chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 28-APR-2014 was vaccinated with PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
A week after receiving the vaccine I noticed a large oval shaped redness around the vaccination site. It is extremely itchy. The swelling and soreness I initially experienced had mostly gone away by this time. I have not applied any medications to the site due to not knowing if I should. I have not visited a doctors office, clinic or emergency room due to not having health insurance. The doctor I listed as the one to contact is who gave me the vaccine. The red ring as remained all day and has not been getting better so far.
retrospective review showed that pt was not 18 years old at the time immunization was given.  Parent was contacted (father). Parent stated that he did not see any adverse reactions out of the norm for a flu shot. Parent also stated pt is close to 300 lbs and would be fine.
Patient received first dose of Moderna, within 3 minutes while sitting  for post-observation. Patient's head went back as if he was falling asleep, but  he began making gurgling noises and his eyes rolled to the back of his head.  Helped him slide him down out of the chair, so he would not hit his head or fall.  Once on the floor the patient began seizing. After a sternum rub, the patient raised up and was helped back into the chair.  He was sweating  and flushed.  He was able to answer questions as we awaited the EMT to arrive.
Within 10 minute of injection, my face was numb and I felt inebriated. My face began to burn for an hour as if it was a chemical burn. Afterwards my face started itching along with my left armpit
States she developed a temp of 101 on 6/9/11, felt achy and had lots of sweating.  States had mild rash to left lower forearm. States she felt weak, achy and sweating 6/10 & 6/11. States on Sunday 6/12 temp was 99-100 and achy and sweaty and weak and tongue was thick.  6/14 feels like she is weak and hot and not sweating today, but symptoms are improving.
9-year-old pt. received adult formulation of Pfizer COVID vaccine. Pt had a rash on her buttocks later that day.
Approximately 5-6 after the injection I became disoriented.  Didn?t know where I was.   10 hours after the injection part of my body was in pain.  I have neuropathy so I know what pain is and this felt 10 times worse.  I was extremely tired and just wanted to sleep but couldn?t.  About 12 hours after the injection I lost muscle control in my entire body.  Everything on my body was shaking and actually had involuntary muscle spasms.  I finally was able to get to sleep and after approximately 16 hours the episode began to wane.  I rested the entire next day because my whole body was exhausted
Patient Complained of heart racing, chest pain and felt like his blood pressure was up. Patient was taken to the ER and returned to work in approx 2 hours and then sent home for feeling faint. fine the next day
Child cannot walk or get out of bed.  Took to hospital for severe leg pain.  Diagnosed with inflammatory response, and water on the hip.  Monitoring child closely
A non-serious spontaneous report of administration to seven-month-old was received from a registered nurse concerning a seven-month-old female patient who received H1N1. The patient's medical history included chronic constipation and concomitant medications included polyethylene glycol. The patient was given one capful OD in an 8-ounce bottle of juice, PO for the treatment of the patient's constipation. Since beginning this medication, no further bouts of constipation have occurred for this patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 10-Nov-2009 and incorporated into the narrative: which includes reporter information, patient's gender, patient's medical history, concomitant medication and its doses.
8/10/09: Rash (small) on the tummy. Went to clinic 8/13 was tested for mono: negative. 8/22/09 got worse: increased rash, increased fever, headache, fatigue, went to urgent care, one doctor said not chickenpox, the other doctor said chickenpox. Dry rash, no blister or fluid, 8/24/09 increased rash to quarter size. Will go to urgent care.
This case was reported by an consumer and described the occurrence of possible pertussis in a male child who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline for prophylaxis. The reported is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date in 2000 the subject received a dose of Infanrix (dose number not reported). On an unspecified date in 2006 on or before 06 October 2006, 6 years after vaccination with Infanrix, the subject experienced a possible pertussis infection and lack of effect. The subject was seen at a physician's office. The mother of the subject reported on 06 October 2006 that she was, "awaiting verification of lab results." The outcome of the event was not reported. Follow-up will not be available.
Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
experiencing digestive issues; Initial information received on 04-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (age unknown) who experienced digestive issues, while he/she received vaccine TYPHOID VACCINE ORAL.  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect TYPHOID VACCINE produced by unknown manufacturer lot number not reported via oral route.  On an unknown date, the patient developed a non-serious experiencing digestive issues (dyspepsia) with unknown latency following the administration of TYPHOID VACCINE.  Final diagnosis was experiencing digestive issues.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for experiencing digestive issues.  List of documents held by sender- none.
Arm pain-started within 8 hours of injection, worst at 24 hours after injection, subsided rapidly Chills - started 24 hours after injection, lasted for 4 hours Fatigue - started 24 hours after injection, lasted for 6 hours
Headache, fever, muscle pains,  unable to walk,  leg cramps,  blurred vision,  chills, skin sensitivity.
