chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brief fainting spell and jerking x once observed. Pt. fell on floor after receiving vaccine. States he did not hit his head on chair that he fell against & states no other injuries. Pt. allowed to lay down in exam room x 45 min. Pt. states he also had blurry vision. No other complaints voiced.
pt inadvertently recvd 2 doses DTP along w/single dose OPV; w/in 24 hrs devel fever approx 100; inject site was warm to touch; pt had abnormal gait for 24 hrs following vax felt by MD to be due to sore inject site;
During the course of the evening of 10/20/21.  The patient's mother called the provider after hours to report it.   The patient began to develop a rash on the right buttocks' and lower back.  Patient denied fever.  No burning around the rash or any drainage.  Patient denied any full body rash or any tingling around the mouth or lops or any difficult with shortness of breath or swallowing.  PA-C recommended they try Benadryl and call the office in the morning to set up an appointment if no resolution.  The following day the mother took the patient to the local ER department where he was evaluated.  The provider noted the rash on the buttock and back and now a spot on his right lower leg was developing.  At that time, the patient denied any pain, c/o mild itching.  Mother had given him Benadryl and applied Hydrocortisone cream to the affected area the night prior.  The patient started to complain of his lips tingling that morning which prompted her to bring to the ED.  C/o tiredness, and decreased appetite.  Denied fever, cough, SOB, rhinorrhea, abd pain, diarrhia, sore throat, or any urinary complaints.   Mother states the patient was ill a few weeks prior to the incident.  Mother also stated patient had ate recalled onions recently.  ED workup found mild leukopenia (WBC 3.13) and determined that rash was consistent with Herpes zoster, although patient had been vaccinated for chickenpox.  The patient was prescribed 1 g Valtrex BID for 10 days.   The patient followed up one week later with PA-C.  The rash was noted to be improvign.  No chest pain, no SOB, no fever, or increased rash at that time.
pt recv vax; 2 hr later, awoke screaming; mom states was not breathing when she went to him;pt's fingertips & toes were blue;mom rubbed pt's chest & he began breathing;to MD; was told had "shot collapse"; he was seen by PMD 27jun95;
Patient complained of chills and fever. Told to take Acetaminophen for fever... .
This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 23-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
On the morning after Flu shot 10/15/2019 I assisted my mother to the bathroom and her legs were very weak, somewhat buckling under her and I had to support her under her arms so she would not fall.  After using the bathroom she returned to bed and slept for 2-3 hours and then I assisted her to the bathroom again and her legs were very, very weak to the point they were not supporting her.  She slept till 1700 and I again assisted her to the bathroom again supporting her.  Given her age this type of episode has never occurred before, since I am her full time care giver. With all of this being said, the following morning she had no more leg weakness and to date no further issues with leg weakness.
03/09/22 presents to Birth Center Triage for "SROM, ctx". PMHx of "Dysmenorrhea ,Dyspareunia, female"
Patienr received expired Fluzone Quad, no AE; Patient received Fluzone Quad while she was pregnant, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA301628 (same reporter).  This case involves a 32 years old female patient who was vaccinated with expired dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUZONE QUADRIVALENT while she was pregnant at 17 weeks of pregnancy, during second pregnancy trimester.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was reported as 03-Jul-2019.  The estimated due date is 08-Apr-2020.  The delivery type, birth type and fetal outcome were unknown.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at a dose of 0.5 ml lot QFAA1816 via unknown route in unknown administration site.  Other relevant tests not reported.    The event outcome was reported as not applicable for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
VERY MILD rash of petechia blood spots on inner calves and arms 48 hr after shot. (Rash looks like tiny freckles or razor burn, maybe 3 doz small spots the size of a pin head to pen mark); This is a spontaneous report from a contactable consumer, the patient. A 40-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 16Apr2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder, HLA-B27 tested, ocular iritis, not in flare, not on steroids this year, history of borderline iron deficiency anemia and low Vitamin D. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included plantago ovata (PSYLLIUM), multivitamin (MANUFACTURER UNKNOWN) and vitamin d nos (VIT D); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received lidocaine hydrochloride (LIDOCAINE) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 16:00, 48 hours after shot, the patient experienced very mild rash of petechia blood spots on inner calves and arms. Rash looked like tiny freckles or razor burn, maybe 3 dots, small spots the size of a pin head to pen mark. The patient's pulse/breathing/temperature seemed okay. The patient had put in call to consult regular doctor and would go to ER if needed. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very mild rash of petechia blood spots on inner calves and arms was unknown 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.
