chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experience some kind of inflammation; spike in temperature- 99'F; body aching; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Experience some kind of inflammation), PYREXIA (spike in temperature- 99'F) and MYALGIA (body aching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Pre-diabetes. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Hypertension, METFORMIN for Pre-diabetes, SIMVASTATIN, ATENOLOL and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INFLAMMATION (Experience some kind of inflammation), PYREXIA (spike in temperature- 99'F) and MYALGIA (body aching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Experience some kind of inflammation), PYREXIA (spike in temperature- 99'F) and MYALGIA (body aching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99 DF (High) spike in temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
It was reported that an 11 year old female patient received a ProHIBit vaccination on 08/25/00. Reportedly the patient developed large area of erythema and a fever. Onset date not reported. Further info requested.
Localized erythema, tenderness, pruritus (L) UE approximately 5 days after injection. Site continued to enlarge. BENADRYL and KEFLEX 500mg P.O. QID x 7 days prescribed with improvement. No fever.
Case number PHEH2013US020529 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow up information received from a nurse on 04 FEB 2014. This report refers to a 66-years-old female patient. On 26 SEP 2013, she was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) at a dose of 0.5 ml intramuscularly in the deltoid. It was reported that before vaccination. FLUVIRIN was placed in the shipping container at room temperature for 72 hours and later administered to the patient (incorrect storage of vaccine). No adverse event was reported following this medication error.  Follow up information received from a nurse on 04 FEB 2014: Site of vaccination updated.
05/03/2021 - Received 2nd dose of Pfizer Covid-19 vaccine.  Experienced mild cold-like symptoms that evening. 05/04/2021 - Awoke to excruciating lower back pain.  Tried to walk it out, but passed out from pain.  Could not sit, stand, or lie down.  Only relief was kneeling with shoulders lower than hips.  OTC pain meds, ice, and (very old) muscle relaxers did not help. 05/05/2021 - Went to ER.  Was given a steroid shot and morphine.  CT Scan came back normal.  Sent home with a steroid pack and pain medicine.  Intention was to schedule epidural steroid injection with spine specialist.  Insurance refused to pay for injection.  Pain meds didn't last long.  Took 2nd steroid pack.  Spent 12 more days on knees.  05/18/2021 - Went to ER for 2nd time.  MRI showed existing issues at L4/L5 and L5/S1 and a new disc protrusion at L1/L2 with severe  impingement of the L1 nerve root. Admitted to hospital for pain control 05/20/2021 - Received epidural steroid injection. 05/21/2021 - Discharged from hospital with 3rd steroid pack, muscle relaxers, and more pain meds.  Over the next 5-7 days, slowly regained the ability to sit and stand.  Have experienced relapses but usually recover in 1-3 days.
pain and soreness in arm (upper left arm-same side as vaccination); This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 22Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced pain and soreness in arm (upper left arm-same side as vaccination) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Flu-like symptoms for two day (I don?t consider this an adverse reaction) followed by intermittent drops in blood pressure and fainting on days 2 and 4
Patient received vaccine, per family at vaccination site patients eyes rolled back and he looked pale. Patient is blind, deaf and nonverbal at baseline. Patient had BP 110/80, HR 84, RR 20 per patients family SpO2 98% on RA. Patient had cookies, applesauce and returned to baseline.  Patient observed for 30 minutes.
Case number PHEH2014US018981, is an initial spontaneous report from a nurse received on 19 Sep 2014. This report refers to a 17-year-old female patient who received FLUCELVAC (batch number: 160233) intramuscularly on 18 Sep 2014. No adverse event reported following this maladministration (inappropriate age at vaccine administration).
Patient came in for a flu shot. After reviewing her consent form it was determined she FluBlok was most appropriate for her. The preparation process and administration all went normally. Upon processing the prescription it was realized she received Fluzone HD instead of FluBlok. The patient was called and notified of the incident at 6:30pm. I explained to her that she received HD instead of FluBlok which is a non-indicated vaccine for her age. I explained to her the differences between HD and FluBlok. She expressed concern but was not feeling any adverse effects at the time. She asked if there was anything she needed to do. I informed her I had reached out to her prescriber to let them know and that she may have a larger immunes response than normal as it was a higher dosage. She thanked me for letting her know. And after apologizing, she said "no problem."
Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (Fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Tylenol 650 mg. No relevant concomitant medications were reported.
p/vax pt devel fever 101;pt w/ faint rash & T105 given APAP;pt irritable throughout time;then started vomiting most of time not retaining much did retain applesauce & some fluids;inj sit tender to touch, sl red;wheeze;dx viral exanthem;
Patient stated she was dizzy and remained in bed for 5 days following vaccination. She said her blood pressure dropped from 140 to 100. She also experienced weakness.
