chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 21 year old female who in approximately June 2007, "9 or 10 months ago", was vaccinated "by injection" with a first dose of GARDASIL (lot # not reported). The physician reported that the patient developed a sore throat after receiving the first dose of GARDASIL. The patient sought unspecified medical attention. The patient outcome was not reported. Additional information has been requested.
Cold like symptoms after getting Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold like symptoms after getting Moderna booster) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    No Medical History information was reported.   On 11-Dec-2015, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram once a day. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced NASOPHARYNGITIS (Cold like symptoms after getting Moderna booster). At the time of the report, NASOPHARYNGITIS (Cold like symptoms after getting Moderna booster) was resolving.            No concomitant medications were reported. No treatment medications were reported.  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.
Large local reaction. Then clumsiness is noted by others. Progresses to ataxia and dysarthria and cerebellar atrophy. Symptoms: Gait abnormality, hyperreflexia, hyperexplexia (heightened startle reactions), inability to speak (slurred speech), paresthesia (numbness and tingling in injected arm, AVA #3). Information received from the 60 day follow-up states client will be permanently impaired from this prgressive cerebellar ataxia. She received 100% disability and is currently being processed out.  Annual follow up infomation indicates patient has not recovered. Service member was discharged with 100% disablity for cerebellar ataxia. Speech is slurred but audible, memory good, fatigues easily, exaggerated startle reactions, balance is impaired, fine motor skills impaired. Uses a cane for ambulation in crowds. Difficulty desending steps. Organic Brain Dysfunction. Cognitive dysfunction. Fine motor skills profound loss.
Pain at injection site for 2 days following vaccine but this resolved. No other issues until red rash site reaction 2 weeks after injection. Slight warmth, no other symptoms.
Anxiety, muscle aches, acid reflux, agitation, allergies, blood pressure varies, cold and flu like symptoms, cough, headaches continuous, lower back pain sinusitis, sleep insomnia, throat swelling and closing. 7/3/06 medical records received from patient (6/04 through 2/06) which reveal patient experienced chronic tonsillitis, GERD & environmental allergies/ss
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Error: Wrong Dose of Vaccine - Too High-, Additional Details: Patient accidently signed up for 3rd dose (0.5ml) instead of booster (0.25ml) but based on how she answered screening questions administering RPH should have caught that she was only eligible for a booster half dose but failed to change to correct dosing and administered full dose. Patient reported severe flu like symptoms that have resolved. I informed her doctor of error and told her to followup with doctor is she has any unusual symptoms going forward.
Varicella vaccine given on 8-18-14. On 9-20-14, mom noticed small pustule on torso. Very scant pustules noted until 9-25/26 when lesions increased on torso, neck, gluteal folds, and proximal thighs. Patient did not have fever/URI symptoms at any time.
06/15/2005 Left deltoid has 3cm x 3 cm area of redness and tenderness at site of injection of tetanus booster. Pt advised to monitor, use ice. Application TID x 2 days and take Motrin 400mg with food TID x 2 days, per FNP.
< 48 hr after vaccine pt developed intense pruritis and multiple discrete red papules over trunk & extremity.  No relief with BENADRYL.  PREDNISOLONE given.
Injected with only the adjuvant; Injected with only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 4n2ab, expiry date 10th February 2023) for prophylaxis.   On 1st September 2021, the patient received Shingrix. On 1st September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant of Shingrix without the powder component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No adverse event was reported. No patient's identifiers were provided. The reporter consented to follow up.
Weakness in arms and legs, weight loss of 15 lbs in a months time, nervous system in chaos, overall malaise, trouble concentrating, a period of insomnia and dark thoughts.
pt recvd vax; pt exp nausea  & headache in eve; intestine & stomach cramping, diarrhea; lack of oxygen; fever; hot & cold flashes; insomnia;
Fainted; Unconscious; A spontaneous report was received from a consumer who was also a 73-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting and unconscious.  The patient's medical history was not provided. Concomitant medications were levofloxacin, metformin, amlodipine and lisinopril.    On 21 Jan 2021, prior to obtaining his vaccination, the patient took levofloxacin, metformin, amlodipine, and lisinopril.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 21 Jan 2021, within minutes of receiving the vaccine, the patient fainted with his eyes open and was unconscious. His health care provider told him he was dehydrated and that might be why he fainted.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, fainting and unconscious, was considered resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 73-years-old male patient, who experienced medically significant unexpected events of Syncope and Loss of consciousness. The events occurred within minutes after first dose of mRNA-1273, lot # 012L20A. Concomitant medication included levofloxacin, metformin, amlodipine and lisinopril. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. Of note, dehydration was reported as potential contributing factor.
