chrisvoncsefalvay/vaers-outcomes huggingface dataset:
migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseous; inability to control temperature regulation; stomach began to have a really intense stabbing pains; Not the worst pain I have experienced but definitely not pleasent; lethargic; getting extremely cold and then hot within a matter of minutes; Her ribs and lungs hurt; Her ribs and lungs hurt; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to Red dye, postural orthostatic tachycardia syndrome (POTS), heart murmur, Wilkies syndrome. The patient was not pregnant. There were no concomitant medications. The patient did not take other medications in two weeks. The patient previously took Excedrin and experienced allergies. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:45 AM (Lot Number: EL9269) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 24Feb2021 at around 7:00pm she started getting a migraine at the base of her head. She then was lethargic, and became extremely nauseous. She started getting extremely cold and then hot within a matter of minutes (inability to control temperature regulation). Her heart rate rose to around 133 just laying down. Her ribs and lungs hurt. And her stomach began to have a really intense stabbing pains. At one point it felt as if she could feel every cell in her body if that makes sense. Not the worst pain she had experienced but definitely not pleasant. On a scale of 1 to 10 (10 being run over by a car and 1 being a paper cut) she would say it was a 5-6. The patient did not receive treatment for the events. Facility type vaccine was facility. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. The outcome of the events was recovered on an unspecified date.
This study case was received from the investigator in a trial on 19 September 2012. A 19 year-old male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) an an unspecified amount of time later was found to have on 25 January 2012 an elevated Troponin, central laboratory level of 0.38 ng/ml (also with as reported date of 27 January 2012). The subject had a rapid Troponin I level on 25 January 2012 that was within normal limits (negative). The subject's ECG on 27 January 2012 was normal. The subject had no concomitant medications. On study day nine, the subject was evaluated for an abnormal EKG and elevated Troponin I but asymptomatic. The subject's vitals included: BP 122/78, HR 56, RR 14, T 98/6 degrees F, HT 71 in, WT 175 lbs, BMI 24.41 and BSA 1.993 square meters. Laboratory and diagnostic testing included: a negative chest x-ray, an abnormal electrocardiogram, hemoglobin 13.7, lymphocytes 1.0, protein plasma 8.6 and creatine kinase serum 248. Treatments included methylprednisolone and naproxen. On study day 43, the subject had a normal ECG. On study day 49, the subject was evaluated and reported that he can feel short of breath at rest occasionally but it resolves with taking deep breaths. The subject also reported at the visit that he has difficulty sleeping through the night and had daytime somnolence. On study day 62, the subject was evaluated for clearance for deployment. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of elevated Troponin was considered another important medical event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
10cm area at injection site was red; 10cm area at injection site was hot; 10cm area at injection site was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA605A, expiry date 30th September 2022) for prophylaxis.   On 3rd August 2022, the patient received Menveo. In August 2022, less than a week after receiving Menveo, the patient experienced injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site itching to be related to Menveo.     Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's Comments: The reporter stated that a female patient was vaccinated with Menveo vaccine on the left arm, but on the day of reporting came into the office and reported a 10 cm area on her left arm (at injection site) that was red, hot and itchy. The reporter consented to follow up.
This study case was received from the investigator on 13 August 2012. A 29-year-old male subject received the following vaccinations on 10 April 2012: an injection of ACAM2000 (lot number not reported), an injection of Anthrax Vaccine (manufacturer and lot number not reported) and an injection of Tdap (manufacturer and lot number not reported). On 22 April 2012, Troponin I was abnormal at 00.19. On 23 April 2012, the subject had a normal ECG. On 23 April 2012, the subject was diagnosed with unspecified disease of the pericardium. The subject had a normal echocardiogram on 07 May 2012. The subject had past medical history of high blood pressure. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
The patient came for a 4 month visit, but had not started any vaccine series at 17 weeks and 3 days. The provider ordered the routine 4 month vaccines. The patient should not have received Rotateq, but received Rotateq at the age of 17 weeks and 3 days.
1PM pt presented to MD w/high pitched shrill cry, unconsolable since vax; lt lat thigh red & warm to touch; t98.7 ax; APAP given; TC to MD no response; pt to ER given DPH;
12 x 13 cm of erythema, somewhat induration with central area with vesicles ~2 cm area & one large bulla.  No fever or other systemic signs.
Arm pain; Redness; This is a spontaneous report from a contactable physician. A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at the age of 77-year-old) as dose 2, single for covid-19 immunization. Medical history included RBBB, LAD Abnormal EKG from 26Mar2018 and Ongoing; Benign neoplasm upper limb from 19Dec2018 and Ongoing; BPH from 08Feb2018; Prostate Cancer from 11Jan2017; Hyperglycemia from 11Jan2017; Osteoarthritis from 10Dec2019 and Ongoing; Vit D deficiency from 10Dec2019 and Ongoing. Concomitant medication(s) included multivitamin [vitamins NOS] taken for routine health maintenance from an unspecified start date and ongoing; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for routine health maintenance from an unspecified start date and ongoing; colecalciferol, ubidecarenone (COQ10+D) taken for routine health maintenance from an unspecified start date and ongoing; naproxen sodium (ALEVE) taken for pain from an unspecified start date and ongoing; paracetamol (TYLENOL) taken for pain from an unspecified start date and ongoing; famotidine (PEPCID [FAMOTIDINE]) taken for gastroesophageal reflux disease from an unspecified start date and ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9263), administered in Arm Left on 26Jan2021 (at the age of 77-year-old) as dose 1, single for covid-19 immunization and experienced Back pain/shingles and Arm pain and redness. Prior vaccination (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. On 03Mar2021, the patient experienced arm pain, redness. The patient underwent lab tests and procedures which included electrocardiogram: LAD abnormal EKG on 26Mar2018. The patient did not receive any treatment for adverse events. The outcome of events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Shortly after receiving the vaccine, I felt intense pain in the left arm - arm of the vaccine.  It was much worse than any other shot I've ever experienced.  Then my left hand went numb.  I looked at the site of the vaccine and noticed it was in front of the shoulder, not in the muscle.  During the night, my head started having excruciating pain and by morning I could not lift or move my head.  This went on for several days, which time I had to lay in bed on my back.  After taking Aleve and one pill of Celebrex over the course of the days in bed, I was able to get out of bed.  However, I then experienced blindness in both eyes which lasted between 15-30 minutes.  My sight then returned.  During the blindness I could make out an outline (barely) of sight.
Patches of rash on checks, arms and trunk.  Rash itches started 12/03/2009 on 12/07/2009 still some rash and itching.  Treatment per home.
Injection site swelling and pain, headache,  muscle and joint pains, minor fever (100.3 degF), loss of appetite Symptomatic treatment with Ibuprofen Peak intensity 4/13 evening Currently resolving
Rash around injection site that lasted about a week. It was red, hot, swollen, and itchy. "Moderna" rash. Went to my PCP just to be safe and get it checked out, she said it looked great, was a localized reaction and to take benadryl until it cleared up.
On 10/15/12 after receiving flu vaccine patient experienced a seizure. She was transported to local ED for care.
Patient received second COVID-19 vaccine around 1445 on NOV 4, 2021 and about 4 minutes later reported feeling flushed , hot and tightness in her throat and lightheaded. Vaccine was administered at an outlying clinic. Administrators on scene gave her half a milligram of epinephrine IM in the right thigh.. She was then transported b to ED and arrived at about 1516 where she reported she had a similar reaction after her first COVID19 vaccine, but she also received a penicillin injection at the same time and the allergy was determined at that time to probably be related to the penicillin injection.  Patient monitored for 3 hours after epinephrine (0.5 mg IM) administered.  At no time (on arrival, throughout stay, at discharge) did she exhibit hives, uvular swelling, stridor, wheezes or any other acute anaphylactic reaction. She was given acet325Tab, 975 mg, Oral; diphSol, 25 mg, IV Push (Intravenous); famotidine, 20 mg, IV Push (Intravenous); mecl25Tab - Shared, 25 mg, Oral; methylPREDNISolone sod succinate 125 mg vial, 125 mg, IV Push (Intravenous) ; NS1000bolus_IP, 1000 mL, IV Bolus (Intravenous). She was discharged with 5 day supply of  prednisone and 10 days of Zyrtec.
patient report that after the 2nd dose he started having headaches and body ache and upset stomach,
This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 72-year-old male patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 31st October 2018; batch number: 49R72, expiry date: 13th March 2021). On 16th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a day after receiving SHINGRIX, the patient experienced pruritus and hives. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with medication unknown. On an unknown date, the outcome of the pruritus and hives were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the pruritus and hives to be related to SHINGRIX. Additional details were reported as follows: The patient was the reporter's father. The patient received a 1st dose of SHINGRIX 0.5ml intramuscularly. A day before the date of reporting, the patient received a 2nd dose of SHINGRIX on the left deltoid. The patient woke up during the night because he was itching and the patient found that he had hives all over his body, included in his scalp. The patient went to his physician today and received unknown medication. The reporter did not consent to follow-up. This is one of the 5 cases reported by same reporter.
Vaccine prepped on 7/2/2021 and administered on 7/6/2021.  Pt reported no s/s.  Moderna notified or error and re-admin not recommended.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 10:00 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac's Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Throat Stricture" (unspecified if ongoing). Concomitant medication(s) included: RIVOSTATIN, stop date: 05Mar2023. Past drug history included: Sporonox, reaction(s): "Known allergies: Sporonox", notes: Known allergies: Sporonox. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Antiviral details included Brand was Paxlovid.Treatment start date was 06Mar2023 and Treatment stop date was 08Mar2023.  No follow-up attempts are possible. No further information is expected.
12/07/21 presents to EC ED for "Fatigue and Fever". PMHx of "recent CVA, DVT on eliquis, CAD, HTN, DM, NASH s/p liver transplant"
patient was exposed to someone positive for COVID on 07/17.  She remains asymptomatic.  Tested positive for COVID on 07/20/21.
5 days after shot, had extreme arm pain and reoccurrence of low grade fever. Also later experienced extreme pain in right calf and left thigh.   8 days after shot, saw nurse practitioner who prescribed keflex for the arm and rest/ice for the legs.  Arm improved but continued to experience low grade fevers every afternoon/evening.  Also showed increase in resting heart rate starting the day after the shot from 55 bpm to 70 bpm 12 days later.  Blood pressure also above normal levels
Seizure; I am scared now, if I have the side effect, it was bad and I don''t know, if I need to get more shot if you say, more difficult; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Lot number: FL3197) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TROVAC. Vaccination history included: Bnt162b2 (DOSE: 1, Anatomical location: Left arm), for covid-19 immunization; Bnt162b2 (DOSE: 2, Anatomical location: Left arm), for Covid-19 immunization. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizure"; FEAR (non-serious), outcome "unknown", described as "I am scared now, if I have the side effect, it was bad and I don''t know, if I need to get more shot if you say, more difficult". Clinical course: The patient did not receive any other vaccines within 3 weeks prior to the COVID vaccine. The patient had no family history for event related to the Covid-19 Vaccination. The patient had no medical problems. Consumer stated, "Yes I was taking one medication, I had only one medication "Trovac". Consumer stated, "I probably should have gone to the Hospital but I didn't go because I didn't know at that time what was the problem."  No follow-up attempts are possible. No further information is expected.
On the date of the vaccine was given patient reports symptoms that included nausea, fatigue, joint pain, a numbing sensation of the throat and tongue, the feeling of palpations, and hives around bra line.  The symptoms improved with Benadryl and within 24 hrs. On 1/5/2021 Patient was seen for a local skin reaction at the injection site. Reports pain on the right upper arms and warm to the touch.
This case was reported in a literature article and described the occurrence of Bell's palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed Bell's palsy. Serious criteria included GSK medically significant. Additional event(s) included cold symptoms. The outcome of Bell's palsy was recovered/resolved. The outcome(s) of the additional event(s) included cold symptoms (recovered/resolved). It was unknown if the investigator considered the Bell's palsy and cold symptoms to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Bell's palsy in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled postlicensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, risk window was 1-84 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. The patient had not received any concomitant vaccine. (In this study, 3 of the 8 Bell's palsy patients in the risk window had comorbidities and infections that could be a prelude to the condition). No information on patient's medical history or family history or concurrent condition was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 1 and 84 days post index vaccination, the patient had cold like symptoms. Subsequently, the patient was diagnosed with Bell's palsy. In this study, cases in the risk window occurred primarily between 5 and 10 weeks after vaccination. Treatment was unknown. The event resolved completely. The authors stated that "there is no clear biological plausibility for a causal relationship between vaccination and Bell's palsy." The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
daily migraines with headaches in between not responding to her Maxalt as usual.  She also had significant pain at the base of her skull with stiffness in her upper neck that lasted 3-4 days and is easing up today on day 10.  Movement is better but spent nearly a week in bed not able to function.  Headaches/migraines are not letting up yet
This spontaneous report was received from a Licensed Practical Nurse concerning an unknown number of patients with no known drug reactions/allergies who on unknown dates might have improperly stored LIQUID PEDVAXHIB (dose, route and lot # not provided) that was exposed to 30F for 12 hours. The nurse stated that this temperature excursion occurred during the 1st week of June 2012. Patients might have been exposed to LIQUID PEDVAXHIB after this time frame, approximately in June 2012. There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Patient received 2nd dose of COVID vaccine at 1:45 pm, reports noticing symptoms at 2 pm.  Patient reports symptoms similar to when she received 1st dose.  Patient reports numbness of lips and roof of mouth.  Patient does not want any Benadryl, reports she feels fine otherwise, denies any other symptoms.  Patient observed for 30 minutes, after 30 minutes patient reports she feels fine to drive, symptoms have NOT resolved, but patient still feeling OK to leave and drive.  Instructed patient if symptoms worsen at any time to return to the ED, patient verbalized understanding.  No meds given at this time.
Very soon after getting the Tetanus shot I began to feel a burning sensation in my legs and very painful. I received this shot in Dr. office at 1:15PM and came home in so much pain. I called his office for 6 days only to hear he's very busy with patients and will leave him a message to call me...Nothing happpened until I called him after hours to tell him why has he ignored me all week? So he came to my house and prescribed gabapentin for the pain and burning along with oxycodone 15mg and told me to come to his office on Monday morning Aug. 27, 2012 which I did. My Son and daughter-in-law had to drive me there since I can not properly without a walker...What will happen to me, when will this go away??