chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urinary incontinence; Swollen, bump at injection site itching; Swollen, bump at injection site; Swollen, bump at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 76-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2021 14:00 (Lot number: EL0142) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LAMOTRIGINE, start date: Oct2020 (ongoing), BUSPIRONE, start date: Mar2019 (ongoing), SYNTHROID, start date: 1992 (ongoing), MONTELUKAST, start date: 2020, LOSTATIN, start date: 2019, OMEPRAZOLE, start date: 2017, IRBESARTAN, start date: 2016, FAMOTIDINE, start date: 2017, CYTOMEL, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: EL0142, Time: 14:00), administration date: 10Jan2021, when the patient was 76 years old for Covid-19 immunisation, reaction(s): "Swollen, very sore, hot arm by injection site", "itching", "fever", "Very tired", "Achy", "Headache", "Diarrhea". The following information was reported: URINARY INCONTINENCE (non-serious) with onset 31Jan2021, outcome "recovered" (2021), described as "urinary incontinence", VACCINATION SITE PRURITUS (non-serious) with onset 31Jan2021, outcome "recovered" (2021), described as "swollen, bump at injection site itching", VACCINATION SITE MASS (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 31Jan2021, outcome "recovered" (2021) and all described as "swollen, bump at injection site". Therapeutic measures were not taken as a result of urinary incontinence, vaccination site pruritus, vaccination site inflammation, vaccination site swelling.  Additional information: Patient reported issue occurred after use of a Pfizer product. No surgical treatment needed for the event. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Emergency room or physician office visit was not required for any event. No admission to hospital due to the events. No prior vaccination within 4 weeks of covid-19 vaccine.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
"Employee reports fever, chills muscle aches " felt like full blown flu" This is the second of 2 such identical reports from this source.  No other information provided
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot # reported as N027883 (verified to be invalid) with expiry date 15-APR-2019, lot # N000238 with expiry date 25-OCT-2019 and lot # M036058 with expiry date 19-MAY-2019 (dose was not specified) for prophylaxis. Administered doses of LIQUID PEDVAXHIB underwent temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 10 days. Data Logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA013078: US-009507513-1709USA013077: US-009507513-1709USA007903: US-009507513-1709USA013076:
Headache, blacked out,  throwing up to severe dehydration, chest pain, shortness of breathe, diarrhea, rash on arm of injection, caused issues with menstrual cycle
Pt in middle of night started shaking, drooling with blank stare in eyes lasting approx. 2-3 min. Mother took in to ER, ERMD thinks symptoms may R/T Immunizations side effects - he took PEDIARIX, HIB, PCV13.
no adverse event, but patient was accidentally given short dated vaccine that expired on 4/28/21
we reviewed COVID shot record and timeline today         pt had pneumonia on 3-1-2021 and he had started to get better and was on on 3-16-2021.         Then pt had first covid shot on 3-18-2021         he was in on 3-29-2021 and reported getting better but was still SOB         pt went to the ED on 4-6-2021 and because he could not breathe and this is when the extensive interstitial lung disease was Dx         then he got second covid shot on 4-16-2021         inflammatory blood markers positive on 4-21-2021, RF 46
This case was reported by a nurse via patient support programs and described the occurrence of death in a 61-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX.5 ml. On 7th March 2019, unknown after receiving SHINGRIX, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 7th March 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to SHINGRIX. Additional details were reported as follows: This case received from the healthcare provider via the vaccine patient assistance program. The age at vaccination was not reported. The patient passed away in hospice care, cause was unknown. The reporter declined consent for follow up.; Reported Cause(s) of Death: Death NOS.
p/vax pt devel extreme agitated depression, necessitating hosp;discharged 10/14/99;intermittent agitation & depression through 10/17/99;
In the evening on the date the vaccine was given, patient developed pain in bilat. fingers and hands. The fingers are numb during the day, and at night she has pain in 2nd and 3rd fingers on (R) hand. Hands get hot, red and swollen.
pt recv vax 9JAN97 & 13JAN97 pt discontinued tx w/salicylate;14JAN97 pt devel an acne-type rash on face which was heat radiating, itchy & burning;pt also felt dizzy;MD reportedly told the pt it was not varicella;
severe diarrhea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (severe diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (has to take heart medication).   On 10-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM A-D) for Diarrhea, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (severe diarrhea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication included heart medication
Mother describes an increasing amount of "slimy" oral secretions. Baby appeared to stop breathing/couldn't catch her breath. EMS was called, examined baby and said he was OK.
received shot at 0955, experienced L sided cheek numbness at 1030. unresolved at 1423 at time of documentation
Narrative: Admission CC: Left shoulder pain and weakness after Vaccine administration SUBJECTION: Patient had the flu shot on Sept 26. He had the usual discomfort but it did not go away and he is now unable to lift objects with his left arm or lift his left arm. Denies other trauma or deformity or having problems in the past. He is right handed. He looked it up on the internet and thinks is could be SIRVA. Should injury Related to Vaccine Administration. He also had the Bivalent Covid shot in September 20 th. He does not deisre surgery for this injury; will to do physical therapy. Inquires about possible MRI. ASSESSMENT/PLAN: 1. SIRVA Shoulder Injury x ray shoulder PT consult RED team same day now/PT recommendations may consult PT Monitor for improvement *** PLAN OF CARE AND RECOMMENDATIONS DISCUSSED WITH PATIENT HE IS AGREEABLE.
Headache, chills, pain the bones, irregular temperature (very cold) and pain in the right arm.
Received PCV, Hib, VZV, and flu vaccines 8/31. That evening had paroxysmal event of flaccidity and unresponsiveness without full LOC, apparently post-ictal. Had a similar episode in ER, witnessed by staff. Taken by EMS to ER, transferred to another Hospital for observation. No further episodes. Had normal EEG, labs; CXR consistent with bronchiolitis but suspect expiratory view given age and lack of URI sx. Has been well since. No family hx epilepsy.
Pt had Pfizer sticker as 1st dose on card but verbally verified Moderna. Pt counseled and given literature
sore arm; Depression have worsened; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain in extremity and Depression.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened). At the time of the report, PAIN IN EXTREMITY (sore arm) and DEPRESSION (Depression have worsened) outcome was unknown.            This case was linked to MOD-2021-085231 (Patient Link).
The patient was injected with a needle on a syringe. There was no air or solution in it.
Patient had a headache at 5pm. Experienced swelling of mouth and lips at 8pm. Developed anxiety at 8:30pm. Took BENADRYL at 8pm. Went to emergency room and was administered an EPIPEN and prednisone.
Pt stated that within a day after receiving the vaccination she experienced a rash that covered her entire face, fever, muscle aches and pains, and fatigue.
DID NOT TAKE THIRD DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1158) was received from a nurse on 09-May-2019. It describes a 51-year-old female consumer who "did not take third dose of Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on Friday (day 1) and the second dose on Sunday (day 3). However, she missed to take the third dose, which was due on Tuesday (day 5).  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take third dose of Vivotif according to schedule" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "did not take third dose of Vivotif according to schedule" was considered as not applicable.
Menstrual bleeding starting 6 days later and ending in 11 days.  Take birth control and have very regular cycle.
Known allergy to Ants. Syncope, Flushing/sweating, dizziness.  Pt had an episode of syncope for a few seconds.  Complained of dizziness and itchiness.  Gave 50mg PO Benadryl. VSS and released from vaccination site.
C/O body aches, headache, which triggered into migraine, terrible body aches, thighs, hips arm pain hurt where she couldnt walk or lift arms. trouble catching breath, very fatigued, N/V/fever.
Chest pain and shortness of breath, onset after a brisk walk, duration of chest pain 4+ hours  23 weeks pregnant, first pregnancy, normal pregnancy, EDD 25 Oct 2021
pain at injection site; redness at injection site; fever of 102 degrees; flu like symptoms; fatigue; sleepiness; feels noticeably without energy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA SHOT with an associated reaction of chronic fatigue syndrome (Approximately 20 years before from the time of reporting (refer case US2019GSK088484) ).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site erythema, fever, influenza-like symptoms, fatigue, sleepiness and loss of energy. On an unknown date, the outcome of the injection site pain, injection site erythema, fever, influenza-like symptoms, fatigue, sleepiness and loss of energy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, fever, influenza-like symptoms, fatigue, sleepiness and loss of energy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced fatigue that causes her to need to take naps and sleep longer at night and she feels noticeably without energy. The patient received flu shot (formulation/brand name unknown) that contained thimerosal. The reporter did not consent to follow-up. Caller notes stated that caller declined for prescriber follow up. For tolerance to 2nd dose, refer case US2019083179.      Lab Comments: On an unknown date, body temperature was recorded.
9 days after vaccine administration developed hives at the vaccine injection site (circumferential around the injection site). No other hives. No other source of hives and no contact exposures to that location (had been in same shirt all night with no changes). Priorities of hives at injection site as well.
Chills (no fever); feeling so cold; cant lift arm at all; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13May2021 at 10:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 16:00, the patient experienced chills (no fever), feeling so cold and can't lift arm at all. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with ibuprofen. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event chills (no fever), feeling so cold and can't lift arm at all was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Tired one day after vaccination.  Very tired two days after.  Woke up from 20-minute nap on second day in a strange mental state.  I knew something was wrong with my cognition but could not articulate it to my girlfriend at the time.  My memory of those conversations is fuzzy.  Symptoms lasted about three hours with no recurrence since.  Best description is that I didn't completely wake up from a dream state - could not clearly distinguish between what was real and what was left over from my dream.  Very strange; have never experienced anything like it.
Immediate swelling and soreness at injection site.  A few hours later, achiness and fatigue. Got worse over the next two days.  Finally started to feel better on third day, but arm was sore for 5 days.
Patient to the ER on 11/17/2021 with symptoms of COVID19 Reported fever (up to 101.3F) and chills, shortness of breath, decreased oral intake (no loss of taste or smell though).  Also, reported headache.  No sore throat, no congestion, no wheezing, no chest pain, no vomiting and no diarrhea
HEADACHE, CHILLS, SOBB, NAUSEA, ARM PAIN, INSOMNIA
administered expired product to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150852, 2019SA150840, 2019SA150851 and 2019SA150853 (same reporter).  This case involves a 4 years old male patient who received fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C52028A, expiry date: 17-May-2019) via unknown route in unknown administration site on 21-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  It was unknown if any adverse event was occurred.  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.
autonomic neuropathy; I fell very sick; my stomach was bothering me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 2, single (Lot number: EL9267) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 02Mar2021, outcome "recovering", described as "my stomach was bothering me"; AUTONOMIC NEUROPATHY (medically significant), outcome "recovering"; ILLNESS (non-serious), outcome "recovering", described as "I fell very sick".  Clinical course: She had a very bad reaction to the shot. On 02Mar2021 she noticed her stomach was bothering her. she was a healthy female and very much a COVID shot proponent. she fell very sick with which had now been diagnosed with autonomic neuropathy from the vaccine. This had been a year and half recovery and she want to offer to be studied by Pfizer to help.
Information has been received from a Registered Nurse, via a company representative, referring to a 71 year old female patient. The patient did not have medical history, concurrent conditions or concomitant therapies. On an unspecified date in September 2017 (also reported as "in the last 2 weeks"), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N011305, expiration date of 20-JAN-2019, intramuscularly (dose, anatomical location and expiration date were not reported) for prophylaxis. On an unknown date in September 2017 (reported as "within a day of receiving the vaccine"), the patient developed cellulitis. The reporting registered nurse stated that on an unspecified date, the patient was examined and treated with unspecified antibiotics at the facility. The outcome of the cellulitis was reported as recovering and the causality between the vaccination with and the event was not reported. Upon internal review, the cellulitis was considered as a medically significant event. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA014175: US-009507513-1710USA001897.
On or about March 25, 2022, I experienced extreme pain and stiffness on the right side of my upper body.  I was unable to turn my head towards my shoulder, the right side of my neck, the right upper back, shoulder and arms hurt with constant shooting and throbbing pains.  The pain subsided, then the weakness started.  I could not lift my right arm to shoulder level.  When I was finally able to lift my arm to shoulder level, my muscles in that arm would fatigue and my arm would lower.  I went to the ER for evaluation for a stroke.  At the ER, I was told that I had not had a stroke, but I needed to follow up with my primary care physician.  The ER doctor placed me on a week long tapering dose of steroids, which alleviated the pain, but did very little for the weakness.  I followed up with my primary care physician, who referred me to an orthopedic surgeon.  The orthopedic surgeon sent me to a neurologist for a nerve conduction study.  The orthopedic surgeon informed me that I had all the symptoms of Parsonage-Turner Syndrome.  I am now on a regime of a tapering dose of steroids for seven weeks, and an anti-convulsant/nerve pill for the pain until the orthopedic surgeon discontinues.  The pain has subsided tremendously, but my right arm is still weak.  My daughter and I noticed that this incident regarding my arm happened in the arm in which I took the vaccine.
Increased redness swelling at vaccine site. Site hot to touch swelling from vaccine site to elbow.
No adverse effects reported; the patient received a dose of PEDVAXIB instead of MENACTRA today; This spontaneous report was received from a medical assistant concerning to a 17-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 09-OCT-2019 (reported as today), the patient received 1 dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (route of administration and anatomical location were not reported) (lot# R027320, expiration date: 08-JUL-2021) for prophylaxis instead of a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (wrong product administered); nevertheless, it was not a product confusion. No adverse effects and no product quality complaints were reported.
When administering the vaccine, I felt that I was pushing the plunger longer than usual, making  me wonder if I drew up a higher volume into the syringe than I was supposed to, but do not know for sure. The only volumes I draw up into syringes are 0.3ml (pfizer) 0.5ml (moderna) and 1.8ml (NS when reconstituting pfizer). As I was doing multiple vaccines around the same time, it is possible that I drew up 1.8mls of moderna. I do not know that this is the case, and the only information I have to go on is that the plunger felt fuller than normal during administration.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot #L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.