chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stiffness of neck mussels; Colon spasm; Constipation; Night sweats; Loss of appetite; Foods don't taste correct; Weight loss; Very vivid dreams; Not sleeping well/can't get enoughsleep; Balance is off; Headache; Fatigue; Tired all the time; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 26Feb2021 at 09:30(at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removal. Concomitant medications included apixaban (ELIQUIS) from unknown date for unknown indication . The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the arm left on 04Feb2021 at 09:30(at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient previously took Bactrim and Flagyl and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 patient experienced Headache, Stiffness of neck mussels, Colon spasm, Constipation, Night sweats, Loss of appetite, Foods don't taste correct, Weight loss, Very vivid dreams, Fatigue, Not sleeping well, Tired all the time, can't get enough sleep. Balance is off. These symptoms still on going as of 4/8/21. On 23Mar2021, the patient underwent Nasal Swab SARS CoV-2 test and the result was Negative. Therapeutic measures included treatment with Given prescription "Hyoscyamine Sulfate 0.125 Mg for unknown event. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Headache, Stiffness of neck mussels, Colon spasm, Constipation, Night sweats, Loss of appetite, Foods don't taste correct, Weight loss, Very vivid dreams, Fatigue, Not sleeping well, Tired all the time, can't get enough sleep. Balance is off were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
4:15 pm - throat started feeling swollen, light headed, tingly throughout body. By 5:00 pm throat was closing, base of tongue felt swollen, lightheaded, head pressure. Tingly appendages.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-055137 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
So on about the 17th of January I noticed that he had a large swollen lymph node on his jawline on the right side by his ear. I asked him when it started and he said he wasn't sure, maybe a few days before. We held off a few days thinking it would go away. It didn't hurt to touch, it was just swollen and hard, it was about 2 in. We waited another week and it didn't go down and seemed to be growing in size and so we decided to go to pediatrician on the 25th. They didn't know anything about it, weren't sure, and they asked us to go and get an x-ray of it. We got a chest x-ray to make sure there weren't any other swollen lymph nodes on February 11th, showed no other lymph nodes other than the one on his jawline. They basically told us to hold off and wait and monitor it and it might go down. So we waited, and then on March 28th we went to an ENT. At this point it was still growing, it didn't hurt him but it was very visible. We went to the specialist and they told us that it was unusual that it had been 3 months of this and ordered a CT scan and that was done on 3/28 and at that time they couldn't decide if it was actually his parotid gland or a lymph node. They were concerned it could be cancerous so they wanted to have a biopsy done. We went in on 5/5/22 to an urgent care and when they read the sample of the biopsy they saw that it was lymphatic material and were quite certain it was a lymph node. Based off of that we had a spinal visit with Dr. again in May, and they said it was a good chance it was a reaction to the booster shot and reactive "benign reactive lymph node" and to keep monitoring it and if it doesn't go down to go back in to have it removed. As of now it has gone down quite a bit, but is still there under the skin. Pediatrician recommended a different brand or dosage for next vaccination.
Patient was inadvertently given 0.3 mL of vaccine instead of 0.5 mL. Per our regional Doctor, patient did receive valid dose since dose administered was over half of CDC recommended dose. Regional doctor instructed that patient should be notified of incident but told that repeat dose is not necessary at this time.
A non-serious spontaneous report of two doses one day apart was received from a physician concerning a nine-year-old male. On 19-Nov-2009 the patient received a second dose of FLUMIST after they received a dose the previous day. There was no adverse event associated with this medication error therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Severe chills, swollen throat and tongue, nasal congestion, excessive sleepiness, total body joint/muscle pain, increased wheezing - all happening within 4 hours of flu shot. 24 hours later increased joint/muscle pain and swollen eyes. Not fully back to normal until 78 hours later.  Husband received same vaccination with same, but not as severe, reactions.
This spontaneous report as received from a nurse refers to 7 patients of unknown age and gender. On an unknown date the patents were vaccinated with PROQUAD (Merck), which was stored improperly. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. No further information was provided. This case is linked to MARRS # 1503USA008748 with the same reporter link. Additional information has been requested.
Site of injection hard red and swollen, pt developed fever and overall feeling of illness as well as a cold sore on her lip.
Information has been received from a licensed practical nurse concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced that she was not feeling well. The patient's mother felt that the vaccine may have weakened her daughter's immune system. it was reported that the patient sought unspecified medical attention. the patient had not yet recovered at the time of this report. Additional information has been requested.
No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 10-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 09-Aug-2022.   On 04-Jan-2023 at 3:57 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Feb-2023 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Feb-2023 at 8:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) to be not related.    No relevant concomitant medications were reported.   Patient had received the Moderna COVID-19 vaccine with 4 days of expiration date.  This case is for 10th patient out of 17 patients reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up document received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated. On 04-Apr-2023: Follow-up received, Additional reporter added, updated patient demographics, medical history, suspect drug information, reporter causality and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 10
Patient's first dose was 11/5/21 and she returned for her 2nd dose and it was administered on 11/19/21.  Follow-up phone call with the patient on 11/24/21 and she reports having no side effects from her second dose on 11/19/21. Advised on current CDC recommendations for vaccination <24 days from the first dose of Moderna. Pt voiced understanding.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On approximately 11-AUG-2014 (reported as since 11-AUG-2014) the patients were vaccinated with an improperly storage (Oka/Merck) VARIVAX, subcutaneous (lot numbers and expiration dates not reported). No adverse effect reported. Additional information has been requested.
Felt weak for 3 to 4 days; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak for 3 to 4 days) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (Felt weak for 3 to 4 days) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Felt weak for 3 to 4 days) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Labor and c-section delivery on date. Hospital admission within 6 weeks of receiving the COVID vaccine.
Hoarseness, congestion and fever on 12-4-09 thru 12-8-09. On 12-10-09 still has minimal hoarseness and congestion.
After about 3 hours after injection, symptoms of lethargy and muscle pain around site of injection. Approx. 5 hours after the onset of lethargy: fever, chills, profuse sweating, increased heart beat, continued lethargy, night sweats, vivid dreams (fever), joint and muscle pain (elbow and wrist of left arm and both ankles.
Client experiencing tingling and numbness that started in her lower extremities and progressed to her upper extremities. Complains of feeling "in a fog". Unable to work due to tingling and numbness. On short term disability. As of time of report, symptoms continue.
congestion, loss of taste and smell, headache, cough starting 12/8/21
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 01-MAY-2015 the patient was inadvertently vaccinated with an expired dose of 2 ml ROTATEQ (lot # J010984, expiration date 23-APR-2015), oral (expired product administered). No adverse effects were reported. Additional information has been requested.
Pain in both arms and hands. Pain includes throbbing, aching, burning, shooting, cramping pain. Pain is constant, but moves locations and type of pain. Multiple types and locations at the same time. For example aching wrists, burning top of hands, throbbing bicep all at the same time. Minutes later will be streaking pain in forearm and cramping fingers. Swelling in hands and feet. Tingling in hands and arms.  Pain spread after a week to include legs and feet. Also includes swelling and pain in abdomen. Six days of Prednisone relieved most of tingling. No relief of pain or swelling. Shot of Toradol with no relief. Gabapentin working to provide some relief of pain.  After three weeks still constant pain without gabapentin.
At nurse visit, pt given flu shot and within 3 minutes became diaphoretic, bp dropped, pulse dropped and pt felt light headed and sl short of breath. Placed in Trendelenburg, given oxygen and monitored bp pulse q5 minutes. Sx cleared and BP rose within 10 minutes without use of epi pen. Hypotension, Bradycardia.
Approximately 4 hours after receiving the vaccine I fell asleep with no recollection of the evenings events when I awoke the next day. Twenty-two hours later I developed a headache at the base of my skull/top of neck. The headache lasted for six days. I avoided taking medication until the sixth day. On day four following the vaccine the headache was severe enough to cause nausea & vomiting and I was unable to work that day. The prior day, I again experienced a complete loss of memory from the previous evening. I do not have any medical history of migraine headaches. I would manage the pain by lying down until it would subside, however, within an hour of resuming normal activity, the headache would return. I also experienced heart palpitations on day five.
Case  number PHEH2013US024206 is an initial spontaneous report from the pharmacist received on 15 NOV 2013. This report refers to an elderly male patient. He received flu shots for number of years but never experienced any event before. The patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308601) intramuscularly on 02 OCT 2013. On an unknown date, after vaccination he experienced an extremely sore arm with sharp pain. The outcome reported as event lasted from past 6 weeks. No other information was available.
On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.  Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.
Initial misuse report received from a health care professional on 08 January 2014.  A 15-year-old patient had received FLUZONE HD. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
8/22/07 AM noted redness, swelling then increase warmth, pain. Rx: Rocephin 250mg IM LUOQ @ 1120.
