chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-MAR-2011, patient received improperly stored VARIVAX dose 1, from batch/lot # 666869/0469Z (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter.
PATIENT WAS GIVEN THE MONOVALENT MODERNA NDC 80777-0273-99  INSTEAD OF THE MODERNA BIVALENT.. NO REACTION PATIENT NOTIFIED
ON 2 OCT 2007, PT RECEIVED DOSE #1 OF ANTHRAX VACCINE (SUB q) IN THE RIGHT UPPER DELTOID REGION. STATES SHE HAD A HEADACHE THAT AFTERNOON. PT STATES THAT THE INJECTION SITE HURT (LEVEL 5 ON THE PAIN SCALE) FOR 5 DAYS. THERE WAS A SMALL HARD LUMP, IT BACAME ITCHY (PT RUBBED, DID NOT SCRATCH THE SITE). SITE STARTED TO LOOK LIKE A RASH. SHE APPEARS TODAY WITH A 50mm X 40mm swollen, reddened raised welt region on her arm. SHE WAS SEEN TODAY BY NP, PRESCRIBED CLARITIN. PT DENIES BREATHING, WEAKNESS, PALENESS, OR SWELLING DIFFICULTIES.
when the patient stood up she fainted, fell forward onto the floor and broke her nose; when the patient stood up she fainted, fell forward onto the floor and broke her nose; fell forward; This spontaneous report was received from an office manager via a company representative regarding a 14-year-old female patient. The patient's medical history, concurrent conditions or concomitant therapies were not reported.   On an unspecified day, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number, expiration dated, dose, frequency, route of administration were not reported) for prophylaxis. The patient was sitting in a chair post vaccination for 5 minutes and then stood up to be taken to the reception area of the office to do another 10 minutes of waiting. When she stood up she fainted, fell forward onto the floor and broke her nose. The outcome of the events was not reported.  The relatedness between the events and the suspect vaccine was not reported.  Upon internal review, the events of syncope and facial bones fracture were determined to be medically significant.
pt recvd vax & exp crankiness & irritability; also has exp fever beginning a few days p/vax & has devel serious ear infect & coughing since immun
fainted, fell out of chair and hit his head, pressure applied to head wound (minimal bleeding), rescue squad called, patient was responsive and aware
"Parents heard a loud cry at 3:30 am - child was found seizuring - lasted about 1 minute. Child was also very hot - temp not taken. Child had been medicated throughout day with Tylenol following vaccinations. 03/12/07-records received from facility for DOS: 02/16/07-ER visit for second seizure in a week. After receiving immunization developed high fever and had a seizure diagnosed as febrile seizure. Same episode today. Temp in ER 100.9. Pulse 210. Resp 30. PE: posterior pharynx cobblestone appearance with drainage. Neck mild cervical lymphadenopathy bilaterally.  DX:Fever. Possible febrile seizure
Red, small dot, size of a dime, raised 1/4 inch does not hurt. If you press on it, sensitive. Not itchy. Applied ice one night during 1st 3 days 1st 3 days lot of redness, center red & raised, very itchy & very sore.
tested positive for COVID-19 1-Apr-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19 1-Apr-2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced COVID-19 (tested positive for COVID-19 1-Apr-2022). At the time of the report, COVID-19 (tested positive for COVID-19 1-Apr-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant products were not reported.  The patient experienced body ache and chills after 24 hours of booster. The patient recovered after 24 hours. It was reported that patient took both the vaccines on shoulder.  It was reported that event did not cause the patient to seek medical care. There was no other potential causes for the event to occur.  Treatment medications were not reported.   This case was linked to MOD-2022-656244, MOD-2022-654618 (Patient Link).
Pt got the flu and the PNEUMOVAX shot on same day 9/17/13 and came back 9/29/13 to show me his hand. The hand was swollen from the shoulder to his fingers, all red, and he says it was very painful. I asked him to see his doctor if it gets any worse.
PATIENT WANTED TO GET THE MODERNA VACCINE BOOSTER BUT WAS GIVEN THE PFIZER COVID VACCINE BOOSTER. THE VACCINATOR ADMINISTERED THE PFIZER COVID VACCINE BOOSTER IN THE LEFT DELTOID WITH NO ISSUES. PT  EXPRESSED DISMAY THAT HE GOT THE PFIZER BOOSTER ONCE HE WAS TOLD THAT HE GOT THE PFIZER BUT DID NOT HAVE ANY ADVERSE REACTIONS DURING HIS 15 MINUTE POST BOOSTER WAITING PERIOD.
Developed a fever to 104.9 (rectal).  Recommended that child go to the ER for evaluation.  Per phone note, mother decided to observe child and not go to ER unless symptoms evolved.  Office visit 02/10/04, temperature 98 (rectal).
This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. On 14-APR-2014 the patient was inadvertently administered ROTATEQ (Oral liquid, lot # H015682, dose: 2 ml, orally) that had expired on 18-MAR-2014. No adverse effects were reported. Additional information has been requested.
Symptoms started around 10pm the day patient received the shot. Started off with an overall feeling of being over heated and clammy skin. Patient reports redness and swelling at the injection site that continued to spread over the next 3 days. (Patient has picture of this on her phone as well). Also had a home thermometer that showed a fever greater than 100 degrees for 2 days.  Patient said she felt really ill and tired, barely got out of bed all weekend. Additionally reports trouble moving arm and numbness in her hand of the arm that received the shot. All symtoms listed in the VIS patient says she experienced besides the swelling of the throat and the nausea.
Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent condition and medical history of the patient were not reported. On 15-JUN-2016 (reported as "one week ago" at the reporting time), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route unspecified). On an unknown date in June 2016, the patient experienced injection site redness. The outcome of the event was reported as recovered/resolved on an unknown date in June 2016. Additional information has been requested.
Two days post vax the pt experienced varicella with approximately 75 red bumps which blistered over most of the body. Pt was treated with Benadryl and recovered from varicella. One of the lesions became infected and the pt developed cellulitis.
PATIENT FAINTED WITHIN ONE MINUTE AFTER THE TdaP (I DO NOT KNOW THE BRAND OF TdaP) INJECTION WAS GIVEN.  THE PATIENT RECEIVED THE TDaP INJECTION FIRST AND THEN GIVEN THE HEP A INJECTION IMMEDIATLY FOLLOWING.  NO PRIOR HISTORY OF FAINTING FROM INJECTIONS. THE REASON I AM REPORTING THIS INCIDENT IS THAT HIS COUSIN HAD THE SAME FAINTING SPELL FOLLOWING HER INJECTIONS OF THE TDaP & HEP A. (GIVEN AT ANOTHER CLINIC IN ANOTHER CITY)  COULD THERE BE A PROBLEM WITH ADMINISTRING THOSE TWO INJECTIONS ON THE SAME DAY?  HE WAS COMPLETLY FINE IN LESS THAN FIVE MINUTES FOLLOWING THE FAINTING.
pt to MD office 5/20/99 c/o rash to face & head;dx ?impetigo pt came back to office 1wk later 5/27/99 c/o itchy rash on arms & legs;dx varicella per MD;
Developed severe nerve pain from her hip down to her R foot, and could not tolerate weight bearing. Then spread to her L leg 2 hours later, it lasted several hours
Soreness in deltoid (L) shoulder and rash and whelps, abscess/swollen area to (L) deltoid & red whelps to (Lt) upper arm.
Pt has had severe upper arm pain -> from the shoulder to the elbow and stated - she developed a hematoma where the vaccine was administered (left arm) she will go to her PCP.
Developed mild case of chickenpox, had fever 99-101.5. Itching and discomfort. Fever with pustules treated wit Augmentin ES and Atarax.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Medical history and concurrent condition were not reported. On 11-DEC-2013, the patient was vaccinated with ROTATEQ (lot number not provided), expiration date 09-DEC-2013. Secondary therapies and concomitant therapies were not reported. On 11-DEC-2013, the primary reporter reported that the patient was vaccinated with ROTATEQ today and it was expired. No adverse effects were reported. Additional information has been requested.
Possible vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 36 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine (incorrect route of product administration).  The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their second of two planned doses of mRNA-1273 LOT # 013L20A on 05-FEB-2021 for prophylaxis of COVID-19 infection.    Female Nursing Practitioner called to report possible vaccine administration via Subcutaneous route. The patient had not reported any side effects. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 013L20A with no associated AEs.
Copied and pasted from Dr's report to me via e-mail: She was seen on 6/27/16 for a checkup.  She was given an ADACEL vaccine.  She called on 6/29/16 because the site was raised, hot, and about the size of a silver dollar.  We advised ice, Benadryl, ibuprofen. It got worse over the long weekend.  She called Dr. on Saturday 7/2 and he advised the same treatment.  On 7/3 it was worse still, and she went to the ER.  The ER doctor told her that the vaccine was administered incorrectly and that she had an infection.  He started her on Keflex 500 mg.  I saw her on 7/5.  She told me that the MA who administered the vaccine swiped her arm once with alcohol, pinched her triceps, and immediately gave her the injection in the triceps.  She had a red area over her triceps where the vaccine was given.  The redness had come down considerably with antibiotics.  She has a firm area in the fatty area near the triceps which represents where the shot was given. Patient is in the process of recovering.
