chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Menactra was administered to a patient, no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient of unknown age and gender, who was vaccinated with expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' 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.  There will be no information on the batch number for this case.
One week after the vaccine his left great toe and foot became red, warm and swollen. He had difficulty walking for several days and is still experiencing swelling. He has been using ice, elevation and Motrin.
Following the vaccine, within 3 minutes her bottom lip got numb, then her tongue swelled and then her eyes got fluttery uncontrollably, dizziness and weak.  They had her lie down in a recliner.  Her BP was 190/110.  She did not need an EPI pen and within 15 minutes her lip became unnumb, and her tongue swelling receded, was still a little thick, and her face was swollen, was red and flushed.  So they waited 30 minutes, her BP was not coming down, sent to the ER and observed for 3 hours and slowly her BP came down, all her other symptoms subsided and she was able to drive herself home.  Last night 2/25/21 she had great itching on her chest, which has since stopped.  Her tongue is still a little swollen, about 20% still feels thick.  When she left the hospital her BP was 146/86.  She has not taken anything for the symptoms just her regular routine medications.   She did feel tired and spacy feeling, and has been off of work since Wednesday as she could not focus to go to work.
About 5 minutes after receiving vaccine I was told the patient had vomited. We gave her a wet compress and then later a plain cold pack and remained with her.  She stated she felt hot, then cold, and her arms were heavy. She said she felt like she might faint, but she did not. She sat still for awhile.  Five to 10 minutes later she said she was feeling better. She then said she thought it was an anxiety attack because she had been nervous about the vaccine. She stated she felt fine and left.
12 hours after Varicella injection c/o sx of nausea, headache, nasal congestion and diarrhea. Swelling, erythema & induration on BACTRIM.
Covid 19; Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: En6198), as dose 2, single (Lot number: En6199), in left arm, on 16Mar2021 as dose 3 (booster), single (Lot number: 3014sba), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: Fj4989), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well; 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 THERAPEUTIC RESPONSE UNEXPECTED (On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient contracted Covid disease in December 2020, since then felt shortness of breath and extreme fatigue.) in December 2020.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information was received from a registered nurse concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the adult patient was inadvertently administered a dose of pediatric VAQTA 25/0.5 (units not provided) lot # N012324, expiration date 05-APR-2018 (route of administration unknown). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 15-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 372 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, chills, head congestion, cough, nausea, headache lasted about 15 hours.
Case previously recorded as MA2009-4529.  Initial case report received from a rheumatologist via MedCom US, on 19 Nov 2009.  A 69 year old male was vaccinated i.m. for the first time with S-OIV FLUVARIN (H1N1 influenza virus vaccine, batch no 1073696P) on 09 NOV 2009.  On 12 NOV 2009, the injection site became painful and the pain worsened as time passed.  On 16 NOV 2009, herpetic like painful blisters appeared near the injection site and spread on his arm.  The patient later experienced neuritic like pain in the same arm, and the pain continued on 19 NOV 2009.  The patient sought medical attention but no information was provided.  These events were reported as neuralgia, injection site reaction and injection site vesicles.  The patient's outcome was not recovered.  MedCom US reference no.: NA09-008573
Child rec'd vaccinations on 4/29/10 and on 5/7/10 mom called to say child had hives on face, trunk and legs but she had bought an off brand of Tylenol with cherry flavor and thought it was the Tylenol.
4/20/05 DTaP right deltoid. 4/22/05 Mom reported redness, swelling to injection site. Advise Motrin and warm compresses. 4/25/05 Spoke with mom; reported no swelling or redness.
Patient experienced a large local reaction extending from elbow to shoulder, myalgias, fatigue, headache, neck pain, and fever to 104.  His visit to the emergency room resulted in a full fever/sepsis workup to include lumbar puncture.  His WBC was extremely elevated at 43,000 with a predominantly left shift.  He was admitted to the hospital and started on rocephin prophylactically.  He did well in the hospital with resolution of his leukomoid reaction and no other cause for symptoms was found.  1/18/07 Received medical records which reveal patient admitted to hospital from 12/2-12/5/06 with fever & r/o meningitis after complaints of headache & neck pain.  All vax had been given in left deltoid & had also developed erythema, tenderness & warmth over left arm.  Temp was 104 on admit.  Improved significantly on antibiotics.  Headache & neck pain resolved, left arm improved & was afebrile for 24 hours prior to d/c to home on continued oral antibiotics.  When seen in clinic on 12/8 was back to baseline & WBC was 11.6, H/H 9.6/29.0  FINAL DX: immunization reaction; & respiratory syncytial virus bronchiolitis.
Began experiencing chills at 2100, felt very tired and weak - to ED on 10/19/11 at 02AM. Temp 104.6, malaise, chills. Pt c/o chest pain with inspiration.
I had a runny nose coughing, I had a very bad sore throat. I was fatigued and very hoarse. I tried to stay hydrated. I went to Urgent Care and was given Monoclonal IV for COVID-19.
20 minutes after first shot, nerve pain in face, energy all over body, fatigue, breasts feeling full, then on third day, thyroid went totally hyper, body temperature dropped to 95, breasts became quite lumpy and painful, breasts themselves, NOT lymph or underarm area.  Had months of heart palpitations, Blood pressure and heart rate extremely low.  Thyroid did equalize in a few days but breast pain remained for six months and got worse with second shot.  Recently had pelvic ultrasound and found thickened endometrial lining, which is still being assessed
This spontaneous report as received from a physician refers to a female of unknown age. The reporter reported that stated the patient "received her first dose of GARDASIL (lot # was unknown) on 22-MAR-2011 and her second dose of GARDASIL (lot # was unknown) on 02-AUG-2012". No adverse symptoms reported. Additional information has been requested.
Flat red splotches at injection site (Right deltoid); muscle soreness at injection site. Neck stiffness, more intense on Right side (same side as injection); enlarged, tender, posterior cervical lymph nodes (x2) on Right side. Sore throat. Dizziness.
PAIN IN LEFT LEG, DOPPLER SHOWED A CLOT AND A BAKER'S CYST AT THE KNEE, SENT TO HEMOTOLIGIST, HAVE BEEN TREATED WITH ELIQUIST 4-20-21 - 6-1-2021, PUT ON LOW DOSE ASPIRN ONCE A DAY, 9-13-21, PAIN BAD AND SHORTNESS OG BREATH, SENT TO ER AND PUT BACK ON ELIQUIST, HAVE HAD 3 DOPPLERS CLOT DECREASING, WILL BE HAVING 4TH SCREENING THIS WEEK AND ON THE 4TH OF APRIL BY VASCULAR DR. PRIMARY DR AND BOTH SPECIALIST QUESTION WHETHER THE SECOND VACINE WAS THE CAUSE BUT THE TIMING OF ALL THIS COMING ON IS SUSPIOUS
prev dose administration date=24Feb2021/prev dose administration date=03Mar2021; got my period 2 days after shot which is one week early. i have tracked my period for the last year and i have consistently gotten it every 28 days, except this month and the months of Mar and Apr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: pfizerer8730) at the age of 34 years as dose 2, single and administration date 24Feb2021 (Lot number: pfizerer6198) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Mar2021, outcome "unknown", described as "prev dose administration date=24Feb2021/prev dose administration date=03Mar2021"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "got my period 2 days after shot which is one week early. i have tracked my period for the last year and i have consistently gotten it every 28 days, except this month and the months of Mar and Apr". Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Patient received dose 3 on 06Dec2021 05:15 PM (Lot number: fj1620). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications received within 2 weeks of vaccination was birth control pill. Patient got her period 2 days after shot which was one week early. She has tracked her period for the last year and have consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of her first and second shot). Adverse event start date and time was reported as 08Dec2021 06:00 PM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 08Dec2021  Follow-up attempts are completed. No further information is expected.
Tinnitus - constant, high pitch (16.7kHz approx), beginning sometime during the night prior to awaking 7:00am  May 5th 2021. As of the time of filing, symptoms remain unchanged. Both ears similarly affected, with a slight bias toward the left ear. Extended pain at the injection site - still mild discomfort after 7 days
Complete lack of energy. Unable to work. Note: Patient received second COVID vaccine 14 days after first vaccine instead of 21 days.
ABOUT H+4 HOURS AFTER WE NOTICED THE RIGHT LEG OF OUR BABY REALLY RED (AROUND WHERE THE VACCINS WERE DONE). ABOUT H+6 HOURS AFTER THE VACCINATION WAS DONE, OUR BABY START CRYING LIKE SHE NEVER DID BEFORE, NON STOP. WE CALLED THE DOCTOR ABOUT 30 MINUTES AFTER AND HE TOLD US THIS WAS A NORMAL REACTION. HE ADVISED US TO GIVE OUR BABY SOME BABY TYLENOL (EVERY 4 TO 6 HOURS) ABOUT .4 ON THE GAGE.
Increased heart rate, resting pulse rate of 120 or higher for 4 hours, decreased but still out of normal range for 4 hours period thereafter of 100-120. Following IV fluids and other medication, heart rate sustained at 85bpm for following 24 hours.
Pt was exposed to chicken pox at school from fellow peer. Pt has been vaccinated and he received the recommended doses on schedule. On Sunday afternoon mom noticed that he was scratching and she applied calamine lotion to his skin and now the virus has spread over his body.   Dates of Immunization: 03/23/2009 12/18/2013  Tx- Acyclovir 200 mg/5 mL oral suspension
HA, dizziness, minor chest pain, body chills, fever starting 1/24/21 Notably, pt had an IV iron infusion on 1/22/21
pt devel a large welt @ the inj site immed p/vax on 30CT96;this was one of three cased reported by a RN;cross reference w/MFR report 0010150960042 & 0010150960043;
Received one dose of Moderna on 2/16 and refused the second on 3/17/21. He was reoffered Moderna Covid vaccine again on 4/30/21 but was inadvertently given the Janssen Covid vaccine that same day, as we are offering both Moderna and Janssen vaccine. The mistake was realized right after that inadvertent administration of Janssen vaccine and so the patient was observed longer than ordinary but did not have any untoward reaction
Patient was waiting for the required 15-minutes in store. He was feeling hot, so he sat down in the pharmacy lobby. He started to have a seizure and his aunt yelled to me that he was having a seizure. I called 911, but the seizure lasted less than a minute. The patient's eyes were darting back and forth and he was white and gripping the sides of the chair while seizing. I got his legs elevated and got him a wet paper towel. His aunt (who said she is a nurse) said that he has muscular dystrophy but has never had a seizure before, although he does currently see a neurologist.  She asked him if he knew where he was, and he did--he said he didnt know what happened (or that he had a seizure, but he knew he had gotten a vaccine and was at Pharmacy). The EMT's came, he was able to get up and go with them to get checked out.
fatigue & left chest tightness Narrative:  Pt reported to nurse giving him his 2nd covid vaccine the following adverse reactions from his 1st dose of covid vaccine: "pt reports after Moderna dose #1 significant fatigue for 2 days, muscle aches, diarrhea, nausea, L chest tightness 5/10, pt informed to seek medical care if chest pain or other symptoms not tolerable, pt verbalized understanding." Pt did not report taking any treatment medications or seeking medical interventions.
ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATIONS. LASTED 48-72 HOURS. ALSO HAD HEADACHE, WHICH WAS PRESUMED TO BE SINUS HEADACHE, BUT DID NOT RESPOND TO SINUS MEDICATION. HEADACHE CONTINUED THRU 1/1/21 WITH NAUSEA ALSO NOTED. SYMPTOMS SUBSIDED BY 1/2/21
One day after receiving the seasonal influenza vaccine - felt tingling in (L) arm, increased heart rate, "flu-like symptoms". Called in sick to work on 12/7/2010. Did not seek treatment; declined follow-up.
cold, chills, high fever;migraines, lower back pain;heavy cough;double vision;saw PCP;rx amoxicillin;saw MD 11/10 rx DPH;saw MD 11/11 rx guaifenesin & augmentin;
face swollen w/herpetic lesions on nose & chin;treated w/Atarax & steroids;6DEC94 f/u recovered;
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. From 01-JUN-2016 to 23-AUG-2016 the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II ( lot # L041457, Exp 22-OCT-2017, dose and route unknown), which was exposed at 47 Fahrenheit for 2016 hours and 34 Fahrenheit for 2016 hours. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient was tested for Covid and the rapid at home test came back positive/ Patient has congestion and cough; patient was tested for Covid and the rapid at home test came back positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "gtube", start date: 08Aug2016 (ongoing); "weaken lungs", start date: 08Aug2016 (ongoing), notes: weaken lungs since birth. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 03Jan2022, outcome "unknown", described as "patient was tested for Covid and the rapid at home test came back positive/ Patient has congestion and cough"; DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown", described as "patient was tested for Covid and the rapid at home test came back positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: the rapid at home test came back positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg
3/29/2021    was observed post Covid-19 immunization for 30 minutes based on complaints of chest pain .  During the observation period, she experienced an adverse reaction with the following symptoms:  difficulty breathing.and chest pain   Assessment : Time of assessment 1500 Alert and oriented.    Actions taken:  Vitals sign taken at 1458. BP-128/61, P- 63, O2- 99%, chest pain 9/10, at 1502 BP- 109/63, 69, O2- 100%, 911 called at 1500, 1509- BP- 108/95, P- 67, O2- 100% pain 6/10, EMS arrives at 1517, patient walks out of building with EMS to do EKG , comes back into the building , juice is given and she is discharged with further complaint, she is advised to follow up with her PCP.       Medications administered: No medication given   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/29/2021  2:47 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EP7534   NDC: 59267-1000-2          Electronically signed by RN at 3/29/2021  3:45 PM  Immunization on 3/29/2021   Detailed Report  Note shared with patient
Patient fully vaccinated (Moderna) and boosted (received Moderna booster on 10/20/21), admitted to the hospital on 1/6/2022 with COVID-19 and associated hypoxia. Patient expired on 1/12/2022.
1st vaccine 12/29/20; 2nd dose 2/11/21; developed visual changes 12/12/21, seen and referred to ED, admitted to Hospital.
I contracted COVID-19 for the 3rd time 09/16/2021 with symptoms of headache, light sensitivity, sore throat, extreme fatigue, myalgia, joint aches, brain fog/trouble concentrating, short lived cough, chest of tightness, shortness of breath, earaches, and I acutely ill for 3 weeks with some of my symptoms persisting into November. I was not offered the Monoclonal Antibody Therapy by my primary care physician. I am experiencing Long COVID-19 with lingering symptoms of brain fog/trouble concentrating, fatigue, headache, light sensitivity, chest tightness, still cannot take a full breath, and bouts of vertigo with slowed reflexes. I'm experiencing cognitive decline which has affected my short-term memory as well. I have short bouts of extreme fatigue, feeling feverish, sore throat every 15 days or so that takes me a few days to recover each time. I am under the care of the Long COVID-19 Clinic at OSU. I have also received Botox injections for the COVID-19 headache that has still persisted, after trying Emgality which also failed to resolve the headache. I have developed ADHD symptoms and am on Adderall and memantine medications. I have not recovered as of yet.
The patient came in to pharmacy with mom. They said he had redness and warm patch on arm that flu shot was given in. The redness was about golf ball size ring, no swelling, warm to touch, and not really itchy. It was not at injection site. The spot was about 3 inches from injection site. The mom said she will watch and see if the redness gets worse or not, if so will seek medical attention if needed.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient. Patient had no known allergies. On 16-DEC-2013 the patient was vaccinated with ZOSTAVAX vial (strength, dose and frequency unknown) lot # J006157 and expiry date 30-AUG-2014 subcutaneously. On 18-DEC-2013, patient experienced injection site reaction described as a red, swollen, warm knot like area at the injection site of the ZOSTAVAX vaccination that was 6 inches by 3 to 4 inches, without pain or itching. It was reported that patient sought pharmacist and was instructed to use ALEVE or Ibuprofen for swelling, but unspecified if patient took any ALEVE or Ibuprofen. No laboratory tests were performed. The outcome of event was reported as not recovered/not resolved. This case # 1312USA009925 is linked to case # 1312USA011095 via same reporter link. Additional information has been requested.
pt recvd vax;devel maculopapular rash all over body;seen by MD w/ numerous scattered erythematous macules & papules on trunk & upper extremities;rash on upper rt eyelid pruritic,erythematous & edematous;tx w/ several doses of dph
Atrial fibrillation, congestive heart failure, pneumonia - requiring antibiotics, long term oral diuretics, electric cardioversion  on two separate occasions,  oral anti arrhythmic drug, oral anticoagulation drug, oral beta blocker drugs. Now followed by a cardiologist and an electrophysiologist.