Body aches, Headache; Treatment: Ibuprofen, Outcome: Complete resolution of symptoms
Numbness of right side of face right arm along with odd radiating sensations right arm and right leg.
Mother reports child reporting itching as soon as she got into car. Went to PCP. Dx Allergic urticaria - Given prednisolone PO and BENADRYL PO.
Patient returned to health center on 11/29/07 one day after receiving 6 month vaccines plus Flu vaccine.  All sites of administration with erythema and induration; Left thigh with greater degree of symptoms. Also fever since 4 am. Insertion sites less than one inch apart.  Cool compresses and gentle massage ordered to sites, along with body temperature monitoring.
May 17 2022 called primary doctor reporting coughing, short breath, chest pain May 22 2022 coughed with blood, visited ER result diagnosed with pulmonary embolism and found 2 nodules in lung. started blood thinner.  June 10 2022 PetCT showed abnormal disease in lung, brain, bone, liver and lymphatic system. June  15-18 2022 stayed in hospital, took liver biopsy, MRI, ultrasound and all the other tests. lab results showed Lung Adenocarcinoma. implanted IVC filter. July 2 2022 started brain radiation treatment and chemotherapy July 15 2022 started targeted medicine
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 90-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 24Oct2021 - 27Oct2021. Date the vial was initially stored in the refrigerator is24-Sept-2021.
Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness  Localized pain and swelling at injection site
BREAKTHROUGH VAGINAL BLEEDING: 10/8/21, 11/2/21, 11/5/21
metallic taste, tongue tingling and numbness began within minutes and numbness took the longest to resolve--hours
Pt started feeling that his face felt funny and was swelling approx 8-9 days after 2nd dose of covid vaccine, On Tuesday 9/7/2021 he went to PCP office for a decadron shot. Wed 9/8/2021 he had lost all ability to blink the right eye, he had facial drooping right side along with drooping of the right eyebrow, mouth, cheek and forehead. He was seen in the ER 9/9/21 and diagnosed with  Bells Palsy. He was given Valacyclovir, methyl prednisone, and saline eye drops in the ER.
Episode of tremors X approx. 30 sec and c/o light headedness, Immediately subsided when placed in Trendelenburg. Then got up in chair smiling and talking.
Initial vasovagal, about 12 hours later developed "extreme fatigue and weakness". "Somewhat improved" 12 days later.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-JUL-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 1026AA, expiration date 30-JUN-2013) (dose and route not reported). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Extreme fatigue, headaches (low grade but persistent), triceps of arm swollen almost as large as biceps. Area of shot is about 4 inches long, red, warm and tender to the touch for about 2 weeks. This was the 4th shot and the worst reaction. Lymph nodes on back of head swollen for several months. Also, joint and finger pain.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's current conditions or medical history were not reported. On 06-NOV-2014, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 10 Y (dose and route not reported) lot number J014312, expiration date 07-SEP-2014. The patient had not demonstrated or reported any adverse effects. Additional information has been requested.
injection site pain, Chills, body aches, fever (101-deg F), tiredness, diarrhea
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. On an unknown date reported as "shortly after" receiving the ZOSTAVAX vaccine, the patient developed a rash, accompanied by pain and blisters, with the pain remaining after the rash and blisters subsided. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Rash, accompanied by pain and blisters was considered to be disabling. Additional information has been requested.
Swollen Lip; Itchiness ( Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lip) and VACCINATION SITE PRURITUS (Itchiness ( Injection Site)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LIP SWELLING (Swollen Lip) and VACCINATION SITE PRURITUS (Itchiness ( Injection Site)). At the time of the report, LIP SWELLING (Swollen Lip) and VACCINATION SITE PRURITUS (Itchiness ( Injection Site)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment information not provided
the whole area is a big patch that is red and feels hot; The area where I had the shot started to itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The area where I had the shot started to itch) and VACCINATION SITE ERYTHEMA (the whole area is a big patch that is red and feels hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (The area where I had the shot started to itch). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the whole area is a big patch that is red and feels hot). At the time of the report, VACCINATION SITE PRURITUS (The area where I had the shot started to itch) outcome was unknown and VACCINATION SITE ERYTHEMA (the whole area is a big patch that is red and feels hot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Symptom began around 10 am. Had strong fatigue that caused me to feel exhausted. Around 3:45 the symptom went away and I was back to normal. Arm was sore for about 5 days.
Sudden strange cold feeling. Feeling of pins and needles on tongue and lips. Occurred about 1 hr. after the shot. Responded to diphenhydramine.
Vaccine exposure during pregnancy with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 36-years-old female patient who was exposed to influenza quadrival A-B vaccine [Fluzone Quadrivalent] during pregnancy with no reported adverse event.  The date of last menstrual period was reported as 18-Jul-2023. The estimated due date is 28-Apr-2024. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On 14-Sep-2023, the patient received unknown Dose 1 of suspect influenza quadrival A-B vaccine, suspension for injection (batch number: UT8040NA; expiry date unknown) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) during pregnancy with no reported adverse event (exposure during pregnancy) (same day latency).  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
I started having symptoms around 01/10/2023. I noticed primarily in the sole of my right foot where the toes meet with the foot. The symptoms that I was having numbness, tingling, feeling of hotness around the toes. I would switch shoes but that did not help. It was not constant but I noticed it when I was walking around in my job. That seemed to exacerbate it. I went ahead and lived with it for a while and tried some different shoes. Eventually, I went to see my PCP in February and told him about it. I was off work for about a week to give it some rest. I did some research and made some appointments with some specialists. The first I saw was a podiatrist and I saw her on 02/23/2023. I told her everything and we also initiated physical therapy as well. My PCP put me on the gabapentin to help with the pain. He started me out at a very low dose which I'm still on right now. Up to this point, the condition doesn't seem to have gotten worse or better. I notice it intermittently. So it's not always there. It seems to be exacerbated when I'm on my feet for a long period of time or walking around a lot. I've talked to my medical staff at work and I'm supposed to be on reduced duty. That's up to me to enforce. In the mean time, I've been doing PT twice weekly and prescribed stretches/exercises that are supposed to help with this condition. My PT had noted Morton's neuroma which is a condition where in the area there can be an aggravated nerve. I talked to my physicians and noted that the pain is sometimes in my left foot as well in the same area. They noted sometimes there's a natural thing called compensatory symptoms. That's something that had been thrown out as a possibility. When I saw the podiatrist, she said that my shoes were too small. She noted it was possible that this could have led to the Morton's neuroma. I went ahead and purchased new shoes for work and home. The condition hasn't gotten better yet. The condition could have also been building over time. I'm trying to give it time. I just saw the neurologist and I told him all the symptoms and he said I have idiopathic peripheral neuropathy and further testing is needed. I may also need a skin biopsy in the future depending on testing that I need to get done soon. If it's Morton's neuroma, then I believe it can get better over time with physical therapy and shoe changes. But if the neurologist is correct, it's concerning because we are unsure of how this came to be.
Herpes Zoster in a vaccinated individual. Painful unilateral rash lasting less than 4 weeks. Unknown if treatment was given.
pt started screaming 45min p/shots cry x 3hr;rash started 45min p/shot on stomach, back & face;t101.4 x few hr;hives started a few hr p/screaming;hives started again 2 days later;family MD saw pt later said hives maybe assoc w/apnea machine
Rash on thighs arms and finally trunk. Consisted on small red dots. No itching. Faded after about 10 days
Itchy Blister rash on upper abdomen area right side, right hip, under upper left arm, lower left leg , right thumb, right side of back - one tender bump
Itchy palms, face and feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy palms, face and feet) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sarcoidosis (for nine years.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy palms, face and feet). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy palms, face and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Patients symptoms were at extreme on 23 Feb 2021.   Reporter did not allow further contact
nausea, h/a, redness & induration @ inj site;18mm in diameter induration h/a but afeb
Cellulitis - secondary to PNEUMOVAX 23 & FLUVIRIN 2011-2012 formula.
p/vax pt devel malaise, sore joints, particular back so sore couldn't bend over to tie shoes;unable to walk w/o pain & had to severely restrict activities;
Approximately  8 hours after injection nonconfluent erythematous rash along majority of left upper arm surrounding injection site - mild itch
bladder cancer; This case was reported by a consumer via call center representative and described the occurrence of bladder cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several days after receiving Shingrix, the patient experienced bladder cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the bladder cancer was not recovered/not resolved.   It was unknown if the reporter considered the bladder cancer to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments: The caller was the patient stating that she got her first Shingrix vaccine in November 2021.  The patient states that shortly after the vaccine, she was diagnosed with bladder cancer. The patient had not received 2nd dose yet due to chemo treatment but does plan on getting the second vaccine. The patient declined to give any further demographic information.  The reporter did not consent to follow up. Additional supportive information: Note: The 2nd dose was not coded due to medical reason.