chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/7/21, patient's husband called 911 and his daughter to the house. The patient had fell going to the bathroom and was passed out. EMS arrived on the seen after daughter started CPR. Patient was found to be in VFIB and wound up defibrillating the patient and getting her pulse back. Patient was also intubated at this time. Patient was transported to the hospital and has been at the hospital since.
The pt had inconsolable crying for almost 24 hours. Her leg at the site of the vaccination was mottled and blue which resolved. Was seen in ER.
pt recv vax 29NOV93 & pt devel persistent swelling, redness & itchiness @ inj site;As of MAY96 these sx cont to flair up intermittently;
Fever, pain at site, mental fog, "randomly" dropping of blood pressure, most sever incident was fainting why deficating (pooping), this lead to head slamming into sink and waking up on the floor butt naked to a panicked wife. luckily minor damage to face, slight pain in neck. (i have never and have never since this vaccine fainted during pooping... this was the one and only occurrence)
Diagnosed with Covid-19 by PCR test on 8/30/21.  Symptoms mild, congestion and cough.
Shingles; This spontaneous report was received from a lawyer and a currently 67 year old male patient regarding a case in litigation on 31-JAN-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date in 2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for shingles. Pt claimed damages as a result of the injuries to himself, loss of consortium, loss of services and economic losses. At the reporting time, the outcome of shingles was unknown. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Client received first COVID vaccine on 02/25/21 at 1:30 pm, adverse reaction noticed on 03/03/21.  First noticed a tiny bruise at injection site, then became red with area of 5 - 7 inches around injection site on 03/03/21.  Rash is not itchy or painful.  Client seen by PCP, was given a cream to put on the rash and to use a cold compress.  Client reported no improvement, PCP determined client can stop applying cream to site but can still use cold compress as needed.
This spontaneous report has been received from a Licensed Practical Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On 27-OCT-2015, the patients received doses of improperly stored PNEUMOVAX 23, (Lot # L003227, exp. date on 13-OCT-2016), (strength, route of administration and dose were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several received from the same reporter. Additional information has been requested.
Patient reported fever of 102.8, diarrhea and nausea for up to 6 days after the vaccination
Patient received two doses of the Boostrix on May 27, 2021 1ml, instead of the 0.5ml.
Around 11pm the same day I received my 4th dose. I started experiencing shaking from my core outward and I had a fever that was around 102 all night. I then went to the emergency room and there they ran a ekg on me and advised me to stay a few more hours to run more test. They are still currently running test on me but I was advised to no longer receive any additional vaccines until further notice.
gave second vaccine dose from the expired vial; first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave second vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E211A. and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave second vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave second vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided. No Treatment Medications were provided.   This case was linked to MOD-2021-133589 (Patient Link).
Arm redness, 4" round at injection site, warmth, hardness x 4-5 days.  Lump under right arm,  Muscle aches
they are unsure if he got a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (they are unsure if he got a dose) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (they are unsure if he got a dose). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (they are unsure if he got a dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Retired pharmacist stated that her 2 year old grandson was taken by his mother to a clinic for his 1st dose of the Moderna Covid-19 Vaccine in his right leg.  As they were getting in their car about to leave that clinic, someone from the clinic stopped them & told them they are unsure if he got a dose.  Caller is unsure what made them think that.  They did say that they counted the doses that were given from the vial & it appears that the correct number of doses were given from it.  Caller says that he hasn't had any soreness in his right leg but  that is not a good indication of whether or not he got the dose.  Caller notes that his pediatrician wasn't involved with the dose administration & that we would want to speak to the vaccination facility instead.  Caller states that her daughter had spoke with the Chief Medical Officer of the vaccination facility who said they may want to consider a blood test to determine if the dose was given.  No treatment medication information provided.
Resident received the vaccine on 6/16/23 and then again on 6/26/23. No adverse event occurred. Medication administration error occurred. Resident received the vaccine twice in a 10 day period.
ACUTE STROKE OF CEREBELLUM, UNSPECIFIED TYPE AND ARTERY ACUTE HYPOXEMIC RESPIRATORY FAILURE
Red rash at injection site on same day as vaccination. On 11/10/2016 developed 6th cranial nerve palsy. ER suggested brain MRI (normal) and lumbar puncture due to possible GBS. In hospital developed severe leg pain and weakness. GBS was never confirmed nor denied.
Slowly starting what felt as muscular pain at first but as it progressed by the next day, it was clear that it was not muscular but severe joint pain leaving the patient immobile for 4 days (from neck down as even it was not possible to lift or turn head) after which the symptoms started to ease and it was possible to get up from bed without help though still in a lot of pain but able to go to bathroom or sofa.  It took overall 4 weeks for the pain to go and be able to move normally. Until then, walking,  or going to lye down or sitting from standing up and vice a versa were difficult, taking stairs relayed on pulling up with hands.
Pregnant; Soreness in arm; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Soreness in arm) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes (Maternal medical history includes gestational diabetes) in April 2017. Concurrent medical conditions included Allergy (Seasonal Allergies).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Jan-2021 and the estimated date of delivery was 10-Oct-2021. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 14-Jan-2021, VACCINATION SITE PAIN (Soreness in arm) had resolved. On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Pregnancy test: positive Positive.         Patient previously had live full term child birth.  The patient's estimated date of conception was 17-JAN-2021  No concomitant medications were reported.   No treatment information was provided/
Fatigue, body aches, flu-like symptoms x 1 week; pain at site for 3 days.
Positive COVID test on 9/17/2022 after third dose of Pfizer on 9/7/2022
a few days after receiving 2nd dose of maderna vaccine patient became shor.t of breath.  was found to be in acute heart failure, was septic with a lactic acid of 5.6, and sustained a NSTEMI with a troponin of >6.0.  stabilized on a bipap for respiratory failure and a nitro gtt for heart profusion.  now on impella device r/t severe cardiac decompensation during heart cath procedure
The team has identified possible quality control issues (intra-lot and inter-lot variability) with MMR vaccine, manufactured by Merck, that may require further investigation. Using non-destructive analytical techniques, FT-NIR spectra were collected for inventory belonging to LotU006488 as part of routine medication quality screening. A representative sample of 12 individual vials were selected for screening and noted to be stored under proper conditions, in their original packaging at between 2 and 8 ?, with an expiration date of 02/26/2023. FT-NIR spectra were collected noninvasively and non-destructively using a Thermo Scientific Antaris II FT-NIR Analyzer. Upon examination of the FT-NIR spectra, absorbance peak location and intensity differences were observed in 6 of 12 vials screened after applying multiplicative signal correction on the spectra. Differences in absorbance peak location were observed at 7000 cm-1, 6050 cm-1, 4700 cm-1, and 4600 cm-1. These findings can be observed directly in the attached image, labeled as MMRB000PPHWR102421. The observation of variability in absorbance peak location differences may indicate the presence of product impurities and/or degradation products. Statistical analysis of the collected FT-NIR spectra indicated the 6 vials that produced the spectra containing variability in absorbance peak location differences suggested intra-lot variability. The 6 outlier vials had a calculated distance of 14.47 multidimensional standard deviations (SDs) from the center of the 6 other vials with the same lot number. Using a group membership range between 0 and 3 SDs, a standard deviation of 14.47 signals potential quality control issue LotU006488. In addition, upon comparing LotU006488 to other lots collected for our spectral library, it was discovered that there is inter-lot variability as well as intra-lot variability. Our library of 198 MMR Vaccine spectra from 11 other lots falls into at least 2 groups, with a large number of observed outlier spectra (see principal component plot). It is not clear which of these groups represent the approved product, or whether they are all the approved product. The 11 other lots forming the spectral library are LotS032826, LotS037501, LotS039310, LotT001213, LotT001214, LotT012807, LotT013725, LotT022310, LotT031436, LotT034389, and LotU011149. The presence of intra-lot and inter-lot variability may warrant further investigation of the product, MMR Vaccine, and the manufacturing process controls of its producer, Merck. 14.47 is the multidimensional standard deviation (SD) value obtained for 6 outlier vials in LotU006488 with respect to the calculated average of 6 additional vials of the same lot number. The low and high test range values are represented by the group membership range, defined as the range between 0 and 3 SDs.