Pt had experienced sore arm for a few days. She also had general weakness for 2-3 weeks. She had on-and-off headaches, fever/sweat (questionable, due to ongoing menopause symptoms), and nausea (she also has acid reflux). She still feels "not totally recovered".
got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This consumer reported similar events for five patients. This is the first of five reports. A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317615 same drug/AE, different patient;US-PFIZER INC-2021317616 same drug/AE, different patient;US-PFIZER INC-2021317617 same drug/AE, different patient;US-PFIZER INC-2021317618 same drug/AE, different patient
Child began fever and vomiting Fri. evening. Child has refused foods and fluids since Friday (04/05/2002) began "screaming" and unconsolable Sunday 04/07/2002. Parent has given child Tylenol.
No additional adverse events reported.; Medical Assistant reports the administration of improperly stored VAQT A at 50.5 F; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe (lot # T031202, expiration date 14-JUN-2022) 0.5 milliliter (frequency and route of administration were not reported) for prophylaxis (product storage error). The vaccine was stored at 50.5 degree Fahrenheit (F) for 57 minutes. No previous temperature excursions were reported. No additional adverse events were reported.
Fatigue, headache, soreness, sore arm about 12-24 hours post injection.  Swollen, red, blotchy painful rash at injection site about 2.5 days post injection.
Became nasally congested - spiked temp. 103 degrees - within 7 hrs after vaccines. C/O headache, body aches.
Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I stood up,  Moved to a different chair from injection chair location.  Passed out.  Never vomited but become very nauseated.  These symptoms all occurred within five minutes of the injection.  Ran low grade fever all day on March 24 (day after).
Pt received vaccine 08Dec09. Pt's mother noticed redness and swelling later that evening. Pt's mother states she suspected the reaction was normal and decided to wait to be seen since she had to return to hospital in 2 days. Site is raised, red and warm to the touch w/some tenderness to palpation.
(L) deltoid swelling, redness and purplish hue, low-grade fever 100.1, otherwise fine.
The next day my injection site swelled up like a bee sting. It was huge. My arm also felt number. Next day it was less swollen but the whole area was a huge bloch of red and hot to the touch for about 3 days. The last two days it was itchy. Now I'm fine.
Muscles aches, uncontrollable chills, weak, feverish; within 3-6 hours after injection then headache, congestion, ear aches; red eyes, dizzy within 4 days after injection. Still weak and headaches, etc. after 13 days. Follow-up information received Jan 19, 2010. Patient states was not able to obtain the manufacturer of this H1N1 vaccine. St Mary's Immunization Clinic told patient reactions were "normal" for a new vaccine she had never had.
Severe anaphylaxis. Epinephrine injectiono, IV antihistamines, Fluid IVs, Steroids. Treatment received at Emergency Room.    Reaction lasted several hours.
Information has been received from a health professional concerning an 11 year old female who on 23-MAY-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (656692/0457U) subcutaneously in the right arm. On 25-MAY-2007, the patient experienced red area and itching at injection site. No illness at the time of vaccination. Outcome of the patient not reported. No further information is available.
After eight days, my arm began itching at the site of the injection and when I checked on it, I saw that there was a rash.  The rash was a number of small raised red spots and it was slightly swollen around the injection site.  I called the Covid-19 medical line and spoke with a doctor there who asked me if there was a weal, which there isn't at this point.  He suggested that I keep an eye on it and see if it turns into a weal and get in touch with you and fill report an adverse event.
Significant whole arm swelling and redness approx. 24 hrs after immunizations in left arm. No fever, some pain.
Information has been received from a physician concerning an approximately 9-year-old patient that was "immune healthy" who was vaccinated with a dose of Varivax. At an unspecified date the patient developed herpes zoster ophthalmicus. The patient has permanent eye damage from the presumed herpes zoster. This is one of several reports received from the same source. Additional information has been requested.
13:10 After 2nd covid vaccine, pt reported feeling "very dizzy and weak" and that her legs from thighs to calves felt numb bilaterally. Reported SOB intermittently. Lungs clear to auscultation. VSS BP 140/72, HR 116, R 20, O2 sat. 76-87%.  13:20 25 mg IM benadryl to right deltoid. Pulse ox replaced to r. finger = 90-94%. This RN consulted with RN director of vaccine clinic, RN who recommends pt follow up at urgent care. 13:40: Pulse ox continues 90-94%. Pt reports legs continue to feel numb. Pt advised to f/u at urgent care. Pt agrees with plan and will be driven there by her sister. 1344: Urgent care called and notified of pt imminent arrival and report given to RN. Care relinquished.
