chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu shot for seniors 11/7/17, started throbbing within 2 hrs., started physical therapy for L. arm wk. 12/11/17 on advice of primary doctor, waking up every time I change positions; can't raise left arm w/o using R hand to help raise it up first thing in the morning; having to carry purse in R hand, hurts when I use my L arm driving; constant throbbing; this is the 7th week of this pain. Was already in PT for surgery of my back 9/22/17. Have to pay copay every time I go to PT; have been dismissed from neurosurgeon for my back 12/19/17. Have complained with my L arm from time I got the vaccine to present, to physical therapist, went to primary doctor, went to orthopedic doctor thinking might be something to do with arthritis, NOPE. Have appt. for 1/8/18 to see orthopedic doctor to check and see if it could be shoulder. Did not do this before I had flu shot and I have not done anything to make my shoulder hurt.
This 14-month-old female received 2 doses of Haemophilus b conjugate vax. Subsequent to the 2nd vax on 03/02/1993. Subsequently, the pt had a blood culture performed which revealed Haemophilus influenzae type B. It was noted that the pt also experienced cellulitis and bacteremia. Upon internal review, the pt's experiences were considered to be "other medical events."  The pt's outcome status was reported as "survived." This was reported as case of vax failure. No further information is available.
No adverse reaction patient was given FLUCELVAX and he is under 18 years old.
Dry cough for a month. Felt like lungs were irritated and muscles were contracting to cough constantly. Cough has calmed down after a month, but still comes back infrequently.
Sore throat occurred after 3rd day and has continued 7 days after the last dose. Right side was first irritated and now both sides of throat are causing issues.  Also, having vivid dreams since the shot and starting to wake up various times throughout the night since. In addition, urinating 2-3 times per the night since the shot. Quality of sleep is being affected  due to symptoms.
I did and guess what I got Covid; I did and guess what I got Covid; vison's blurry; my back hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I did and guess what I got Covid"; VISION BLURRED (non-serious), outcome "unknown", described as "vison's blurry"; BACK PAIN (non-serious), outcome "unknown", described as "my back hurts". Clinical course: Patient is having all these side effects, that actually are worse than covid itself.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & devel fever 105, emesis x 1, h/a, DTP rxn no hx of prev rxn;
Per AGENCY: Regarding The form for Clinic on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a AGENCY Reports on the all clients you have identified.
Narrative:  Fully vaccinated, admitted for elevated LFTs and found to be COVID positive
arm stay sore; pain where he got the shot; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 12Jul2021 as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced arm stays sore on an unspecified date, pain where he got the shot on an unspecified date. Upon follow-up on 14Jul2021 spontaneous report from a contactable consumer. This male consumer (patient) reported about characteristics (age, sex, version for reaction or event term LLT was not applicable, Reaction or event in terminology (LLT)was medical information potential AE, drugs information (proprietary medicinal product name, dose details). Patient wanted to know how long does pain in the arm and swelling of the arm usually lasts after getting the Pfizer BioNTech Covid-19Vaccine. Outcome of the event was unknown.   No follow-up attempts are possible. No further information expected. Information on batch/lot num-ber cannot be obtained. Follow-up (14Jul2021): This is a follow-up spontaneous report from a contactable consumer. This male consumer (patient) reported about characteristics (age, sex, version for reaction or event term LLT was not applicable, Reaction or event in terminology (LLT) was medical information potential AE, drugs information (proprietary medicinal product name, dose details). Patient wanted to know how long does pain in the arm and swelling of the arm usually lasts after getting the Pfizer BioNTech Covid-19Vaccine
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). This report received from a Pfizer-sponsored program. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot number: unknown), at the age of 64 years old, in Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Two weeks later, the patient experienced tested positive for COVID-19 on an unspecified date in 2021. Caller was asking about taking the second dose. Caller stated he wouldn't be allowed to receive the second dose until he tested negative for COVID-19, "which put him over the 42 days window." Caller was asking if there was adverse effect receiving the second dose now. Seriousness criteria was reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 test: positive in 2021. The outcome of events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Fever, nausea, fatigue, muscle aches, I felt like I had the flu.
Severe body muscle and bone aches, nausea, episodes of feeling faint, Orthostatic hypotension, loss of color in face and lips, headache, weakness, lethargy
pt recv vax & exp soreness & heat @ the inj site, devel redness @ the inj site, & exp muscle aches to point could not lift arms;
No adverse events as far as symptoms. Vaccine was administered 6 hours and 40 mins post reconstitution time.
fever 100 & generalized flushing face & body w/in 6-8hrs of inj;also recvd PCN for cat bites & scratches;14DEC94 series completed w/no addl events;fever & flushing disappeared p/4 days & did not return
Information has been received from a consumer concerning her 8 year old daughter with no pertinent medical history and no drug reactions/allergies who in 11-SEP-2000, was vaccinated with one dose of VARIVAX (Merck) (Lot#: not reported). There was no concomitant medication and no lab diagnostics studies were performed. The consumer stated that since 2006 her daughter had had four episodes of shingles. The rash consisted of red, raised lesions and a few blisters distributed around the left mid-torso. The rash resolves within 2 weeks without requiring treatment. The consumer added that her daughter had a negative varicella antibody titer approximately on 28-JUL-2010. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow up information was received from a certified medical assistant who stated that the patient had one non-confirmed case of shingles in June 2006. Follow up information has been received from a physician who reported that the patient had received the first dose of VARIVAX (Merck) only. The patient was diagnosed with shingles in June 2006 and had only few vesicles vs macules, Herpes Simplex Virus (HSV). The patient's mother stated that the patient had had these lesions 3-4x and that "other family members would get similar lesions, even the children that had not received VARIVAX (Merck) at all". MMR and varicella titers were performed showing no immunity to VARIVAX (Merck) or mumps. So likely lesions were not varicella and Enzyme immunoassay (EIA) serology was not very sensitivity for vaccine immunity. Bottom line, likely lesions in past were not varicella and the patient would need second vaccine. Follow up information received from a physician indicated that the patient had a history of negative titers while on prior therapy with MMR II (WAES 1101USA01355). This is one of several reports received from the same source. Additional information is not expected.
hives; This is a spontaneous report from a contactable consumer (patient)  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on an unspecified date as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Patient got her first dose of the vaccine and experienced side effects after getting it, she said she had hives on an unspecified date. The outcome of the event was unknown. Patient asked if it was safe for her to get the second dose of the vaccine. No follow-up attempts are possible, information about batch number cannot be obtained
sore arm; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 2 patients of unknown demographics who had sore arm (pain in extremity), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient's received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient's developed a non-serious sore arm (pain in extremity), unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was sore arm.   It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as unknown.  Information on the batch number was requested.
GAVE THE MODERNA BIVALENT COVID SHOT INSTEAD OF THE ORIGINAL MODERNA FORMULATION FOR PRIMARY SERIES.
THe second vaccination hit harder than the first.  The tingling of my lips started after 45 minutes.  The fever hit me in an hour.  I ended medicating with allergy pills and Ibuprofeen.
body ached; head is pounding; whole body was shacking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (whole body was shacking uncontrollably), MYALGIA (body ached) and HEADACHE (head is pounding) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced TREMOR (whole body was shacking uncontrollably). On 30-Dec-2021, the patient experienced MYALGIA (body ached) and HEADACHE (head is pounding). At the time of the report, TREMOR (whole body was shacking uncontrollably) outcome was unknown and MYALGIA (body ached) and HEADACHE (head is pounding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.
Hospitalized for chills, dry cough, dyspnea.  Requiring O2.
wheezing when breathed.; Gestation 26 weeks; This is a spontaneous report from a contactable consumer (patient). A 43-year-old pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot num-ber: EK(orR)8130 7/21), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 43-year-old) as a dose 1, single for COVID-19 immunisation. Maternal exposure during pregnancy second trimester (26 weeks). The medical history of the patient included renal tubular acidosis, hypertension, gestational diabetes. The patient was allergic to doxycycline, KEFLEX, OM-NICEF, amoxicillin, pollen, mold and animal danders. The patient last menstrual date was reported on 21Sep2020 and delivery date to be 26Jun2021. The concomitant medication of the patient included po-tassium chloride (KLOR-CON), cetirizine (ZYRTEC) and levothyroxine (MANUFACTURER UNKNOWN), labetalol (MANUFACTURER UNKNOWN) and insulin (MANUFACTURER UNKNOWN), all are taken on an unknown date. The patient experienced wheezing an hour and a half after the vaccine on 23Mar2021 at 11:30. Therapeutic measures were taken as a result of wheezing and included treatment with BEN-ADRYL and one puff of inhaler. The patient thinks symptoms were gone by about 20 minutes. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of wheezing was recovering at the time of this report.  Follow-up attempts completed. No further information expected.
Arm soreness for a couple of days with the first 2 doses; Fatigue for a day with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (Arm soreness for a couple of days with the first 2 doses) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.  On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (Arm soreness for a couple of days with the first 2 doses). At the time of the report, FATIGUE (Fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (Arm soreness for a couple of days with the first 2 doses) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No treatment information was reported.  The patient had no comorbidities, no regular chronic medications.   Patient received second dose of Moderna vaccine on 02-Mar-2021; batch number 011A21A and Expiry Date: 16-Aug-2021.  Patient received third dose of Moderna vaccine on 08-Nov-2021; Batch number: 039F21A.   This case was linked to MOD-2021-384343, MOD-2021-384344 (Patient Link).