ARM PAIN; SHOULDER PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced shoulder pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm pain, and shoulder pain. This report was non-serious.
Right arm sore 5-7 days Fevers off and on  15+ days, getting worse, now up to 100.9 degrees Very tired Eyes burning Body aches Dizziness when standing up.  Nausea Stuffy nose Symptom have persisted since injection, some have worsened.
episodes of shortness of breath, elevated temps of >101.5, < 104.8; blurred vision, dizziness
Allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4564946 (Genentech, Inc.).  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Area itches; Area sore to touch; This case was reported by a consumer and described the occurrence of localized itching in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On 24th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced localized itching and tenderness. On an unknown date, the outcome of the localized itching and tenderness were unknown.   It was unknown if the reporter considered the localized itching and tenderness to be related to Shingrix.  Additional details were provided as follows: On thursday before the reporting date, the patient received second shingle shot. The patient experienced area itched and sore to touch. The patient did not had his with first one.
11/2/12 AM, patient called to report red, swollen, itchy area below and adjacent to injection site. Hot to touch no headache, no fever, no nausea or vomiting. Referred to her MD for presumed cellulitis. MD ordered cephalexin 250 mg four times a day x 1 week, MEDROL DOSE Pk & cetirizine 10 mg daily x 1 wk.
Fever, unable to move arm where injections were given, chills, pale, labored breathing, rapid heartbeat, restless
Pt was the last patient of the day for the provider and the error was noticed the next day. The provider and patients mother were made aware by employee. The agency was contacted by clinic employee and spoke to agency employee. They stated the patient would be fine and the doses would count. Upon discussion with employee, she stated she did not know the Kinrix was for 4 years and up. After this I looked at the box but it does not state that it is for 4 and up. We wrote on the box 4 and up and then posted a note on the fridge with a breakdown of the combo vaccines and information on the ages for them. A coaching and mentoring was done for the employee.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 29May2022 and stop date: 02Jun2022, indication is used for treatment of COVID-19, Administrator route: Oral. The patient did not receive other medication in 2 weeks. Adverse event experienced on 11Jun2022. Rebound Covid. The outcome of event was not recovering. The patient did not receive treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Myalgia, Fever, left axaillae lymphadenopathy , fatigue Narrative:  suggest using different site for the two vaccinations
pt recv 2 doses of vax 29FEB96 & 15MAY996 & 9SEP96 lab eval revealed a negative titer;
No further AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE  TE Case02454494; This spontaneous report was received from pharmacy technician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #w024333, expiration date: 01-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine was administered during an excursion (Product storage error). No additional adverse event was reported.
MYOCARDITIS.  I experienced extreme chest pain, tightness, shortness of breath, painful heart beats, I could feel each beat. I hunched over in my bed groom grabbing my abdomen and fell onto my bed and almost passed out from whack I?d assume is lack of oxygen. I could barely breathe for about five minutes and felt relatively severe pain particularly in the right side of my chest. I could feel every muscle, tendon, and artery inflamed, enlarged, and hurting. My chest felt like it filled up with a balloon. Heart rate went up too. I have NEVER EVER felt ANYTHING like this in my LIFE. Not even close. It was a brand new sensation to me first time I?ve ever felt anything like this at all, and very intense and frustrating. Keeping in mind I am in perfect health. I am a body builder with a perfect physique. I work at a high end restaurant and have an extremely good diet. I have a normal sleep and sexual routine, I don?t use any medications whatsoever even Tylenol or ibuprofen. I have no pre existing conditions. I have no history of heart or cardio problems. My family has a history of low blood pressure. I have next to no stress or anxiety in my life. I am 24 years old I work out and run miles, five to six days a week. I don?t use nicotine, tobacco, and I haven?t had a drink of alcohol in ten years (14yrs old). I smoke marijuana on a daily basis. After about ten minutes the incident went down and I was able to breathe a little better but still had pain and tightness in my chest. I have had shortness of breath ever since. This is being written the day after the event about 26 hours later. I ran a mile last night and went to the gym it seemed to help both my breathing and the pain and tightness but it has not fully gone away. I feel my heart straining somehow as I am typing this. One thing to note is I did not want to get vaccinated but was pressured to do so, and before getting it I was very nervous and honestly upset. The woman administering it was not helpful at all and actually mocked my unsureness and was very rude and unprofessional. She didn?t answer any technical questions I had. During my interaction with her between my nerves and her behavior I?m absolutely certain my heart rate was elevated at the time of getting the shot. I have only had one shot. The episode of  myocarditis occurred two weeks after my first shot. Two days after my scheduled second shot, which I missed because of work and was going to reschedule before this occurred. I am not going to be getting the second shot. Will be following up with my primary care doctor as soon as possible. Haven?t had time.
This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The certified medical assistant reported that on unspecified dates, unspecified number of patients received improperly stored doses of VARIVAX (Merck) (lot#, strength, dose #, dose and route of administration were not reported). There was not concomitant medication reported. No adverse effects were reported and there was not a product quality complaint involved. This is one of two reprots received from the same source. Additional information has been requested.
2 weeks later I am still experiencing  Severe nausea, severe back pain, extreme fatigue
Patient reports redness to chest area; no itching , no hives, no flushing. Patient was seen and cleared by EMS. HR = 88 SPO2 = 95
Information has been received from a health professional concerning a 16 year old white female student with syncope after receiving kindergarten shots et zoole flu vaccine, and no known allergies, who on 01-Nov-2007 was vaccinated IM in the left deltoid, with the second dose of Gardasil (lot #658560/1062U).  There was no concomitant medication.  The patient had no adverse event after the first dose of Gardasil.  On 01-Nov-2007, three seconds after the second dose the patient fainted on exam table.  Unknown medical attention was sought.  She was sitting and lied down.  She was very pale and wasn't breathing for 5 seconds.  She came out of it, got her color back and was fine afterwards. The patient was recovered without treatment. No product quality complaint was involved. No product quality complaint was involved. Follow up information indicated that the patient needed no treatment. No diagnostic work up was done on the patient. No hospitalization or as a out patient.
The next night, 30 hours after the vaccine, she experienced a low grade fever and vomiting. For up to 5 days after the vaccine, she would not sleep very well, scream for no reason, low grade fevers, no appetite, nap for extra time. 3 days later (72 hours later), she developed a body rash on her upper body. 4 days later (96 hours later), she developed a rash on her lower body.
Patch of small red pustules, forming a rash, developed above the left eye, on the forehead area.   It was extremely itchy.  When I accidentally scratched it and touched another part of my face, another pustule developed. No other rashes were noticed.
I had some localized redness at the sight of injection and chills horrible headache body aches cough shortness of breath fever it lasted for 24 hrs.
Started 2 days after vaccine, headache, low grade fever, nausea (mild), dizziness, exhaustion, malaise, sleeplessness, throat irritation, chills, flushing, symptoms have occurred since 2 days after having the vaccine; blood sugar also more elevated. Currently being treated with magic mouthwash for throat irritation.
Uncontrolled  full body tremors, picked up by ambulance about 7:30pm, 2/7/21, and taken to ER, admitted due to heart attack, angiogram done 2/8/21, echo  done 2/9/21, released 2/9/21
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L010143 and expiry date 24-SEP-2016) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: Ranging from -14.9C to -9.8C for 30 to 31 minute increments from 01-MAR-2016 through 15-MAR-2016. Previous temperature excursion: No. Data logger in use: No, possible malfunctioning thermometer. This is one of the two reports received from the same reporter. Additional information has been requested.
Posterior R arm with red, hot, wheal 6.5 cm x 3cm which started 12/13/07 and has progressively gotten larger.  Pt denies any systemic S/S.
within 24 hours felt slightly flu-ish for about 1 day.  2 weeks later patient; developed very stiff/sore shoulders, neck, that progressed to hips/thighs/groins during the next few weeks. VERY fatigued and very hard to walk and have a normal life. He had about 5-7 lb weight loss over 2 months. By end of October he did see a internist who did basic blood work and an orthopedic doctor prescribed steroids which helped dramatically.  He will be seeing the rheumatologist at the end of November. Both doctors think he might have developed PMR and once we see the doctor, C-protein and ESR levels will be drawn. He does have all symptoms of PMR and I have done much research of the potential effects of this vaccine.
Headache, extreme body ache all over, no energy and loss of appetite for 3-5 days.
Axillary Web Syndrome "lymphatic cording" in right axilla and upper arm preceded by lymphadenopathy of the right axilla.
bilateral sensorineural hearing loss; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 27-MAR-2020. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or around 21-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss in both ears, she was diagnosed with bilateral sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient sustained severe, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event was considered as not recovered. The reporters considered bilateral sensorineural hearing loss to be related to Zoster Vaccine Live (ZOSTAVAX).      The reporters considered bilateral sensorineural hearing loss to be a disabling event. Upon internal review, bilateral sensorineural hearing loss was determined to be medically significant.
My period/menstrual cycle is highly irregular following receiving my second dose of the vaccine. I was on my period while receiving the second dose, and this period lasted around 2.5 weeks, with spotting on and off afterwards. After only a week or two off of my period, I am now spotting again as of the time of this report.