chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; She missed her appointment for her second dose; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache, chills, she missed her appointment for her second dose. It was stated that now patient would like to get her second dose but she do not know if she needed to start over the vaccination series and what she should do. She received response that second dose of Pfizer-BioNTech vaccine should be administered as close to the recommended interval as possible, but not earlier than recommended (3 weeks [Pfizer-BioNTech]). But if it was not possible to give the second dose at 3-weeks and a delay could not be avoided, it might be given up to 6 weeks (42 days) after the first dose. If the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There were only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time. Stated she was working right now and the reason she called was that she do not want to wait any longer. The clinical outcome of the headache, chills, she missed her appointment for her second dose were unknown.  Information on lot/batch number has been requested.
hair lose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 13:00 (Lot number: EL1283) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "shell fish" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; HYDROCHLOROTHIAZIDE; LAMICTAL; BUSPAR. Past drug history included: Phenergan for Phenergan:Allergy. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL5730, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 21Dec2020, when the patient was 26 years old, for Covid-19 Immunisation. The following information was reported: ALOPECIA (non-serious) with onset Jan2021, outcome "unknown", described as "hair lose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Vyvanse, hydroclothized, lamictal, buspar. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19. Device Date : 06Nov2021. The patient had hair lose since January and 2 days after booster the patient menstrual cycle came early and with bleeding heavy.  No follow-up attempts are needed. No further information is expected.
After the vaccine I had burning in my arm off an on the day of injection. Today at around 9:30 am I developed numbness, tingling, and pain going down my right arm. The pain radiated into my back and shoulders. I called the vaccine manufacturer and was told to go to the hospital. My treatment consisted of Tylenol and a physical exam. I was told to watch out for nerve damage in a few days and look for severe swelling in my arm due to possible blood clot. I'm still having pain
really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "My husband have auto-immune diseases" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "really sick".  Additional information: Reporter and her husband have auto-immune diseases. Every time they taken a Covid shot or booster, they gotten really sick for at least 5 days. Reporter asked if there ways they can avoid becoming sick after every shot.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151351 same reporter/product/event, different patient;
Severe chills, temperature 101, severe headaches, thirst, weakness, body aches , insomnia
per patient NKDA or NKFA at time of 1st COVID 19 vaccine. Client did state that she shas a history of syncopal episodes during blood draw and that she fears needles. Vaccine administer via car in the syncopal area at 10:06am. Client alert and orientated about 10:08 client spouse called for help, we arrived within seconds and noticed that the client had a neurological reaction, body stiff and back arched with stridor. Epi administered and client came to and breathing well, Benadryl 10cc administered as well for possible hives. 911 called at 1008 they arrived onsite within 10 minutes from call. 1st BP 160/80 pulse 58 @ 1015 2nd BP 140/80 pulse 54 @1020. EMS took over, assessment completed, patient left via own vehicle. Alert and oriented x 4 when they left the site. VEARS form completed and reports sent via email to appropriate persons. RN
Positional vertigo episodes, beginning about 3 weeks after vaccination, lasting 5-10 seconds, brought on by sudden change in position. Occurring up to 10 times a day.  No other symptoms.  Did not seek medical care.   This has never happened in the past.
Minor received both Moderna vaccination 2 months before her 18th birthday. Guardian did not consent to the vaccination. Department of Health verified with statistical records that the patients DOB is 4/19/2003 which made the vaccine a contraindication.  1st Moderna vaccine given: 02/01/2021 2nd Moderna vaccine given: 02/26/2021  No known adverse reactions noted.
Patient received covid-19 vaccine. 20+ minutes later patient states she began feeling flushed and nauseous. Patient states she look at her injection site, and it was hot and red. Local reaction approx. 2 inches x 2 inches. Dr. ordered 25 mg oral Benadryl. Vitals stable at 1840 133/88, 66 for pulse and regular, SPO2 99% on room air, respirations 20. Patient continued having complaints of light headedness and nausea. 1850 119/79, 74, 99% RA. Dr. states patient may depart from clinic if able to sit up and walk out, patient given instructions go to ED in symptoms progress. 1857 120/82, 70, 99.4. Patient's face becomes flushed and hot on left side, patient states she is shaky, and does not feel well at all. 1905 patient transferred to ED on 2L O2 for further evaluation and workup. Narrative ER Medical decision making narrative: Accu-Chek was obtained noting a glucose to be at 80. She received IV fluids as well as Solu-Medrol Benadryl and IV Pepcid.  She also received IV Tylenol as she developed a headache while in the emergency department.  Headache resolved and she was able to ambulate without assistance.  Requested to go home states she felt much improved near normal.   Clinical Impression:  Adverse reaction to drug Patient Education:  Anaphylaxis (ED)
STOMACH ACHE/ ABDOMINAL PAIN/ ABDOMINAL CRAMPS/ FELT LIKE SHE HAD BEEN POISONED; This spontaneous case report (PVX2019-2062) was received from a consumer on 09-Aug-2019. It described a 60-year-old female consumer who reported "stomach ache/ abdominal pain/ abdominal cramps/ felt like she had been poisoned" (PT: Abdominal pain), after the administration of oral Vivotif for typhoid fever prophylaxis.   Case report: The consumer took first dose of Vivotif on 06-Aug-2019. On the same day, she experienced stomach ache/abdominal pain and abdominal cramps. Also, she felt like she had been poisoned. Her physician told her to stop taking remaining doses of Vivotif. Moreover, she had no prior history of abdominal pain and cramps.  Action taken with Vivotif was vaccine discontinued.  The consumer had been recovering from the reported event.  Company's Comment: In this case, it was reported that the consumer experienced "stomach ache/abdominal pain/abdominal cramps/felt like she had been poisoned". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, abdominal pain is labeled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "stomach ache/abdominal pain/abdominal cramps/felt like she had been poisoned" . There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, abdominal pain is labeled as per CCDS.
Case number PHEH2015US023400 is an initial spontaneous report received from a pharmacist on 09 Nov 2015. This report refers to a 16 year old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 173906) intramuscularly at a dose of 0.5 ml on 07 Nov 2015. The case was reported as non-serious. No adverse events were reported following the maladministration.
Systemic: Dizziness / Lightheadness-Severe, Additional Details: Pt reported feeling dizzy during observation after the vaccination. Pharmacist immediately had pt lay down on the floor and elevate her feet. I monitored her blood pressure and pulse (119/72 and 56 bpm). I stayed with the patient while she was on the floor. She never lost conciousness, but felt lightheaded for about 10 minutes. She did not require assistance to lay down or stand up.
Sore right arm.  red right arm.  This was followed by pain to the right scapula, fatigue, and "brain fog". This finally has improved as of today 4/26/21
This spontaneous report as received from a nurse practitioner refers to a 67 year old female patient with no reported medical history. On 07-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (route dose and lot number unknown). No other suspect therapy or concomitant medication was reported. On 07-AUG-2013 the patient experienced severe swelling and severe pain in the arm where PNEUMOVAX23 was administered. The nurse practitioner reported that the patient's blood pressure is a little low and the patient feels a little fatigued. No treatment information was reported. The outcome of severe swelling and severe pain   in the arm where PNEUMOVAX23 was administered, a little fatigued and blood pressure is a little low was reported as not recovered/not resolved. The reporters relatedness of severe swelling and severe pain in the arm where PNEUMOVAX23 was administered, a little fatigued and blood pressure is a little low to PNEUMOVAX23 is unknown. Additional information has been requested.
Information has been received through the Merck pregnancy registry from a registered nurse concerning a 37 year old female with a history of unspecified IM pain medications causing nausea and vomiting, who on 07-SEP-2006 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (lot # 651280/0803R). It was unknown if the patient had a local reaction at the injection site or if the patient had varicella or herpes zoster symptoms post vaccination. Concomitant therapy included prenatal vitamins. It was unknown if the patient was tested for varicella antibodies prior to vaccination. "Around 11-OCT-2006 or 12-OCT-2006," the patient conceived with the date of her last menstrual period reported as 26-SEP-2006. Unspecified medical attention was sought. A prenatal profile consisting of a complete blood count and urine analysis was performed, the results were not reported. On 14-NOV-2006, at the patient's first OB visit, an ultrasound was performed and showed an intrauterine pregnancy and fetal heart, the estimated delivery date was confirmed to be 05-JUL-2007. It was reported that the patient had 2 previous pregnancies and 1 full term birth. No birth defects, stillbirths or miscarriages occurred in any previous pregnancy. No further information was provided. There was no product quality complaint involved. Follow up information form the registered nurse indicated that the patient had a serum alpha-fetoprotein test on 16-JAN-2007 which was within normal limits and a level II ultrasound on 01-FEB-2007, which was also within normal limits. It was noted that all routine prenatal testing was within normal limits. The patient was placed on therapy with famotidine (MSD) over the counter on 08-FEB-2007 for heartburn during pregnancy. On 04-JUL-2007, 39 weeks from her last menstrual period the patient gave birth to an 8 pound 13 ounce normal girl. There were no congenital anomalies. There were no complications during the pregnancy though she did have a prolonged 2nd stage labor with posterior occiput presentation. The patient had no infections or illnesses during pregnancy and no concurrent medical conditions. The baby had no feature of congenital varicella zoster syndrome. No further information was provided. Additional information is not expected.
Allergic reaction following administration of Covid19 (Janssen) vaccine included urticaria on the lower part of both legs, upper part of both legs, lower back, and underneath both forearms. Steroid injection was adminstered and patient took OTC antihistamines. Three days following the sterioid injection, the urticaria began clearing up.
Found painful lump between neck and collar bone; BNT162B2 and Flu Vax, drug start date: 08Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2022 at 11:00 as dose 1, single (Lot number: 6H90z) at the age of 55 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUVAX), on 08Oct2022 as unk unk, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "BP" (unspecified if ongoing), notes: other medications in two weeks: BP/ cholesterol; "Cholesterol" (unspecified if ongoing), notes: other medications in two weeks: BP/ cholesterol; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 08Oct2022, outcome "unknown", described as "BNT162B2 and Flu Vax, drug start date: 08Oct2022"; MASS (non-serious) with onset 09Oct2022, outcome "not recovered", described as "Found painful lump between neck and collar bone". The events "found painful lump between neck and collar bone" required emergency room visit.  Additional information: The patient received other vaccine in four weeks. The patient received other medications in two weeks for BP/ cholesterol. The patient was not diagnosed with covid prior to vaccination. Post vaccination the patient was not tested for covid.
Worst back pain ever felt. Horrible, lingering headache. Complete body pain and weakness. Could not sleep. Took acetaminophen at 6 am the morning after vaccine.
Patient is fully vaccinated.  COVID + at hospitalization 1/5/2022. 80y.o. year old male with PMHx of atrial fibrillation, CAD, DM, HTN, MI, and stroke presents with COVID. Per ER note, Pt was brought in after having 5 episodes of diarrhea at home.Pt presented in Afib with RVR on presentation. Started on Cardizem gtt with improvement in HR. Troponins noted to be elevated, started on Heparin gtt. Pt reported that he also had some congestion and cough.  Imaging was negative for PE. Started on IV antibiotics. Was given 2L bolus. He states that he does not have any chest pain, shortness of breath, abdominal pain or fever. Treatment with decadron and remdesivir.  Discharged home.
pt recvd vax & had t 100; foot twitch & wks later grand mal sz; now sz every day;
2 days following, patient had sore throat, onset of vesicular rash in left vulvar area.  3 days following, erythema uracular/papular rash over trunk, upper and lower extremities.
Large reaction to vaccine, 1/3 of back of arm not quite to elbow red, swollen, armpit tightness/swelling and center part blistered. Went to walk in clinic, got VISTARIL, told her it was the gelatin she was allergic to, but she didn't know she was allergic to gelatin, has some reaction with flu vaccine in past as well.
The patient reports fatigue beginning the day of the vaccine, and persisting to the time of this report.  He had residual episodes of fatigue (1 per week) after his stroke 11/20, however after the vaccine he has been fatigued all day. His neurologist changed his Plavix to Brilinta on 2/11/2022 due to fatigue, without effect.  During these episodes he sleeps excessively He does not report insomnia, dysarthria, focal weakness/numbness, dizziness or fainting, or new memory issues.
Woke with hives on backs of ankles, hips, tops of posterior thighs and on in inside of one upper arm.  Itchy, no respiratory distress.  Gave benadryl and recommended continuing til resolved.
pain in back, achy all over, no fever, started morning after immunization. pt related symptoms to how he felt when he had the flu in February 2019
Pericarditis 1 week after 2nd Pfizer vaccine. Rushed to hospital at 2 AM in cardiac shock to have 1 liter of fluid drained from pericardial sac. Doctors said it was "idiopathic" . Such liars, eh? Event was not reported to VAERS. Duration of adverse event 14 days. FDA failed their duty of care when they approved this vaccine.
about 30 hrs after the vaccination I began to feel very dizzy and lying down made it worse, so sat up-was quite concerned for a time, but the feeling went away after a few hours. Since my husband experienced similar symptoms I felt there must be a relationship to the vaccination.
Right after I received the vaccine I had intense pain at the injection site and at the top of my arm. It hurt to sleep at night, it hurts to touch my arm in that area, even to look at it. It's an intense pain the goes down my arm to my wrist. I have a heaviness to my arm now and it feels much weaker than before the vaccine. The unbearable pain is less but still constant, I still have the heaviness and weakness. I am scheduled for an MRI for a Nerve Conduction Study. I have been prescribed Gabapentin and Lidocaine Patch that I am to pick up at my pharmacy and use until further instruction.
BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS). At the time of the report, EXPOSURE TO SARS-COV-2 (BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS) outcome was unknown.            No concomitant medications were provided. Treatment information was not provided.   Reporter did not allow further contact
Patient reported to the clinic 2/8/19 that she was having erythema and edema to the left deltoid at the injection site. Denies having pain.
The patient reported feeling flushed. Vitals taken and noted to be hypertensive (76 pulse, oximetry 100%, 198/90 BP). Rested 10 minutes and took vitals again (Pulse 77, BP 204/114). Patient reports taking her medications today as prescribed, but does not take BP regularly at home. RN present and assessing patient. Consulted with Dr. and recommended ED for assessment. RN took patient to ED.
Left deltoid area injection site area reddish-pink and hot to the touch measuring 3 1/2 in Length and 3 1/4 in width.
felt lethargic; hot flashes; night sweats; not able to sleep; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic), HOT FLUSH (hot flashes), NIGHT SWEATS (night sweats), INSOMNIA (not able to sleep) and CHILLS (chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced LETHARGY (felt lethargic), HOT FLUSH (hot flashes), NIGHT SWEATS (night sweats), INSOMNIA (not able to sleep) and CHILLS (chills). At the time of the report, LETHARGY (felt lethargic), HOT FLUSH (hot flashes), NIGHT SWEATS (night sweats), INSOMNIA (not able to sleep) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .No concomitant medications was provided.  Treatment information was not provided.
24 hours post vaccination, I developed significant and noticeable swelling of my lips and areas of my face where hyaluronic filler was placed six months ago. Swelling began 24 hours after vaccination and increased up to 36 hours post vaccination before symptoms began to subside.  I did not have any  reaction like this after the first injection.
Dizziness; Sudden worsening of vision; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration (left arm), on 19Jan2021 11:15, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medications included calcium citrate and, probiotics. The patient previously took tamoxifen and experienced allergies. The patient experienced dizziness starting on 22Jan2021 and worsening on 23Jan2021. The patient also experienced sudden worsening of vision on 22Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. At the time of the report, the patient was recovering from the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.