chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; This case was received via Medicines Agency (Reference number: US-irms-MOD21-126672   ) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications   Treatment details were reported.   Reporter did not allow further contact
symptoms started on 11/28 with tingling/numbness to hands/feet. By 12/01 she was having generalized parasthesias, weakness, and difficulty with ambulation. Admitted to hospital. Diagnosed with GBS  Numerous IVIG treatments. Receiving intense physical therapy at Hospital for Special Care due to weakness and inability to walk without assistance
states that she did not get the second dose; can barely hear over the ringing; It has been causing a lot of anxiety and stress.; stress; Screeching tinnitus and ringing in ears; Screeching tinnitus and ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 (Lot number: EN6203) as dose 1, (0.3ml) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "states that she did not get the second dose"; TINNITUS (non-serious), TINNITUS (non-serious) all with onset 26Feb2021, outcome "not recovered" and all described as "Screeching tinnitus and ringing in ears"; HYPOACUSIS (non-serious), outcome "unknown", described as "can barely hear over the ringing"; ANXIETY (non-serious), outcome "unknown", described as "It has been causing a lot of anxiety and stress."; STRESS (non-serious), outcome "unknown", described as "stress".  No follow-up attempts are possible. No further information is expected.
HEADACHE; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a 63 year old white ,Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: 05-MAR-2021) dose was not reported, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced headache ,fever and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from fever, and body aches. This report was non-serious.
Got it once and was deathly sick for weeks; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult patient of an unknown demographics who got it once and was deathly sick for weeks (illness), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) patient stated that it can shove that flu shot where the sun didn't shine. Got it once and was deathly sick for weeks (illness).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
Patient said she began to experience swelling, redness, itchiness, stiffness, and pain in the arm the next day. The patient stopped by the pharmacy on 5/8/2021, her arm appeared red, swollen, hot. She said her arm was in pain, stiff, and her head hurt.
On 01/14/2023, I started to experience symptoms of watery eyes and a stuffy nose. I had been around my grandson and he had tested positive for Covid-19. I found out the evening after I watched him. I tested myself on 01/15/2023, and the result came back positive. I called my doctor on 01/16/2023, and spoke to the nurse on the phone. I explained my symptoms to them and they told me that they were minimal and if anything became worse to keep in touch with them. After about 48 hours, I felt like everything was fine. I probably wouldn't have even tested if I didn't know my grandson tested positive.
On 16 OCT 2008 we received the following information from a physician: It was reported that multiple patients developed bloodshot of eyes and gait loss after vaccination with Influenza virus vaccine (manufacturer unknown).  No further information available.  Seriousness criterion: medically significant.  Causality: insufficient data (the amount of data is not sufficient to assess this case).  Expectedness assessment according to label: The reported symptoms are not expected after vaccination with BEGRIVAC, FLUVIRIN, AGRIPPAL and FLUAD.  No change in benefit-risk-ratio.  No measures necessary.
Booster for immunocompromised patient was given at 0.5ml Moderna instead of 0.25ml. Patient states that she was fine. She had a sore arm and red itchy rash day following vaccination. She got Pfizer the last 3 doses.
Patient received vaccine on Monday (10.09.06) patient complained to pharmacy on or about Wednesday (10.11.06).  Patient described edema, redness and swelling on left arm.  Patient complained to physician of itching, chills, fever prior to report.  Patient saw PA on Wednesday and allergist on Thursday.
Pt received first dose moderna 4/19 under a false DOB which made her 18 years old. This was discovered after she received dose. We were advised to complete the series with the second dose today and to report it.
No adverse event; Only one dose of the vaccine in Jun 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021).    No concomitant medication was reported.    Pharmacist stated that they have a patient who received only one dose of the Moderna vaccine in Jun 2021 and their job now requiring them to repeat the entire series. HCP was asking what will be Moderna's recommendation in this situation. No treatment information was reported.   Reporter did not allow further contact
REALLY BAD REACTION; STILL HAVE CHRONIC PAIN FROM IT MONTHS LATER; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced really bad reaction, and still have chronic pain from it months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still have chronic pain from it months later, and the outcome of really bad reaction was not reported. This report was non-serious.
no adverse events, reporting due to vaccine administered at age 10 y 10 months when adacel is indicated for age 11yrs
Vaccine expired on 2/1/2022.  Vaccine was given to patient outside of expiration dating.
accidentally gave a TENIVAC vaccination to a 16 month old patient/ no AE; rash on the right cheek; accidentally gave a TENIVAC vaccination to a 16 month old patient instead of their fourth dose of DAPTACEL; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Agency (under the reference: 00891947).  This case involves a 1-year-old female patient who had rash on the right cheek (rash), accidentally gave a DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of their fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered, Product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB).  On 09-Dec-2021, the patient received a O.5 mL total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [frequency once, strength: standard, lot C5779AA, expiry date: 02-Oct-2022] via intramuscular route in the left vastus lateralis for prophylactic vaccination.  On 09-Dec-2021, the patient developed a non-serious rash on the right cheek (rash) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "Caller states that a new employee accidentally gave a TENIVAC vaccination to a 16-month-old patient in the office on 09-Dec-2021 instead of their fourth dose of DAPTACEL. Caller states that the patient has returned to the clinic due to a rash on the right cheek and was given Benadryl 1mk/kg to treat this. Caller states that she has reported this incident to safety online."  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  No laboratory data reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash.  At time of reporting, the outcome was unknown for the events.  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.
dizziness, syncope at 02:30pm; regained consciousness after 5minutes. transported to emergency room with full recovery. Discharged from emergency room without further issues.
pt recv vax in 1989 & devel pneumonia & a blood dyscrasia;
No adverse event; expired dose administered; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and Concomitant therapies were not reported.  On 14-FEB-2023, the patient was vaccinated with an unknown expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection,  lot #T025374, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided).  The pharmacist confirmed that the vaccine did not experience temperature excursion through the date of administration. At the reporting time, no adverse events were reported.
On Sept. 30 2018, my body felt like it was vibrating internally. I had a terrible headache. My feet were swollen (feet were normal the next day). My top teeth hurt. My legs were weak, esp. the left one. I fell 3 times. My memory was also affected but that is coming back. I saw my primary care doctor 10/11/18. Both my blood work and physical were great. About 2 weeks later, I felt so bad that I went to the ER. They did a CT scan and blood work, both were normal. Dr. asked if I was sick the day of the shot, I said "no". He referred me back to my PCP. I went back to Dr (PCP) and he gave me (6) days of methylprednisolone 4 mg tabs. I finished the Rx, but I still have the vibrating, headache, and weak legs. The symptoms aren't as bad, but they're still there. Where do I go from here! It takes 2 months to get an appointment with my PCP for a referral to a specialist and 6 months for an appointment if you're a new patient. Will this ever go away? I would appreciate any help you can provide me with. You'll also be getting a form from my husband who also had a reaction. "Thank you" in advance for any help you can provide.
Since four hours after shots, patient cried inconsolably for 90 mins, this was the first time he had done this.  He has been projectile vomiting and been running a fever of 100.1 with Tylenol.
Pt received first dose of moderna 3/8/2021 at vaccination site Pt was verified and consented by parent and pharmD today at acc. Consent signed and efficacy discussed with mom per guideline and cdc. Patient received second dose today
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored doses of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), on 18Feb2021 as dose 2, single (Lot number: EN6198) and on 19Nov2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Allergy: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: VENTOLIN [SALBUTAMOL SULFATE]; LEVOTHYROXINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was reported about covid treatment. Patient received vaccine and patient received other medication in 2 weeks. On 16Jun2022 to 21Jun2022 patient took anti-viral drug Paxlovid indicated as treatment of COVID-19. It was reported that rebound Covid symptoms and test positivity on day 11 after starting Paxlovid. Acuity of symptoms was similar to initial onset prior to Paxlovid. Patient had history of Mild asthma, hypothyroidism and known allergies to Shellfish. Patient is Recovering and there were no treatment adverse events.  No follow-up attempts are possible. No further information is expected.
