chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling ranges from shoulder all the way to the elbow on an unspecified date. It was reported that the patient had the vaccination five days ago on an unspecified date and she still had a really big swelling that was not subsiding. Outcome of the event was not recovered. The reporter's opinion of causality between the event and the suspect drug was related.
Redness; Vaccination site reaction; puffiness; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (Redness), VACCINATION SITE REACTION (Vaccination site reaction) and SWELLING (puffiness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ERYTHEMA (Redness), VACCINATION SITE REACTION (Vaccination site reaction) and SWELLING (puffiness). At the time of the report, ERYTHEMA (Redness) and SWELLING (puffiness) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment or concomitant medication was reported
A consumer report has been received. The report concerns a, male consumer, who had been receiving FLUMIST, 0.2 Millilitres, unknown. Concomitant medications included Measles, Mumps and Rubella vaccine and vaccines. The patient experienced sniffed and threw up. The outcome of sniffed and threw up is unknown. The report was considered to be non-serious.
The patient's mother complained of patient experiencing vomiting and diarrhea.  Stool also had blood present.  Pt also had anorexia, fatigue and fever.
Patient has migraine and did not take medication this morning. Brought to EMS room for a quieter environment. Patient given 2nd vaccine in EMS room. patient became nauseated. Laid patient down. Cold pack and water given. Patient stayed in EMS room for approximately 45 minutes. Patient felt okay to leave once 45 minutes passed.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277148, 2018SA278731 and 2018SA278737. This case involves 17 years male patient who received vaccine IPOL lot number not reported via unknown route in the left deltoid (expiry date and dose not reported) on 28-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that stability of IPOL after the temperature elevated for 3 days to 46.6 Fahrenheit and 48 Fahrenheit. The caller reports that 4 IPOL vaccines were given. It was reported that no reactions were 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 Directive and Module VI of the 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.
HALO VISION; HORRIBLE FEELING; COUGH; FAST HEARTBEAT; FEVER; FATIGUED/EXHAUSTED; THROAT TIGHTNESS; DIZZY; FEELS PRESSURE INTERMITTENTLY; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced chest tightness. On MAY-2021, the subject experienced feels pressure intermittently. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. On 21-MAY-2021, the subject experienced throat tightness. On 21-MAY-2021, the subject experienced dizzy. On 21-MAY-2021, the subject experienced fatigued/exhausted. On 22-MAY-2021, the subject experienced fast heartbeat. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) Fast. On 23-MAY-2021, the subject experienced cough. On 27-MAY-2021, the subject experienced halo vision. On 27-MAY-2021, the subject experienced horrible feeling. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fast heartbeat on 22-MAY-2021, and feels pressure intermittently on 23-MAY-2021, had not recovered from cough, and dizzy, and the outcome of chest tightness, halo vision, throat tightness, fever, fatigued/exhausted and horrible feeling was not reported. This report was non-serious.
Death.  EMS called to residence 9 hours later for cardiac arrest. Pt pronounced at Emergency Room.  Pt sent to ME office for autopsy.
pt recv vax & devel full blown chickenpox w/approx 50 lesions on face, nose, abd, back & legs;pt devel T99.2 & abd discomfort;
Information has been received from a physician concerning a 8 year old male who on 04-FEB-2003 was vaccinated with the first dose of MMR II. On 22-MAR-2006, the patient was vaccinated with the second dose of MMR II. On 02-DEC-2009 the patient experienced mumps. It was diagnosed on 15-DEC-2009 that the patient had left parotitis. The patient experienced fever which was 101 degree F. On 15-DEC-2009, the first blood work revealed that IgM was less than 1:10, IgG was 7.04, and serum amylase was 73. At the time of this report, the patient's outcome was not reported. Follow-up information was received from the physician indicating that on 03-JAN-2010, the 11 (previously reported as 8) year old patient developed mumps. On 05-JAN-2010, it was diagnosed that the patient had right parotitis. On 05-JAN-2010, the first blood work revealed that IgM was less than 1:10, IgG was 8.13, and serum amylase was 545. No further information is available.
Swelling in her fingers; Tingling in left hand (ulnar distribution); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left hand (ulnar distribution)) and PERIPHERAL SWELLING (Swelling in her fingers) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (Patient had bad reaction to this vaccine.). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (MIBELAS 24 FE) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-May-2021, the patient experienced PARAESTHESIA (Tingling in left hand (ulnar distribution)). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her fingers). At the time of the report, PARAESTHESIA (Tingling in left hand (ulnar distribution)) and PERIPHERAL SWELLING (Swelling in her fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-209168 (Patient Link).
Systemic allergic reaction, hives on upper & lower arms, legs, & back within a few minutes of receiving vaccines.
Red, swollen, warm, and tight skin. Started a few hours after injection and has continued and gotten worse over the last 2 days. 1/30/19 at 11:10am - received injection. 1/30/19 at 9pm - site was red, 1/31/19 at 9pm  - site was red, warm and swollen. 2/1/19 at 10am - his school nurse called and concerned about his arm. It is still red, warm, and swollen. Nurse requested me to contact his doctor's office.
Adult staff experienced feeling dizzy & nauseated after receiving H1N1 at school flu clinic. Assessment: BP 120/60, RR=18, HR=84. No SOB, wheezing, itching swelling or hives. Rested for 15 minutes, reported feeling better. Returned to class at 9:30am.
Generalized macular papular rash in the trunk region 6 hours after administration of KINRIX & PROQUAD and Influenza.
Initial attempt to administer vaccine in LA was unsuccessful due to vaccine leaking from syringe. Second attempt to vaccinate performed by clinical instructor Dr. and was successful in administering full dose in RA.
I began experiencing tinnitus for the first time approximately 2 weeks after the second does of the Pfizer vaccine. I now experience tinnitus several times a week. I have no other circumstances or medical variables that I know of surrounding this sudden onset of tinnitus other than the vaccine.
Complete loss of menstrual cycle and severe period like cramps daily. Confirmed not pregnant. Onset at the time of vaccine.
May 1, 2021, Patient was admitted to the hospital with Blood clots in both lungs. The hospital is unable to figure out what has caused the blood clots. We do not know if this is related to the vaccine but would like to know if it is.
I had my vaccination in 09/2022. I started to have increase in sinus swelling around 11/2022. I had a lot of stress in my life during this time. I saw an ENT but they didn't notice the swelling. I was prescribed medication which reduced the swelling. I was scheduled for Turbinate surgery in 02/2023 but due to anxiety I decided to not go through with the surgery.
I felt well for the 8-9 hours after the shot, around 8pm that  evening, a headache and mild fever started.   By 1am, fever, chills, increased headache, severe joint pain were in full swing, muscle almost felt like they were on fire.  Even rolling over in bed HURT.  Fever got as high as 101.8 (I usually am around 97.6 or so).  Symptoms started to abate by mid morning, but I was essentially useless until that evening.  By May 6, I felt like I had a really bad hangover all day, then was mostly recovered by that evening.  It is now May 9.  I have a long history of knee/arthritis pain, and am generally a rather active person, but since the second dose, my knee pain as well as my hands to a large degree, have been extraordinarily sore and painful.  My knees in particular, while the symptoms were really peaking, I experienced some very acute,atypical pains a couple times in both knees that seem to keep recurring 2-3 times per day, as well as exacerbated, continual soreness and general pain when I am active.
patient came to our Offsite even and she is not mobile so one of our vaccinator Dr adminstered while she was in the car and when we try to complete the check out we realize that she was one week earlier then she was suppose to get her second dose, ( last was on 02/13/2021) patient has not reported any side effects
Patient states within 15 to 20 minutes after receiving vaccine and leaving pharmacy he noticed a blood floater spot which appeared in his left eye. Patient made appointment and saw his eye doctor who didn't do anything for his eye. The doctor stated the blood would eventually drain, but it was hard to say if the floater would resolve.
Employee stated that she experienced nausea, projectile vomiting, diarrhea, headache, chills, and spinal stiffness, along with hives all over body which lasted about 2.5 days. These symptoms began a few hours after the injection.  The injection was given 11-7-02, reported to me 11-26-02.  She states that she has taken Motrin and Benadryl for the symptoms
Diahrrea - lasted day 2, 3, 4 Body Aches - lasted day 2, 3, 4 Blurred Vision - day 1 Confusion - day 1 Tightness of chest - night 1, 2, 3, 4 Gasping for air - shortness of breath - night 2, 3
T101-102.8, despite APAP on nite of 21JUN91; On 22JUN91, low grade fever w/light rash, awoke fr nap, covered head to toe w/rash; t101; Seen in ER; Tx APAP & DPH; r/o measles;
Patient was admitted in Hospital on 11/14/2016 and released on 11/16/2016 with a diagnosis Guillain-Barre syndrome resulting in weakness of both legs.
pt recv vax 3PM 30MAY95 sore Tuesday evening; by Wed morning 31MAY95 pt couldn't move arm w/small red raised area; by evening on 31MAY area inc to 1/2" 1JUN; arm has been swollen; c/o chilling, sweating & body aches, joint pain
After I had my second Covid vaccine, I experienced amenorrhea.  My doctor had advised that this was being reported by women and research showed my menstural cycle should return to normal within a few months but I have not had a menstural cycle since.  Menopause age for maternal side ranges from 56-62 (mother, grandmother and great grandmother) and no other illnesses were identified.
Bleeding vaginally for 30+ days; Dizziness; Disorientation; Loss of Appetite and extreme weight loss; Headaches;                                                                  Your form does not allow reports for non-vaccinated people who are affected by vaccinated people.  The patient information at the beginning of this form does not allow for text fields to explain this type of adverse effect.
No adverse s/s given Menactra instead of Menomune discovered because charges not covered no problems
Redness, warmth, pain at injection site (1.5 inches wide, 4 inches in length). No treatment used.
Muscle pain, tiredness, headache, shivering, fever, and upset stomach for about 48 hour so far; getting, taking TYLENOL.
Information has been received from a healthcare worker (medical assistant) concerning unspecified number of patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 20-APR-2016 the patients received improperly stored doses of ROTATEQ (dosage not provided, lot # L035510 with expire date of 13-MAY-2017). The temperature of storage excursed to was 32.5F for 7 hours and 38 minutes. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Left deltoid very red, hot, edematous and measuring approximately 6x4cm. The site was painful to the touch for several days. The area was hard with skin intact. Very difficult to sleep for 4 nights.
Elevated heartrate (approx. 120 bpm) for duration of approx 30 minutes; elevated blood pressure (150/90)
Pt presented with large red area around injection site. Pt states reaction does not itch. "No rash-like". Advised pt to contact PCP.
1:12pm - called to parking lot for this patient c/o rash and hot.  When arrived at patients vehicle, patient is alert and oriented.  States that she is having an itchy rash on chest and feels like she is burning up.  No distress noted at this time.  Patient reports that she spoke with her allergist and she was recommended to take a benadryl and xanax before vaccine, which she reports she took right before she came to park.  1:15pm BP 200/90, Pulse 100.  Patient reports she has high blood pressure and did take BP med this am.  Patient then reports that her throat is feeling tight and burning.  Patient is talking fine and no distress noted.  Patient reports she has her own epi pen but doesn't feel like she needs to use it at this point.  1:17pm - called 911.  1:20pm - patient still feels the same, but doesn't feel like she needs her epi pen.  1:29pm - ambulance arrived.  All info given to EMT.  Patient requesting that she wants to go to ER to be evaluated.  Patient walked to ambulance and left to go to ER.
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Arm pain developed throughout the day starting 4 hours post vaccination administration. That pain then spread to my upper back alongside a mild headache. I was otherwise well until 12.5 hours post the vaccine where I developed fever and debilitating chills which went on for the remainder of the night. I had full body aches and immense pain in my arm, and kind of a stiffness all over my body accompanied by fatigue which may just be due to the lack of restful sleep I obtained. I also had a loss of appetite. I took 2 advil the next moring and felt better within 2 hours and regained my appetite. The sweating from what I presume to be fever still hadn't subsided nor had the chills. I would say within 36 hours all that remains is mild arm pain.
Patient states that he was in excruciating pain in his right should area the day after his vaccination.  His primary care physician was unable to get him to evaluate, so he went to Emergency Room.  Patient states that he was given an injection at the hospital that was meant to relieve the pain.  Patient states he is still in a lot of pain after the injury.  I directed the patient to continue to seek treatment since his pain is still persisting. Patient was hesitant to seek further treatment.
Swollen lymph nodes under left armpit, right arm pit; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm  on 10Mar2021 at 12:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to formaldehyde. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN) for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 21:30, the patient experienced swollen lymph nodes under left arm pit, right arm pit and neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures was 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 swollen lymph nodes under left arm pit, right arm pit and neck was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
elevated temp, sz approx 830PM, taken to Er spinal tap? results, inc pheno Barbital & returned home 2nd sz approx 2AM, t105.4;
Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer and physician, via a memo and medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000365), concerning a 6-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-APR-2008 and 31-OCT-2008, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as HBV) (dose, route of vaccination, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).On the same day (31-OCT-2008), the subject was also vaccinated with diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL).  The pt's vaccines also included diphtheria, tetanus, acellular pertussis, hepatitis b, polio (dTAP-HBV-POL) administered on 20-JUN-2008 and 29-AUG-2008; haemophilus influenzae b (HIB) vaccine administered 20-JUN-2008, 30-JAN-2009 and 06-AUG-2009; diphtheria, tetanus, pertussis (DTaP) vaccine administered on 29-APR-2009; measles, mumps, rubella (MMR) vaccine administered on 29-APR-2009 and 09-AUG-2012; hepatitis A vaccine (HAV) administered on 29-APR-2009 and 06-NOV-2009; pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered on 30-APR-2010; influenza (INF) vaccine administered on 17-OCT-2011, 22-SEP-2012, 21-DEC-2013 and 15-NOV-2014; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) administered on 09-AUG-2012; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT) administered on 11-OCT-2015; influenza vaccine inact sag 3v (FLUVIRIN) administered on 11-NOV-2016; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered on 25-JUL-2017 and 25-JAN-2018; meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) administered on 28-NOV-2017 and influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) administered on 27-OCT-2017 and 26-OCT-2018.  This is one of the three reports concerning the same patient.; Sender's Comments:  US-009507513-2303USA000365: US-009507513-2307USA001584: