chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first itching eye and throat a few minutes after injection, then immediately  heat spreading from injection site,  sweating, getting hot, blurred vision, and fainted. An epipen was used on me, had itchy throat, uncomfortable to swallow and chest tightness when came to, some tingling in my left hand. Was taken to ER for observation, experienced some slight itchy throat and tightening in chest there however was cleared to leave after 3 hours of observation with an prescription of steroids, an epipen and Benadryl.  Still feel the next day, itchy throat and mild chest tightness along with fatigue and arm pain. Feel like I was hit by a truck.
LEFT ARM PAIN AND RADIATED INTO MY LEFT SHOULDER, AND IT HURTS BADLY WHEN I RAISE MY LEFT ARM. IT IS VERY PAINFUL A WEEK LATER. I HAVE A DOCTORS APPOINTMENT ON 11/11/2016 AT 9AM. I ALSO CALLED THE PHARMACIST TO LET HER KNOW ABOUT THE REACTION I AM HAVING.
Patient got his first shot 1/23. 1/30 he developed involuntary bilateral arm, neck, and head movements. He went to the ED and was admitted to the PED unit. He was diagnosed with a sudden onset severe tic disorder.
pt recv vax 30OCT95 & for 24 hr pt exp body aches & fever;
Pt recvd vax 24JAN92 @ 1045AM & @ 115PM devel vomiting, shaking, pale; @ 130PM EMS called pt taken to hosp fever 102.7 R; @ 7PM fever 101.7 R; 27JAN92 temp normal pt taken to MD poss immun related;
Information has been received from a registered nurse, for the Pregnancy Registry of GARDASIL vaccine, concerning an 18 year old female with migraines who was intramuscularly vaccinated with the first , second and third 0.5 ml doses of GARDASIL vaccine on 27-SEP-2007, 17-JAN-2008 and 10-NOV-2008 respectively (lot number: dose 1: 658563/1063U, dose 2:  658558/1061U, dose 3:  659184/0843X).  Concomitant therapy included IMITREX (Sumatriptan).  The patient was pregnant and her LMP was 06-OCT-2008.  On 23-NOV-2008 the patient performed urine pregnant test but no result provided.  No symptoms reported.  The patient went to the office for medical attention on 24-NOV-2008.  It was reported that the patient began albuterol and augmentin for an unspecified illness.  Additional information has been requested.
Aunt called clinic today; stated that child's arm had swollen to "3x the normal size" from the shoulder to the elbow. Arm is red, hot and hard to the touch.
mom called 7MAY97 stating child had become light-headed w/limp arm on 6MAY97 PM p/vax;no reported fever or redness &/or swelling @ inj  site;instructed to take child to family MD;
From initial information received on 08/09/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a two month old male patient received his first doses of Daptacel, ACTHIB, IPOL and Prevnar, administered on an unspecified date in 2004. The lot numbers, routes and sites of administration were not provided. Within 48 hours post administration the patient developed petechiae and purpura around his foot and ankle. No other complaints were reported. The patient's recovery status was not reported.
A non-serious, spontaneous report of "some of the H1N1 mist got into the child's eyes" was received from a registered nurse concerning a 5-year-old patient. The patient's medical history and concomitant medications were not reported. The patient received H1N1 on 21-Oct-2009. While the vaccine was being administered into the child's nose, some of the H1N1 mist got into the child's eyes. There was no adverse event associated with this drug administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Breakthrough case admission after 4 vaccines  Pfizer 2/5/21 Lot# EL 9261;  Pfizer 2/26/21 Lot# EM9810;  Pfizer 12/15/21 Lot# 330268D;  Pfizer 7/2/22 Lot# FM0173
After giving the vaccine, I was talking with the patient and he said he felt dizzy. He passed out and while he was out/when he was regaining consciousness, he started having seizure like movement. EMS was called and were here within 5 minutes. The paramedics took his vitals which were all WNL. Approximately 15  minutes later, the patient had a repeat episode. The paramedics and I suggested that the patient go to the emergency room via ambulance. He declined and left with his wife. They both reported that he would seek care at the emergency room.
Pt was given pneumococcal in R deltoid IM, 1 day later return to office with cellulitis and itchiness red hot arm with some slight swelling.
Doesn't feel great; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 90-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The case was reported by patient's daughter. The patient was not feeling great after receiving the dose of Flu vaccine. No further information was provided. Follow up was requested. The case is linked with the case- US2020198044 and case- US2020AMR199016, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198044:same reporter US-GLAXOSMITHKLINE-US2020AMR199016:same reporter
Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM; No adverse event; patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.), PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 038C21A and 036B) for COVID-19 prophylaxis.     Concurrent medical conditions included Cirrhosis of liver (Cirrohsis of the Liver related to Hepatitis C).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2022 at 9:50 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2022 at 9:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.), PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient who received Moderna Monovalent vaccine on 15AUG2022. That vial had first been punctured on 12AUG2022.) and PRODUCT STORAGE ERROR (Vial was first punctured on 12-Aug-2022 at 7:30 AM and was administered on 15-Aug-2022 at 9:50 AM).    Concomitant drugs were not reported. Patient reported no adverse reactions It was reported that the 1 individual monovalent vial of 5.5ml was initially stored in refrigerator on 3-Aug-2022 and was stored in refrigerator itself post puncture. The vial did not undergo any temperature excursion. Treatment medications were not provided.   This case was linked to MOD-2022-649966 (Patient Link).
Near syncope on escalator - vision started to go black. BP 114/74, pulse 78, 99% O2.
Information has been received from a registered pharmacist reporting on a 55 year old male patient. The patient had no concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medications. On 24-JAN-2018, the patient received an unspecified dose of PNEUMOVAX 23, intramuscularly, lot # N027624, expiration date 11-MAY-2019 for prophylaxis (strength and anatomical location were not reported). On 24-JAN-2018, two hours after the administration of PNEUMOVAX 23, he complained of swelling at injection site, vomiting and fever (onset date of the adverse event of fever was also reported as on 26-JAN-2018). There were no lab/diagnostics performed and the patient had not received treatment for the adverse events; however, the patient sought medical attention and the pharmacist recommended to the patient to take TYLENOL 325 mg, 2 tablets every 4 to 6 hours. The pharmacist also suggested contacting his doctor if the patient did not experience relief after a couple of days. At the reporting time, the patient's status was reported as not recovered. The reporter did not assess the causal relationship between site swelling, pyrexia and vomiting and therapy with PNEUMOVAX 23.
Following SARS-CoV-2 vaccination on 7/8 the patient then developed a subjective fever and chills, after which she took Advil.  On 7/9 she then developed waxing/waning shortness of breath and tachycardia with palpitations.  On 7/10 the patient then developed chest pain which lead to ED presentation and admission.
This spontaneous report as received from a Doctor of pharmacy refers to unspecified number of patients. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The pharmacist reported that the patients experienced less injection site adverse reactions when the sterile diluent was stored in the refrigerator versus at room temperature. The outcome of injection site adverse reactions was unknown. Additional information has been requested.
Only 1 Pfizer vaccine shows up in MCIR. Patient states he is fully vaccinated. Trying to get nurse to look at vaccine card. Symptoms are shortness of breath, cough, and malaise. Hospitalization.
she had swollen lymph nodes on the left side where she was administered the vaccines; she had normal pain vaccine arm; nodules inflamed but on the left side; She had fatigue with the Bivalent vaccine, and also with the other doses too; she just had strep 2 times, in Nov2022 and beginning of Jan2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 61 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EL8982, Expiry: May2021, 1st 2 doses were from Withheld), administration date: 01Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "arm was very painful", "she had swollen lymph nodes on the left side where she was administered the vaccines", "nodules inflamed but on the left side"; BNT162b2 (Dose: 02, Lot: EN6204, Expiry: Jun2021, 1st 2 doses were from Withheld), administration date: 23Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "nodules inflamed but on the left side", "She had normal pain", "she had swollen lymph nodes on the left side where she was administered the vaccines". The following information was reported: STREPTOCOCCAL INFECTION (non-serious) with onset Nov2022, outcome "unknown", described as "she just had strep 2 times, in Nov2022 and beginning of Jan2023"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "she had swollen lymph nodes on the left side where she was administered the vaccines"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she had normal pain vaccine arm"; LYMPHADENITIS (non-serious), outcome "unknown", described as "nodules inflamed but on the left side"; FATIGUE (non-serious), outcome "unknown", described as "She had fatigue with the Bivalent vaccine, and also with the other doses too". Therapeutic measures were taken as a result of vaccination site pain, streptococcal infection.  Additional information: With the 3 prior vaccines she had swollen lymph nodes on the left side where she was administered the vaccines. She had swollen lymph nodes on her left arm after the first 3 vaccines. After the 1st vaccine her arm was very painful, and after the 2nd and 3rd vaccine she had normal pain. If she needed to, she took Advil but it didnt improve the pain so she used ice. She did the same with the other doses, just used ice. She does not have the Advil to provide the Lot/Expiry numbers. She had fatigue with the Bivalent vaccine, and also with the other doses too.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036537 same patient, different vaccine dose number, different event;
Patient received shot around 2:45pm.  Around 2:48, patient started feeling nauseous, sweating, flushing in face.   Gave patient bag incase of vomiting, applied two ice packs, one to back of neck, one to forehead.  Around 2:52 patient said was feeling less nauseous, a little less flushing.  Around 2:56 patient asked for a cool rag rather than ice packs, very little sweating, little redness in face, asked for water and felt better.  Patient stated prior to immunization has problems like this with blood draws, however did not recall having this reaction before with vaccinations.
Her daughter had 4 Pfizer covid shots and she has had covid twice now, once last year and once right now; Her daughter had 4 Pfizer covid shots and she has had covid twice now, once last year and once right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her daughter had 4 Pfizer covid shots and she has had covid twice now, once last year and once right now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Arm swelled up twice the size size of my palm; Achy; Tired; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), VACCINATION SITE SWELLING (Arm swelled up twice the size size of my palm), VACCINATION SITE PAIN (Sore left arm) and FATIGUE (Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 025J202A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-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 VACCINATION SITE PAIN (Sore left arm). On 24-Oct-2021, the patient experienced PAIN (Achy) and FATIGUE (Tired). On 25-Oct-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelled up twice the size size of my palm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), VACCINATION SITE PAIN (Sore left arm) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE SWELLING (Arm swelled up twice the size size of my palm) had not resolved.            No concomitant medications were reported.
Exacerbation of Myasthenia Gravis ( breathing difficulty, right leg not responding well, right eye ptosis, fatigue, choking, food coming from nostrils when swallowing, unable to sleep lying down). Breathing was quite impaired.  I phoned pulmonologist to be screened for myasthenia crisis. She recommended I go to largest nearby ER and did not want to see me in the office. Due to Covid 19 patients being in ER, I did not want to go to ER. I used my bi-pap at home as much as possible.  My regular IVIG infusions was scheduled 7 days out.  I?ve just finished them and feel better currently.
occasional nystagmus, regular dizziness (possible benign positional vertigo?), minor tinnitus
Started with upset stomach that continued in intensity.  Not feeling well then about 10 days later I woke up with Vertigo. The symptoms are slowly reducing.
Patient presented to local ER:  Per ER records from local HCP: Pt states that he woke up feeling weak and short of breath. Pt denies chest pain. Pt is diaphoretic.  At approximately 1215, Patient and/or parent advised this RN they no longer desired to wait due to "wanting to go home" and decided to leave against medical advice. This RN highly discouraged patient leaving and advised the following:       EDP in room for risks and benefits, please return to the emergency department at a later time if possible.  If you decide NOT to return to the emergency department, please follow up with PCP/Urgent Care the following day and/or as soon as possible.
COVID arm; it's itchy; blurry vision; feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy; it's affecting his neurological; a big rash on his arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy) and NERVOUS SYSTEM DISORDER (it's affecting his neurological) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Received the monoclonal antibody drip treatment) in March 2021.    On 11-Aug-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 VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy), NERVOUS SYSTEM DISORDER (it's affecting his neurological), RASH (a big rash on his arm) and FATIGUE (tiredness). At the time of the report, VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy), NERVOUS SYSTEM DISORDER (it's affecting his neurological), RASH (a big rash on his arm) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.   This case was linked to MOD-2021-294319 (Patient Link).
After 17 hours: Uncontrollable chills, though temperature was only slightly elevated at 99 degrees. Malaise lasted 10 hours. Pain at arm lasted 40 hours. Slight pain with pressure continues now. (about 60 hours)
Left Deltoid muscle red/swollen and warm to touch 1 and 2 days after administration. Size of tennis ball.  Improving today on day 2.
Area sore evening after administration. Day after patient worked then went home and slept from late afternoon until 6am next day. At that time patient noticed large (4 x 4 inch) area of redness on arm around injection site. Patient called Rph and counseled to try BENADRYL, ibuprofen and ice. Complained of mild headache as well.
First dose was in the right arm and it it became inflamed about a week after the shot. Itchy, hot, inflamed, and pink. I visited the doctor advised warm compresses and the problem subsided in a few days. After the second dose I woke up in the middle of the night with the chills and chattering teeth. It was uncontrollable shaking. My temperature of 102 degrees in the morning. I had shooting pains in my arms and legs. Felt terrible all day. Took Tylenol no effect. Advil worked better.  The lymph nodes were sore under my arm. On the third day I felt a little better but on the fourth day I felt a little better.
Headache, nausea, "heavy chest". Ibuprofen, Tylenol.
Patient experienced drop in blood pressure 4 hours after shot and went to hospital  where she received epinephrine
Pain up left arm neck and back. Felt dizzy. Headache all night felt like a vice.  Headache caused nausea and vomiting.
severe chills; chest pain returned; dizziness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Nov2021 08:30 (Lot number: FJ8757) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose; 1, Time: 09:00, Anatomical site of injection: right upper arm, Route of administration: Intramuscular, Lot: FE3590), administration date: 17Oct2021, when the patient was 36 years old, for Covid-19 immunization, reaction(s): "Chest pain". The following information was reported: CHILLS (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "severe chills"; CHEST PAIN (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "chest pain returned"; DIZZINESS (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "dizziness"; FATIGUE (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of chills, chest pain, dizziness, fatigue.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected.