chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had no immediate reactions. Starting on 11/14/2021 I developed skin itchiness in my hands, palms, feet, chest, and back. It was itchiness that was deep in the skin, so I didn't feel relief after itching. I went to the doctor and was told to stop taking my Lexapro and Prozac medications. I went to an urgent care and had blood work did. I don't have a diagnosis yet. I am going to see my PCP and possibly an allergist as well.  I have been taking Benadryl and Zyrtec on and off which has been helping with the itching. I am feeling a little bit better now.
patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients were given shots during excursions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (patients were given shots during excursions). On 28-Oct-2021, PRODUCT STORAGE ERROR (patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.
On 5/24/21 patient stated at injection site, arm feels raised, warm and sore
Acute liver failure. Patient treated with steroids for autoimmune finding on liver biopsy.
So that night I would say it was quite severe arm pain and swelling. I developed a red lump oval shaped it was red and raised, I had a larger hand sized bruise on my upper arm. I had a lot of trouble moving arm and had extreme joint pain. Hypersensitivity reaction due to having both shots in one arm. The symptoms left and returned for a couple a  months.
his speech was incoherent, he was dizzy and fell.  He was unable to get up by himself.  Got him standing, but he could barely walk.
Patient received DTAP and IPV in the right arm on 8/16/2007 and returned 1 day later with right arm and shoulder swelling, induration, erythema and warmth. Patient prescribed Keflex for cellulitis and asked to return on 8/20/2007. Ptaient did not return for follow up.
pt ran 104.7 fever on 7NOV92 was very irritable, didn't act like self, acted mean as reported by mom; had some local reaction, pain, swelling, limping on rt leg; was seen by MD; was told by that pt had a reaction to DTP; limping, wheezing
Random muscle twitching, with constant headaches and increased anxiety. Started softwave stem cell therapy today (04/15/2021) and will go through 6-7 more treatments to see if adverse reactions go away.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not reported. On an unknown date in August 2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # K021484, expiration date: 03-MOV-2016 and lot # reported as "L002868", expiration date 27-JAN-2017 (administration routes was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse the doses were exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015 for a total of 17 hours at 5.5C. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of PAIN (Experiencing severe pain ever since I took my booster on April first and its's affecting functionality of my left arm / Excruciating pain after Moderna booster) and LIMB DISCOMFORT (Affecting the functionality of left arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Experiencing severe pain ever since I took my booster on April first and its's affecting functionality of my left arm / Excruciating pain after Moderna booster) and LIMB DISCOMFORT (Affecting the functionality of left arm). At the time of the report, PAIN (Experiencing severe pain ever since I took my booster on April first and its's affecting functionality of my left arm / Excruciating pain after Moderna booster) and LIMB DISCOMFORT (Affecting the functionality of left arm) had not resolved. No concomitant medication was provided. Patient had experienced excruciating pain after Moderna booster. Treatment medication was not provided.
One week after I received the second MODERNA  dose, I experienced swelling of my upper lip and tenderness of facial muscles left side of my face. The symptoms are similar to the sensation I feel after a dental procedure when I have an injection. I have experienced side effects for one week. ( ,  ,
Pt received MMR booster 4/17/15, pt returned to office today 4/21/15 for Tdap vaccine. She mentions that her right arm where MMR booster was injected has "a lump and feels bruised". Area on back of right arm shows 2cm raised area, surrounded by 5cm redness.
On Saturday the 18th I woke up with a sore throat and a headache.  Sunday, I has a worse sore throat and headache.  Monday, I still didnt feel well.  Tuesday I felt just fine.  On Wednesday, sept 22, I woke around 4 a.m. thinking my leg was asleep.  I moved around and realised it wasnt going away.  My left calf, the sensation is not "normal".  Almost like how it feels when your foot is waking up from "falling asleep".  Today is 9/28/21, I have been to the walk in clinic and ER.  Both referred me to Neurology but all the neurologists around cant see me or wont, I'm not sure.   I have been diagnosed with Arnold chiari Malformation.  I have not had any Chiari symptoms for 2.5 yrs.  Since getting Moderna, I have had a headache and my left calf feels "numb/asleep" ever since!
14SEP92 mom in today w/pt for #2 MMR states p/11AUG92 devel c/o of severe h/a & nausea unrelieved by APAP; h/a persisted thru the noc; mom stated had crying due to severity of h/a & had emesis thru the noc; pt warm to touch but temp not tak
Had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had COVID) 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.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COVID-19 (Had COVID). The patient was treated with MONOCLONAL ANTIBODY 17-1A (intravenous) for COVID-19, at a dose of UNK infusion. At the time of the report, COVID-19 (Had COVID) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient had Covid in October, 1 week before boosters approved.  Company comment: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 approximately nine months after the second dose of mRNA-1273 vaccine. The details regarding the first dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 approximately nine months after the second dose of mRNA-1273 vaccine. The details regarding the first dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Tested pos for Sars cov2 on the 27th. Symptoms started on the 26th w headache. Sore throat and stuffy nose
I started to get a really bad headache, then the next day it was worse the pain, then the next day the head pain with dizziness, then the next day the head pain dizziness and throwing up. It got to the point I went to the ER. Its been a week and 2 days and I still have symptoms.
lymph nodes are still swollen; lymph nodes are still sore; lump on her arm pit; Nodules armpit area; minor injection site reactions; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump on her arm pit), VACCINATION SITE REACTION (minor injection site reactions), NODULE (Nodules armpit area), LYMPHADENOPATHY (lymph nodes are still swollen) and LYMPH NODE PAIN (lymph nodes are still sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included Ovarian tumor benign and Oophorectomy unilateral (removal of  one ovary due to tumor at age 40.). Concurrent medical conditions included Hot flashes (every 7 minutes began after removal of  one ovary). Concomitant products included ESTROGEN NOS;PROGESTERONE;TESTOSTERONE from 01-Sep-2004 to an unknown date for Hot flashes, Hormone replacement therapy and Oophorectomy unilateral.    On 04-Apr-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced NODULE (Nodules armpit area). On 10-Apr-2021, the patient experienced AXILLARY MASS (lump on her arm pit). In April 2021, the patient experienced VACCINATION SITE REACTION (minor injection site reactions). On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes are still swollen) and LYMPH NODE PAIN (lymph nodes are still sore). At the time of the report, AXILLARY MASS (lump on her arm pit), VACCINATION SITE REACTION (minor injection site reactions), NODULE (Nodules armpit area), LYMPHADENOPATHY (lymph nodes are still swollen) and LYMPH NODE PAIN (lymph nodes are still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Bilateral mammogram, ultrasound  was done before the 2nd shot due to nodules inflamation throughout the arm of vaccine side. No treatment information was provided. Soreness and vaccination site inflammation started 3-5 days after vaccination and remained for 40-50 days. Mammogram of the left side was suggested by the doctor but patient did not want to get it done .   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant Follow document received  contain new event updated  (Lymph node still sore ) and lab data is added.
This spontaneous report as received from a physician refers to a 1 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 03-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M039904, (dose, dose number, albumin status, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587.
Localized rxn to DTaP- area of erythema, localized firm edema, and heat at DTaP site on arm
No additional AE; PNEUMOVAX 23 instead of the intended PREVNAR 13 was administered to 10 month old child; 10 months old patient was administered Pneumovax 23; This spontaneous report was received from a practice manager on behalf of physician and refers to a 10-month-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 25-SEP-2020 at 16:45, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T010779, expiry date 30-JAN-2022 (dose, route of administration, anatomical location were not provided) for prophylaxis, instead of intended pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T010779; expirationdate: 30-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient's mom reported patient having a history of lightheadedness and dizziness after vaccination but reported this time was worse than previous episodes.  After administration of the vaccine the vaccination site bled and the patient did see the blood.  After I applied the bandaid the patient reported dizziness.  The dizziness and lightheadedness was progressive.  Her mother and I kept telling the patient to keep taking deep breaths.  One of my technicians brought the patient a wet paper towel to apply to her head and we gave her water once she was no longer dizzy.  The patient reported seeing "stars" and wanted to know if she should "just passout".  I told her no she should just keep breathing and taking big deep breaths.  She was yawning and closing her eyes but never lost consciousness completely.  I offered to call EMS but mom and patient did not feel like that would been necessary.  After about 10 minutes the patient was no longer dizzy and was feeling better then with in 15 minutes the patient was walking around the store and after 30 minutes was fully recovered and left the store with her mother.  No signs of hives or rash.  Patient was pale but color returned after recovery.  Patient was warm and sweaty while she was experiencing the dizziness but returned to normal after the dizziness subsided.
Information has been received from a physician concerning a 13 year old female with no relevant medical history reported who on 04-OCT-2007 was vaccinated with the first dose Gardasil (lot 656049/0187U). On 06-OCT-2007, the patient was seen at the office complaining of severe headache and vomiting. The patient was transferred to the hospital by ambulance and was admitted. A diagnosis of cranial bleeding due to an aneurysm was made. The patient underwent surgery. At the time of reporting, the patient was recovering. The patient's aneurysm and intracranial bleeding were considered disabling, immediately life-threatening, and other important medical events. Additional information has been requested. 11/09/07-records received for DOS 10/6/07-seen in ED of transfering facility-Acute 4 hour onset o occipital headache, constant crescendo-decresendo. Nausea vomiting, Headache exacerbated with movement of head, radiating to neck. Awake, alert, oriented X3.  12/06/07-records received from receiving facility for DOS 10/09-10/31/07-DC DX:SAH/IVH secondary to right paravermian/posterior fossa AVM. Procedure:angio cerebral artery-and suboccipital craniectomy, resection of tumor, surgical resection placement of VP shunt. Transferred to rehabilitation facility
Day 1:  by the time I was going to bed that night, started running a fever. Temperature was between 99.8 - 100.2.  Day 2:  woke up with a fever of 99.8. Felt like I had the flu. Body aches, shivers, nausea. Arm was sore.  Day 3:  arm began turning red at injection site and swelling. By the end of the day, red and swollen area was about 7 inches long by 4 inches wide, and the red area was hot to the touch.  Day 4:  redness and heat started to dissipate, but arm was still sore.  Day 5:  redness was significantly less prominent and it was no longer hot to the touch.  Day 8:  still a small patch of redness remains about 6 inches down from injection site, but no pain and no heat.
Headache, Arthralgia, NauseaVomiting, chills Narrative:
Patient c/o vaccination evolving into systemic sx: fatigue, chills, headache, nausea, arthralgia.
C/o pain at injection site immediately, reported cont. pain and decreased strength in arm. Pain increases with movement of are.  Currently being seen by Work Comp MD for filed work comp claim due to this at our facility where employee works.
Severe muscle pain injection side of upper back between spine and shoulder blade; severe pain in injection side elbow and triceps; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 03Aug2021 at 11:45 (Batch/Lot Number: FA7485) as dose 1, single (at the age of 46-years-old) for Covid-19 immunisation. Medical history was reported as none. The patient had no Covid prior vaccination and had not tested post-vaccination. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. On 04Aug2021 04:30AM, the patient experienced severe muscle pain injection side of upper back between spine and shoulder blade. Also developed severe pain in injection side elbow and triceps-ongoing for 7 days. Therapeutic measures taken as a result of the events included muscle relaxer and anti-inflammatory. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
Fever; headache; nausea; chills; muscle soreness; fatigue; soreness at injection site; sore throat; lightheadedness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 at 11:30 as dose 4 (booster), single (Lot number: GJ6796) at the age of 12 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin", notes: known allergies Augmentin; Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies amoxicillin. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer unknow, Lot batch number unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; FATIGUE (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; HEADACHE (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; DIZZINESS (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "lightheadedness"; MYALGIA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "muscle soreness"; NAUSEA (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "sore throat"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2022 at 21:15, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of pyrexia, headache, nausea, chills, myalgia, fatigue, vaccination site pain, oropharyngeal pain, dizziness.  Additional information: If other vaccine in four weeks: no. Other medications in two weeks: no, If covid prior vaccination: no, If covid tested post vaccination: no.  No follow-up attempts are possible. No further information is expected.
Injection site has a hard knot in it, is very hot to the touch, burns and is red and itchy
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
1st Vax 4/1/21 - general arm soreness less than 24 hours.  2nd Vax 4/27 - general arm soreness, chills for 24 hours.  Booster Shot 12/13 minimal arm soreness less than 24 hours.  All 3 shots were Moderna.   Wife tested positive for COVID 19 on 12/21.  I had no symptoms and tested negative 3 times.  On/around 12/28 I started to get very itchy for no reason.  Dr. recommended I a get a PCR.  PCR taken and came back negative on 12/31.   Since 12/28, random bouts of red skin (in lines) hives (raised) and very itchy skin happen several times per day.  More profound at night and last 20-30 minutes before subsiding.   The rash seems to bounce around my body randomly appearing on my neck, back, arms, groin, privates, ankles, forehead, shoulders etc. There is no pattern to where they show up.  The back of my ears every night get very warm & red.    Showers make skin appear red, but do not make it itchy on its own. When I dry with a towel, the skin gets redder and becomes more itchy.    I have not introduced anything new to my diet and we have used the same detergent/soaps for years.   I saw the Dr. again on 1/11 and he noticed dermographism & skin got redder after light scratching/touching.  Referred me to allergist.    During 1st 2 weeks I tried Benedryl, it did not help.  As of 1/10, I took a 24 hour Zyrtec and itchiness subsided.  I will pause the use of Zyrtec after a couple days to see if itchiness/rash is resolved or if it comes back without the use of Zyrtec.
11 hours after booster.        Shaking uncontrollably,   stomach cramps. Vomiting. Diarrhea, fever =100.4,  severe headache
12/6/21 Pt had bilateral chest tubes placed for pneumothoracies.  Then, Pt developed acute O2 desaturation in the 70's. Pt placed back on ventilator.  BP dropped to 60/30. Lactated Ringer bolus given. Neosynephrine gtt initiated.  Pt was placed on comfort measures and was terminally extubated per family request.