chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 21-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Recombinant human albumin (rHA), lot # T006792, expiration date 24-AUG-2021 (exact dose and route of administration were not reported) for prophylaxis. Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) (dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis.     Digital Data logger was involved. The administered vaccine experienced temperature excursion of -13.5 degrees Celsius (C), -11.4 C, -1.8 C for 24 min, 27 min and 2 h 8 min. There was previous temperature excursion reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010374: US-009507513-2007USA010893: US-009507513-2007USA010419: US-009507513-2007USA010252: US-009507513-2007USA010361: US-009507513-2007USA010001: US-009507513-2007USA010334: US-009507513-2007USA011962:
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On unknown dates, the patients were late to received second doses of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax;leg swollen,red area,"spasms", episode of "stopped breathing","turned blue" per mom; mom states began breathing again; no oth sx; fine today per mom;
Have checked on patient twice via phone w/mother. No noted adverse effects, mild low grade fever treated w/Tylenol.
Tested Negative for Covid at home and Negative for Covid and Flu at walk in clinic 2 days after first symptoms. Treated with anti-biotic for Bronchitis. Tested positive for Covid-19 5 days after symptoms started. Had a raspy voice, cough, and some body aches. No fever.  Was treated with molnupiravir anti-viral medication.
Patient recieved vaccine on 04/11/2023 and about 3-4 days after the vaccination patient developed painful red rashes over skin, was originally  up and arms  then extended to the legs then treated with po steroids with no improvement.  Patient came in 06/08/23 due to pain. As per MD, patient appeared to have significant  dermatocholosis started after after patient recieved Zoster vaccine and getting progressively worse.
Superior mesenteric vein thrombosis.  No known cause at this time.  Hypercoag panel negative.  patient hospitalized and currently on Xarelto for 6 months. Received vaccination dose 2 1 week prior.
Pt returned the day after immunizations with feelings of fatigue + malaise, soreness in L arm. Labs drawn. Pt returned the following day to review lab results, L arm with clear demarcated erythema along L deltoid, no significant swelling or heat. Pt afebrile the whole duration.
post herpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer referring to a currently 65 year-old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 11-JUN-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions. (strength, route, dosage schedule, lot number and expiration date were not reported).       On an unknown date, the patient was treated by providers for the following injuries resulting from zoster vaccine live(ZOSTAVAX) vaccination: multiple outbreaks of herpes zoster and post herpetic neuralgia.     The outcome of post herpetic neuralgia and herpes zoster was unknown.
Vaccine was expired, no temperature excursion occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Got Rashes all over body & face three times starting 12/7/2009. The first H1N1 was given on 11/20/2009. The second booster shot was given on 12/21/2009 and rashes started appearing again 12/25/2009. It has appeared thrice since my daughter was administered booster shot.
45 y/o AD. SM is preparing to retire from the military as of 01APR10 and contacts to "tie up any loose ends" and make sure there is documentation and a VAERS filed about the tender, 1/4 inch nodule he developed in his right supper arm at his AVA injection site, in addition to the joint stiffness and chronic discomfort he experienced in his right shoulder, hip and knee for 6 months after receipt of AVA #5 on 29MAR04, upon return from deployment. He experienced similar tender nodules at the injection site (LUE) w/ AVA #4 (03/11/2004); AVA #3 (03/14/2003); AVA #1 (02/11/2003), but did not developed joint pain and stiffness until mid April 2004, 2-3 weeks after receipt of AVA #5 on 03/29/04 and his sx continued x 6 months from APR-SEP 2004. He denies any personal hx of RA, SLE or joint trauma. His family hx is unknown as he is adopted. He never saw a Rheumatologist, as his sx basically resolved after 6 months, but now he c/o's residual dx of OA a/w stiffness and pain in his lumbar spine and knees (R>L). NKDA, no environmental allergies, no food allergies. PMH neg for DM or CA. Personal Hx: 45 y/o AD x 27 years. Married, 2 children. Tobacco: 18-yr pack hx smoking- quit in 2000. ETOH: social only, no binging, DUI'S or blackout's. No illicit drug use.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L051122, expiration date 12-OCT-2018; lot # M006709, expiration date 06-DEC-2018; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Menactra that reached 33.5 degree Celsius was administered; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an-other health professional by phone.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660. (Same reporter).  This case involves a 11 years old patient (gender not reported) who was vaccinated with 0.5 ml first dose of vaccine MENINGOCOCCAL VACCINE [MENACTRA] (lot number U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. These vaccines reached at 33.5 degree Celsius on that day.  Medical history: not reported.  Concomitant medications included patient was vaccinated with a dose of HPV VACCINE.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Shingles rash on left side of forehead and left side crown of head.  Mild headache.  Sensitivity of skin in area.
