chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a clinical lead refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-MAY-2018, the patient was inadvertently vaccinated with both PROQUAD lot # N025719, expiration date 17-MAR-2019 (dose and route of administration were not reported) and VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). No adverse effects were reported in the patient at  time of the report.
missed their menstrual cycle after their second shot of their COVID 19 vaccine.; This is a spontaneous report from a contactable Pfizer colleague and a contactable Nurse reported for three adolescent female patients. This is 2nd of 3 reports.  An adolescent non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was unknown whether the patient was diagnosed with Covid prior to vaccination or was tested for COVID-19 post vaccination. On an unspecified date, after second shot of Covid-19 vaccine the patient missed her menstrual cycle. It was unknown if the patient receives any treatment in response to the event. The outcome of the event was not resolved.  The lot number for [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202100929375 Same reporter/drug/AE, different patient;-PFIZER INC-202100930371 Same reporter/drug/AE, different patient
INITIALLY PT DEVELOPED REDNESS BEHIND EARS ON THE MORNING AFTER PER MOM.  PT WENT TO DAYCARE AND DAYCARE CALLED MOM TO PICK UP CHILD B/C HE WAS DEVELOPING A RASH.  CHILD WAS BROUGHT INTO CLINIC AND DR SAW CHILD.  CHILD HAD RASH ON CHEST AND EXTREMITIES.
started w/fever climbing to 105.7 even p/5 doses of APAP 4 hrs apart; taken to ER & told to cont w/APAP inc fluids; 22AUG92 pt still w/fever of 103; taken to family MD;
4 hours after injection felt like I had Covid coming back on me. Felt sever headache, elevated temperature, chills flurry vision.  Lack of appetite.  Just general malaise?. Laid on couch after taking Tylenol Extra Strength 2 tablets and napped.
I experienced stabbing pain in the right kidney for ten days. The pain level for the first three days was about a seven. The injection site from the vaccine was sore for a couple of weeks. At a three month point I had lipoma. I got the lipoma on my shoulder removed September 30,2021. I have a another lipoma that needs to be removed but it will not be removed because it is close to my arteries.
3-4 days after receiving the vaccine, the pt developed a baseball sized swelling (approximately 20cm in diameter). The swelling took 21 days to resolve. The pt also reported swelling and pain in the joint especially in toes and fingers. This lasted for 10 days. Pt went to a Dr and aspirated the swelling site and no uric acid crystals were found. The swelling occurred at the injection site.
no additional AE reported; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a healthcare business professional (HBP) and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 06-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, 1 dose, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 5.7 Fahrenheit (F) for a time frame of 0 hour 30 minutes and 0 second. Additional prior excursion include 6 F up to 14 F (10 F) for 1 hour 8 minutes 0 second (on 18-JUL-2022). Previous temperature excursion included 6 F up to to 14 F (9.1 F) for 1 hour 6 minutes and 0 second.   No additional adverse event (AE) information was reported.
1st: 5 minutes after I felt flush and had an elevated heart rate & blood pressure which usually runs low. The following two days I had sensitivity to light and louder sound, as well as, some nausea when slightly physically active.  Fatigue for about 3 days and a swollen lymph node from day 3-7 after injection. Also soreness at injection site for 2-3 days.  2nd: No immediately reaction like last time. This time more covid like symptoms: fatigue, sore throat, and a minor cough with phlegm. Although I did notice some irritability for 2-3 days following the injection.
After receiving first does of Moderna vaccine , patient became lightheaded and nauseous - symptoms resolved after patient placed briefly in Trendelenburg and  drank 16 ounces of water , ate bag of chips. Patient was discharged form vaccination site with mother , symptom free
fast heart rate; arm numbness; tingling; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart rate), HYPOAESTHESIA (arm numbness) and PARAESTHESIA (tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-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 HEART RATE INCREASED (fast heart rate), HYPOAESTHESIA (arm numbness) and PARAESTHESIA (tingling). At the time of the report, HEART RATE INCREASED (fast heart rate), HYPOAESTHESIA (arm numbness) and PARAESTHESIA (tingling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report was received from a nurse referring to an 18 year old female patient. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient received a dose of injectable GARDASIL 9 for prophylaxis (lot # M044717 with expiration date on 19-JUL-2019) (strength, dose, frequency, route of administration and anatomical location were not reported). On 03-JUN-2017, the patient woke up and noticed red itchy bumps around her neck and under the arm. Moreover, it was reported that one of the bumps under her arm was painful. On the same date, the patient's mother called the doctor to report the experience. The patient's mother had given her BENADRYL to treat the itchy red bumps. At the time of reporting, the patient had not recovered from the events. The relationship between the events and the vaccination with GARDASIL 9 was not provided. Additional information has been requested.
Chills, fever, stomach pains, back pain, leg pain, severe redness, swelling of arm. Severe pain in arm - inability to raise etc.
Approximately 8 hours after the vaccine the child was noted to have a crying spell followed by a limp and pale episode of one minute duration.  No stiffness or tonic clonic activity.  Patient was taken to local ED.  A CBC and CXR was obtained.  Child was observed for several hours and discharged with diagnosis of possible reflux event.  Seizure was considered but felt unlikely.
lt arm w/hard area which surrounds inj site;stiffness in lt shoulder up to neck & all the way down into elbow, then pass elbow ok but index finger large joint hurts;no lymph node involvement noted;can't pick up arm past shoulder;fever;
Pruritis, severe red "blotchy" raised spots (hives?) covering right arm from injection site down to elbow, rhinitis, followed by COPD exacerbation on 10/9/15.
It hurts; Size of a dime; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (It hurts) and VACCINATION SITE SWELLING (Size of a dime) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 002A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (It hurts) and VACCINATION SITE SWELLING (Size of a dime). At the time of the report, VACCINATION SITE PAIN (It hurts) and VACCINATION SITE SWELLING (Size of a dime) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2021-416089 (Patient Link).
pt recv vax 5MAY98 & 12MAY98 pt devel Henoch-Schonlein purpura & was hosp & reported stable;
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a adult patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a reaction to a previous DTaP vaccine. The patient described the reaction as a severe anaphylactic reaction. No additional details were available. The reporter consented to follow up.
Patient feels slight tingling sensation on posterior neck, and slight tinglingsensation on L hand.   Vitals: 116/69 BP 84 bpm 18 cpm 97% RA  #21 pt. stable and sent home
After receiving my second dose of the Moderna vaccine, I initially felt extremely sick for at least two weeks. Symptoms included cough, sore throat, fever, extreme body muscle and joint pain, nausea/dry heaves, increased frequency and severity of headaches, major fatigue/exhaustion.  2 months later, I?m still  experiencing symptoms that are interfering with my life. However, I am/have been hesitant to discuss this with my primary care physician; I feel that because of my age, I?m not taken seriously.
Patient hospitalized Hospital Admission Diagnoses: Severe sepsis (CMS/HCC) [A41.9, R65.20] Discharge Diagnosis: Patient Active Problem List Diagnosis Date Noted  *Elevated troponin 03/30/2021  *B12 deficiency 03/30/2021  *Acute systolic heart failure (CMS/HCC) 03/25/2021 Discharge Diagnoses: Patient Active Problem List Diagnosis Date Noted  *Elevated troponin 03/30/2021  *B12 deficiency 03/30/2021  *Acute systolic heart failure (CMS/HCC) 03/25/2021  *Acute respiratory failure with hypoxia (CMS/HCC) 03/24/2021  *Acute pulmonary edema (CMS/HCC) 03/24/2021  *IVH (Intraventricular hemorrhage) (CMS/HCC) 06/06/2018  *Brain edema (CMS/HCC) 06/06/2018  *Brain compression (CMS/HCC) 06/06/2018  *Benign essential HTN  *Coronary artery disease * Type 2 diabetes mellitus with hemoglobin A1c goal of less than 7.0% (CMS/HCC)  *Nontraumatic right thalamic hemorrhage (HCC) 06/05/2018  Consults:  IP CONSULT TO PULMONOLOGY IP CONSULT TO CARDIOLOGY INPATIENT CONSULT TO PHARMACY INPATIENT CONSULT TO PHARMACY IP CONSULT TO NUTRITION SERVICES IP CONSULT TO NUTRITION SERVICES Procedures:  Intubation Catheterization  Significant Diagnostic Studies: Cardiac Catheterization
Sore arm; 2 days  Insomnia; 1 night (the night the vaccine was received)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Nov2023 to 09Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370233 Same patient/same product, different dose/event;
Had reaction 18 min after vaccination. Flushing and rash on upper chest, neck and face.  Tingling in whole body. Throat "felt funny", but only noted after 25 mg of Benadryl.  Symptoms resolved within 10 minutes - chest was clear, HR was normal on exam - slight erythema on upper chest and cheeks, no lip swelling.  Oropharynx was clear.
Fever (low-grade to 101°) started July 11 and has persisted through today, July 15.  Persistent dry cough.  Sinus pressure and headache.  Diarrhea started today, July 15.
Constant Sneezing and moderate nasal drainage started about 7.5 hours after she had 2nd Moderna Covid-19 vaccination as well as has had fatigue
It started the next day, I had dizziness, fatigue, lower back pain, lower pelvic pain, soreness, nausea, chills and low grade fever. I had all of the flu like symptoms. Am not a person that gets sick, so I know that it was from the vaccine. My pain in my lower pelvic area was like if I was coming on my menstrual, my reproductive area was hurting me very bad. I have a IUD and I haven't had a cycle in three years. So, I don't have a cycle or do I have any of those symptoms.
the throat closes; lumps all over my body; fillers were bursting/fillers from 10 months or a year ago filled up; hives on her scalp; rash; hives; lips are swelling; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), LIP SWELLING (lips are swelling), OROPHARYNGEAL DISCOMFORT (the throat closes), SKIN MASS (lumps all over my body) and DERMAL FILLER OVERCORRECTION (fillers were bursting/fillers from 10 months or a year ago filled up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Genioplasty (Patient had chin implant from 25 years ago) and Breast implant user (Patient had silicone breast implants). Previously administered products included for Product used for unknown indication: Botox (Patient had Botox about 7 months ago) and Restylane. Concomitant products included STEROIDS, HYALURONIC ACID (JUVEDERM VOLUMA) and HYALURONIC ACID, LIDOCAINE (JUVEDERM ULTRA PLUS) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced URTICARIA (hives) and RASH (rash). On 22-Jan-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (the throat closes), SKIN MASS (lumps all over my body), DERMAL FILLER OVERCORRECTION (fillers were bursting/fillers from 10 months or a year ago filled up) and URTICARIA (hives on her scalp). On an unknown date, the patient experienced LIP SWELLING (lips are swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous) at a dose of 125 milligram; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (oral) at an unspecified dose and frequency; LORATADINE for Antihistamine therapy, at a dose of 10 milligram twice a day; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), LIP SWELLING (lips are swelling), OROPHARYNGEAL DISCOMFORT (the throat closes), SKIN MASS (lumps all over my body), DERMAL FILLER OVERCORRECTION (fillers were bursting/fillers from 10 months or a year ago filled up), URTICARIA (hives on her scalp) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: Additional events added.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-AUG-2017, the patient was inadvertently received second dose of PROQUAD (lot # M004897, expiry date: 26-JUL-2017) (route: subcutaneous) that was past its expiration date (inappropriate schedule of vaccine administration). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
This medically confirmed literature report (initial receipt 23-Feb-2016) concerns a male patient. On an unknown date, the patient received an influenza vaccine (brand, batch number and route unspecified) for indication not provided. On an unknown date following vaccination, the patient developed GB syndrome from which he died. The outcome was reported as fatal. Linked to case: 2016059460 (same reporter). Reporter's Comments: Reporter comments: n/a. Sender's Comments: Company's evaluation and comment: Seriousness criterion/criteria: Fatal outcome. Listedness: Unlisted. Brand of Influenza vaccine not provided. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCDS and the Afluria Product Information, GBS is unlisted due to the fatal outcome. Company Causality: Unassessable. Temporal relationship could not be established. GBS is a known class effect of Influenza vaccine in general and is mediated by immune attack on peripheral nerve myelin. Risk factors include upper respiratory, infections, (40% of cases) and or preceding diarrheal illness due to campylobacter infection (20%). The outcome is usually complete recovery over weeks to months however fatal outcome is due to autonomic disturbances resulting in cardiac arrest being the most common cause, in 20-30% of deaths. Due to missing information causality is unassessable.
severe cervicle neck pain for 3 weeks including radiculapathy  severe headache inter cranial pressure for 2 weeks non stop pressure in head and different parts of the brain due to elevation swollen lymph nodes left side of face correlates to vax in left arm swollen face and neck  fluid filled ears and pressure & mastoid bone pressure  neasua due to constant feeling of unsteadiness dizziness & vertigo for 7 weeks     tingling in each section of brain electrical shock sensations weakness in arms legs hands  severe fatigue and malaise  lingering severe brain fog  peripheral vision blurriness constant tunnel vision spine pain to middle spine after neck pain stopped chest bone pain and tightness  heart pressure and pain  random joint pain weakness tingling in hands and legs and head stomach discomfort  diarrhea for 6 weeks and soft stool ringing in ears occasionally  arachnoid cyst found where grinding & neck pain originated radiating into back of head and severe headaches to entire  brain or different sections at random
On 7/11/2021 patient became hypoxic with oxygen saturation of 83% requiring supplemental oxygen.  Did not improve and on 7/14/2021 and was sent to the hospital.  She was diagnosed with bilateral pulmonary embolus and was found to be in A flutter with RVR.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 02Apr2021 as dose 2, single (Lot number: ER8734) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 30Aug2023 to 04Sep2023.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported) No concomitant medications were reported. No adverse effect and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on an unknown dates which lasted 100, 96, 24 and 24 hours with lowest recorded temperatures of 34 F (reported as 1.111111111 Celsius degrees), -1 F (also reported as -1 Celsius degree), 32 F (report as 0 Celsius degrees) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Large (>15cm) erythema/edema/tenderness of skin, duration >48 hours
Pounding rapid heart rate approximately 11 hours after getting the vaccine and lasted about 4 hours.  Onset was at the time of onset of chills and fatigue.  Next day I felt better but just very tired. The same thing (rapid heart rate) happened after my second dose. However, with the second dose I didn?t get the sever chills like I did with the third dose.  The side effect of concern is the heart rate not the chills though.  I did not notice being short of breath after either dose. Just pounding (loud) rapid heart rate for hours despite resting and breathing regularly.