Cough, shortness of breath, fatigue, body aches, headache, nausea-vomiting, diarrhea, congestion.  Symptoms lasted 7-10 days. Treatment was antibiotic, tested negative for influenza and COVID-19.
gave an expired dose of Menactra/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18 years old male patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received VARICELLA ZOSTER VACCINE (VARICELLA VACCINE as concomitant therapy.   On 26-Aug-2019, the patient received a 0.5 ml single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5986AA via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
profuse watery diarrhea for 3 weeks, then continuing loose stools at 5 weeks
Urticaria (approx. 1 inch lateral to site) close proximity of vaccine admin. (L) deltoid. BENADRYL PO given. Monitored in office x30 min.
Pt. states that after receiving the 2nd dose of Moderna 01/21/2021. started experiencing symptoms 01/28/2021 of swelling of the arm, redness, and rash. Rash was raised, hot to the touch, and hive-like. Pain in the left arm and rash lasting 2-3 days after being self-treated with Anti-Steroidals and Alieve. No noted Primary visit.
In the morning your stool was mucus- constipation, skin rash, fever, arm pain, pretty intense backpain, fatigue.
Information has been received from a nurse concerning a female with no medical history or allergy who on 26-DEC-2008 was vaccinated with the first dose of GARDASIL IM, 0.5 ml (lot# 660616/0570X). There was no concomitant medication. Subsequently the patient experienced an irregular menstrual cycle. The patient's irregular menstrual cycle persisted. The patient was seen at the practice. Additional information has been requested.
The day after Bexsero imm #1 reported hard knot at and around site of injection, felt like injection stayed in area and did not disperse, swelling, warm to touch, painful
pretty affected by the first two doses/it was very hard; diarrhea for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard) and DIARRHOEA (diarrhea for 10 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     "No medical history was provided by the reporter.".  Concomitant products included HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for Anxiety, TRAZODONE for Sleep disorder.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard) and DIARRHOEA (diarrhea for 10 days). At the time of the report, VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard) outcome was unknown and DIARRHOEA (diarrhea for 10 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-342423 (Patient Link).
Had swelling and pain from 7/1 to 7/2 but was able to deal with it, on 7/2 7pm I started getting chills and body aches. The arm was also swollen and more tender. I could not go to work due to the body aches and dizziness started on 7/3 which ended late on 7/4.
This spontaneous report as received from a physician assistant refers to a male patient of unknown age. The patient was vaccinated with dose 1 GARDASIL in 2011 (dose, route, site of administration and lot # not reported). The reporter stated that in 2012, the patient received the second dose of GARDASIL (dose, route, site of administration and lot # not reported) well outside the recommended interval between the first and second dose. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
pt recv vax 3NOV97 & 13NOV97 pt devel disseminated rash, less than 50 lesions;
got more energy than she normally had; She hasn't slept yet until now; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "Booster"; ENERGY INCREASED (non-serious), outcome "unknown", described as "got more energy than she normally had"; SLEEP DISORDER (non-serious), outcome "unknown", described as "She hasn't slept yet until now".  Additional information: The patient reported that she took the Pfizer Booster vaccine yesterday afternoon, and that she got more energy than she normally had. She haven't slept yet until now.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever; Chills; Not feeling the greatest.; felt weak; Blood pressure dropped to 80/44; A spontaneous report was received from a consumer concerning a 78-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, not feeling the greatest, and felt weak and blood pressure dropped to 80/44.  The patient medical history was not reported. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (041L20A) in the right arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced fever, chills, not feeling the greatest, felt weak and blood pressure dropped to 80/44.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events fever, chills, not feeling the greatest, felt weak and blood pressure dropped to 80/44 was considered recovering.; Reporter's Comments: This case concerns a 78-year-old female who experienced nonserious unexpected events of asthenia, malaise, and hypotension and nonserious expected events of fever and chills.  The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported.  Event outcome recovering. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of ZOSTAVAX (lot # M001746 with expiration date 07-APR-2017; dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed a rash from head to toe the day after receiving the immunization. He went to an urgent care and was prescribed both oral and topical steroids.
Swelling and erythema at injection site.  Treatment included Keflex and Prednisone.
Pt was given FLUMIST on 10-17-14. He developed fever on 10-22-14 but had nml exam. Seen again 10-27-14 w/persistent fever and now w/RLL pneumonia clinically. Fever persisted so CXR on 10-29-14.
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 62-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: fj9843) at the age of 62 years 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: "Stage 4 cirrhosis" (unspecified if ongoing). Concomitant medication(s) included: VEMLIDY. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (07Jun2022) Positive, notes: 7 days after completing Paxloid. I again tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: took Paxlovid for 5 days and seemed OK until today which was 7 days after completing Paxlovid, again tested positive for Covid. No follow-up attempts are possible. No further information is expected.