.  Patient with increased lethargy, generallized edema, UTI and pneumonia,
Stiff person syndrome with multiple autoantibodies: anti-GAD,  anti-TPO, and CSF oligoclonal bands. Anxiety, stiff legs, diplopia, right ptosis, left lid retraction, stiff legs, gait ataxia.
I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 5/6/2021 ST ELEVATION MI INVOLV OTH CORONARY ART ANT WALL
Vaccine administered from a vial that was out longer than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that was out longer than 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that was out longer than 12 hours). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that was out longer than 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vial punctured on 05-Jul-2021 at 12:30 P.M and vaccine administered on 06-Jul-2021 between 9 A.M and 1:30 P.M  Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
pt recv vax 1997 & in JUN97 pt exp a rash w/in 7 days p/vax;
Patient states: -Increased volume of my tinnitus -Mild headaches, but also a feeling that I'm wearing a helmet that's too tight -Pronounced balance problems. Difficulty balancing on one foot, and unable to balance on one foot with eyes closed. -Increased sensitivity to noise and light -Occasional blurred vision in one or both eyes. Having trouble focusing often. Dizzy if I move my gaze too quickly. Headaches when reading -Strange feeling of being on the verge of shivering, tightening muscles, etc. -Having a very difficult time sleeping.
The day after the vaccine injection, 3/26/21 I had pain in my right arm from my shoulder to my elbow.  It did not go away or seem to get better the next day and I called my providers office and spoke with the provider on call who stated it was probably from the vaccine and to give it a few days.  The problem persisted and became worse with the pain going from my right should to my wrist and often causing me to wake up at during the night.  It was a constant ache and increased when I used my arm with activity such as using the vacuum, cleaning, cooking, typing.  At times I felt that my arm was so weak that i could not hold my coffee cup comfortably.  I saw my provider again in April and told her about the pain.  I started phsysical therapy (PT) in May and had 4 sessions.  PT gave me exercises and I was instructed to use my are as I normally would.  The pain continues to this day and NSAIDS did not seem to work.
HYPOTENSION 12/21/2021 UPPER GI HEMORRHAGE  HYPOTENSION 12/21/2021 CANCER METASTATIC TO INTRAABDOMINAL LN
In the ED she was found to have a positive covid test and her cXR was also noted to have bilateral infiltrates suggesting the same although superimposed bacterial pneumonia can not be excluded.
Injection site red and swollen about 4 inches in diameter. Patient reported itchy skin all over body. Cool compress applied at home. Ice pack applied at flu clinic on 10/18/2012 when patient returned. Patient referred to primary care.
Within 24 hours, had fever 102 degrees, aches (body) ankles swollen and tender to touch.
during noc p/shot awoke w/twitching of eyes & gurgling noises from throat; went back to sleep & when awoke couldn't speak for about a minute; episode happened again assoc w/nap; exame by neurologist; had 1-2 subsequent episodes milder;
The patient received their second pfizer dose on day 13 which is noted to be an early administered dose.
vaccination site pain and limited arm motion; vaccination site pain and limited arm motion; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative.  A female patient of an unspecified age started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  On an unknown date the patient experienced vaccination site pain and limited arm motion on an unspecified date with outcome of unknown.    Information on lot/Batch number has been requested.
Received second dose of Japanese encephalitis vaccine on 5/1/2017.  Began to feel ill over the weekend: Nausea, vomiting,diarrhea. unsure of fever. Headache, felt faint, felt like passing out but did not.
Raging bilateral tinnitus; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0150), via an unspecified route of administration administered in right arm on 31Mar2021 at 12:00 PM (at the age of 37-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took tetracycline and experienced allergies to it. On 01Apr2021 at 12:00 AM, the patient experienced raging bilateral tinnitus. The event was considered as serious as it was disabling/incapacitating. There was not treatment given for the event. Since the vaccination, the patient has been tested for COVID-19 (nasal swab, PCR) on 02Apr2021 which was negative. The patient had not yet recovered from the event.
Patient's husband reported to us on 5/19 that pt had nausea and vomiting and  mild fever after getting the J&J vaccine on Saturday 5/15. patient then had a mild fever on 5/16 which was resolved on its own after 1 day but nausea and vomiting persisted, pt sough care from her PCP on 5/19 and was prescribed 2 antiemetics to treat. Patient's husband verified no other symptoms, patient doing well otherwise.
It was reported that pt has irritability and fatigue off and on since receiving MMR vaccine. Had 8-9 days of fever after MMR and had an atypical measles rash. She also had markedly decreased appetite.
Initial report received on 20 September 2009 from a consumer. A 36 year old female patient developed a reaction the same day after receiving FLUZONE (lot number was not provided) in the right deltoid on 16 September 2009. Later that day the patient complained of having a sore arm and stated that she yeast infection signs and symptoms such as vaginal irritation and itching. She did not have a fever or discharge. The patient did not receive treatment, however the patient was planning on going to see a health care professional. Recovery status was not reported. Follow-up information was received from a health care professional on 20 November 2009. The reporter stated that "patient is unknown to me, cannot find in my database". No additional information was provided. List of documents held by Sender: none.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 9 AM, temperature was 34, total doses given for the day was 188, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Began complaining that she was short of breath at 10pm on 3/16, needed nebulizer treatment for wheezing on 3/17 at 1am, could not get wheezing under control with 2 nebulizer treatments at home, so went to ER at 2am. Was dosed 16 puffs of albuterol over about 40 minutes. Vomited and then administered IV fluids and blood was drawn/chest x-ray performed. Discharged at 6am on 3/17.
Flu vaccine was administered higher than I have ever had it given. It started hurting after I received it. I am still experiencing occasional pain when I move my arm a certain way. I am also unable to lay on my left side without feeling some pain in the area where the vaccine was administered. Arm, Upper Left.
Bleeding at time of injection. Site on this day shows bruising, some inflammation and warmth. No redness, No fever per patient.
Patient is a 62-year-old female who is seen in consultation for APRN, for evaluation of left arm injection site reaction. Patient states she had hepatitis A vaccination injection in her proximal left upper extremity on 10/8/18. Patient states that 3 weeks after she got the vaccination, she noticed her proximal left upper extremity near the injection site became red, warm, and it drained. Patient states the area improved following the drainage. Patient states that the area has since worsened and improved again since then. Patient states she has tried antibiotic ointment, peroxide, and clean bandages. Patient states that the drainage has been thick pus followed by black bloody drainage. Denies fever, sweats, chills. States she has not had any antibiotics. States she has not had the lesion lanced. Patient states the area has not drained in 2-3 weeks.
Patient on 12/18/2021 got 2nd Covid shot, but instead of Pizer-Biontech, he got Pizer PED .2 ml, both parents and his PCP got informed. According tp CDC, Patient does not suppose to get any extra shot at this time.  nNo adverse affect from the shot.
fell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious), outcome "unknown", described as "fell". Additional information: The reporter wanted to know if her mother (patient) can reschedule her second dose appointment a month later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was supposed to be receiving Menactra and instead Trumenba was pulled and given. There was NO adverse reactions noted. I spoke to Mom again this morning and she reports the patient is fine with no adverse reactions today either.
Office visit attached. Indurated red area at site of MMR/Varicella vaccine. Not tender or warm to touch. (25 cents diameter).
approx 2 yrs p/ vax pt broke out in chickenpox rash  w/clear vesicles on a red base of which approx 20 ruptured. rpt felt rash was not related to therapy w/varicella
The patient had worsening arm shoulder and neck pain that got so bad through the night that she "screamed out in pain anytime she moved". Movement was possible but did cause pain. Patient stayed in bed 24 hours and symptoms subsided.
102 degree fever; lymph node swelling; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 degree fever), LYMPHADENOPATHY (lymph node swelling), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (102 degree fever), LYMPHADENOPATHY (lymph node swelling), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). On 24-Feb-2021, PYREXIA (102 degree fever), LYMPHADENOPATHY (lymph node swelling), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax & exp high pitched cry for 2 1/2 hrs;
Sore arm, fever like symptoms,: headache, chills, aches and pains,  nausea,
Vaccines administered without issue- patient took Rotavirus first without difficulty and tolerated well. He then received 3 IM injections listed above. After nurse left exam room, within 5 minutes of vaccine administration, nurse was called back to exam room by mom. She reported to nurse that he looked pale and nurse noted significant facial pallor and flushing of thighs. Flushing of thighs was resolved at the time of provider eval., but face did have some residual pallor that slowly improved over 5 minutes. Pulse ox. 100% and HR 150. He was breathing comfortably, alert. Cardiac and lung exam WNL. No overt breath holding spell witnessed, no perioral cyanosis. Possible vasovagal or pain response. Mom & provider comfortable with discharge home. Provider discussed with attending- felt this was possible HHE (hypotonic-hyporesponsive episode).