chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got Moderna vaccine on 02/15/2021. She was feeling good until today. She called pharmacy and complained that recently all at sudden her arm got swollen and having redness and tenderness at injection site. Just reporting this because she has this side effect after a 10 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-APR-2014, the patient was vaccinated with MMR II injection, lot #0184AE, expiry date 18-JAN-2014, 0.5 ml, subcutaneously, for unknown indication. No concomitants were reported. On 09-APR-2014, the patient was inadvertently administered MMR II that had expired on 18-JAN-2014 and no adverse effects reported. The outcome of events was unknown. Action taken with respect to MMR II was not applicable. No PQC (product quality complaint) was reported. No further information provided. Additional information has been requested.
Severe shivering, inability to get warm in night. Fever of 100.2 at 6:30 AM. Symptoms lasted for about 12 hours.
received only the liquid portion / adjuvant only.; received only the liquid portion / adjuvant only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant stated that, the patient had received only the liquid portion of the shingrix, they did not reconstituted with the powder. which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further data reported. The the medical assistant states that a husband and wife were in the office and one of them received only a partial dose of the shingrix for dose 2 of the series. They had no way of determining which patient (the husband or wife) received the adjuvant only. They intend to revaccinate both patients in four weeks time. No further details were provided at the time of this call, and the medical assistant rushed off the line at the end of the medical discussion. No further details provided. The reporter consented to follow up.
Swollen lymph nodes on both side of neck area close to collar bone; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Feb2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease (CKD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 04Feb2021 at 09:00, the patient experienced swollen lymph nodes on both side of her neck area close to her collar bone. It was reported that swollen lymph nodes were not there prior to the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether therapeutic measures were taken as a result of the reported event. The clinical outcome of the event swollen lymph nodes on both side of neck area close to collar bone was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Left arm is throbbing; rash around injection site.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 09Apr2021 at 16:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications within two weeks prior to vaccination. The patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 6:00, the patient experienced left-arm throbbing and rash around the injection site. The clinical course was reported as follows: Left-arm was throbbing even after 30 hours post-injection and 3 diameter rash around the injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the events left arm is throbbing and the rash around the injection site was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient was injected initially by RN into the right arm. After removing the needle, the RN noted several drops of vaccine exit the injection site. He was unable to quantify whether greater or less than 1/2 of the dose remained intramuscularly so the patient was counseled by PA-C. The patient was provided with and counseled on the current CDC guideline regarding partial dose administration and elected the option to receive another dose in her opposite (left) arm. She was counseled on the potential side effects, risks, and benefits of doing so. The second injection into her left arm was administered by another RN per patient request for an alternate vaccinator. She was advised to return on schedule in 4 weeks for her 2nd dose per CDC guidelines,
No additional adverse events/product quality complaints reported.; Caller is inquiring if administered expired VARlVAX is viable.; This spontaneous report was received from a other health professional concerning to a patient of unknown age and gender. The patient's current conditions, medical history and historical drug were not reported. No concomitant therapies were provided.      On an unknown date the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S002740 and expiration date since it makes match with the autopopulated expiration date expiration date:20-JAN-2021) (dose, strength, vaccination scheme, anatomical site of injection, route of administration and indication were not reported).         On 02-FEB-2021, the reporter was inquiring if administered expired varicella virus vaccine live (oka/merck) (VARIVAX) was viable.   No additional adverse events were reported.
No additional AE's and no PQC's were reported; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report has been received from a registered nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, or allergies, and concomitant medications were not provided.  On 13-MAY-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, vial (valid lot number U024220 (also reported as U024229) [expiration date 04-AUG-2023]) for prophylaxis (reported as use as directed to prevent varicella infection), after a temperature excursion of 32.9 degrees Fahrenheit (F) for 24 hours (h) 30 minutes (min) and 0 seconds (sec) (product storage error) (dose, dose number, vaccination scheme frequency, route, and anatomical location of vaccination were not provided). No previous temperature excursion was reported. No additional adverse events (AE) were reported.  This is one of some cases from same reporter.; Sender's Comments:  US-009507513-2205USA004149:
pt recvd vax @ approx 20 to 30 yrs old w/2 dose of MMR & lab eval revealed neg titers; No further details were provided; nurse reported 8 pts;
Immediately after receiving 1st dose head above neck area itches. (tongue, scalp, forehead, ears, inside of the mouth area, eyes, and nose) Pain in arm down to elbow and pinky finger. Arm and pink unable to move and lift properly.