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS TEST POSITIVE (tested positive for COVID) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CORONAVIRUS TEST POSITIVE (tested positive for COVID). At the time of the report, CORONAVIRUS TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Patient received the Pfizer/BioNTech vaccine (1 dose).  Patient had already received the Janssen/Johnson & Johnson on 5/19.
She got the vaccine, there was nothing at first, lazy feeling, dragging feeling.  Then 1 week later, she felt tired, and was going to her doctor for routine physical and was doing an US and then it came back that she had an enlarged heart, myocarditis.  She was not given anything for it, told to watch it and to FU with him.  This was her PCP.   She went to the cardiologist 9/22/21, was in a hurry and didn't give her anything specific to do, told her to exercise.    She feels OK.
Pt who is 16 years old receive Moderna vaccine instead of Pfizer by mistake. Pt did not experience any adverse reactions.
Presents to ED with c/o cough, fever, fatigue, body aches, sore throat and decreased appetite x 6 days.
Swelling, Redness, Rash, Recommended IBU and Neosporin
2nd day Monday, 15th, swelling on the left breast and inner was red and swelling, My arm was sore. 16th the breast started changed color to purple. the following day it burst and blood was oozing out.  I went to urgent and they sent to ER and 1 was. The wound was open and given anti biotics and had flu like symptoms. I had a blood clots in my arms.  Notes - left arm , lymph notes was swelling for 1st dose. hospital for 6 days. Shot on Sat and Sunday I got tenderness. sore and then bursting at work.
Development of hypertension , prior to vaccine patient with well controlled HTN  (stage1), after vaccine, rapidly progressive HTN to stage 3, with need of increasing  of HTN medication.
BLOOD CLOTS OF LUNGS; BLOOD CLOTS OF LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown ) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient ended up getting blood clots of lungs and legs and was wanting to know more information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots of lungs and blood clots of legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556674-COVID-19 VACCINE AD26.COV2.S-Blood clots of lungs, blood clots of legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
A day after receiving the vaccine on 03/23/2021, I started to experience chills when I woke up and I had a slight pain going from my armpit down to my breast. Throughout the day I started to monitor the area and noticed swelling underneath my left armpit so I scheduled a doctors appointment for the following day. I was told by my doctor that I was experiencing swollen lymph nodes and was advised to take Aleve and to rest.
Patient presented with bloody diarrhea 4/8/7. DX of intussusception - Surgically reduces. Had Rotateq 2/16/07. No known association. 06/06/07-received observation note for DOS 4/9/07-DC Probably intussusception. Two day history of low grade fever and vomiting, decreased appetite. On day of admission developed bloody diarrhea. Transferred to another facility 6/21/07-records received from receiving facility for DOS 4/10-4/13/07-DC DX: Intussusception and necrotic cecum. Presented with 24 hour history of emesis and bloody mucous per rectum.  Exploratory laparotomy and reduction of ileocolic intussusception with ileal cecetomy and primary ileal colostomy.
Headaches/Headache; Body aches; Soreness at the injection site; Fever; This is a spontaneous report from a Pfizer sponsored program support.  A contactable 38-year-old Nurse (patient) reported for herself. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178; Expiration Date: unspecified date in 2022), via an unspecified route of administration, administered in arm left on 09Jun2021 at 11:15 as 2nd dose, single for COVID-19 immunization. The patient did not had any medical history. Family medical history were none. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186; Expiration Date: Unknown), via an unspecified route of administration, administered in arm left on 19May2021 as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On 10Jun2021, the patient experience soreness at the injection site, headaches, fever, and body aches. It was reported that soreness has worsened but the other symptoms have improved. The patient would like to know if these symptoms are normal, and will they go away and like to know if there is anything else, she can take for her symptoms. It was reported that she missed work yesterday and today and she was supposed to return to work tomorrow, but she was not sure if she will be able to. The patient stated she has been taking Tylenol and Ibuprofen and they have not been working. The reporter seriousness of the events Headache and body aches are reported as serious. The patient had not yet recovered from the events   Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available
restlessness, tightness in throat, nausea, shaky, dizzy, BP dec, inc pulse, anxious & apprehensive, poss allergic reaction; light headed, pale;
Around 9 pm on 5/6/21 began to experience chills and body aches. Around 7am on 5/7/21 nausea, dizziness and a temp of 100.6 noted. The symptoms are now subsiding on 5/7/21
Pt waited for 15 minutes and had a reaction to PROQUAD. Welt measured 1in by .5 in. Pt was given 3.75 of BENADRYL and kept for an additional 15 minutes.