chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 days before my second Moderna shot, I started seeing hives on my arms but didn't know why. After taking the second dose, I started to experience hives and welts all over my body. I went to an urgent care and got a week steriod pack which helped but after the course was done, my hives came back and were worse. In July 2021, I was rushed to the ER and put in the ICU for a clogged throat and angioedema in my face. I then was seen by two allergist who put me on three medications (montelekaust, famotedine, and cetrizine) and I have been on those medications ever since. I would stop then my hives would come back and my whole body flares up. Different temperature changes take part in the flare up, sensitivity to fragrances (detergent), specific material in clothes and so much more. This should stop..
First , I had very loose stools the next day (Friday).  On Sat. night I felt tingling near my coccyx and started Valtrex 500 mg. Sunday it was more painful and by Monday morning I had a large,, painful herpes lesion at the coccyx and a larger red rash surrounding it.
Hives for 12-18 hours - red, hot, swollen arm, 24hrs later.
I woke up the next day with a fever of 101.2 and terrible chills/shakes, very painful injection site. No redness noticed.
Pt recvd 1st dose of Engerix-B 16AUG91 & seven days post vax exp acute labyrinthitis; on 24AUG91 @ 4PM acute onset of dizziness;
This spontaneous report as received from a licensed practical nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patients pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, an unspecified amount of patients received improperly stored doses of PROQUAD (Lot# N002915, exp. 24-JUL-2018) (dose, frequency and route not reported) for prophylaxis which was reconstituted with properly stored sterile water diluent (manufacturer unknown). No adverse effects reported. No further information provided. Vaccines involved: PROQUAD Temperature: 6 degrees Fahrenheit (F) to 14 degrees F. Time frame: 55 Minutes. No previous temperature excursion. Digital Data logger report was involved. As of 30-AUG-2017, a request was made for patient identifiers and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same reporter (1707USA004913, 1709USA004723 and 1709USA004724). Narrative updated. Sender's Comments: US-009507513-1709USA004724: US-009507513-1707USA004913: US-009507513-1709USA004723.
Information has been received from a medical assistant referring to unknown number of patients of unknown ages and genders. The patient's medical histories and concurrent conditions were not reported. Since February 2016 the patients were administered improperly stored oral ROTATEQ (lot# L027719, expiration date 28-APR-2017, dose not reported) orally. Concomitant therapy was not reported. The vaccine was improperly stored in 27.1 degree Fahrenheit for 10 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
I fear Pzizer because I don't often but once had an allergic reaction to a pill for parasites
erythema, pruritis, edema of palms, soles, fingertips,  Pain with flexion of fingers, skin taut & shiny.  symptoms started 2/27/07 continued though 3/1/07.  Treated with ibuprofen 200 mg two tabs every 4-6 hours and diphenhyrdamine 25 mg at bedtime.
Had a bad reaction to the three Moderna shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Allergy to nuts (Nuts), Allergy to grains (wheat) and Milk allergy (can not drink milk). Concomitant products included ESTRADIOL (DIVIGEL) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots). At the time of the report, IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2022-586557 (Patient Link).
Patient was given the 2nd vaccine but it was not documented, 3rd given as he was showing overdue at the time. Symptoms started same day as 3rd vaccine
Approximately 3 days after vaccination, ringing in the ears developed. It has continued, in varying intensity, through the present. MD has treated for otitis media without resolution of symptoms of tinnitus.
Pt developed a small, red, blotchy rash on her face and a 1cm to 2cm local reaction at the injection site (LL).
Patient was given her 1st dose of Moderna COVID vaccine at clinic on 1/20/21.  Patient states she had no reaction initially but started to develop a rash on 1/28.  rash red, raised, itchy and sore.  Rash 4 inched long and 2 inches wide.  Continues to be red and sore, but no longer raised or itchy.  Instructed patient to contact her PCP for further treatment of reaction and recommendation for second dose.