I am her mother reporting and also an RN.  She rarely complains of symptoms whenever I?ll.  C/O 12 hours post vaccination began feeling of throat closing- able to breath ok/safely but short of breath (O2 says 99% HR 60?s - WNL), feeling floaty and light- as if not on ground, body feels tingling and numb, difficulty sleeping, right pupil dilated greater than left but both pupils reacted to light appropriately with check.  Pupil over dilation one side resolved by next morning.  Other symptoms still continue.  Other SE?s are common: HA, low grade fever 100.9, body aches.  Currently 33.5 hours post vaccination at submission. Pfizer #1 on 4/30/21  Lot# EW0173 Pfizer #2 of 5/21/21. Lot# EW0187
86 y.o. year old female with h/o Hypertension, CAD, Bilateral Adrenal Gland removal with resultant Cushing's disease on chronic Prednisone. Pt was seen in PMD's office yesterday for a flu shot. At that time, the pt's PMD discontinued Norvasc secondary to pt having a low normal BP. Pt developed right arm pain and nausea later on in the evening and did not take her evening Prednisone dose or AM dose. Pt's family states that pt was "normal" yesterday and even prepared dinner for the family. Today, pt developed worsening nausea, diarrhea and felt weak. She initially declined going to the hospital but asked family to call 911 when she felt worse. In ER, pt was hypotensive and tachypneic and was intubated. Pt was hypothermic with profound hypotension despite 6 liters of fluid requiring pressors. She was placed on Dopamine and Levophed. Pt given a STAT dose of Hydrocortisone 100mg IVP x 1 and another liter of IVF. Pt also found to have ST depressions on EKG and Cardiology was also consulted. Transferred to ICU for further management.
Delayed onset (8 days) injection site induration and itching along with joint pain and myalgias, Resolved 3 days later.
Patient seen in office for routine office visit and requesting a COVID vaccine booster.  He reported that he didn't want the "new booster" and wanted the "old one".  The nurse tried to reassure the him that the Pfizer Bivalent booster was the correct one to receive that day, but he declined the Bivalent.  The nurse didn't think to double check the new guidelines and administered the Pfizer monovalent vaccine instead.  The patient did not experience an adverse reaction to the 3rd monovalent dose, and the administering nurse was reeducated about current vaccine scheduling and administering guidelines.
I immediately felt tingling that traveled down to my fingers of my left arm and hand after receiving the modern COVID-19 vaccination. I felt some numbness at the site of injection immediately after. I told the nurse or medical providers at the facility and they told me to sign up forvsafe.cdc.gov to monitor my symptoms.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling felt in cranium\r\n
On 8/10/01, the vaccinee received a left deltoid dose of Infanrix and an IM 0.5ml dose of IPOL; the vaccinee had received an unspecified number of previous doses of Infanrix. Subsequently, the vaccinee developed a 5-6cm lump in diameter at the injection site which was more diffuse than a palpable mass. It did not extend to the joints. It was "slightly enlarged". The lump was hot to touch. The injection site was painful and the the pain was confined to the injection site. The vaccinee had no fever. There was diffuse erythema not confined to the injection site. The swelling resolved in 5 days after being treated with ice and observed. No drugs were used to treat the adverse event. The vaccinee was treated by a physician. The reporter stated that the adverse events were moderate in severity and were related to Infanrix. The adverse events resolved on 8/16/01. As of 8/28/01, the adverse events had resolved.
7/15-7/20 85y.o. female presenting with altered mental status. She has known advanced Alzheimer's disease, and was found to be COVID-positive upon presentation. She did not have any indication of viral pneumonia or hypoxia and thus did not require any COVID directed treatments. She was managed supportively, given IV hydration. Of note, she did have asymptomatic bradycardia as demonstrated on TMS. She was recommended for eventual 2D echocardiogram once cleared from COVID isolation. Patient's mental status improved, however not completely back to previous baseline. There was an element of suspected delirium. Determined that she would be best served at home. She was otherwise medically stable.
Patient had TDaP on 1-20-10. She called the office on 1-27-10 with complaint of painful (R) upper arm. Some redness at site and warm to touch. Provider looked at and circled area. Patient came back next day and increased redness area 4 1/2 x 2 3/4 red swollen put on antibiotic KEFLEX 500 mg IID elevation and heat.
