chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 03/29/2005pm - developed 102 degree Fahrenheit fever with sore muscles. Took ibuprofen every 4 hours. On 03/30/2005, temp in AM was 98.6, PM temp was 100 degrees. Took ibuprofen. Denies local reation or symptoms of anaphalyxis. Referred to PMD for evaluation refuses, agrees only if condition worsens.
Shortly after shingles vaccine administered by nurse, I felt like I was going to faint. Started to blackout, blood pressure dropped, became clammy and pale, sweaty. Had to lie down, nurses came and then doctor. Had to rest for awhile until my counts went back to normal. They did an ECG before I was allowed to leave. I did not eat breakfast before coming to see doctor, but the reaction was so fast and immediate, I feel that it was the shingles vaccine.
At 1422 on 22Feb2008, pt was brought to the treatment room with c/o tightness in throat in obvious distress. 1mg of Epinephrin inj 1:1000 amp given IM to pt. Respiratory treatment of O2 face mask. Peripheral IV Catheter placed on pt. At 1430, pt states relief, airway improved, calm, no acute distress. At 1550, symptoms resolved and pt released.
Redness and swelling of entire upper arm and extending slightly below elbow. Began the morning of 12/13/18 upon awakening. Advised cold compress, antihistamine oral and topical OTC corticosteroid.
Patient was inadvertently sprayed with FLUMIST on (R) side of face and possibly (R) eye when student was attempting to deliver intranasal mist in (R) nostril. Eye was immediately flushed with eye rinse by RN. No swelling or redness noted before or after eye rinsing. Both nostrils effectively sprayed with FLUMIST by RN. No irritation of eye when client left clinic around 10AM.
The covid vaccine designated for ages 5-11 year olds was given to a 4 year old.  One day later this child has no symptoms related to this vaccine.
runny nose; chest congestion; severe sore throat; headache; body temperature of 99.8 Fahrenheit; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Consumer via Media Information (under reference- 00824391) and transmitted to Sanofi on 22-Oct-2021.  This case involves a 67-year-old male patient who experienced runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion), headache and body temperature of 99.8 Fahrenheit (Pyrexia) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 12-Oct-2021, the patient received a 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date in Oct-2021 the patient developed non-serious runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion) and body temperature of 99.8 Fahrenheit (Pyrexia) (on 3rd day after shot) and headache (5th or 6th day after shot) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 99.8 Fahrenheit  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test negative - On 20-Oct-2021: Negative  The patient was treated with paracetamol (tylenol) for Headache and performed steam inhalation and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At the time of report, patient was recovering from Oropharyngeal pain and outcome of other events was unknown.  There will be no information available on the batch number for this case.
Surface blood clots in right leg, shin to thigh, causing severe pain and swelling for several weeks. Was initially treated as an infection and given antibiotics, which were discontinued after 3 weeks.
Patient was given a MENVEO but her minimum age did not qualify her to have this vaccine at time of administration.
Generalized tonic clonic seizure 11/12/17. 2 minutes of BUE contraction with extension of BLE and shaking head up and eyes rolled up. Post ictal 10-15 min. Menses 2 day prior. Second episode 01/01/19 20 min into a nap had 1-2  minutes of similar activity., post ictal 30 min. Some sleep deprivation,  menses 3 days later.
Patient received on 2/21/23 a Menquadfi on left deltoid and a Bexsero on the right deltoid. The next day she had mild tenderness on both arms. On 2/26/23-2/28/23. She had more pain on right deltoid. No erythema or warmth at time of visit and no fever. Her left deltoid felt fine at this visit of 2/28/23. She has taken Motrin with no relief. No redness or swelling of right deltoid but is tender to palpation, no bruising.
Started with pain at the right shoulder (SHINGRIX injection), headache, later developed into chills, body aches. The site of the SHINGRIX injection was much more painful than the TDAP. The SHINGRIX injection hurt even when standing still, with no pressure on my shoulder. I had abdominal pain and thought I was going to have diarrhea, but nothing happened, just the pain. Bowel movement the next day was normal.
Mom noticed blood in stool 3 times in the evening of the day the pt received the ROTATEQ vaccine.
Reaction started with soreness and by day 2, there was significant redness and swelling. The redness continued to increase to cover much of my upper arm. I was scheduled to see my primary care doctor on day three anyway, so I used OTC antihistamines and steroid cream until then.
p/vax last of 4 immun pt became limp & unresponsive-vital signs WNL 02 sat 98-became responsive in 1-2min;
Patient's daughter reported to pharmacy that patient was experiencing fever (101.7F), vomiting, congestion, chills, headache, swollen glands, and general body aches that started somewhere around 12 hours after vaccine was administered.
Breakthrough case admission; event occurred after 3rd vaccine 3/8/21 Moderna Lot# 045A21A 4/15/21 Moderna Lot # 044B21A 12/22/21 Moderna Lot#067H21A
Pt came to pharmacy and said his arm was red and swollen. He was breathing normal. Also, complained of itching on arm. Tx = ice pak throughout day plus hydrocortisone 1% cream. Allergic to BENADRYL.
Headache; Brain fog; Stomach cramps; Diarrhea; Chills; This is a spontaneous report from a contactable consumer. This consumer reported for 59-year-old male patient (age at vaccination: 59 Years) received a dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient had headache, brain fog, stomach cramps, diarrhea, and chills which was started 24 hours after vaccination on 27Feb2021. The patient did not receive any treatment for the adverse events. The reporter responded to the query that the reporter became aware of the occurrence on 01Mar2021. The reporter was not the patient in this case and the patient was not a Pfizer colleague. Outcome of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 83 year old female patient with pertinent medical history, drug allergies and concomitant medication unspecified by reporter. On 20-MAY-2015 (also reported as 20-MAY-2016), the patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number L006381 and expiration date 25-MAY-2016). On 21-MAY-2015, 24 hours following the administration of ZOSTAVAX, the patient experienced a localized injection site reaction that consisted of swelling, and the red itchy rash. There was no treatment given to the patient for the events. Patient's lab diagnostics studies were reported as unspecified. The outcomes of the events were not reported. The patient sought medical attention (she was seen at the pharmacy). The relatedness between the events and the ZOSTAVAX therapy was not reported. Additional information has been requested.
Patient required hospitalization due to breakthrough infection. He received Moderna vaccine (2nd dose in series) on 04/21/21. Hospitalized from 08/16/21 - 08/21/21. Below is copied from discharge summary:   Acute metabolic encephalopathy on admission: resolved - GCS scale WNL - CT head wo acute process but with chronic WM changes - Ammonia WNL - TSH WNL - Haldol IV prn for agitation - last dose 8/18/2021 - no restrains - STR accepted   Complicated UTI Urinary retention with chronic Foley: - BP 88/50s initially but now WNL s/p 1L IV fluids - CBC WBL - UA with positive LE; prior cultures review but no bacteria identified - BC x 2 no growth - U/C: Staph 1K colonies, Yeast not candida albicans 18 K colonies - CT A/P with no acute GI process - Vancomycin, Cipro empirically given while inpatient   Atypical PNA COVID 19 pneumonia - Non septic - normal O2 sats at room air - Chest Xray with possible PNA - CT A/P showed possible atypical infection; recent hospitalization this month - COVID test negative - MRSA surveillance not taken - CT chest results reviewed - Duo nebs prn - Contact/ Droplet precautions    Infected sacral ulcer present on admission: - unstageable - continue Vancomycin and Cipro empirically - CT A/P did not showed any bone erosions - Continue Vancomycin, Cipro and Flagyl empirically - Generale surgery signed off 8/20/2021 - s/p I+D 8/19/2021, no wound culture available - Hydrocodone prn for pain - ID consulted - wound care:  Daily wet to dry dressing changes by nursing and WCT' - Infectious Diseases recommendations noted , case discussed: augmentin + linezolid x 4 weeks - monitor CBC weekly while on linezolid   AKI on CKD AKI resolved -Cr 1.6 > 0.98 -Likely med induced -IV fluids given -Renally dose meds   Macrocytic anemia/ Hematuria: - hemoglobin stable 9.3 -UA with hematuria, no blood seen on foley -CT A/P wo masses   Hypernatremia: resolved -145 > 139   Hypomagnesemia - 1.4 - replaced   Atelectasis: - EZPAP   Hx of HTN/ Hypotension: - BP soft s/p IV fluids - Hold amlodipine 5,  HCTZ and Losartan (normotensive): re start as outpatient as needed / indicated   Morbid Obesity, BMI of>40: -would benefit from lifestyles modifications regarding low fat diet, weight loss and daily excercise -F/U OPD with PCP   Chronic Afib on pacemaker: - On Pradaxa  - SCDs - re start carvedilol 25 mg BID - Interrogate pacemaker - IV Metoprolol prn   Chronic pain s/p lumbar fusion, inmobility: - Resume hydrocodone and gabapentin when feasible - Morphine Iv prn for pain - Hold amitryptiline due to AMS   BPH/ urinary retention: - Resume flomax and terazosin  - Foley in place   HLD: - Resume rosuvastatin when feasible   Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever of 102F, muscle aches and had a syncopal episode.
Digestive distress, nausea vomiting, prolonged  dizziness, lightheadedness, shaking, malaise.  Lab results continually look normal, no problem ever found but symptoms persist. Been to ER and urgent care several times but no answers for symptoms ever found. ENT said it could be vestibular related.
Within 3 minutes of receiving vaccines, pt developed red rash, right eye, cheek, right leg, right foot with urticarial lesions plus indurations. Zero drooling, zero resp distress. Benadryl given and within 20 min decreased erythema and itching.
Narrative: COVID infection following COVID vaccine series 01/21, Modena, dose #1 02/19, Moderna , dose #2 08/04 COVID swab, result: detected 08/01 pt cc: cough, fatigue, fever, rhinorrhea, congestion exposure: unknow 08/01-08/12 pt's symptoms continued 08/12 SARS-COV-2 Variant Sequencing results: pending
Information has been received from a nurse practitioner concerning a 69 year old female with osteoporosis, labile blood pressure, hyperlipidemia and a history of breast cancer who on 04-JUN-2007 was vaccinated IM (previously reported as SC) in the left arm with a first dose of Zostavax (Oka/Merck) (lot #657675/0618U).  Concomitant therapy included AROMASIN. There was no acute illness at the time of vaccination. On approximately 08-JUN-2007 the patient experienced back pain.  On 14-JUN-2007 the patient developed 5 red lesions on her left lower back, with dermatomal distribution.  No other symptoms were noted. Medical attention was sought, the patient was treated with FAMVIR and VICODIN. There were no labs performed. On 15-JUN-2007 the patient was recovering. On 13-JUL-2007 the patient recovered. There was no product quality control complaint involved. Additional information has been requested.  Additional information is not expected.
No additional AEs reported; administration of vaccines involved in a temperature excursion; This spontaneous report was received from a medical assistant referring to a 1-year-old female patient.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 16-FEB-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U024090, expiration date 28-OCT-2023, intramuscular in the left arm for prophylaxis (dose and vaccination scheme frequency were reported as "1") (product storage error).         The vaccine was stored in a temperature of 1.35 degree Celsius for1 hour as recorded by a data logger. There was no previous temperature excursion reported.  This is one of three reports received from the same reporter.
Body aches, swollen area in left arm pit, elevated temperature, exhaustion.  Elevated temperature resolved on 3/28/2021 but other symptoms continue at this time
Patient suffered chest pain and then passed out. She was taken to a hospital and held for observation for 3 days. She describes a battery of tests with negative results.
Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration, administered in left arm on 17Mar2021 at 15:45 (at 50 years old) as Single dose for COVID-19 immunization.  There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There were no medical history and concomitant medications. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath which continued from 19Mar2021 to 30Mar2021. Start date of the events was reported as on 17Mar2021 at 18:00. No treatment received for the events. Outcome of the events was not recovered.  Information about Lot/Batch number was requested.
sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient).   This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
Started feeling very fatigued about 9:30 pm.  took a nap until 12:30 a.m., got up to finish a work project and went to bed at 1:30 a.m.  Felt very achy overnight and woke up with a 102 fever.  Tood Advil at 7:30 a.m., was feelign better by 11 am
got the shot and then got shingles/Suspected vaccination failure; got the shot and then got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient got the Shingles shot and got shingles. The patient was not happy. The reporter said everybody was different no one can be guaranteed of anything. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Red circular irritated vaccine lump at injection site approximately 1 week after  Mild lymph node to axillary area tenderness   MILD symptoms
Received rabies injection 03 20 07 waited 15 minutes in center for reaction-was ok. Went home felt dizzy and vomited slight amount of phlegm. Lay down and went to sleep for 1 hour upon awakening felt fine no nausea or dizziness present.
This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (exact dose, route, loot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
one day after receiving the second dose of the modern vaccine I began to have intermittent pain in the heart
15-18 cm sized red, swollen area around injection site on left deltoid where Tdap was given. Tx - comfort measures.
CHRONIC PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number was not reported Per procedure, no follow up will be requested for this case and expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination.  Concomitant medications included ibuprofen for drug used for unknown indication. On an unspecified date, the subject experienced chronic pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chronic pain was not reported. This report was non-serious.
Conceived approximately  4 days after obtaining booster. Miscarriage determined around approximately 6 weeks later.
Dizzy/lightheaded; Legs also hurt when she bends; Arms hurt from the shot; chills; body aches; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache).   At the time of the report, DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      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.
localized swelling, redness, warm to touch, knot x7 days (still continues)
Lip tingling 5 minutes after injection Metallic taste and headache 8 hours after vaccine: increase in lips tingling, peri-orbital tingling, throat itching, burning, roof of mouth burning, decreased swallow sensation, heart palpitations, fatigue 1/13 Fatigue, weakness, decreased swallow sensation, phone call with physician 1/14 Fatigue, weak, decreased swallow sensation, heart palpitations 1/15 Diarrhea, weakness, fatigue, decreased swallow sensation, phone call with physician's office 1/16-1/18 Weakness, fatigue, decreased swallow sensation
Passed out; blood pressure bottomed out; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Fc3183), administered in the left arm on 11Sep2021 at 16:00 (at the age of 53-years-old) at dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were reported as none; no other vaccine in four weeks and no other medications in two weeks. The patient passed out and blood pressure bottomed out on 13Sep2021 at 05:00. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was unknown.   Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected.