chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors in a published literature article, concerning an 12-year-old previously healthy female. Six days after a receiving a second dose of GARDASIL vaccine, the patient began experiencing episodic loss of consciousness, which after neurological and cardiac evaluation was determined to be secondary to neurocardiogenic syncope (NCS). Holter monitor demonstrated a heart rate range from 44 bpm to 212 bpm with the patient reporting shortness of breath and palpitations at the time of sinus tachycardia occurring with exertion. Orthostatic blood pressure and heart rate assessment demonstrated a supine heart rate of 65 bpm and a maximum heart rate of 122 bpm without orthostatic hypotension during a 5 min standing test, which was consistent with Postural orthostatic tachycardia syndrome (POTS); a tilt table test was not obtained. The patient's symptoms improved significantly with the use of fludrocortisone and high sodium diet for volume expansion, and she was able to attend school full-time and play sports. Subsequently, she received a third dose of GARDASIL vaccine, and 3 weeks after vaccination her symptoms of dizziness and episodes of loss of consciousness intensified. After a second MRI of the brain and 24-h video EEG at the epilepsy monitoring unit revealed no abnormalities, the etiology of the episodes was determined to be once again secondary to NCS. The course of her symptoms over the following 12 months after the third GARDASIL appeared to be relapsing and remitting, with several syncope-free months followed by recurrence of syncope. Three years after the onset of syncope, the patient's daily symptoms have mostly resolved, and she experiences syncope only occasionally. The patient improved over 3 years. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that The temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review loss of consciousness was determined to be once again secondary to NCS was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003813, 1310USA003819. Additional information has been requested.
Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) had resolved.        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 given by reporter.  No treatment medication was given by reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Added reporter information: first name, last name, occupation, reporter type, address, postal code.added patient detail: Date of birth, pregnancy status no. On 14-Sep-2021: Non-significant follow-up appended; Sender's Comments: This case concerns 30 -year-old female patient with no medical history, who experienced the unexpected event of Expired product administered. First dose of mRNA-1273, Moderna COVID-19 was administered after exposure to room temperature more than 24 hours. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was considered unknown. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
This spontaneous report as received from a nurse refers to a 4 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included sterile diluent. On 10-OCT-2017, the patient was inadvertently vaccinated with expired dose of M-M-R II lot # L023385, expiration date 25-JUN-2017 (concentration and route of administration were not reported). No adverse effects were reported. The outcome of expired product administered was unknown.
I received the 2nd shot of Moderna Covid-19 vaccine on 6/4/21 at 4pm and started to have  a lot of pain in the arm that received the vaccine from shoulder to wrist and 102.3 fever by 11pm on the same day. I took Tylenol and went to bed. Next morning on 6/5/21, I woke up with a lot of muscle aches and weakness and couldn't function, so I mostly spent the morning laying down. I didn't eat and drank very little. By 12pm on that day I started to feel nauseous, I got up and walked to the kitchen to have a drink. At that point everything started to go dark in front of my eyes and I fainted and fell on the floor. I was told by my son that I was unconscious for 2 or 3 minutes and when I started to regain my consciousness,  I realized I was moaning and my face was covered with cold sweat.  I had fever between 99.8 and 100.8 that whole day on 6/5/21 and felt better with no fever the next day on 6/6/21.
Patient states that the night he received the vaccination he had tightness throughout his body, especially in his back and chest to the point that he felt like he needed to go to the ER. The tightness eventually subsided enough that they felt comfortable enough not being seen. Patient states that he has had reaction like this before when receiving tetanus shot and possibly the diptheria shot but never with a flu shot.
Mom reports that evening after shots that the patient's right quad became swollen, warm to touch, and fever present.  Mom brought child into health dept today 3/11/16.  T97.9 auxillary. No SOB and lungs clear.  Top of right quad swollen 2-3+, tight, and warm to touch. Mom reports edema is increasing.  Referred to Dr. and will be seen today.
Pt. came in on 2/11/14 - said her arm was still very sore from flu shot given on 1/23/14. She said there was no swelling, rash or redness but her arm still hurts to move. Pt was told to let us know if she was still experiencing pain after a few more days. 2/14/14 pt returned said she took a muscle relaxant and her arm was feeling much better.
Pt recvd vax 26JAN95 & devel a severe allerg local react followed by cellulitis @ the inject site, fever to 104.6, nausea, vomiting & joint pain; pt was hospitalized on 02FEB95; addtl details are being requested;
Coughing so bad is a dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing so bad is a dry cough) 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.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced COUGH (Coughing so bad is a dry cough). At the time of the report, COUGH (Coughing so bad is a dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  The patient reported that second dose is scheduled on 28 May 2021.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-MAY-2015, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV; PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had five temperature excursions: 40 hours, 72 hours, 304 hours, 48 hours and 712 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 47 F (8.333333333 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Chief Complaint: COVID 19,cough, congestion, shortness of breath. positive COVID 19 test 2 days ago.  Acute hypoxemic respiratory failure ; secondary to covid pneumonia  Admit to medical service  Supplemental oxygen , IV solumedrol  Zinc, vitamin C  IV abx ,  Covid pneumonia with hypoxemia and early cytokine storm  IV dexamethasone , and abx  Started on remdesevir.  discharged today to Hospital  Zinc vitamin C and singulair
Severe pain in right shoulder few days after vaccine, treated with prednisone for 6 days, referred to orthopedic doctor. He did x-ray and diagnosed me with frozen shoulder and referred me for physical therapy. After 3 weeks of therapy with no improvement, had MRI which showed no problem, then referred for nerve study and diagnosed with Parsonage-Turner syndrome.
covid vaccine breakthrough case   dose 1 Janssen  4/9/21  041A21A
Temperature Excursion; Initial Report Received on 16-May-2023  A registered pharmacist reported that a 50-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the refrigerator had multiple power outages.  Medical history, allergies, and medications at the time of vaccination were not reported.   On 15-May-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941591, expiration date 31-Aug-2025, and NDC # 43528-003-05) intramuscularly in the left arm. The injection was given after the refrigerator had multiple power outages. No adverse side effects were reported.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
12/3/2022   I knew I had been exposed to COVID. I had symptoms of a severe head cold, achy and very tired. I had trouble staying awake. The symptoms stayed primarily in my head which made it hard to breathe. I had some coughing and a lot of nasal drainage to the back of my neck. I took a home COVID test which was positive.  I called an urgent care and they prescribed Paxlovid which I began taking on 12/4/22 in the evening. By 12/5/22, I was doing pretty good. My symptoms stopped within a few days.  The lack of energy and being tired lasted about three weeks. On 12/8/22, my home COVID test was negative.  I have recovered.
On May 16, 2022, I tested positive but had no symptoms at that time.  A few days later I began to have a strong, dry cough.  I was really tired.  These symptoms lasted about week or so and then I began to get better.  But then it got worse.  I was so tired I slept for 3 days.  I went to ER on June 10th because I was coughing and I just didn't feel right and I was so tired.  I was there for a few hours and I was advised that I had bronchitis and COVID-19.  The next morning I was having trouble rolling over.  There was pain when I walked upstairs.  It felt like I had bruised my rib from all the coughing.  I then saw that I had bruises on my back.  I went to Urgent Care because of my back/side pain.  Doctor saw the bruises and thought I may be bleeding internally and sent me to the ER.  They didn't find any internal bleeding and did a Coagulation Test and it was normal.  They sent me home after giving me ibuprofen for the pain.  This was June 13th.  I saw my regular doctor, on June 20th.  She found a lump right in the middle of where my bruise was.  It was suspect to be a hematoma or a burst blood vessel.  As of today I have no symptoms.
Pt recvd Td vax & devel localized swelling, tenderness & warmth;
This spontaneous report as received from a health professional refers to an unspecified number of patient of unknown demographics. The concurrent condition, medial history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L041204, Expiry: 20-OCT-2017). The vaccines were stored at 19 F for 160 hours. There were no previous temperature excursions. No adverse events were reported. Additional information has been requested.
vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second 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 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given. Other event included updated patient information.   Reporter did not allow further contact
Adult patient, 71 years of age, was incorrectly administered the Moderna Pediatric Covid 19 vaccination 6m-11 years.
continual mild headache, fatigue, nausea, soreness in arm/shoulder/neck, loss of appetite, diarrhea; all lasting first 24 hours after shot
Shingles showed up about 4 weeks after second dose on right side of the neck affecting nerves causing headaches and numbing of the right side of face.   Had chicken pox as a young child.
worsened vision; runny nose; Gi upset; intermittent chest pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (worsened vision), RHINORRHOEA (runny nose), ABDOMINAL DISCOMFORT (Gi upset), CHEST PAIN (intermittent chest pain) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VISUAL IMPAIRMENT (worsened vision), RHINORRHOEA (runny nose), ABDOMINAL DISCOMFORT (Gi upset), CHEST PAIN (intermittent chest pain) and HEADACHE (headache). At the time of the report, VISUAL IMPAIRMENT (worsened vision), RHINORRHOEA (runny nose), ABDOMINAL DISCOMFORT (Gi upset), CHEST PAIN (intermittent chest pain) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
After Covid vaccine patient reported shortness of breath. @9:36 25 mg of Benadryl administered  BP 140/90...Pulse Ox 98%, Pulse 88, lungs clear at 9:40 patient reported shortness of breath worse...Epi Pen administered, 911 called...patient transported to ED by Ambulance
Pt devel GBS p/recvd flu vax; additional info has been requested;
About 10 hours after the vaccine I started feeling sick.  Aches and pains everywhere. nausea, no appetite, headache, chills, fever of 102, shaking.
Fainting episode approximately 5 min following vaccination. Hypotensive and bradycardic . Resolved in 1 hour.
experienced tenderness and soreness on both breasts; experienced tenderness and soreness on the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of BREAST TENDERNESS (experienced tenderness and soreness on both breasts) and INJECTION SITE PAIN (experienced tenderness and soreness on the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure measurement (Mentions blood pressure condition.) since an unknown date and Diabetes since an unknown date.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (experienced tenderness and soreness on the injection site). On 14-Jan-2021, the patient experienced BREAST TENDERNESS (experienced tenderness and soreness on both breasts). At the time of the report, BREAST TENDERNESS (experienced tenderness and soreness on both breasts) and INJECTION SITE PAIN (experienced tenderness and soreness on the injection site) 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.
Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy.  Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that unspecified number of patients received RECOMBIVAX HB which was stored improperly. No adverse effects reported. Additional information has been requested.
Initial report received from a healthcare professional on 03 OCTOBER 2014. 5 patients (demographics not reported), had received an intramuscular dose of FLUZONE QIV, (batch  number UI205AD, expiry date 30 JUNE 2015, dose in series and site of administration was not reported) on an unspecified date of SEPTEMBER 2014. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On an unspecified date in September 2014, after vaccination, the patient developed large red, swollen and hot area where vaccine was administered, some as large as a baseball. The patient also experienced constant radiation pain up and down the arm and into the neck and bruising at injection site. Corrective treatments and laboratory tests were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none
Gave expired vaccine RotaTeq. Vaccine expired on 4/26/2013, date vaccinated was 4/30/2013.
Pt fainted after receiving Pfizer COVID vaccine. It was standing and began swaying and not verbally responding to pharmacist. Pharmacist was able to catch her before she fell and he slowly lowered her to the ground. Pharmacist had her lay on her back. Another Pharmacist assisted and had pt put her feet up on a chair to improve blood flow to pts head. PT laid on the ground for about 10 minutes and was conversing with Pharmacist. She was able to sit in a chair and stated she was feeling better, but had a warm sensation. We provided her with an orange juice and she had her own water. Pt hadn't eaten for a few hours and had a history of fainting after giving blood. Her dad came and drove her home after 45 minutes as a safety precaution.
First Pfizer vaccine was given 6/5/2021. When contacted Mom to schedule 2nd vaccine, stated child felt "off" and achy the following day with this lasting about 24 hours. Mom has read recent new information regarding another child passing away after developing myocarditis after the second Pfizer vaccine. She feels unsure about moving forward with the second vaccine. Will call if decides to schedule
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 17:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: Other medical history: IBS. Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2019. Past drug history included: Lactose, reaction(s): "Known allergies: Lactose intolerant", notes: Known allergies: Lactose intolerant. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive immediately. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course: It was reported that the patient had taken previous vaccination and medications within 2 weeks rebound occurred four days after last pill was taken. Basically the same symptoms of head congestion, fatigue, watery eyes and dry mouth. Tested positive immediately. Initial Paxlovid was taken with hours of first symptoms.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
1/11, 7pm: Headache, nausea  1/12, 4:30am: Body aches 1/12, 7pm: Vaginal lesions 1/13, 5am: Increase in number of vaginal lesions 1/13, 2:30pm: Seen by primary care physician, increased number of lesions, open and bloody, labs and cultures drawn, prescribed topical Lidocaine and Valacyclovir 1/13, 7pm: Lesions progressed to open ulcers 1/13, 11pm: Development of new lesion on labia majora  1/14, 5am: Increased edema and deterioration of ulcers 1/14, 7pm: Worsening edema and further deterioration of ulcers 1/15: Seen in clinic by a dermatologist, prescribed topical Clobetasol, additional blood work drawn 1/16: Started topical Clobetasol 1/22: Follow-up lab work 2/1: Ulcers started to heal 2/8: Internal ulcers nearly healed 2/10: Labia majora ulcer nearly healed