Muscle pain; I spit saliva with in combination with mucus; cannot sleep for 2 or 3 days; got dizzy; choking; shortness of breath; I can't eat anything; This is a spontaneous report from a contactable consumer, the patient.  A 57-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205), via an unspecified route of administration on arm left on 06Mar2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205), via an unspecified route of administration on arm left on 30Mar2021 for COVID-19 immunization. The patient medical history was not reported. The Concomitant medications were not reported. On an unspecified date, one day after, the patient experienced like choking, breathing air, shortness of breath and choking that patient can't eat anything and all food goes different ways in trachea was the first experience with first dose and also experienced first shot muscle pain, which is normal okay. The patient felt second shot was terrible, and had same symptoms and got muscle pain, got dizzy, then most hard time again had for 2 night 3 days a lot of saliva, saliva comes from gland. The patient felt water comes through saliva, and cannot sleep for 2 or 3 days." The patient had expel, expel choking in the day and when laid down the other night and spit saliva with in combination with mucus, mucus and saliva and cannot sleep for 3 days, Friday Saturday and Sunday. The outcome of the events was unknown.
This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitant were reported. On 21-MAY-2014, the patients were vaccinated with ROTATEQ INJ, lot J015062, expiration date 13-OCT-2015 )dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1405USA0139151406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
101 fever; injection site pain; muscle pain; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:3), administration date: Oct2021, for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 Immunization; Bnt162b2 (Dose:1), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 25Jun2022, outcome "not recovered", described as "101 fever"; VACCINATION SITE PAIN (non-serious) with onset 25Jun2022, outcome "unknown", described as "injection site pain"; MYALGIA (non-serious) with onset 25Jun2022, outcome "unknown", described as "muscle pain"; FATIGUE (non-serious) with onset 25Jun2022, outcome "unknown", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  QR Comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  Additional information: Reporter stated that the first Pfizer shot they have taken it was last year in Feb and after that they received two more boosters the second booster was taken on last Oct again all of them are Pfizer. Now, yesterday they got the third booster, and until now never had any problem but now reporter's wife is showing other than regular things which are all listed in documentation like injection site pain, muscle pain and tiredness but now she was running 101 fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
limited arm movement; arm to be sore; This is a spontaneous report from a contactable consumer or other non hcp.  A 66-years-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. It was reported that it was stated that a couple of years ago, he had a Prevnar 13 vaccine where he had a side effect of limited arm movement on the same arm he received the vaccine. Caller asking if there is anything in the COVID vaccine like there was in the Prevnar 13 vaccine that would cause his arm to be sore? He does not want the same side effect if he gets the COVID Vaccine. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Red spot at injection site; red rash on upper arm above the elbow; mild itching; soreness in upper arm for one day.
pt recv vax 10MAR97 4PM & ate dinner 6PM;@ 8PM pt exp profuse sweating & nausea which resolved w/in 24-48 hr;did not require a MD or ER visit;it is not know whether further vax was discontinued;
Throbbing pain in left upper arm with eventual loss of range of motion and strength to the left arm.   Began Aleve BID on 10/7/17 with no relief of pain, Tylenol helped with the pain. Over the next 7-10 days the ROM and strength returned to the arm.
paralysis of my right hip/leg- could not move it and had to spend hours laying on floor working it to try to get up.  Even after hours I could barley walk.  By the next day I could walk but now the pain is in my left hip area  and stiffness there so not sure if it is from the vaccine but it is  different than my normal stiffness there as I broke that hip a while ago but it still feels different.  It is much more sore and in a different location that it is normally stiff.   I also have a huge bruise that has not gone away. Shot was given in the left arm.
5 days later, couldnt go up stairs, started having breathing problems that progressed and caused chest pains, memory loss
A non-serious spontaneous report of rash and swelling around nose and face has been received from a nurse practitioner concerning a 24-month-old female patient subsequent to receiving FluMist. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. On 24-Sep-2009, the patient received FluMist. A few hours after receiving FluMist, the patient developed a rash and swelling around the nose and face. No further information was provided. The outcome of the events, rash and swelling around nose and face was unknown. All follow-up attempts have been completed per company SOP.  No futher information available.  10 Mar 2010.
feel like going trough a cold or flu; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel like going trough a cold or flu) and MYALGIA (sore left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was  reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 19-Jan-2021, the patient experienced FEELING COLD (feel like going trough a cold or flu) and MYALGIA (sore left arm). At the time of the report, FEELING COLD (feel like going trough a cold or flu) and MYALGIA (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Blood pressure medication, diabetes medication, arthritis medication were the Concomitant Products.  Treatment information was not provided.