Sore arm, shakes, low grade fever (not measured) - no treatment, started approx. 24 hours after vaccine given. Shakes and fever resolved but arm is still sore 48 hours after vaccine given.
Pt experience soreness, redness and inflammation at the injection site. Pt also devel swelling around the injection site all the way to the elbow and difficulty raising her arms.
2"x2" swollen lump at vaccination site, hot to touch, very itchy, sore to touch. (Above symptoms started about 1.5-2 hours after vaccine administered). Lasted for 4 days.
Hypersensitivity; pt exp h/a, fatigue, fever & migrating arthralgia starting 18hrs p/being administered DT for peds; sx over p/24hrs & resolved spontaneously; later localized erythema lt deltoid w/induration & tenderness; SOB 36-48hr p/inj
Patient went to emergency room, I got call from ER stating patient had allergic reaction, facial swelling and swelling at site of injection.
Rash on left arm and itchiness on arm as well as hands and the opposite upper arm - prescribed antibiotic and steroid - 2 weeks. Fever and shivers - alternate. TYLENOL and ALEVE. Headache and body aches, coughing - 24 hours.
Area around the site of injection on arm became red and swollen on 04/07/2021, and felt tender. The area was treated with an ice compress. About 24 hours later, an itchy rash with hives appeared below the initial swollen, painful area.
This is a spontaneous report from a non-contactable consumer. This reporting consumer of an unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date in 2017, at single dose, for immunisation. Medical history and concomitant medications were not reported. The consumer experienced pneumonia 2 days after vaccination, on an unspecified date in 2017. Pneumonia outcome was unknown at the time of report. No follow-up attempts possible. No further information expected.
7 x 7 cm area at induration, pain to right anterior thigh at varicella vaccine administration site - improving.
TERRIBLY SICK; A spontaneous report has been received from a consumer. The report concerns a female patient  of Unknown ethnic origin.    No medical history was reported.    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced terribly sick (preferred term: Malaise).     The outcome of the event  terribly sick was unknown.    The event  terribly sick  was considered non-serious.
She got her vaccine, she felt numbness going down her arm and into her hand, but is used to numbness.  She then got a mild sharp pain in her chest that went away.  After that she felt OK, but then hours later she started feeling pain in her kidneys and she laid in bed and when it got crampier.  Then her legs started cramping like circulation in them was not going good, and she went ahead and waited to see if it was going to go away and moved around, but it did not go away.  She took 2 more baby aspirin for the circulation, and was drinking cranberry juice for the kidney pain.  She went to bed and was in pain throughout the night with kidney and leg pain.  Right now the leg pain is not bad, but her kidneys are aching.  Her blood sugar is mildly elevated at 202 right now.   She also had  little sharp pain in her left breast but went away.  Her kidney on the left side is her main concern as it is aching and won't stop.    She is going to call her doctor later once the office opens, and she took the vaccine at her doctors recommendation and her job.
Hyper feeling on the first day, headaches migraines (5 total days unsure if any more) ,chills the next day,dizziness currently ongoing, soreness currently ongoing
Hives covering trunk, itchy arms and hand. Swollen lower lip and fever blister on chin.