This is a spontaneous case, initially received from other health professional (nurse) on 16-Jan-2018, concerning a 50-year-old, adult male patient. This report was linked to the case (201800102). The patient's medical history and concomitant medication was not reported. It was reported that, the FLUCELVAX QUADRIVALENT vaccine was exposed to 2 temperature excursions, above 46 F (48 F) and below 36 F (33F). On 03-Jan-2018, the patient was administered with FLUCELVAX QIV after second excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195219 and expiry date: 30-Apr-2018). It was reported that, no adverse event was reported post vaccination. The reporter assessed this case as non-serious.
On 06/02/2015 client called PHN stating a couple of hours after she received the vaccinations, while she was at home she started to develop small red itchy bumps all over, mostly on her trunk, not much on arms or wrists. Denied fever/chills. Denied any breathing problems, denied itchy throat . PHN referred client to see her local HCP that day and to call PHN back with report from MD. Client saw a doctor that afternoon who told client she was not sure what was going on, unsure if from vaccination or if client developed an allergy to latex. MD recommended client not get the next, 2nd Hepatitis B shot. Client denied any allergies to anything.
2/16/15 2 hrs after receiving injection, patient developed left arm pain and decreased motion. 2/18/15 patient evaluated by MD, exam shows pain at left shoulder with limited ROM due to pain, treatment: ibuprofen, ice/heating pad prn, rotator cuff exercises to aid w/ ROM. Follow up visit scheduled for 2/23/15.
Patient reports numbness and tingling in arm up to now. Issues gripping boxes and carrying out job functions. Weakness in Arm post vaccine administration.
Patient has only just contacted the pharmacy to report that 24 hours after the 1st dose of COVID Moderna vaccination she developed hives on her face and chest, and moderate heart palpitations. She states that the hives were more of an annoyance and she did not take anything for them and did not reach out to her PCP nor pharmacy at this time to report the hives or the heart palpitations. Patient stated that the hives stayed present for almost a month  appearing and resolving.
Swollen lymph nodes and pain under left arm and base of neck.  Breast tenderness.
Day after the vaccine I was very tired with muscle aches and a headache.  Two days after my right ear has been ringing and wont stop.
Per conversation with the patient, she started running a high fever the night after vaccination and then for two days after, she took tylenol to control the fever and starting this morning fever is gone, also starting the night after vaccination a few bumps started to appear which as steadily gotten worse and turned into a red, bumpy itchy rash running down both arms which led to report today, injection side is a red knot and warm to touch, patient advised to take oral antihistamines and apply hydrocortisone and follow up with md
This spontaneous report as received from a nurse refers to a 15 year old female patient (first client). The patient's pertinent medical history was not reported. On 24-APR-2014 the patient was inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. Reported as staff error only. Nurse states they are unsure which client the vaccine error occurred. For First client, this should had been the client's second dose of GARDASIL. For second client it should have been her first dose of GARDASIL. Both clients were vaccinated on the same day of 24-APR-2014. Nurse stated unsure which client got the Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL. No adverse effects reported. The outcome of inadvertently vaccinated with Dtap (unspecified), tetanus toxoid (manufacturer unknown) instead of GARDASIL and no adverse effects reported was unknown. This case is linked to case # 1405USA004069. Additional information is not expected.
From telephone correspondence received at AP Inc on 12/11/02, it was reported that a 5 year old child received Tripedia (Lot # U0581AA) given in the left deltoid in August of 2002.  One to two days after vaccination, the pt developed swelling 3x size of arm.  The area was red, warm and painful.  It was diagnosed by the physician as Cellulitis.  No lab/diagnostic tests were needed, it was very obvious.  The pt was not taking any other medication at time of vaccination, and did not receive any other vaccinations within a 4 week time period.  The pt did not have any illnesses or pre-existing diagnoses at time of vaccination.  The pt reportedly recovered from the event.  The case is closed.  See cases U2002-00494, U2002-01160, U2002-01161 and U2002-01163 with the same reporter.
dose of expired Daptacel was inadvertently administered to a patient, no adverse event; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5190AA, expiry date: 24-Apr-2019 via intramuscular route in the right thigh on 20-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  Dose of expired Daptacel was inadvertently administered to a patient on 20May2019.  No adverse event 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 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.  Documents held by sender: none.
Itching started on Friday; Two pin pricks with two little red dots one may be injection and one is next to it; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching started on Friday) and VACCINATION SITE ERYTHEMA (Two pin pricks with two little red dots one may be injection and one is next to it) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PRURITUS (Itching started on Friday) and VACCINATION SITE ERYTHEMA (Two pin pricks with two little red dots one may be injection and one is next to it). At the time of the report, PRURITUS (Itching started on Friday) and VACCINATION SITE ERYTHEMA (Two pin pricks with two little red dots one may be injection and one is next to it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX, (lot #, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
35 year old female who reported lip tingling and dry mouth post vaccination. followed by sensation of tightness to her throat. Stated " I feel like I have a ball in my throat". Patient was observed for worsening symptoms, MD STAT called for evaluation by MD and team. After MD evaluation, it was determined that patient would require further observation in the clinic. Patient was taken to clinic for further obs.  Through Process, patient is awake, alert, and oriented. Speaking in full sentences with a clear speech. Respirations are even and non labored. Patient did not report shortness of breath. VS checked while patient was in observation here in the vaccine clinic.
I received a flu shot at the school clinic yesterday and immediately after the injection (upper right arm) the muscle started spasming for a few minutes and a dull pain spread all the way down to my hand. I didn't think anything of it since it's happened before and I was fine. But shortly after I got home from running errands a couple hours later I started feeling extremely disoriented and lightheaded. My head felt weird in a way I've never experienced, it was like an intense but dull pressure that also burns. My whole body became extremely tense and shaky and my body temp went from 97 earlier to 100.5 and I started feeling random sharp pains around the brain stem area of my head and became nauseous. At this point I was considering calling 911 but decided to wait and see whether things would get any worse. After about 3 hours the symptoms slowly began to fade away and were fully gone by late this afternoon.
Suspect COVID breakthrough case  admitted 1/17/22 for acute pulmonary embolism- positive for COVID 12/30/21 and subsequently tested positive 1/17/22
Over a week: 4 inch diameter reddened swelling; 2 or 3 days: shivering, muscle pain, low-grade fever, headache.
Herpes Zoster Ophthalmicus to the left eye.  Given 7-day course of Valacyclovir, two types of eye drops and an eye ointment.  Patient was deployed the next day.  Outcome unknown at this time.
Became ill Saturday 05/30/2009 with headache, stomachache.  Also injection site of menactra (r arm) red and swollen approx. 1cm.
Patient came up about 10-15 minutes after receiving the shot to let me know he was feeling lightheaded, hot, and sweaty. I had him sit down and put his head between his knees and got him a bottle of water. I asked if he had someone else to drive him home so he would not be alone so his wife came and got him. I checked on the patient today, and he said he felt fine. He said his wife thinks he just had a panic attack.
pt co rxn before so we scheduled so we scheduled to give only .01 i beginning then wait. 15 mins to admin second half. 10 minutes with .01 admin pt co rash at injection site extending down arm with lethargy. Benadryl administered. Second dose with held.
Worse headache ever..felt like head was going to explode..light sensitive...blurred vision...horrible muscle cramps all over body...swollen legs arms face eye area...freezing cold for 24 hours straight - had on 2 swestshirts, 2 shirts, 3 blankets and heater at 75 with no relief...could barely get out of bed to use bathroom - had to crawl...horrible arm pain, couldn't move arm at all, hot to the touch, extremely sore..that was all in the first 24 hours...
Pt recvd vax 12NOV92 & w/in a few hrs, pt noticed swelling of lt eye; later the same evening noticed swelling of rt eye; both eyes also began to itch; devel patch of welts or urticaria;
Painful injection site, Pt reports decreased grip affected side within one day of receiving injection. States pain throbbing. Exam find no increased local temperature, no palpable mass day after injection. Still pain with ROM 10 day later. States shoulder painful. Ortho DX tendinopathy rotator cuff probable. Final outcome of symptom progression/resolution uknown at this time.
Vaccines administered, baby cried, good color. Shortly after baby's skin color changed from pink to pallor. Change in vitals. Heart rate 70 beats less and respirations reduced by 40 points. HR-184 to 110 RR 80-40. Took 20 mins to resolve. Good pulses, strong suck and responsive the entire time.