13/03 that was stored below 35 degrees F.
Pt. received flu shot at 6 pm. The next day her arm was swollen and red (about 6" by 3" area). Took TYLENOL for pain. Pt stated no itching or troubles breathing. 9/7 -> pt went to hospital got prednisone. Pt said arm was sore and still red, slightly swollen.
Fever, sore And red at injection area. Dizzy, nausea. Tired. Weak. Listless.
Burning and soreness instantly in left arm Development of nausea and headache by later that evening and into the next day. Also weakness in arm that the injection was done continuing in day 2.
Since I got the vaccine other than arm pain that was sever and it had decreased but still not gone completely. I also started with similar problems like bronchitis. Consulted with Dr. (medical assistant) and prescribed nebulization's and they gave me the nebulizer device and liquid albuterol medicine for the nebulizer but I still feel bad, with nausea that does not allow me to eat until later in the afternoon. Problems with respirations with white phlegm, fever, cough and sneezing, sore and tired body, severe head pain and dizziness. Primary doctor prescribe antibiotics and medicine for nausea and dizziness, now almost a month has passed and I still get severe fevers and dizziness, head pain, tiredness, sore muscles, trouble breathing and constant pain, burning in the chest. It was so bad that I was so scared and I took a covid test but it was negative. I only want to get better and if I am doing this form is to prevent others. Maybe it was the vaccine lot because with the one they use is a Utep, I did not have any adverse reactions and it was the Pfizer vaccine. I took the third dose because I have comorbid conditions like HIV, COPD, asthma, and obesity.
sores on mouth- could be impentigo or a cold sore.  I did also suffer from fever/chills for 24 hours after vaccine (already reported to CDC via app). no doctor seen.
Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Patient was not enrolled in covid-19 vaccine trial.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood alkaline phosphatase: High.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  The concomitant medication was not reported.  On an unknown date the lab data was reported as Blood alkaline phosphatase increased.The reporter causality for the events with respect to Humira was provided as not reported.  The treatment medication was not provided.
The pt's brother got chicken pox and the pt woke up with lesions all over his body.
After receiving the Chicken Pox Booster Vaccine, He has a huge red, swollen circle around the site.  It was very uncofortable and was feverish.
This spontaneous report as received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAR-2017, the patient was vaccinated with the improperly stored dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse symptoms were reported. The vaccines were exposed to the light varying from 1 to 6 hours. The administrator confirmed that only 3 patients received the vaccines (captured in MARRS # 1705USA002115 and 1703USA005830) and the rest of the doses were discarded. his is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005830: US-009507513-1705USA002115:
Bright red swollen, itching, pain to touch. Arm swollen 10% more than other arm. Red rash from site all the way down to elbow and around arm to arm pit.
Pfizer inserts Alerts in our computer system when a patient is in need of a pneumococcal vaccine. We have been assured that these alerts are accurate since they query more than a decade of  records. In this case, the alert was inaccurate and it resulted in a duplicated administration of Prevnar 13. There was no adverse event and no harm to the patient.
Tingling sensation heavily on tongue and face, also all over body.  Body feels warm, with no sweating.  Metal taste in mouth.
high pitched cry for 3 days; fussy x 3 days; if held could comfort; gave APAP q 4 hrs for 3 days; No medical care needed;
Patient has a rash all over her body. Though, it appears in clusters. They are itchy. Has lasted 3 days without improvement
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for four patients. This is for the second of the four reports. A patient of an unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced body ache and chills. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018186943 same reporter/drug/event, different patient. US-PFIZER INC-2018186901 same reporter/drug/event, different patient.
Large local reaction left upper arm, with redness and itching, then few days later systemic allergic reaction with whole body rash, itching. Unfortunately he was given both immunizations AFLURIA flu shot and SHINGRIX at the same location in the left upper arm at the pharmacy.