Was vaccinated, got shingles/Suspected vaccination failure; Shingles on eye; Shingles on face; Horrible pain; Rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced pain and rash. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown and the outcome of the pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and rash to be related to Shingles vaccine.     Additional Information: GSK receipt date; 4-Dec-2022 Reporter's comment: The case was received from the patient interactive digital media. The patient stated that vaccine did not prevent shingles. The patient questioned whether it minimized them, she was vaccinated and got shingles on her face, and eye medications early, horrible pain, rash going 1 month. The reporter denuded for the follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Back calculation was done for onset date of horrible pain and rash asmper reported information.
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of GARDASIL 9, lot number not reported. Improperly stored vaccines included VAQTA, RECOMBIVAX HB, M-M-R II, PEDVAXHIB and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected.
Pt woke up at 0400 on 11/16 with stomach ache and nausea.  Got up and went to the bathroom at 0600 with nausea, dizzyness, and cold sweats.  Pt passed out leaving the bathroom.  Woke on the floor by himself without any noted injuries.  Had 99.7 temperature, fatigue, and did not feel well all day.  Remained not feeling good on 11/7, felt better by the afternoon on 11/18.
Child broke out in Rubella like rash beginning on face and spreading to trunk, arms, and legs. With fever of 101.2 and fussiness,  cough and rhinorrhea. Began 10 days after MMR vaccine.
I am 60. According to my medical chart I saw the lot # for shot given is one given below my chart said manuf GlaxoSmithKline debilitating itching flu shot site LA and spreading. Rash forearms today.
Presented with progressive weakness in the lower extremities with numbness and paresthesias in his lower extremities.  Eventually admitted to hospital on 10/12/2023 and had lumbar puncture demonstrating high proteins with oligoclonal band and myelin basic protein pending. NCS/EMG of the lower extremities demonstrated demyelinating polyneuropathy.  He received 5 days of IV IG and presently receiving IV pulse steroids as well and receiving Aggressive PT/OT. Awaiting transfer to rehab facility
mom reported pt dx w/hepatitis yesterday;pt had severe diarrhea & vomiting in AUG;saw MD in Mexico transferred to hosp in CA 1OCT;dehydrated, ultra sound, blood test, stool samples;MD dx hep a 21OCT98;
Patient's mother reports after receive vaccine pt with congestion, cough, weakness, fever & acute onset of RLQ pain. To ER, had labs drawn CT ABD within normal limits & discharged to home. Continued congestion, no fever, & light ache on 9/20/11.
different, a sensation across all the body; started having problems with her right foot/noted differences in the ability to raise and use her foot while driving and since then, this problem has been getting worse; painful and persistent problems in her legs; rheumatic arthritis/Now she has inflammation, painful and persistent problems in her legs/had health problems with her right, but not left leg.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "rheumatic arthritis" (unspecified if ongoing), notes: she has had health problems with her right, but not left leg. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), when the patient was 73 years old, for COVID-19 immunization, reaction(s): "nothing happened with the first and second dose"; Covid-19 vaccine (Dose 2), when the patient was 73 years old, for COVID-19 immunization, reaction(s): "nothing happened with the first and second dose". The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "unknown", described as "rheumatic arthritis/Now she has inflammation, painful and persistent problems in her legs/had health problems with her right, but not left leg."; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "different, a sensation across all the body"; MOBILITY DECREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "started having problems with her right foot/noted differences in the ability to raise and use her foot while driving and since then, this problem has been getting worse"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "painful and persistent problems in her legs". Clinical course: Caller was a patient who received the booster dose of Pfizer-BioNTech COVID-19 vaccine 2 months ago (Jan2022). Within 1 hour after receiving the dose, she felt "different, a sensation across all the body". She started having problems with her right foot as she was driving to a market, and also mentioned that she had suffered from rheumatic arthritis. Caller stated she has noted differences in the ability to raise and use her foot while driving and since then, this problem has been getting worse. Now she has inflammation, painful and persistent problems in her legs. She stated that she had had health problems with her right, but not left leg. Also stated that nothing happened with the first and second dose. Caller just wanted to know if her symptoms have any correlation with the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
she accidentally administered a dose of FLUZONE HIGH-DOSE QUADRIVALENT to a patient from a box that was in the refrigerator from last year, with no adverse event; Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a nurse via Agency Inquiry Number: 00782410).  This case involves a 71- years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 23-Sep-2021, the patient received a first 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ552AA and expiry date not provided via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "Nurse stated that she accidentally administered a dose of FLUZONE HIGH-DOSE QUADRIVALENT to a patient from a box that was in the refrigerator from last year. Caller asked how to proceed and whether or not she could have the patient come back in today to be revaccinated."  At the time of reporting, no adverse event was reported.  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 the 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.
