chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had light flow; I had continual spotting ranging in color; Abnormal Menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Jul2021 (Lot number: EW0181) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos Syndrome", start date: 26Jan1999 (ongoing), notes: Illness/AE: Ehlers-Danlos Syndrome, Onset Date: Birth, Stop Date (check box if ongoing): ongoing; "Idiopathic Urticaria" (ongoing), notes: Reason for Use: Idiopathic Urticaria, Route: Oral, Start Date: 2018, Check box if ongoing: (Checked); "Pain" (ongoing), notes: Reason for Use: Pain, Route: Oral, Start Date: 2021, Check box if ongoing: (Checked); "GERD" (ongoing), notes: Reason for Use: GERD, Route: Oral, Start Date: 2020, Check box if ongoing: (Checked). Concomitant medication(s) included: SINGULAIR taken for idiopathic urticaria, start date: 2018 (ongoing); MELOXICAM taken for pain, start date: 2021 (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Anatomical Site of injection : Right Deltoid, Batch/Lot number - FA6780, Route of administration: Intramuscular, Date: 02Jul2021, Site and Route of injection, Anatomical Site of injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: FA6780), administration date: 02Jul2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 20Aug2021, outcome "not recovered", described as "Abnormal Menstrual cycle"; INTERMENSTRUAL BLEEDING (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "I had continual spotting ranging in color"; MENSTRUAL DISORDER (non-serious) with onset 06Sep2021, outcome "recovered" (09Sep2021), described as "I had light flow". The event "abnormal menstrual cycle" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: From 20Aug - 23Aug Patient had an abnormal period where she was only shedding the lining without much blood. 28Aug - 05Sep she had continual spotting ranging in color. From 06Sep - 09Sep she had light flow. From 10Sep - 22Sep she had continual spotting ranging in color from bright red to black. she had not had a normal period since 02Oct2021. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Prior Vaccination was reported None. VACCINATION FACILITY TYPE reported as Pharmacy or Drug Store. FAMILY MEDICAL HISTORY RELEVANT TO AE(S) reported as None  Follow-up attempts are completed. No further information is expected.
A 45 years old patient received FLUZONE QUADRIVALENT HIGH-DOSE with no reported adverse event; A 45 years old patient received FLUZONE QUADRIVALENT HIGH-DOSE with no reported adverse event; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via  Media Information (under reference 00824871) in the .  This case is linked to cases 2021SA356620 and 2021SA355376 (same reporter).  This case involves a 45 years old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  On 22-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Total, lot UJ769AA and expiration date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose (same day latency).  It was reported "Pharmacist states that today, during a flu-shot clinic, 3 of the patients who received FLUZONE QUADRIVALENT HIGH-DOSE, after attesting to be less than 65 years of age, were found to be younger. Two of the women were 60 and one was 45 years old. Caller asking what should be done."  At time of reporting, 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient developed ataxic gait determined to be Guillan-Barre syndrome. Was treated with course of IVIg with improvement but not resolution.
Admitted for COVID pna. Fully vaccinated. Rocephin, zithromax, O2. Discharged to SNF with hospice due to lung cancer.
no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JAN-2019 the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, 1 dose, lot # R020678 expiration date: 15-JAN-2020, (frequency and route of administration were not reported).  The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported.  The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003435: US-009507513-1904USA003434: US-009507513-1904USA003436:
Patient presented to the ED and was subsequently hospitalized for abdominal pain, vomiting r/t acute diverticulitis within 6 weeks of receiving COVID vaccination.
Information has been received from an investigator concerning an 8 month old male with reflux, eczema and reactive airways disease and a history of negative endoscopy and colonoscopy at 2 months of age and viral gastrointestinal illness one week prior who was vaccinated PO with his second dose of ROTATEQ. This report was part of a post-marketing surveillance program. The patient experienced less than 24 hours of bilious vomiting, abdominal distention, abdominal pain and lethargy 45 days after vaccination and was hospitalized for 3 days (possible intussusception). Reduction with an enema was unsuccessful but the patient's symptoms were reduced via surgery. The patient was discharged from the hospital on day 3. The outcome was unknown at the time of this report. At this time, relationship of bilious vomiting, abdominal distention, abdominal pain and lethargy to study therapy is unknown. Bilious vomiting, abdominal distention, abdominal pain and lethargy were considered to be an other important medical events (surgery) by the reporter. Additional information has been requested.
Patient was experiencing fever (pt reported peak temp to be 100.7F), fatigue, malaise and aches.
Tremendous pain at injection site.  I had the pneumonia shot once before in 2010 with relatively little pain. The pain was unbearable. It lasted till today 09/14/2011 and the medication Dr prescribed helped a great deal.  The pain medication and other medications were Loritab, Meloxicam, and the equivalent of Claritin.
Septic arthritis L knee with MRSA after corticosteroid injection.  Presented with swelling, pain & hot joint 3 days after injection.  Required six weeks of IV Daptomycin and 4 weeks oral Rifampin and orthoscopic surgery to flush out knee.  Infection cleared 10/8/21 but continues on Bactrim.
INJECTION SITE PAIN; MOBILITY DECREASED. This report was received from GlaxoSmithKline for hepatitis B vaccine recombinant (ENGERIX-B) and was assigned manufacturer report number A0392993A. This was originally report by a physician's assistant concerning a 29-year old female who in October 2001, was vaccinated with the second dose of hepatitis b virus vaccine rHBsAg (yeast). Subsequently the patient experienced "mild", persistent, left arm pain. The pain was exacerbated by palpation and "specific movement of the arm." Concurrent conditions and current medications were unknown. In May 2002, the patient received the third dose of hepatitis b vaccine recombinant (ENGERIX-B) (lot #ENG5216A2) administered into the left deltoid. Subsequently, the patient experienced increased pain at the injection site. The patient was seen in the clinic. The pain was not located in the shoulder joint and the subject had full range of motion. However, the patient reported difficulty reaching into the back seat of her car. The pain persisted as of 14APR2003. The reporter considered the injection site pain to be possibly related to "scar tissue from injection". No further information is expected.
Fever/chills/fatigue/muscle & joint pain 2 days later developed itchy red rash at injection site
Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 27-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
1 day p/vax pt devel fever up to 103.8, joint pains, severe headache, back pain, & a very dry hard cough;
Information has been received from a 56 year old female with allergic to Sulfa and no relevant medical history who on 07-Oct-2008 was vaccinated with a first dose of GARDASIL,(lot number, injection site and route not reported). Concomitant therapy included hormone replacement therapy. In October 2008, also reported as a couple of weeks later, the patient experienced pain in her left arm where she received the vaccine. The patient reported that as the weeks went on she had pain in her arm to the point where she could not lift it up, but for now the pain subsided but had a "dull" ache. The patient called the doctor's office. At the time of this report, the patient's  events was recovering. No further information is available.
Right arm at vaccine sit, red, swollen, hot. Patient has chills and hot sweats.
p/vax pt swollen lymph nodes; pain; itchy; small pink blistered raised areas
AFTER VACCINE PATIENT HAD EXACERBATION OF MS. PATIENT WAS HOSPITALIZED FROM 2/3/10 TO 2/7/10.  HE IS RECEIVED OUTPATIENT SOLU MEDROL 500 MG Q12H THROUGH 2/8/10/.
a strain of blood came out of her arm; This is a spontaneous report from a Support. A contactable consumer reported that a female patient (reporter's wife) of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration on the arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after the injection of the Covid vaccine a strain of blood came out of her arm, about 6 inches. They put a bandaid on and the bleeding stopped, but the reporter wants to know if any of the vaccine came out and if that would be a problem. The outcome of the event was recovered.   Information about Batch/Lot number has been requested.
Elevated HR and Blood pressure. Chest tightness. Blood pressure 154/111, HR 154
On day 20 after 2nd dose I began to experience dizziness at 2PM that turned extreme being unable to stand or move without support followed by violent vomiting every 20 minutes for the next two hours.  The dizziness was in the form of visual spinning of all things in sight and/or the sense of body spinning with eyes closed.  Breathing remained full and thinking was not impaired.  Symptoms began to subside after 2-1/2 hours and normal feeling returned after 5-6 hours.  These events followed a modest lunch; however,  for the sake of elimination I had the same lunch ingredients 2 days later with no adverse reactions.
Patient fainted while doing IM COVID injection. RN called another staff to assist lowering patient to ground and elevating feet. Patient felt better after laying down. Nursing staff took vitals (supine), which were BP - 118/84, SPO2 - 97%, pulse - 48. Patient rested for a while, taking some deep breaths and putting an ice pack on the back of her neck. After approx. five minutes staff helped patient to a seated position and re-took vitals which were 122/80, SPO2 - 99%, pulse - 57. Patient drank some water and was observed for approx. 30 minutes following injection, stating she "felt better".
After vaccine given, second Public Health Nurse discovered variance of vial with remaining vaccine appeared too little for the number of doses that had been administered that morning.  It appeared that the vaccine administered to the child had not been diluted.  The guardian was notified.
2 months old child was only given half of the vaccine dose as DTaP-IPV & ActHIB were given separately with no reported adverse event; 2 months old child was only given half of the vaccine dose with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old patient of unknown gender who was only given half of the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] vaccine dose as DTaP-IPV & ActHIB were given separately with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date, the patient was only given half of the vaccine dose as DTaP-IPV & ActHIB were given separately with no reported adverse event (wrong technique in product usage process) (incorrect dose administered) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event wrong technique in product usage process and incorrect dose administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About 8 days after the vaccine, I felt a thousand "ants" crawling down on my right arm. I looked down on my arm and I saw little red dots popping up and disappearing from my shoulder to my fingers and then they disappeared. Then, the injection site/upper arm shoulder area became extremely swollen like the size of a softball. I ran to get some Benadryl and about 30 min after taking that it went down. It remained red and swollen and extremely sore to move/touch for about 3 days. I went to see my PCP and she dismissed it as a sore muscle. Then, when I went to see my orthopedic doctor, I got a shot (steroid) but it was the most excruciating pain and I had him stop. My arm is still sore and it mainly only hurts now when I lay on it/put pressure on it. If I lay on it when I sleep, I will bolt up out of my sleep and be in excruciating pain. I have an MRI scheduled for 12/29/2021 at 7:30pm and my doctor thinks maybe the rapid swelling tore a muscle.
Metallic taste in her mouth Itchiness to site, then progressed to whole body and back pain  Arm pain
Metallic taste, face flush, redness on cheeks, above eyes/forehead. Dizziness and stomach upset. Gave 25 mg Benadryl and observed for 45 minutes. Pt felt better, clearing of symptoms, returned to work.
This spontaneous report as received from a pharmacist via company representative refers to a male patient with no pertinent medical history. On an unknown date the patient was vaccinated with ZOSTAVAX injection (strength, dose, route, lot number and expiration date not provided). No concomitant medication was used. On an unknown date the patient developed a baseball size welt at the injection site that lasted 3 days. No treatment was given for adverse event. None of lab diagnostics was performed. The patient did not seek a medical attention. The outcome of baseball size welt at the injection site was reported as recovered/resolved. The relatedness between vaccination with ZOSTAVAX and baseball size welt at the injection site was not reported. Additional information has been requested.
Headache, NauseaVomiting, Chills, Fatigue, injection site soreness Narrative:
experienced: some localized itching at the site of the injection, but no hives, followed by more generalized itching (still no hives). Then I started to feel really congested and could feel quickly worsening sinus pressure, which put pressure in my ears, thus making me feel a little dizzy. But that was where things maxed out and it got better from there. I took a Zyrtec and Aleve and am mostly back to normal. Not sure if it was a reaction to the vaccine itself or something I was exposed to in the process. I do have some environmental allergies and sensitivities, so perhaps that was a factor.
Covid Rash and hives, for over 30 days. Elevated blood pressure and blood glucose levels ( when tested on meter regularly for 3 weeks since September 1st 2021).  Please call to discuss further.
Baby went limp and quiet after getting the shots. Examined vital signs are good. After 5 minutes became reactive to external stimuli such as flicking of toes, cool water to face.
Painful site of injection, swelling, reddening. Asthenia and overall body aches.
case was not feeling well and tested positive with home test and daughter called ambulance and case taken to hospital and admitted and tested positive there
Information has been received from a registered nurse concerning an approximate 8-year-old patient who on 01-FEB-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Patient received a COVID-19 vaccine on 07MAR21 @ 0830 and approximately 10 minutes later, she compained of an itchy rash on bilateral ankles.  She was evaluated by one of our nurse practitioners for an additional 30 minutes.  She was instructed to follow-up if her condition worsened.
09/13/22 presents to ED for "respiratory distress". PMHx of "PNA, COVID, pacemaker, diabetes"
This spontaneous report was received from a nurse and refers to a 31 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L023587, expiration date 26-JUN-2017, exact dose and route of administration were not reported). The vaccine was exposed to refrigeration temperature not exceeding 46F for 6 days. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
shingles; Ill-defined disorder; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 70 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 01-DEC-2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, Plaintiff was treated by healthcare provider in a healthcare facility for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related injuries. The outcome of the events was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
PFIZER MONOVALENT WAS GIVEN AS BOOSTER DOSE FOR PATIENT ON AUG 31, 2022.  FDA APPROVED PFIZER BIVALENT AS BOOSTER DOSE ON AUG 31, 2022 AND WE ARE UNWARE OF THE CHANGES.  PATIENT DIDN'T REPORT ANY SIDE EFFECTS. WE ARE REQUIRED BY PHARMACY TO REPORT THIS ERROR TO VAERS AND KEEP RECORD FOR 3 YEARS
This spontaneous report as received from a other health professional refers to a 13 month old patient. On 15-JUL-2014 the patient was vaccinated with MMR II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
No additional AEs; Caller reported expired MMR II was administered.; This spontaneous report was received from an office manager and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided     On 14-APR-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # U007686 and expiration date 09-MAR-2023, 0.5 milliliter, subcutaneously for prophylaxis (dose number was not provided) (expired product and no adverse event).
PATIENT WITH SYNCOPE EPISODE WITH TONIX POSTURE NOTED. PATIENT AROUSED TO VERAL STIMULATION POST EPISODE. VITAL SIGNS WERE 99/56, HEART RATE 63, RESPIRATIONS 20, OXYGEN 98%. CLEAR BILATERAL BREATH SOUNDS. NO INCREASE OF SHORTNESS OF BREATH NOTED. WATCH AN ADDITONAL 15 MINUTES.
Chills night of shot. Next morning (Wednesday)got chills, hot sweats, headache, fatigue, muscle cramps. Lack of appetite. Could not get out of bed. Thursday morning was fatigue with a bit of brain fog. Friday morning a bit still fatigued but not as bad. Saturday Brain still feels foggy.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. From an unspecified date, unspecified patients were vaccinated with 59 doses of improperly stored ROTATEQ (dose and frequency were not reported) (lot # K005396 and expiry date: 28-SEP-2016) since the excursion. No adverse effects reported. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1501USA005041 and 1501USA008492 (same reporter link). Additional information has been requested.