hives inner aspect of rt elbow & lt wrist;took DPH & resolved by 27JUN96;
This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. In approximately April 2014, about a year ago, one year after the first dose of GARDASIL given approximately in April 2013, the patient was vaccinated with the second dose of GARDASIL (dose: 0.5 ml, intramuscularly, lot number and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
No other adverse events reported.; Caller reports that doses of improperly stored vaccines were administered to patients. Additional adverse events 02189027, 02189036, 02189037, 02189038, 02189039 and 02189040 were filed. No further information provided. No other adverse events report; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown gender and age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUN-2022, the patient was vaccinated with one dose of improperly stored hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, lot #U026792, expiration date: 28-OCT-2022 (both confirmed to be valid), administered for prophylaxis (strength, route and site of administration were not provided) (product storage error). The vaccine was exposed to 47.17 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. There were no other adverse events reported.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2206USA006061: US-009507513-2206USA006116: US-009507513-2206USA006096: US-009507513-2206USA006272: US-009507513-2206USA006141:
Blood shot eyes; Pus/white stuff from eyes; Clear water pouring from eyes; Swelling of eyes; Right side neck stiffness; Lights hurt eyes; Nauseated; Headache; Fatigue / Exhaustion; Sleeping 14 hours; Left arm soreness; Sweats; Sleeping 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours) and OCULAR HYPERAEMIA (Blood shot eyes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0481321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Flu shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Tetanus: Tetanus shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Pneumococcal infection: Pneumococcal (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down). Past adverse reactions to the above products included Headache with Flu shot, Pneumococcal and Tetanus shot. Concomitant products included FEXOFENADINE HCL for Seasonal allergy, VALPROATE SEMISODIUM (DEPAKOTE), SERTRALINE HYDROCHLORIDE (ZOLOFT) and CLONAZEPAM for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats) and SOMNOLENCE (Sleeping 16 hours). On 21-Apr-2021, the patient experienced SOMNOLENCE (Sleeping 14 hours). On 22-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Blood shot eyes), EYE DISCHARGE (Pus/white stuff from eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 20-Apr-2021 for Pain in arm, at an unspecified dose and frequency. On 22-Apr-2021, EYE DISCHARGE (Pus/white stuff from eyes) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours), OCULAR HYPERAEMIA (Blood shot eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On April 17th developed pain in BL arms and feet..4/19-calling her pcp tomorrow and if any worsening will go to the ED tonight
Aching at the location where shot given; could not raise arm; applied heating pad & took Advil; next day aching stopped; following day could raise arm a little.
received booster and is under 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received booster and is under 18 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received booster and is under 18 years old). On 21-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received booster and is under 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.~ Treatment information was not provided.
**Kinrix (Dtap was the 5th dose & IPV was the 4th dose)**  The following Sx started about 10 minutes after vaccines were given: Patient started c/o eye pain (like sun was in his eyes), his mother then noted his eyes were red and lids were puffy, his nose was swollen and lips were swollen,  Patient was starting to wheeze when they returned to our office.    He was speaking and swallowing  normally no stridor, Lungs Normal effects but he has diffuse wheeze.    TREATMENT: Mother had given 37.5mg of Diphenhydramine before returning to our office, No resp distress.  Patient was given a FULL dose of albuterol nub.
This spontaneous report as received from a female patient of unknown age. On 15-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot number and frequency unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date in March 2014 the patient experienced slight itch at the injection site. The outcome of slight itch at the injection site was reported as recovered. The action taken with the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Information has been received from a consumer, a female physician, who was vaccinated with on an unspecified date with a dose of Zostavax (Oka/Merck) by another physician. Subsequently, one day after the vaccination the patient developed a hematoma and swelling at the injection site. The second day after the vaccination, she had a high fever and chills. Unspecified medical attention was sought. She took an unspecified medicine for the fever. After a couple of days, the patient recovered. This is one of several reports received from the physician. Additional information has been requested.
fever of 104 x 5-6 staring 1 or 2 p/vax;malaise;pt did not seek med attention but reported for hep B 3 vax 21MAR97;immun deferred;
PT STATED THAT THE FINGERS ON HER RIGHT HAND FELT COLD AND NUMB AFTER RECEIVING MODERNA.  SHE REPORTED THIS DURING THE 15 MINUTES OBSERVATION PERIOD POST INJECTION. SHE SAID SHE HAD NO OTHER ISSUES/SYMPTOMS/SIGNS
"My arm started itching and a rash developed around my arm, face and became hot and red." Given IV Medrol, IV Benadryl.
Administration error. During vaccine administration, PFIZER's COVID-19 vaccine was administered instead of the influenza vaccine (FLUCELVAX QUAD PF INJ) Two doses of MODERNA had previously been administered. PFIZER's vaccine would be the third in the series of COVID-19.
Feel slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area; Feel slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included vitamins nos, minerals nos, nutrients nos (OLLY WOMENS MULTIVITAMIN). On 21Apr2021 at 15:45, 15 minutes after the first dose, the patient felt slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area. It was reported that two hours after the injection the symptoms were only improved slightly and the patient did not experience any other symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The patient's breathing and blood pressure were normal. The clinical outcome of the events feel slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt told administrator before shot that shots made him anxious. When administering the shot, he started having a little bit of clamminess. Immediately after the shot, he vomited several times into  a bag he had brought. No syncope. Pt left before proper discharge. He was called and reported he was feeling fine and denied further symptoms. Precautions given.
7 x 7 cm raised erythematous plaque at vaccination site in R arm after 24 hrs.
24 hours after vaccines, she developed redness, swelling and pain. States more fever, possible hives. Pt advised to come to office but she chooses not to.
Left arm swollen from deltoid to just above elbow. Swelling moderate area warm to touch.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had a fainting episode after experiencing dizziness around 11:45 AM.  Patient was alert after episode and stated he had experienced some anxiety during today's vaccine.  Has experienced vomiting secondary to anxiety s/p vaccination in the past.  BP 110/65, HR 84 a few minutes after incident.  Patient is in care of parents and walking under his own power.