Fever, Aches, Fatigue Treated with Acetaminophen and rest.
I had no symptoms at first. My right arm swelled 24-48 hours after and it was red and warm to touch. On April 9th I had a left heart catherization done and everything went well, nothing wrong with heart except that it was enlarged which confirmed the cardiomyopathy. When they was finished and about to release me then my vision started to become blurry and my eyes were feeling like they crossed and I could not see things clearly. I had a stroke. The Nurse thought it was a reaction to the medication since I was awake when they gave it to me. They gave me Narcan to combat the fentanyl they gave me along with something else that I am not sure of. A stroke code was called and then I passed out and was unconscious. I am not sure how long it took for me to wake up but I know I was sleeping off and on throughout the day. The next day when the doctors came to me they said I had a fallamos stroke. I have weakness on my left side of my body but everything cleared up and I was able to walk. Everything happened in 24 hours but my eyes was off centered and things were very blurry. They placed me on many medications and said I need to go to therapy. Eyes are straight now but a little off.
Fever, 12 hr post injections 100.4, nausea, chills, muscles aches, fatigue, small itchy spots developed 48 hrs post injections and continue to develop 144 hrs. Post injections. Small red spots extremely itchy on thighs (mostly right thigh? They develop into small blisters.
On 7/28/2000 AM, onset of urticarial rash. Seen in office with same and Rx'd Zyrtec after given Benadryl in office on 7/28/00, On 7/27/00, had peanut butter and eggs in potato salad.
The patient reported redness and swelling around her whole upper right arm at 10:30 pm on 10/18/2017. The patient was told to take Tylenol (patient can not take Advil) and apply a cold compress. The patient came in this morning at 9:30 am 10/20/2017 and observed the swelling and redness has gone down the arm and near the elbow. She said the swelling has gone down though.
Patient complaint of tightness in throat and upper chest lasted 3-4 minutes. No SOB, no rash, skin warm and dry, color good, no pain. vitals 167-98, pulse 78. Complaint resolved 2:30
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 01J20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Outcome induced abortion) from 2006 to 13-Sep-2006. Concurrent medical conditions included Epilepsy (stable for years-no seizures) since 1998, SLE (Lupus-stable) since June 2006, Asthma (childhood asthma), Drug allergy (sulfa) and Fruit allergy (Blueberries). Concomitant products included LAMOTRIGINE (LAMICTAL), HYDROXYCHLOROQUINE, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LEVOTHYROXINE, ALBUTEROL SULFATE, SALBUTAMOL (ALBUTEROL HFA), FOLIC ACID and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Dec-2020 and the estimated date of delivery was 02-Oct-2021. In January 2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  In January 2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Pregnancy: positive (Positive) Positive.         No treatment information provided.  This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
On Jan 26, the day after shot one, I had numbness between my lip and nose, with a slight swelling under the nostril/above the front teeth  On Feb 24, the day after my second shot, my vocal chords developed paralysis, causing me to lose my voice for over a week  On April 11,  I experienced sudden sensorial hearing loss in my right ear.  This was remarkable because on Ag 25, 1995, I experienced SSHL in my left ear, which left me permanently deaf in that ear.  No ENT has ever met a person before who had SSHL a second time.
p/ pt recv vax exp 30 pox within 5 days p/ 1st dose
Patient received vaccine 3/30. On 4/6 she stated she started experiencing pain (upper left shoulder chest area below collar bone, pain radiates to the back). She said she didn't have any pain at the moment and she also had shoulder surgery so she does not know if pain is from shoulder or vaccine. She has been taking advil and has some relief but will follow up with Dr. I recommended if pain persist to go to the emergency room. Will call her tomorrow for follow up.
38 year old male was vaccinated with a booster 5 days before the recommended interval of six months  following the   Moderna primary two (2) series. Date of 2nd dose vaccination was June, 4th,2021
Two hours after receiving the vaccine, I had extreme headache, this lasted for over 24 hours, after that the next 2 days was a lighter headache and some light brain fog feeling.  The day after the vaccine had some mild chest pain, 5 minutes worth and than went away. Left arm hurt but just the usual with a shot. 6 days after vaccine, I had a rash and bump over my right ear, itchy arms and hands and neck area.