8/11 positive ovulation test  8/20 1st vaccine 8/24 positive pregnancy test 9/3 2nd vaccine  8/30-9/9 positive HCG blood levels 9/9 first ultrasound = blighted ovum
1 of 4 pts (out of 38 pts vaxed) who had an adverse event following vax; pt had an inject site reaction; seen in ER; pt recovered;
pt recv vax 2OCT95 & 28DEC97 pt devel a mild case of chickenpox;
Patient reported feeling lightheaded after vaccination around 1111AM. Patient pale in color and sweaty. Patient instructed to lay down. Feet were elevated. MD called over to assess patient. Radial pulse weak. 911 called at 1112 AM. Blood pressure assessed to be 100/76. Patient began to feel better.  Water given to patient. EMS arrived to assess patient and vital were reassessed by EMS. Patient confirmed feeling better and was released from EMS care. Patient observed until husband arrived at 1155AM. Released from facility with husband.
Persistent fever, chills, body aches, headache, fatigue  Treated with Advil - symptoms fade and then return several hours later
Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21  with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions.  Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion.  It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment.  He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home.  There was no fever no hemoptysis chest pain or pleuritic pain.   Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen.  He had a CT of the abdomen and pelvis which was negative for any malignant spread.  Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21
Pain in arm, bones, and end of bone- nerve endings and right side of head, redness, pain.
Woke up on 3rd day after receiving shot with a red , warm spot the size of a fist 2 inches below injection site. This was new as I had no other symptoms except injection site soreness hours after the injection.
Client stated she had a wave of lightheadedness.  No other complaints.   Evaluated by EMS.  BP146/82.  2:34 pm client states symptoms resolved, kept for additional monitoring.  2:54 client stood and became lightheaded.   Evaluated by EMS.  BP 151/78, repeat 147/85, HR-82,  O2-99% on room air.  2:59pm client took Xanax 0.25 mg po pres ribed by her PCP.   3:14pm. Sx resolved.  3:20pm discharged home.
Had covid arm on April 2 when I woke up  It?s itchy and the red spot from scratching is about 3in diameter  No other symptoms observed
This spontaneous report was received from a physician (who was the patient's spouse) via a company representative and refers to a 48-year-old female patient. There was no information about the patient's concurrent conditions, drug reactions or allergies or medical history provided. On 10-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, 0.65 ml, in left arm (lot #: M032139, expiration date: 02-OCT-2017, route of administration was not reported) for prevention of shingles. ZOSTAVAX was reconstituted with a sterile diluent (manufacturer unknown) injection (lot#, expiration date, dose and route of administration were not provided). There were no concomitant therapies reported. On 11-MAR-2017, next day after the vaccination, the patient developed shingles on upper-right side of her body. The patient sought medical attention by seeing a physician. On an unknown date in 2017, the patient was given valacyclovir hydrochloride (VALTREX) for 3 weeks as a treatment of shingles. On an unspecified date in 2017, the patient improved and she discontinued therapy with valacyclovir hydrochloride (VALTREX) for two days. After that (unspecified date in 2017), the symptoms came back. At the time of this report, the patient was back on therapy with valacyclovir hydrochloride (VALTREX). The outcome of shingles (herpes zoster) was reported as not recovered. The relatedness between the event of shingles and the suspect therapies was not reported. Additional information has been requested.
Tested positive for COVID for the 3rd time - asymptomatic this time; Tested positive for COVID for the 3rd time - asymptomatic this time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 21 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID for the 3rd time - asymptomatic this time". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Tested positive for COVID for the 3rd time; positive; positive. Therapeutic measures were not taken as a result of asymptomatic covid-19. Clinical course: It was unknown if other vaccine in four weeks. Other mediation in two weeks included medication for anxiety and ADHD (unspecified). No Covid prior vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Arm pain post about 30 minutes of injection lasting about 3 days.  On morning of second day I felt tired and by around 3pm had a fever of 100* with chills and flu like feeling.  A few days later a odd shaped bruise was noted with what appeared to me multi colored mostly yellow and slight purple. Over the last 3 weeks the bruise has grown slightly and has become more pronounced. Pictures were taken at both March 9th and today March 17th showing the progression.
Headache, severe chills, rash at injection site 2??x 6?, body aches, shaking.