Very sore arm about  5 hours after the shot. After about 8 hours, I could not use my left hand (I could not close my hand in order to hold an item or pick up a piece of paper). By  12 hours after the shot, I had a fever of 100, chills, body aches, headache. All of these cleared up and returned to "normal" by 2 pm the following day. Full use of my hand returned and the fever/chills/aches went away. My arm was swollen at the injection site (to the point that people could see the swollen area through long sleeved shirts) for about one week.
Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right deltoid injection of 2nd dose noticed on 1/12/21 at 05:30 which is 4 days post dose.  No advert issues or need for medication treatment.
Flu shot administered on 11/07/2016, began menstrual cycle on 11/28/2016 and still have a menstrual flow (13+ days as of today, 12/10/2016).
Swelling, redness at pneumonia site, blistering, abscess. Received antibiotics at ER 10 days after vaccination.
From phone contact w/PT's parent, was stated that an 18 y.o. female PT received a TD adult vaccination, lot #U0361AA exp. 10/12/02 on 8/28/01. The PT developed fever 104 deg F, chills, a sore arm and leg- muscular, as well as a headache. PT was seen in MD's office.
Patient got a red rash from immunization beginning the day after he received the immunization. Was instructed to take BENADRYL.
5/7/07: Received vaccines. 5/8/07: Mom calling to report large red raised area, warm to touch and pain temp - 101.0. Mom to apply ice, give Motrin also itch.
Around 2AM I awoke with a headache, sore throat not feeling well. I took two TYLENOL and went back to sleep. I awoke again at 6AM not feeling any better, I had a runny nose. I took a home COVID-19 test that came back positive. I called my doctor and had a telehealth visit. I was prescribed PAXLOVID, advised to take zinc 50mg, vitamin C 500mg, vitamin D 500mcg iu once a day. I was feeling better and back to work in five days as long as I wore my mask. My cough lingered for a bit but I felt much better.
6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder). At the time of the report, PRODUCT STORAGE ERROR (6 patients got a dose of the Modena vaccine from a vial that was stored in a super cold freezer temperature with -66°C and colder) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  HP stated that at least 6 patients got a dose of a Moderna vaccine from a vials previously stored in this freezer of temperature is -66°C and colder between 01Sep2021 till past Monday,11Nov2021. vials of 14 doses are still in the ultracold freezer, 1 vial is thawed and in the refrigerator,  HCP is looked for some guidance in regards to the vaccines in the freezer and a vial that has already been thawed and is under refrigerator conditions, but remains unpunctured.  Excursion duration: From the packing slip HCP found out the date in the computer stated it was received in 01Sep2021, but HCP stated they think it was there before that date, and that the quality check stated 19Aug2021.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains dose number information.
Sore arm, chills, tired, muscle aches occurred approximate 22 hours after the injection.
No adverse effects were reported in the patient; the patient received an expired dose of VAQTA (lot R010369 exp 3/25/2019) after its expiration date; This spontaneous report was received from a pharmacist regarding a patient with no name or other demographics provided. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  On 16-AUG-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), lot # R010369 and expiration date 25-MAR-2019 (expired product administered) (strength: 25/0.5 (units not provided); dose, frequency, route of administration not provided) as prophylaxis. No adverse effects were reported in the patient. No product quality issue was present.  The case is non-valid due to lack of patient's identifiers.
Small, red, puss-filled vesicles on the skin. Itching and spreading across the body. First location in the underarm and on the knee of the same side. Now scabbed and still itching/painful. Appears to be a chicken pox and/or shingles-like reaction. Not from bugs or contagious illness as none in household are affected. Mottled net rash throughout body that does not itch.
I had chills, body aches. headache. Left arm had a large red spot , large as grapefruit, very sore and tender. Became tired and felt like flu symptoms Went to bed and in the morning felt better but very fatigues for 3 days, and headaches for two days.
Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional (Medical assistant). This case involves a 73 years old male patient who had received an expired dose of FLUZONE HIGH DOSE inadvertently. The patients past medical history, concomitant medication and family history were not provided. On 30-Aug-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI885AB, expiry date 29-May-2018 via intramuscular route in right arm. It was a case of actual medication error due to expired vaccine used. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender - none.
patient did not receive second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 09-JUL-2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not receive second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-OCT-2023 The pharmacist reported that, patient did not receive a second dose of Shingrix. Pharmacist could not provide lot number or expiration date of the dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Arm, upper sore and did not resolve over long period of time. Had to see doctor for pain (10/8/13-to current).
fainting hoarsness muscle aches nauseasneezing wheezing, headache within 20 minutes after shot progressively has gotten worse and hasnt stopped, weakness came on about 1 to 1 and a half hours after shot got worse during the night on dec 4 and has lessened but still keeping me from daily activity , have not went to doctor as i thought symtoms would reside and have no insurance but will call doctor tommorow for advice
Pt was sitting in observation area and suddenly passed out and fell to the floor and hit her head.   She stayed and received an ice pack, and once she felt better ended up leaving.  We took her blood pressure and had her stay here for awhile.  We also gave her some water while she waited.
Just a sore pink arm the first few days.  About day 6 after the shot, it got angry pink, very hard, swollen, and very itchy. It was the size of a baseball.    It stayed a localized reaction but was very uncomfortable for about 8 more days. By day 14 it was just an outline of what it was, skin colored inside, no longer hot but still a little bit itchy.
Patient had  rashes, fever 1 day after vaccine was administered. Rashes are minute vesicular "chicken pox like lessons, generalized. with erythematous linear macular .  Supportive treatment: daily baths, acetaminophen,Benadryl.Stay at home until scabs are dry and no new scabs are coming in. Follow up in 2 weeks.
On March 28, I woke up completely deaf in my right ear. Over the days it has been improving very little. And my hearing hasn't fully returned until today. I do not feel pain, being noises, beeps all the time that do not let me understand.
Hospitalization: 1/20/2023 - 1/24/2023 (4 days) Presentation to the ED: Admitted for transient ischemic attack COVID + date: 1/22/2023 Treatment: No indication for antiviral or steroids therapy.  Discharge to: SNF  EN5318 1/29/2021 EN6200 2/20/2021 32030BD 11/1/2021
Pt received PENTACEL, Hep B #1 & PREVNAR-13 on 5-16-11. Within 12 hrs pt was fussy, inconsolable crying, whining, jerky movements in sleep, interrupted sleep patterns, loss appetite, no fever.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 13 days post expiry) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A and 011L20A) for COVID-19  immunization. No medical history reported. On Jan 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 19, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 19, 2021, patient administered expired product (vaccine given 13 days post expiry). On Nov 19, 2021, administered expired product (vaccine given 13 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-395985 (patient link).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on patient's concurrent conditions, medical history and concomitant medications was reported. On 31-MAY-2017, the patient was vaccinated with an expired dose of VAQTA 50/1 U/ml, 1 ml, intramuscular, lot # M022556, expiry date: 26-MAY-2017. No adverse event was reported. Additional information has been requested.
Information has been received from a registered nurse concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. On 13-SEP-2016 and 14-SEP-2016 two doses of improperly stored PROQUAD (dose and frequency unknown) (lot # M015698, expired date 26-SEP-2017) were administered to unspecified patients. The PROQUAD was exposed to 11F for a time frame of 12 hours 35 minutes. No adverse effects reported. Additional information has been requested.
No additional adverse event reported; Patient was accidently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a registered nurse and refers to a 10-year-old female patient. The patient's medical history included leukaemia with bone marrow transplant in approximately March 2021(also reported as approximately 20 months ago). The patient's concurrent conditions and drug reactions or allergies were not reported.  On 24-OCT-2022, accidentally the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # U003306, expiration date 15-OCT-2022,  in the right deltoid for prophylaxis (dose and route were not reported) (expired product administered). The product had no prior temperature excursions. No additional adverse event and no product quality complain were reported.   Concomitant therapies included ketoconazole and colecalciferol (CHOLECALCIFEROL).
Itching from my head that progressed to my knees by early afternoon.  No hives or anything else. Resolved after two doses of benadryl about 4 hours apart.  Woke up next morning feeling fine.
10/4/2021 - Sudden stabbing pain in upper right chest.  Radiates to neck and back, right side 10/5-10/6 - pain subsides, but coughing  10/7 - Stabbing pain in upper right chest more severe, scheduled appointment with PCP 10/7 - PCP (Primary Care Physician) did EKG, D-Dimer and Chest X-ray.  D-Dimer positive; X-ray shows fluid in bottom of right lung.  PCP orders CAT scan 10/8 CAT scan shows pulmonary embolism.  EKG and other heart health tests come back normal.  Sent home with 20mg/day apixaban (blood thinner). NOTE:  no history of clotting, no risk factors for clotting.
A report was received from a health care professional on 12/9/03 concerning a 23 month old male vaccinee who inadvertently received Fluvirin on 12/5/03. On 12/5/03 the vaccinee inadvertently received 0.5ml Fluvirin IM. The vaccinee had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 4/5/04: Follow up information received from a health care professional indicated that the vaccinee inadvertently received 0.25ml Fluvirin on 12/6/03 and 1/8/04. No adverse events have been reported to date. No follow up pending. All information received.
Initial overdose report received from a healthcare professional on 18 March 2013. A patient (No information was provided regarding the patient) had received ACT-HIB and PENTACEL so the patient received double ACT-HIB dosing. No adverse event was reported. List of documents held by sender: none.
Red, swollen inject site w/corresponding cellulitis - 9 cm x 7 cm lesion noted on 2/19/03. Tx with warm compresses, Septra DS QD x 7 days. Motrin 600 PRN
Fever; Chills; Nausea; Tiredness; Body-aches/Soreness; Small red rash near injection site; Persistent Headache; Dehydration; This is a spontaneous report received from a contactable consumer, the patient. A 31-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO175) via an unspecified route of administration in the left arm on 22Apr2021 at 10:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included VITMAIN D deficiency and allergy to PENICILLIN. It was unknown if the patient was pregnant. Concomitant medications included VITMAIN D 50000 MG. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 01Apr2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 21:00, the patient experienced fever, chills, nausea, tiredness, body-aches, soreness, small red rash near injection site, persistent headache, and dehydration. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, nausea, tiredness, body-aches, soreness, small red rash near injection site, persistent headache, and dehydration was resolved with sequelae (also reported as recovered with lasting effects) on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
I waited the 15 minutes after the shot like they asked. About half an hour after I got the shot I started feeling a touch woozy.  I was driving home and had started moving my arm around some to work out the soreness.  A few minutes later I got really nauseated and started fading out of it.  I pulled over, put my  car in park, and put my hazards on. I passed out for 5-10 minutes. It was not just falling asleep but actually going unconscious. When I woke up I was covered in sweat and was very nauseated.   I had a friend come pick me up (obviously it was unsafe for me to drive). I have continued to feel a little woozy and nauseated (about three hours now after the injection). I also have cold sweats come on and off and I feel very tired.   I was well hydrated, not hungry (had eaten semi-recently), and well rested when I went to get the vaccine.
I had a fever of 102.7, chills, muscle pain, stomach cramps, extreme headache, and the 2nd day it turned into a bad cough. And extreme fatigue. I had at home covid test and it was positive. They gave an antiviral and then it lasted for, and I only started to feel well this week. The symptoms have been very bad.
Fever of 101.5°, vomiting, nausea, stomach pain, lethargy/fatigue, loss of appetite