chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 5 year old white female with no known drug allergies who on 23Apr01 was vaccinated SC with a first dose of varicella virus vaccine live (lot637671/1609K). Concomitant vaccination on the same day included a SC first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot637434/1513K). There was no illness at the time of vaccination. On 08Jul05, the pt had a rash on the entire body per her mother. It was described as very itchy. All had white centers. There were a few on the fingers which were bigger and blistered and swelled up more than the other ones did. Per the mother, all told the pt had 300 plus lesions over one week. No diagnostic lab tests were performed. The pt recovered on 15Jul05. Additional information is not expected.
Aux lymph node (left armpit) was swollen both vaccine doses.  2nd dose: diarrhea and blood in stool. Fatigue as well. Injection site is hard, red and swollen.
Pain, swelling, redness, and warmth at injection site. Stated swelling was size of grapefruit 11-6-13. Area improved 11-8-13.
Extreme itching after 24 hours had passed from receiving the vaccine. 3 full days of extreme itching, then went to Care Now.
Wheezing, hoarsness, weakness, dizziness, headache, muscle aches, fever, nausea and vomiting
My head and skull felt that every nerve ending was on fire and electrified.  It radiated down to both of my eyes.  Cold did not help.  Light hurt so bad. I could hardly stand it.  It was severe for 10 hrs. And then had a very bad headache for 36 hours.  I didn't go to emergency room because it hurt to bad. My daughter gave me Imitrex twice in the 36 hours.
High fever day of vaccines, admitted to hospital for observation, high fever persists today w/TYELNOL, MOTRIN, diarrhea.
No adverse events. Patient received #1 Moderna 2/5/21 and #2 Moderna 3/5/21 so she was supposed to not qualify for Pfizer booster.
08/08/14-Mom reported rash on trunk of body with "zit-like" spots on his side. No fever, good PO. She also called to say rash ongoing for 2 weeks. No medical treatment sought.
This spontaneous report as received from a other healthcare worker refers to a 13 month old patient. On 22-AUG-2014 the patient was vaccinated with ZOSTAVAX, (0.5 ml, route, dose number, dosage and lot number unknown). The reporter stated that the vials of ZOSTAVAX and VARIVAX "do look kind of similar" and they kept them next to each other in the freezer". No adverse effect reported. Additional information has been requested.
multiple excurion occured during shiping time  with no adverse event; Initial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care profession and non-healthcare professional via Medical Information under reference - 00773210.  This case involves a unknown age of 13 female patient's were vaccinated INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which went on multiple temperature excursions (product storage error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On an unknown date, the patient's received a 0.7 mL (total) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot - UJ716AB and expiry date 30-06-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "The caller stated that she was contacted by a Sanofi Rep who advised her that her recent shipment of FLUZONE HIGH DOSE QUADRIVALENT was not viable. The caller stated that she has already contacted Sanofi regarding a product replacement, as directed by her Sanofi Rep. The caller stated that the product was shipped on 02 SEP 2021 and received on 07 SEP 2021. The caller stated that 13 patients have received the vaccine since delivery. At this time, the caller is requesting medical information for the proper care for the 13 patients who received the vaccine. Note from Agent; At the time of the call back the clinic did not have the information for the patients that received the vaccines."  It was a case of a actual medication error due to incorrect product storage.  At the time of reporting, no adverse event reported.  Outcome of event was unknown.   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.
40 y/o FEMALE reports she received her first dose of the pfizer covid  vaccine on 8/6/21.  She felt fine afterwards, went home and did some pressure  washing.  2-3 days later she developed stinging pain at the site of the  injection.  Since then she has had intermittent stinging pain at the site. But  then 4 days ago she was cooking and noticed tingling, numbness and pain  radiating down her arm to her pinky finger. Since then it has worsened and now  she says the pain is so severe she can barely use her arm or hand. She has taken  tylenol and took ibuprofen last night without relief of symptoms. She says she  can't work because she needs to type for her job as a nurse.   Plan: -recommend ibuprofen scheduled 600mg
2-3 days p/vax given on 13OCT92 pt devel fever to 105.2; notified MD & gave APAP; on 2nd day of the fever, pt refused to drink and produced no urine for a period of 8 hr; was quiet, refused to permit touching; devel tiny red spots;
Information has been received from a registered nurse concerning a male patient who was vaccinated several months ago with zoster vaccine live (Oka/Merck). The nurse reported that another nurse and her husband were " indeed vaccinated with zoster vaccine live (Oka/Merck) IM instead of SQ". The nurse reported that the patient had a sore arm (unspecified) for a day or two after the vaccination was given. Additional information is not expected.
Swollen tongue, red,splotchy puffy cheeks, giggly lips , mild nausea Sought medical attention- given epinephrine and prednisone and Benadryl
Pt seen on 6-21-13 for vaccines. DTaP to be held per MD due to prolonged crying with 1st vaccines on 2-20-13. Give IPV, Hep B, HIB, PCV-13 and RV5. Pt broke out in hives over entire body by night of 6-21-13. Vaccines given about 11:00 AM on 6-21-13 also had 101 degrees temp.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The information on pertinent medical history and drug reactions or allergies was unknown. On 26-JUN-2014, the patient was vaccinated with M-M-R II (dose, frequency, route unknown), lot # H009784, Expiry date: 15-MAY-2014. The reporter stated that patient received an expired dose of M-M-R II on 26-JUN-2014. No adverse symptoms reported. There was no product quality complaint involved. Additional information has been requested.
Red patch extended over (L) upper arm area with well defined margin. Has since resolved. No treatment needed at this time.
Information has been received from a registered nurse concerning a 13 year old female patient who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 660387/1967U) IM. There was no concomitant medication. On 30-JUN-2008 the patient experienced headache, lethargy, slurred speech and brain swelling. The patient was diagnosed with acute cerebellitis (cerebellar encephalitis). The patient took an overseas trip when these symptoms occurred and was hospitalized. The patient will be on IV Acyclovir for 3 weeks and has been on Dexamethasone but is being weaned off. The patient was on acetazolamide and that was subsequently discontinued. The patient will be on ceftriaxone for 2 weeks and doxycycline for 28 days. The patient was considered to be recovering. The plan by the hospital was to discharge the patient on 17-JUN-2008 and have her on a flight back home by 19-JUL-2008 and to be directly admitted to a pediatric hospital. Lab Diagnostics studies performed were 3 MRIs to monitor brain swelling, serology for Lyme's disease IGG, mycoplasma IGM, mumps IGG and IGM, rubella IGG and IGM, varicella IGG and IGM, parvovirus IGG and IGM, HSV IGG and IGM, however not results were reported. Acute cerebellitis was considered to be immediately life-threatening. The patient sought medical attention, called the physician's office. Follow-up information was received which reported that on 19-JUL-2008, the patient was admitted to the hospital. The patient was subsequently discharged from the hospital on 22-JUL-2008. It was reported that the patient was sent home with a PICC line for antibiotics for the next several weeks. The registered nurse stated that the patient was stable. The registered nurse reported that the physician felt that the patient's Encephalitis was related to GARDASIL (Lot # 660387/1967U) vaccination. Additional information has been requested.
Shortness of breath; O2 sats 65% on EMS arrival to patient's residence. Per EMS COVID-19 has went through the patient's home over the last month.  All of his family has now had negative Covid test.  Patient had a negative rapid test.  He has been feeling ill for the past 10 days and had an onset of shortness of breath 2 days ago.  Has had 3 doses of the Moderna vaccine with his last dose on 11/11/2021.
30 MINUTES AFTER VACCINATION:FLUSHING SENSATION, ANXIOUS FEELING.  THIS WENT AWAY, THEN 90 MIN POST VACCINATION LFUSHING, COLD SWEAT, VERY LOW BP, INCREASED HEART RATE. BLOOD SUGAR WAS NORMAL.  FEELING OF "ICYNESS" IN BOTH ARMS AND ACROSS BACK FOR 2 HOURS.  THE FOLLOWING DAY, ALL SYMPTOMS RESOLVED. NEW SYMPTOMS INCLUDE HEADACHE AND ARM TENDERNESS.
Patient reported dizziness, throat swelling, and heart palpitations shortly after receiving vaccine. Clinic staff member administered diphenhydramine HCl liquid 75mg/30cc PO at 11:40am. Vitals WNL during this time. Patient reported throat swelling resolved at 11:50am, kept for additional monitoring and released at 12:00pm. Recommend patient follow-up with provider and head to ER if symptoms recur.
She became light headed, nauseated,pupils dilated, pale and narrowed vision. Nursing staff assisted her to lay on floor with feet elevated. Vital signs with in normal limits. She did not lose conciousness.
Patient sitting in observation area. Patient stated "I don't want to overreact but my pinky  feels numb and tingling." Patient assessed at this time. Alert, verbal clear speech. Denies pain . Skin warm and dry to touch. PERRLA noted. Patient has no change in LOC. V/S BP120/94 T98.4 P98 R18 PO2 99% on room air. Hand exercised performed. Full ROM. Patient monitored for additional 15 minutes. Ambulated with steady gait out of facility at 1145.
Tingling hand and arm, in both hands.  Daily Headaches, sometimes 2 or 3 times a day
Information has been received from a 20 year old female consumer for Merck pregnancy registry who on 23-JAN-2008 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot# 657006/0188U).  There was no concomitant medication.  The patient indicated that she is now pregnant.  She had been experiencing "very light spotting" over the past two weeks which she did not experience with her previous pregnancies.  Medical attention was not sought.  The patient's very light spotting persisted.  The pregnancy outcome is unknown.  Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent, historical conditions were not provided.Concomitant therapies included sterile diluent. On 27-JUL-2018 the patient was vaccinated a dose of Oka/Merck VARIVAX 0.5 mg once via intramuscular (incorrect route of drug administration) (lot number N035937, expiration date 18-DEC-2019). No adverse effects were reported. No further information was provided.
Neck stiffness after injection, head feels full, No SOB or Tachycarida Neck stiffness after injection, head feels full, No SOB or Tachycarida
Menstrual cramps and early heavy periods since then. Cramps continue. Period is early. Skin rash.
Pharmacist reports patient received PNUMOVAX 23 and reported hives the next DAY; This spontaneous report was received from a pharmacist and refers to a 65-year-old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On approximately 28-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis.  On the next day, on 29-JUL-2020, the patient experienced hives. The outcome of hives was unknown. The causality assessment between the event of hives and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Pt did receive 3 doses of Moderna vaccine. on 02/01/2021, 03/01/2021 and 07/19/2021 by error. pt signed up for Shingles shot but a pharmacist gave her a covid shot. We did file a claim to Corporate and DHS and was advised to submit a report. pt is complaining from flu symptoms and sore arm that has not gone away for 2 weeks.
sore arm; Itchy ears; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (Itchy ears) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PRURITUS (Itchy ears) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (Itchy ears) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Severe chills, fever for 24 hours after shot. Saw doctor 11/14/02; antibiotics given.
Pt. awoke vomiting and then vomited several times thereafter; refused breast. Went to ER, given ondansetron ODT; no more vomiting. Had 1 loose stool 3 hours later.
Feels like a burning sensation and area is red and tender/warm to touch and feels thickened underneath skin - started 9/4/13 when noticed area - only treated 9/5/13 with Triamcinolone. She has warmth to touch at site, erythemas, and tenderness burning.
PedVaxHIB was given at the same time as Pentacel DTaP-IPV-HIB Lot UJ435AA Exp 05/17/2022 Manufacture Sanofi Pasteur was given in Right Thigh. Family was called and instructed to watch for signs of a reaction.
Diagnosed with varicella type rash received varivax 06/17/2002.
Pt vaccinated with DTP/OPV developed six hrs of uncontrollable screaming 3 hrs after immunization.
This spontaneous report was received from a registered nurse and refers to a 19-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Itchiness, slight redness within 15 min of vaccine.  Subsided before leaving clinic, no further incident reported
Woke up on 5/30, I heard a loud ringing in left ear, it felt funny inside like an echo chamber and I was having difficulty hearing. I went to urgent care and saw a doctor, the doctor couldn't see any fluid but wasn't sure if there was something going on in middle ear and thought it could be an upper respirator and recommended I see an ENT and follow up with my doctor. No meds were prescribed, I saw my PCP and it was stated that there is fluid behind my ears, I was given a prescription for Amoxicillin.
Sore arm where the vaccine was injected; This is a spontaneous report received from a contactable consumer.  An adult male patient received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2), administration date: 05May2022, for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Dec2022, outcome "unknown", described as "Sore arm where the vaccine was injected". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT UNDERAGE (17YO) RECEIVED BOOSTER AT OFFSITE CLINIC
pt recvd vax & 24 to 48 hrs later pt devel soreness, swelling & redness @ the inject site;
tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.   This case was linked to MOD-2021-272823 (Patient Link).
History obtained from patient records. Member has been deployed and is not available for clinical interview. Patient is a 22 year old active duty without significant past medical history who has received the small pox and anthrax week prior Sept 26 2005. At the time of his vaccination, the patient was in his usual state of good health without any preceding medical complaints. On Sept 26, the patient received the small pox vaccination and 10 days later noted the sudden onset of severe sharp chest discomfort, 10/10 with increased pain on inspiration, with limited inspirator capacity. At that time, the patient went to sleep with the chest pain, feeling like it was heart burn. Approximately 13 hours after the onset of the pain (0400 hrs) the patient went to the ER for evaluation. He was referred to cardiology and evaluated by DR, and diagnosed with myopericarditis based on elevation of cardiac enzymes and ECG consistent with pericarditis. Patient was given an unspecified IV medication and experienced little relief after 15 min, and he was subsequently admitted, and started on Ibuprofen, with gradual relief of the chest pain over two days. Since Oct 8 2005, the patient did not experience any recurrence of his chest pain and discontinued the ibuprofen on Oct 11 2005. problems related to adverse event 10/27/2005 myocarditis, acute NOS
3 days after injection of Td noticed large red spot around injection site; hot red.  Patient states was as large as 11cm at one time.
1st dose I had a severe pain in my stomach. I called my doctor and she told me to take 2 Tylenol. After the 2nd dose I took two Tylenol a few minutes after they made me sit for 15 minutes. On about a few weeks later I started having a severe pain in my breast. I called my gynecologist. They sent me for an ultrasound of my breasts and found swollen lymph nodes. They felt it was caused by the vaccine. I have been taken Tylenol for the pain. So far, it's pretty good. I go back next month for an ultrasound to see if there are any more problems.
Patient describes red, inflamed, and induration at injection site a few days after Zostavax.
Red, firm, swollen deltoid, measures 7" x 3 " center 4" x 2" is hard, bright red & shiny. Warm to touch. 3-9-12 saw MD. 3-10-12 Symptoms started to resolve.
We are unsure of the exact date but within 1-2 weeks of vaccine, he developed recurrent left facial tics. We believe they were more prevalent when he was tired. These tics lasted for about 4-6 weeks. He had never experienced tics before nor has he experienced them since. During this time period, he was seen by his physician, Dr., who told us that what he had been experiencing were tics.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 25Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive; Negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid rebound. Tested negative for 2 days post-completion of 5 day course of Paxlovid. Tested positive again on post-Paxlovid day 3. The patient started COVID 19 treatment with Paxlovid (Lot number: GA1529) on 20May2022 till 25May2022. No other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sudden onset of muscle cramps, light headed, uncontrollable shivering, abs fever at 8 pm. Fever got worse all night up to 101.8. Treated with ibuprofens and Tylenol. Still aching and chilled the next night. Exhaustion and fever continued but lower and comes and goes
VERY SICK; This spontaneous report (social media) received from a health care professional via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included possible idiopathic thrombocytopenic purpura, and possible cyclic thrombocytopenia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.