Swollen nymph node after two days.  That subsided and  on day 9 after shot rash over whole body - head to legs but most on torso- raised red dots very itchy.
The doctors at the hospital diagnosed as a stroke/She was discharged the next day; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03B21A and 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), QUINAPRIL and ATORVASTATIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.  On 13May2021, she had started with numbness on fingertip of right side of the hand and it progressed to the whole right side. She called 911 and she ended up in hospital on 13May2021. The doctors at the hospital diagnosed as a stroke. She was discharged the next day (14May2021).  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
pt recv vax 17OCT98 & 18OCT98 c/o a hive like rash;no SOB or diff breathing;given pred for hives;
60 seconds, post vax X 4, the pt went limp, dusky and unresponsive. The episode lasted less than 2 minutes. He responded to stimulation and O2. Presumed vasovagal episode. Recovered spontaneously. Had not eaten before vaccinations.
PNEUMOVAX administered 6/26 at 2:45 pm. Pt presented at 8:15 am on 6/28 with pain, swelling, redness of the arm. Pt used BENADRYL, helped with pain - no affect w/ swelling & redness. Pt to f/u w/ physician on 6/29 if still having problems.
5 hypotonic/hyporesponsive episodes starting 3-4 hrs post immunizations, ending  21 hrs after vaccines. 4 episodes associated with vomiting & diarrhea, 5th was not. Stool cx had no WBC, (-) campylobacter Ag but culture grew campylobacter. Remainder of work up including CBC, blood Cx, LP, culture, urine, EEG, head CT all neg. Pt was started on KEPPRA but episodes had already stopped.
MY LEFT WRIST DEVELOPED A SMALL KNOT AND BECAME SWOLLEN.  THERE WAS NO REDNESS BUT IT FELT LIKE I HAD A SPRAIN.
severe left side ankel, knee, and hip joint pain. Approximately 8 days after shot, lasting 3 days, minor pain for next 3 days.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
I had no problems with the first dose. I got the 2nd dose and felt fine. I went home and went to bed. I woke up about 1:30AM and was miserable felt like I had beaten me up. I had body aches, chills, low grade fever 100.2, fatigue, lethargic, nausea and headache. I did not go to work the next day. I stayed in bed and slept most of the day. It lasted 24 hours and then I felt back to normal.   I spoke with primacy care provider and she told me take Vitamin D since my annual labs the Vitamin D levels were and low. But she said just let it run it's course since it meant my immune system was working the way it was supposed to.
pt recv vax 29DEC97 & 30DEC97 pt to ER w/red, hot arm, swollen from shoulder to wrist;pt arm was about twice the nl size;T99.6;pt placed in a sling & instructed not to use arm;
06/10/2016 patient presented with raised rash measuring 6.5 cm x 7 cm at vaccine site.
Shingles, treatment with Acyclovir, bumps on shoulder, pain, itch. Started 3/28/2022, still have bumps 4/5/2022
Patient became dizzy- light headed and blurred visoin. Patient experienced syncopal episode and blood pressure dropped to 90/48. Patient was laid down and feet elevated. Juice given and patient recovered feeling after ~ 15 minutes.
Started feeling sick 3rd day after shot. Started as head  cold symptoms, progressed over next week into stomach upset, nausea, light headedness, overall body discomfort.  Missed school or had to be picked up early sick with stomach issues for four days. Stomach issues continued through rest of month into December. Went to urgent care Dec. 5. Continued stomach issues caused multiple school absences through Dec. 10, 2019.